Final Clarification for Chemical Identification Describing Activated Phosphors for TSCA Inventory Purposes, 8266-8272 [2010-3675]
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Final Clarification for Chemical
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Identification Describing Activated
provided an EPA/DC badge that must be
Phosphors for TSCA Inventory
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Purposes
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
AGENCY: Environmental Protection
general information contact: Colby
Agency (EPA).
Lintner, Regulatory Coordinator,
ACTION: Final clarification.
Environmental Assistance Division
(7408M), Office of Pollution Prevention
SUMMARY: This is a clarification under
and Toxics, Environmental Protection
which certain activated phosphors that
are not on the Toxic Substances Control Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
Act (TSCA) section 8(b) Chemical
number: (202) 554–1404; e-mail address:
Substance Inventory (TSCA Inventory)
TSCA-Hotline@epa.gov.
will be considered to be new chemical
For technical information contact:
substances under TSCA section 5, and
David Schutz, Chemical Control
thus will be subject to applicable
Division (7405M), Office of Pollution
notification requirements under TSCA
Prevention and Toxics, Environmental
section 5. In certain letters and other
Protection Agency, 1200 Pennsylvania
statements issued by EPA from 1978 to
2003, the Agency erroneously indicated Ave., NW., Washington, DC 20460–
0001; telephone number: (202) 564–
that activated phosphors (otherwise
9262; e-mail address: schutz.david
known as doped phosphors) constitute
@epa.gov.
mixtures of phosphors and dopants for
purposes of the TSCA Inventory, and
SUPPLEMENTARY INFORMATION:
thus that they were not separately
reportable as chemical substances under I. Does this Action Apply to Me?
TSCA section 5(a) new chemical
You may be affected by this action if
notification requirements. This
you are, or may in the future be, a
clarification is necessary because EPA’s manufacturer or importer of an activated
statements in this area have not been
phosphor that requires submission of a
consistent.
premanufacture notification (PMN) or
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exemption request under TSCA section
5. Special procedures will apply to
persons who manufactured these
chemical substances after the
publication of the Initial TSCA
Inventory and before the effective date
of this 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.
II. Background
A. What Action is the Agency Taking?
EPA is clarifying that certain previous
EPA statements which indicated that
activated phosphors are mixtures rather
than chemical substances in their own
right were erroneous, and that TSCA
Inventory listing may be required for
these materials. This action provides a
clarification in the approach used for
the chemical identification of activated
(doped) phosphors for purposes of
listing on the TSCA Inventory. This
clarification was proposed in the
Federal Register issue of January 16,
2008 (73 FR 2854) (FRL–8131–8) and a
reopening of comments on the proposed
clarification was announced in the
Federal Register issue of May 2, 2008
(73 FR 24187) (FRL–8360–7).
An 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 substances as
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yttrium, europium, germanium, gallium,
strontium, antimony, manganese, or
magnesium. When an activated
phosphor 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 (which
includes import) or processed for
commercial purposes in the United
States. This inventory is known as the
TSCA Chemical Substance Inventory
(TSCA Inventory). EPA promulgated a
rule 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.
Building on several earlier interim
policies, EPA promulgated a rule in the
Federal Register issue of May 13, 1983
(48 FR 21722) setting forth procedures
for the submission, receipt, and health
and safety review of PMNs covering
chemical substances not yet in
commerce when required under TSCA
section 5, 15 U.S.C. 2604. Section
8(b)(1) of TSCA, 15 U.S.C. 2607(b)(1),
instructs EPA to add a PMN substance
to the TSCA Inventory as of the earliest
date on which it is manufactured or
processed in the United States.
Manufacture of a non-exempt new
chemical substance is prohibited prior
to the expiration of the new chemical
notice 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);
the Agency has 30 or 45 days to
complete its review of exemption
requests. During the review period, EPA
may act under TSCA section 5(e) or 5(f)
to regulate the new chemical substance.
If EPA has not prohibited manufacture
of the chemical substance during the
review period, manufacture 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 begins, the notice
submitter must provide a Notice of
Commencement of Manufacture or
Import (NOC), after which EPA adds the
chemical substance to the TSCA
Inventory. If the Agency receives a new
chemical notice submission for a
chemical substance which EPA
determines is excluded from
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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.) the Agency
will not accept the new chemical notice.
Similarly, during the period 1978–1979,
when EPA was accepting submissions
for the Initial TSCA Inventory, and
during 1979–1983, prior to
promulgation of the May 13, 1983 PMN
rule, the Agency rejected notifications
for materials which it determined to be
excluded.
B. Why is the Agency Taking this
Action?
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 was inconsistent in its statements
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 many doped phosphors for
listing, but in some cases it sent
‘‘problem letters’’ to the manufacturers
of doped phosphors indicating that they
were mixtures of the phosphor and
dopants and thus ineligible for listing.
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 certain chlorophosphate activated
phosphors could be regarded either as
physically altered chlorophosphates or
as mixtures, thus not subject to
premanufacture notice. 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 new chemical notice was
appropriate for another activated
phosphor but that ‘low levels’ of an
activator would not require a separate
new chemical notice.
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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 document 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
asserting that activated phosphors
should, in fact, be considered to be
mixtures and requested 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 https://www.epa.gov/
opptintr/newchems/pubs/mixtures.txt),
which provided guidance regarding the
mixture definition given at 40 CFR
710.2(q) 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.
‘‘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, multicomponent blends or formulations of
chemical substances, or certain reaction
product combinations which can be
completely characterized as consistently
formed definite 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
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this document, 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, EPA does not consider this
reaction product to be 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 its interpretation
of ‘‘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 document, 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 EPA generally
considers activated phosphors 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 reaction
characteristics and stoichiometry in
activated phosphor manufacture:
Activated phosphors are in general
synthesized by means of a solid state
reaction at high temperature and
typically 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 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 often an
indication of chemical substance
synthesis. During the manufacture of
activated phosphors, other volatile
reaction products are often emitted,
another indication that chemical
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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. Each of these reaction
characteristics is a strong indication that
a chemical substance is being
synthesized. Since most or all of these
characteristics are generally present in
activated phosphor manufacture, EPA
believes that activated phosphors are
manufactured for commercial purposes
with 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 are
considered to be reactants which must
be included in the chemical identity.
Therefore, in EPA’s view these materials
are not ‘‘mixtures’’ of phosphors and
dopants.
C. Why is this Chemical Identity
Clarification Necessary?
Because EPA does not view activated
phosphors as mixtures, some previous
EPA statements that such materials may
not need to be reviewed through the
new chemicals process were incorrect.
As a result of certain past EPA
statements, some manufacturers of
activated phosphors have not submitted
new chemical notices under TSCA
section 5 because those statements
incorrectly indicated that activated
phosphors were covered for TSCA
purposes if the phosphors and activators
were already on the TSCA Inventory.
Other manufacturers have submitted
new chemical notices for similar
materials, and they have generally been
given TSCA Inventory listings. 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. This
document provides a clarification to
previous statements on chemical
identity for activated phosphors. On the
effective date of this clarification,
activated phosphors that are not on the
TSCA Inventory will be considered new
chemical substances under TSCA
section 5.
Because some of the statements
provided by the Agency prior to 2003
led some manufacturers to believe that
the products they manufactured were
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already on the TSCA Inventory if the
phosphors and activators were on the
TSCA Inventory, some manufacturers of
activated phosphor products have not
submitted new chemical notices
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 chemical
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 addressing this
activated phosphor situation in a similar
manner.
III. Activated Phosphors Under the
TSCA Inventory and Implications for
TSCA Section 5 Reporting
EPA is clarifying that those of EPA’s
earlier statements which indicated that
activated phosphors are mixtures rather
than chemical substances in their own
right were erroneous, and that TSCA
Inventory listing or TSCA section
5(h)(4) exemption will be required for
these materials. Pursuant to TSCA
section 5(a)(1), 15 U.S.C. 2604(a)(1),
new chemical notices will 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
clarification. See EPA PMN regulations
at 40 CFR part 720 for details regarding
when reporting is required. Consistent
with TSCA Inventory correction
guidelines published in the Federal
Register issue of July 29, 1980 (45 FR
50544), EPA does not consider activated
phosphors that were never reported for
the Initial TSCA Inventory to be eligible
for TSCA Inventory correction as an
alternative to new chemical notice
submission.
A. What are the Nature and Scope of
this Clarification?
EPA does not believe that activated
phosphors are mixtures rather than
chemical substances in their own right.
Thus listing on the TSCA Inventory
established under TSCA section 8(b)
may be required for these chemical
substances. This clarification will affect
anyone who manufactures, or who plans
to manufacture, an activated phosphor
not currently listed on the TSCA
Inventory and for a TSCA-covered use.
B. What are the Key Dates and
Provisions of this Clarification?
The effective date for this
clarification, described in Unit II.B., will
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be 18 months after date of publication
of this final document in the Federal
Register. After the effective date, any
person manufacturing an activated
phosphor for a non-exempt commercial
purposes and who has not met the new
chemical substances requirements of
TSCA section 5 will not be considered
in compliance with TSCA. By that date,
companies required to submit PMNs or
exemption notices must have done so at
least 90 days (for PMNs, less for
exemption notices) before the effective
date, to ensure that Agency review is
completed before this clarification takes
effect.
By that date, companies required to
submit premanufacture notices or
exemption applications must have done
so at least 90 days (for PMNs, less for
exemption applications) before the
effective date, to ensure that Agency
review is completed before this
clarification takes effect. New chemical
notice review may entail suspension of
the notice review period (either by EPA
or at the request of the submitter). If a
new chemical notice seeking an
exemption is rejected, a PMN may need
to be filed. Because manufacture may
not continue after the 18–month period
provided in this notice, companies are
advised to submit any required new
chemical notices well before the
effective date to ensure that all issues
are resolved in a timely fashion.
EPA will work closely with
manufacturers to resolve chemical
identity issues for any specific material
that the manufacturer believes should
be viewed as a mixture.
To facilitate the new chemical notice
process for activated phosphors
currently being manufactured but which
are not listed on the TSCA Inventory as
distinct chemical substances, EPA will
allow an exception to its TSCA new
chemicals program policy limit of six
chemical substances per consolidation
notice for these chemical substances.
EPA encourages persons intending to
manufacture activated phosphors to file
new chemical notices using the proper
chemical identity immediately instead
of delaying their submissions to near the
effective date of this document.
New chemical notices filed in
response to this chemical identification
clarification shall, as specified in 40
CFR 720.50, include all information
normally included with a new chemical
notice submission, such as toxicity data
on the chemical substance that are in
the possession or control of the notice
submitter, or known to or reasonably
ascertainable by the notice submitter.
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C. Will a New Chemical Notice Be
Required for Persons Who Did Not
Submit One Due to an Incorrect EPA
Statement, Regardless of Whether They
Still Manufacture the Chemical
Substance?
Where required by TSCA section 5
and in accordance with 40 CFR part
720, a new chemical notice must have
been submitted for any manufacture for
a non-exempt commercial purpose that
takes place on or after August 24, 2011.
No new chemical notice need be
submitted for manufacture taking place
before that date. For example, if you
manufactured such a phosphor in 1986
but will not be resuming manufacture
after August 24, 2011, you are not
required to submit a new chemical
notice at this time. However, if you later
form an intention to manufacture the
activated phosphor on or after the
effective date of this clarification and
the chemical substance has not in the
interim been placed on the TSCA
Inventory due to another company’s
manufacture or import, you will need to
submit a new chemical notice (and the
review period must be completed)
before commencing manufacture.
Activated phosphors manufactured
before August 24, 2011 can be used or
processed after the effective date,
whether a new chemical notice has been
filed or not.
D. Discussion of Public Comments on
the Proposed Clarification
The Agency reviewed and considered
the comments submitted on the
proposed clarification published in the
Federal Register issue of January 16,
2008. Copies of all submitted comments
are available in the docket for this
action.
1. Comment. Commenter OSRAM
Sylvania questions the Agency’s
authority for requiring new chemical
reporting for chemical substances that
have been in production for some time.
The commenter states that ‘‘EPA lacks
the authority to extend the scope of the
TSCA Inventory and PMN requirements
to the regulations of these existing
chemicals.’’ The commenter suggests
that the Agency use TSCA Inventory
correction procedures to deal with
activated phosphors, and argues that the
clarification as to the TSCA Inventory
status of activated phosphors constitutes
rulemaking, as ‘‘it would impose new,
substantive legal obligations upon a
class of chemicals and companies.’’
Response. EPA disagrees with the
comment. TSCA section 3(2) defines
‘‘chemical substance’’ in relevant part as
‘‘any organic or inorganic substance of a
particular molecular identity.’’ Two
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chemicals with differing molecular
identities are therefore considered
different chemical substances under
TSCA. TSCA section 3(9) defines a ‘‘new
chemical substance’’ as ‘‘any chemical
substance which is not included in the
chemical substance list compiled and
published under section 2607(b) of this
title’’ (i.e., the TSCA Inventory). TSCA
section 5(a)(1) applies PMN reporting
requirements (or applicable exemptions)
to new chemical substances. Thus,
regardless of the fact that an activated
phosphor may have been in commerce
for years, if it has not been reported for
the TSCA Inventory or added to the
TSCA Inventory via PMN and NOC per
40 CFR part 720, it constitutes a new
chemical substance subject to TSCA
section 5.
This clarification does not create
obligations under TSCA. Requirements
for new chemical notice reporting are
self-executing in TSCA, flowing from
TSCA section 5(a)(1) (with ‘‘chemical
substance’’ being defined in TSCA
section 3(2) and ‘‘mixture’’ defined in
TSCA section 3(8)). The purpose of this
document is simply to provide notice of
how EPA intends to enforce these
provisions with respect to activated
phosphors. EPA does not believe that
this action constitutes rulemaking, but if
it were rulemaking it would be
interpretive rulemaking not subject to
notice and comment under the
Administrative Procedure Act (APA).
The TSCA Inventory correction
guidelines published in the Federal
Register issue of July 29, 1980 indicate
that materials that were never reported
for the Initial TSCA Inventory are not
eligible for TSCA Inventory correction
as an alternative to premanufacture
notice submission. The guidelines
describe three main categories as
appropriate for correction: Corrections
to the identity of previously reported
materials, corrections identifying
previously unrecognized isolated
intermediates, and corrections made in
response to Agency communications
which identify reporting errors and
request corrections. For the first
category, the TSCA Inventory correction
procedures are appropriate when errors
may have been made in reporting the
identity (‘‘(1) corrections of
typographical or transcriptional errors
in recording chemical identity on the
Inventory reporting forms..’’) or when
new information improving a previously
reported identity can be developed
because improvements in analytical
methods and equipment regarding a
previously reported chemical substance
indicate that the accurate description of
the chemical substance is different from
what was previously reported (‘‘(2)
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refinement of the identity of a reported
substance, e.g., by narrowing the range
of the values for a polymer; (3)
identification of new components in the
material, e.g., finding that a chemical
substance reported as A is actually a
mixture of A and B; and (4) discovery
that a chemical substance is different
from that reported previously, e.g.,
determining that a substance reported as
A is actually C or that a substance
reported as D is actually a mixture of E
and F.’’) Manufacturers’ failure to report
activated phosphors for the TSCA
Inventory under the first category is
covered by none of the four eligibility
criteria listed in this unit, which cover
improved information about a
previously reported chemical rather
than failure to report it. Neither the
second nor the third category is
applicable here.
Under these guidelines, a blanket
exclusion from TSCA section 5
reporting, and inclusion on the TSCA
Inventory by correction, for all activated
phosphors including those first
manufactured subsequent to the
reporting period for the Initial TSCA
Inventory, would be inappropriate. EPA
believes such an exclusion would
prevent these materials from receiving
the environmental, workplace safety,
and consumer safety review
contemplated by TSCA.
2. Comment. Commenter Color
Pigment Manufacturers Association
(CPMA) stated that because the EPA
made its initial error in 1978, when
materials were being entered into the
TSCA Inventory by survey, EPA should
allow for listing of the materials which
are the subject of the action by survey
and correction to the TSCA Inventory.
Response. CPMA has raised three
issues here: Addition to the TSCA
Inventory by survey for materials which
were first manufactured before the end
of the Initial TSCA Inventory reporting
period, addition to the TSCA Inventory
by survey for materials which were first
manufactured after the end of the Initial
TSCA Inventory reporting period, and
use of the TSCA Inventory correction
mechanism to enter non-TSCA
Inventory materials onto the TSCA
Inventory. CPMA’s comment provides
no apparent rationale for allowing
survey addition to the TSCA Inventory
for materials first manufactured after the
Initial TSCA Inventory reporting closed
in 1979. We have responded to the
suggestion that the corrections
procedure be used for activated
phosphor materials in our response to
the comment by OSRAM Sylvania, in
Unit III.D.1.
In regard to materials which were in
commerce already before the end of the
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Initial TSCA Inventory reporting period
in 1978, the Initial TSCA Inventory has
been closed to survey reporting since
the end of TSCA Inventory reporting in
1979, with the only mechanism for
changing the Initial TSCA Inventory
listings and compilation having been
TSCA Inventory corrections. Although
there may have been some persons
manufacturing activated phosphors
during the Initial TSCA Inventory
reporting period for TSCA who were
confused by EPA guidance at that time,
irrespective of the guidance, those
persons should have reported for the
Initial TSCA Inventory in some manner
to account for their manufactured
activated phosphor products. For
example, in their Initial TSCA Inventory
reporting, some persons may have
identified their phosphor compounds
without including the activators
(dopants) in the chemical names. Others
may have viewed their activated
phosphors to be mixtures of two
chemical substances (i.e., the activator
and the phosphor host material), and
reported both of their perceived mixture
components.
EPA believes that a survey process for
adding certain activated phosphors
which may have been in commerce
before 1978 to the TSCA Inventory at
this late date would not be warranted.
TSCA section 5 reporting for all
activated phosphors not on the TSCA
Inventory (and for which a TSCA
section 5(h)(4) exemption has not been
granted) and which are to be
manufactured on or after the effective
date of this clarification is a practical
way to enable the affected
manufacturers to come into compliance
without undue disruption; it will
facilitate the safety and environmental
impact review for these materials
intended in the statute; and the criteria
used to assess these materials will be
uniform.
3. Comment. Commenter American
Chemistry Council (ACC) stated that
this is more than a ’clarification’, but
that it is a reversal of a position held for
20 years. Therefore, a public review and
comment period, and consultation with
stakeholders, is in order.
Response. Rather than having stated a
consistent position, EPA’s guidance has
been inconsistent, as noted in the
proposal. This clarification provides the
guidance necessary to go forward with
one policy about the activated phosphor
materials. A significant number of
manufacturers have in fact submitted
PMNs and exemption notices covering
over 200 activated phosphors (this
includes reporting forms for the Initial
TSCA Inventory) and the Initial TSCA
Inventory reporting form and PMN
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substances have been given TSCA
Inventory listings. The Agency has
provided an opportunity for stakeholder
input in the comment process via the
proposed clarification, and met with
one manufacturer before the
clarification was written and one during
the comment period.
Most of the chemical substances
subject to this clarification, and which
are reportable, were manufactured after
the close of the TSCA Inventory
reporting period and new chemical
notices would have been submitted had
there not been any erroneous guidance
from EPA. Therefore, the net new
chemical notice reporting burden
should be little greater than if EPA had
issued accurate guidance on activated
phosphors after the publication of the
Initial TSCA Inventory. Those who have
already reported activated phosphors
will not need to do anything, while
those who have not yet reported such
chemical substances must do so by the
effective date of this document. In this
way, new chemical notices will finally
have been submitted for all of the
activated phosphors initially
manufactured for a non-exempt
commercial use. Due to the confusion
caused by EPA’s earlier erroneous
guidance, the Agency wishes to
minimize any inconvenience to the
chemical industry by providing an
exception to its TSCA new chemicals
program policy of a limit of six chemical
substances per consolidation notice for
these chemical substances and by
setting an effective date for the
consistent interpretation at 18 months
after date of publication of this
document in the Federal Register.
4. Comment. Commenter ACC said 12
months is not sufficient to do the work
required to come into compliance with
this clarification. ACC noted that
regulated industry is doing a good deal
of ongoing work to come into
compliance with the European Union
REACH program. EPA should lengthen
time to come into compliance to 18–24
months.
Response. The Agency believes that
the number of new chemical notice
submissions which will be prepared to
conform to the clarification will not be
large, nor will they be unusually
difficult to write. EPA’s estimate of the
total number of premanufacture notices
it will receive in response to this
clarification is 30. After considering this
comment, however, EPA agrees that 1
year could provide insufficient time to
complete the new chemical notice
review process for all activated
phosphors affected by this clarification.
Therefore, EPA has extended by 6
months the time that manufacturers and
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importers who are currently
manufacturing or importing affected
activated phosphors would have had
under the proposed clarification to
complete the TSCA section 5 review
process.
Under the proposed clarification,
such manufacturers would have had to
submit a premanufacture notice to EPA
within 6 months after publication of the
final clarification in order for EPA to
have had the entire 180 day period
authorized by TSCA section 5 (90 days
plus opportunity for up to a 90–day
extension under TSCA section 5(c)) to
complete the PMN review. This time
frame may have been too short in some
circumstances. Under this final
clarification, such manufacturers and
importers will have up to12 months to
submit a PMN in order for EPA to have
the entire 180–day review period (90
days plus opportunity for up to a 90–
day extension under TSCA section 5(c))
to complete the review of a PMN. This
approach will allow such manufacturers
and importers additional time to
compile the information necessary to
prepare and submit PMNs or exemption
requests. However, EPA encourages
manufacturers and importers to submit
PMNs or, alternatively, exemption
requests as soon as possible after
publication of the final clarification.
Doing so will provide EPA with more
time to complete any consent orders
and, if necessary, establish testing
requirements for those activated
phosphors for which EPA may have
concerns of potential unreasonable risk
to human health or the environment.
5. Comment. Commenter CPMA said
this action is onerous and punitive for
CPMA members, and results from EPA’s
mistake. It will be disruptive if it results
in materials being unavailable for
manufacture during the PMN review
process, and will be costly to small
businesses.
Response. As noted in Unit III.D.1., it
is the statute that imposes the
requirement for new chemical notice
reporting. This document is not
punitive; rather it clarifies EPA’s views
with respect to the chemical identity of
activated phosphors. The commenter is
correct that the need for this action
arises from the Agency’s error, and EPA
will make a diligent effort to complete
the new chemical notice reviews as
quickly as possible. We recommend that
manufacturers submit as promptly as
possible, and well before the effective
date of the clarification. As noted in
Unit III.D.4., we have lengthened the
time period for coming into conformity
with the clarification to 18 months from
12 months as proposed, and the
effective date of the clarification has
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been chosen to enable the reviews to be
completed before the effective date.
CPMA provided no information to
support the claim that there are such
small businesses and that the economic
impact on them would be significant.
EPA estimates that the number of new
chemical notices which may be received
from small businesses is 10. When EPA
receives applications from small
business as a result of this clarification
we will make every effort to assist these
submitters to navigate the process as
necessary.
6. Comment. Commenter CPMA said
the Agency has not provided any
evidence in the proposed clarification
that the phosphor materials subject to
the clarification pose a significant risk
to humans or the environment.
Response. TSCA compels TSCA
section 5 review for new chemical
substances, regardless of what
information may be available regarding
their risks. A TSCA section 5 notice
presents information available to the
submitter regarding risk for review and
assessment by EPA.
7. Comment. Commenter CPMA states
that EPA rarely meets the statutory 90–
day review period for inorganic
substances, and that a multi-year review
would impose a burden on
manufacturers of these materials.
Commenter cited several cases.
Response. EPA will strive to complete
the review of new chemical notices
submitted in response to this
clarification promptly. For more than
80% of submitted chemical substances,
the new chemical notice review process
is completed at the EPA Focus meeting,
which takes place well before the end of
the statutory 90–day PMN review
period, and without the chemical
substance being restricted or regulated
in any way. For those new chemical
substances for which EPA determines
that regulatory action may be necessary,
the new chemical notice review period
may be suspended by the submitter to
enable the Agency to consider
additional information in its review
and, if necessary, to develop and
negotiate a consent order. The cases
cited by the submitter were cases in
which TSCA section 5(e) consent
orders, which enabled the submitters to
commence manufacture subject to
certain conditions, were signed within a
year of submission. The Agency
recommends that affected
manufacturers should submit their new
chemical notices early in the period
following publication of this document,
and that they consult prior to
submission with EPA’s New Chemicals
Management Branch ((202) 564–9373) in
the New Chemicals Program to
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8271
determine what information will
facilitate quick review.
8. Comment. Commenter CPMA said
EPA has not substantiated that activated
phosphors are not statutory mixtures
and this action relative to activated
phosphors is inconsistent with EPA
policy on other mixtures.
Response. EPA believes that activated
phosphors are chemical substances, not
mixtures, under TSCA. These chemical
substances consist of reaction products
resulting from chemical bond formation
between the activators and the host
materials or precursors. As a result, the
Agency considers the activators to be
chemically incorporated in the activated
phosphors, becoming part of the
phosphor structure and composition.
9. Comment. Commenter OSRAM
Sylvania said the host portion, not the
activators, should be used in
determining the TSCA Inventory status
of phosphors.
Response. EPA believes that an
activated phosphor is appropriately
viewed as a chemical substance instead
of a mixture under TSCA because the
activator species (also known as
dopants) are chemically incorporated
into the structure of activated
phosphors, and because the dopants
provide the essential property of
luminescence to the materials. Chemical
incorporation is consistent with the
wording used by the commenter to
describe activated phosphors, such as
‘‘The activator(s) occupies lattice points
at random or interstitial positions in the
structure,’’ and ‘‘...to form the host
materials with the activators
incorporated into the crystal structure,’’
and is consistent with EPA’s
understanding of the nature of the
activators’ chemical interaction and
incorporation during the manufacture of
activated phosphors.
IV. Statutory and Executive Order
Reviews
This document announces a
clarification of one aspect of the TSCA
Inventory chemical identification
policy. This action is not a regulatory
action under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
As such, this action does not require
review by the Office of Management and
Budget (OMB) under Executive Order
12866.
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. Under
PRA, an agency may not conduct or
sponsor, and a person is not required to
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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
EPA’s regulations 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 in
certain EPA regulations is consolidated
in a list at 40 CFR 9.1.
The information collection activities
related to the submission of information
pursuant to TSCA section 5 have
already been 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.
This action is not subject to noticeand-comment requirements under the
APA or any other statute, and is not
subject to the provisions of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), or to sections 202
and 205 of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). In addition, this action
does not significantly or uniquely affect
small governments or impose a
significant intergovernmental mandate,
as described in sections 203 and 204 of
UMRA. This action will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, 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 (59 FR
22951, November 9, 2000).
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 this action is not
‘‘economically significant’’ as defined by
section 3(f) of Executive Order 12866.
Nor does this action establish an
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15:09 Feb 23, 2010
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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 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
Low-Income Populations (59 FR 7629,
February 16, 1994), the Agency is not
required to and has not considered
environmental justice-related issues.
V. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1966, does not apply
because this action is not a rule for
purposes of 5 U.S.C. 804(3).
List of Subjects in 40 CFR Subchapter
R
Environmental protection, Chemical
substances, Hazardous substances,
Imports, Manuafacturing, Reporting and
recordkeeping requirements.
Dated: February 17, 2010.
James Jones,
Acting Assistant Administrator, Office of
Prevention, Pesticides and Toxic Substances.
[FR Doc. 2010–3675 Filed 2–23–10; 8:45 am]
BILLING CODE 6560–50–S
ACTION: Interim rule with request for
comments.
SUMMARY: DoD is issuing an interim rule
amending the Defense Federal
Acquisition Regulation Supplement
(DFARS) to implement the Weapon
Systems Acquisition Reform Act of
2009, section 202, Acquisition Strategies
to Ensure Competition throughout the
Lifecycle of Major Defense Acquisition
Programs.
DATES: Effective Date: February 24,
2010.
Comment Date: Comments on this
interim rule should be submitted in
writing to the address shown below on
or before April 26, 2010, to be
considered in the formation of the final
rule.
ADDRESSES: You may submit comments,
identified by DFARS Case 2009–D014,
using any of the following methods:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
E-mail: dfars@osd.mil. Include
DFARS Case 2009–D014 in the subject
line of the message.
Fax: 703–602–0350.
Mail: Defense Acquisition Regulations
System, Attn: Ms. Meredith Murphy,
OUSD (AT&L) DPAP (DARS), 3060
Defense Pentagon, Room 3B855,
Washington, DC 20301–3060.
Hand Delivery/Courier: Defense
Acquisition Regulations System, Crystal
Square 4, Suite 200A, 241 18th Street,
Arlington, VA 22202–3402.
Comments received generally will be
posted without change to https://
www.regulations.gov, including any
personal information provided.
FOR FURTHER INFORMATION CONTACT:
Ms. Meredith Murphy, 703–602–1302.
SUPPLEMENTARY INFORMATION:
A. Background
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Part 207
[DFARS Case 2009–D014]
RIN 0750–AG61
Defense Federal Acquisition
Regulation Supplement; Acquisition
Strategies To Ensure Competition
Throughout the Life Cycle of Major
Defense Acquisition Programs
AGENCY: Defense Acquisition
Regulations System, Department of
Defense (DoD).
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On May 22, 2009, The Weapon
Systems Acquisition Reform Act (Pub.
L. 111–23) was enacted to improve the
organization and procedures of DoD for
the acquisition of major weapon
systems. This law establishes new
oversight entities within DoD, as well as
new and varied weapon system
acquisition and management reporting
requirements.
Section 202 directs the Secretary of
Defense (SECDEF) to ensure that the
acquisition strategy for each MDAP
includes: (1) Measures to ensure
competition at both the prime contract
and subcontract level of the MDAP
throughout its life cycle as a means to
improve contractor performance; and
(2) adequate documentation of the
rationale for selection of the
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Agencies
[Federal Register Volume 75, Number 36 (Wednesday, February 24, 2010)]
[Rules and Regulations]
[Pages 8266-8272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3675]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Subchapter R
[EPA-HQ-OPPT-2007-0392; FRL-8798-9]
RIN 2070-AJ21
Final Clarification for Chemical Identification Describing
Activated Phosphors for TSCA Inventory Purposes
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final clarification.
-----------------------------------------------------------------------
SUMMARY: This is a clarification under which certain activated
phosphors that are not on the Toxic Substances Control Act (TSCA)
section 8(b) Chemical Substance Inventory (TSCA Inventory) will be
considered to be new chemical substances under TSCA section 5, and thus
will be subject to applicable notification requirements under TSCA
section 5. In certain letters and other statements issued by EPA from
1978 to 2003, the Agency erroneously indicated that activated phosphors
(otherwise known as doped phosphors) constitute mixtures of phosphors
and dopants 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 clarification is
necessary because EPA's statements in this area have not been
consistent.
DATES: EPA's clarification is effective August 24, 2011.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2007-0392. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://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 legal
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. 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 will apply to persons
who manufactured these chemical substances after the publication of the
Initial TSCA Inventory and before the effective date of this 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.
II. Background
A. What Action is the Agency Taking?
EPA is clarifying that certain previous EPA statements which
indicated that activated phosphors are mixtures rather than chemical
substances in their own right were erroneous, and that TSCA Inventory
listing may be required for these materials. This action provides a
clarification in the approach used for the chemical identification of
activated (doped) phosphors for purposes of listing on the TSCA
Inventory. This clarification was proposed in the Federal Register
issue of January 16, 2008 (73 FR 2854) (FRL-8131-8) and a reopening of
comments on the proposed clarification was announced in the Federal
Register issue of May 2, 2008 (73 FR 24187) (FRL-8360-7).
An 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 substances as
[[Page 8267]]
yttrium, europium, germanium, gallium, strontium, antimony, manganese,
or magnesium. When an activated phosphor 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 (which includes import) or processed for commercial
purposes in the United States. This inventory is known as the TSCA
Chemical Substance Inventory (TSCA Inventory). EPA promulgated a rule
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. Building on several
earlier interim policies, EPA promulgated a rule in the Federal
Register issue of May 13, 1983 (48 FR 21722) setting forth procedures
for the submission, receipt, and health and safety review of PMNs
covering chemical substances not yet in commerce when required under
TSCA section 5, 15 U.S.C. 2604. Section 8(b)(1) of TSCA, 15 U.S.C.
2607(b)(1), instructs EPA to add a PMN substance to the TSCA Inventory
as of the earliest date on which it is manufactured or processed in the
United States.
Manufacture of a non-exempt new chemical substance is prohibited
prior to the expiration of the new chemical notice 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); the Agency has 30 or 45
days to complete its review of exemption requests. During the review
period, EPA may act under TSCA section 5(e) or 5(f) to regulate the new
chemical substance. If EPA has not prohibited manufacture of the
chemical substance during the review period, manufacture 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 begins, the notice submitter
must provide a Notice of Commencement of Manufacture or Import (NOC),
after which EPA adds the chemical substance to the TSCA Inventory. If
the Agency receives a new chemical notice 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.) the Agency
will not accept the new chemical notice. Similarly, during the period
1978-1979, when EPA was accepting submissions for the Initial TSCA
Inventory, and during 1979-1983, prior to promulgation of the May 13,
1983 PMN rule, the Agency rejected notifications for materials which it
determined to be excluded.
B. Why is the Agency Taking this Action?
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 was inconsistent in its
statements 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 many
doped phosphors for listing, but in some cases it sent ``problem
letters'' to the manufacturers of doped phosphors indicating that they
were mixtures of the phosphor and dopants and thus ineligible for
listing.
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 certain
chlorophosphate activated phosphors could be regarded either as
physically altered chlorophosphates or as mixtures, thus not subject to
premanufacture notice. 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 new chemical notice was appropriate for another
activated phosphor but that `low levels' of an activator would not
require a separate new chemical notice.
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 document 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
asserting that activated phosphors should, in fact, be considered to be
mixtures and requested 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 https://www.epa.gov/opptintr/newchems/pubs/mixtures.txt), which provided guidance regarding the
mixture definition given at 40 CFR 710.2(q) 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.
``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 definite 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
[[Page 8268]]
this document, 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, EPA does not
consider this reaction product to be 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 its interpretation
of ``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 document, 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 EPA
generally considers activated phosphors 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 reaction characteristics and stoichiometry in
activated phosphor manufacture: Activated phosphors are in general
synthesized by means of a solid state reaction at high temperature and
typically 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 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 often 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. Each of these reaction
characteristics is a strong indication that a chemical substance is
being synthesized. Since most or all of these characteristics are
generally present in activated phosphor manufacture, EPA believes that
activated phosphors are manufactured for commercial purposes with
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 are considered to be
reactants which must be included in the chemical identity. Therefore,
in EPA's view these materials are not ``mixtures'' of phosphors and
dopants.
C. Why is this Chemical Identity Clarification Necessary?
Because EPA does not view activated phosphors as mixtures, some
previous EPA statements that such materials may not need to be reviewed
through the new chemicals process were incorrect. As a result of
certain past EPA statements, some manufacturers of activated phosphors
have not submitted new chemical notices under TSCA section 5 because
those statements incorrectly indicated that activated phosphors were
covered for TSCA purposes if the phosphors and activators were already
on the TSCA Inventory. Other manufacturers have submitted new chemical
notices for similar materials, and they have generally been given TSCA
Inventory listings. 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. This document provides a clarification to previous statements
on chemical identity for activated phosphors. On the effective date of
this clarification, activated phosphors that are not on the TSCA
Inventory will be considered new chemical substances under TSCA section
5.
Because some of the statements provided by the Agency prior to 2003
led some manufacturers to believe that the products they manufactured
were already on the TSCA Inventory if the phosphors and activators were
on the TSCA Inventory, some manufacturers of activated phosphor
products have not submitted new chemical notices 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 chemical
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 addressing this activated phosphor situation in a similar manner.
III. Activated Phosphors Under the TSCA Inventory and Implications for
TSCA Section 5 Reporting
EPA is clarifying that those of EPA's earlier statements which
indicated that activated phosphors are mixtures rather than chemical
substances in their own right were erroneous, and that TSCA Inventory
listing or TSCA section 5(h)(4) exemption will be required for these
materials. Pursuant to TSCA section 5(a)(1), 15 U.S.C. 2604(a)(1), new
chemical notices will 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 clarification. See EPA PMN regulations at 40 CFR part 720 for
details regarding when reporting is required. Consistent with TSCA
Inventory correction guidelines published in the Federal Register issue
of July 29, 1980 (45 FR 50544), EPA does not consider activated
phosphors that were never reported for the Initial TSCA Inventory to be
eligible for TSCA Inventory correction as an alternative to new
chemical notice submission.
A. What are the Nature and Scope of this Clarification?
EPA does not believe that activated phosphors are mixtures rather
than chemical substances in their own right. Thus listing on the TSCA
Inventory established under TSCA section 8(b) may be required for these
chemical substances. This clarification will affect anyone who
manufactures, or who plans to manufacture, an activated phosphor not
currently listed on the TSCA Inventory and for a TSCA-covered use.
B. What are the Key Dates and Provisions of this Clarification?
The effective date for this clarification, described in Unit II.B.,
will
[[Page 8269]]
be 18 months after date of publication of this final document in the
Federal Register. After the effective date, any person manufacturing an
activated phosphor for a non-exempt commercial purposes and who has not
met the new chemical substances requirements of TSCA section 5 will not
be considered in compliance with TSCA. By that date, companies required
to submit PMNs or exemption notices must have done so at least 90 days
(for PMNs, less for exemption notices) before the effective date, to
ensure that Agency review is completed before this clarification takes
effect.
By that date, companies required to submit premanufacture notices
or exemption applications must have done so at least 90 days (for PMNs,
less for exemption applications) before the effective date, to ensure
that Agency review is completed before this clarification takes effect.
New chemical notice review may entail suspension of the notice review
period (either by EPA or at the request of the submitter). If a new
chemical notice seeking an exemption is rejected, a PMN may need to be
filed. Because manufacture may not continue after the 18-month period
provided in this notice, companies are advised to submit any required
new chemical notices well before the effective date to ensure that all
issues are resolved in a timely fashion.
EPA will work closely with manufacturers to resolve chemical
identity issues for any specific material that the manufacturer
believes should be viewed as a mixture.
To facilitate the new chemical notice process for activated
phosphors currently being manufactured but which are not listed on the
TSCA Inventory as distinct chemical substances, EPA will allow an
exception to its TSCA new chemicals program policy limit of six
chemical substances per consolidation notice for these chemical
substances. EPA encourages persons intending to manufacture activated
phosphors to file new chemical notices using the proper chemical
identity immediately instead of delaying their submissions to near the
effective date of this document.
New chemical notices filed in response to this chemical
identification clarification shall, as specified in 40 CFR 720.50,
include all information normally included with a new chemical notice
submission, such as toxicity data on the chemical substance that are in
the possession or control of the notice submitter, or known to or
reasonably ascertainable by the notice submitter.
C. Will a New Chemical Notice Be Required for Persons Who Did Not
Submit One Due to an Incorrect EPA Statement, Regardless of Whether
They Still Manufacture the Chemical Substance?
Where required by TSCA section 5 and in accordance with 40 CFR part
720, a new chemical notice must have been submitted for any manufacture
for a non-exempt commercial purpose that takes place on or after August
24, 2011. No new chemical notice need be submitted for manufacture
taking place before that date. For example, if you manufactured such a
phosphor in 1986 but will not be resuming manufacture after August 24,
2011, you are not required to submit a new chemical notice at this
time. However, if you later form an intention to manufacture the
activated phosphor on or after the effective date of this clarification
and the chemical substance has not in the interim been placed on the
TSCA Inventory due to another company's manufacture or import, you will
need to submit a new chemical notice (and the review period must be
completed) before commencing manufacture. Activated phosphors
manufactured before August 24, 2011 can be used or processed after the
effective date, whether a new chemical notice has been filed or not.
D. Discussion of Public Comments on the Proposed Clarification
The Agency reviewed and considered the comments submitted on the
proposed clarification published in the Federal Register issue of
January 16, 2008. Copies of all submitted comments are available in the
docket for this action.
1. Comment. Commenter OSRAM Sylvania questions the Agency's
authority for requiring new chemical reporting for chemical substances
that have been in production for some time. The commenter states that
``EPA lacks the authority to extend the scope of the TSCA Inventory and
PMN requirements to the regulations of these existing chemicals.'' The
commenter suggests that the Agency use TSCA Inventory correction
procedures to deal with activated phosphors, and argues that the
clarification as to the TSCA Inventory status of activated phosphors
constitutes rulemaking, as ``it would impose new, substantive legal
obligations upon a class of chemicals and companies.''
Response. EPA disagrees with the comment. TSCA section 3(2) defines
``chemical substance'' in relevant part as ``any organic or inorganic
substance of a particular molecular identity.'' Two chemicals with
differing molecular identities are therefore considered different
chemical substances under TSCA. TSCA section 3(9) defines a ``new
chemical substance'' as ``any chemical substance which is not included
in the chemical substance list compiled and published under section
2607(b) of this title'' (i.e., the TSCA Inventory). TSCA section
5(a)(1) applies PMN reporting requirements (or applicable exemptions)
to new chemical substances. Thus, regardless of the fact that an
activated phosphor may have been in commerce for years, if it has not
been reported for the TSCA Inventory or added to the TSCA Inventory via
PMN and NOC per 40 CFR part 720, it constitutes a new chemical
substance subject to TSCA section 5.
This clarification does not create obligations under TSCA.
Requirements for new chemical notice reporting are self-executing in
TSCA, flowing from TSCA section 5(a)(1) (with ``chemical substance''
being defined in TSCA section 3(2) and ``mixture'' defined in TSCA
section 3(8)). The purpose of this document is simply to provide notice
of how EPA intends to enforce these provisions with respect to
activated phosphors. EPA does not believe that this action constitutes
rulemaking, but if it were rulemaking it would be interpretive
rulemaking not subject to notice and comment under the Administrative
Procedure Act (APA).
The TSCA Inventory correction guidelines published in the Federal
Register issue of July 29, 1980 indicate that materials that were never
reported for the Initial TSCA Inventory are not eligible for TSCA
Inventory correction as an alternative to premanufacture notice
submission. The guidelines describe three main categories as
appropriate for correction: Corrections to the identity of previously
reported materials, corrections identifying previously unrecognized
isolated intermediates, and corrections made in response to Agency
communications which identify reporting errors and request corrections.
For the first category, the TSCA Inventory correction procedures are
appropriate when errors may have been made in reporting the identity
(``(1) corrections of typographical or transcriptional errors in
recording chemical identity on the Inventory reporting forms..'') or
when new information improving a previously reported identity can be
developed because improvements in analytical methods and equipment
regarding a previously reported chemical substance indicate that the
accurate description of the chemical substance is different from what
was previously reported (``(2)
[[Page 8270]]
refinement of the identity of a reported substance, e.g., by narrowing
the range of the values for a polymer; (3) identification of new
components in the material, e.g., finding that a chemical substance
reported as A is actually a mixture of A and B; and (4) discovery that
a chemical substance is different from that reported previously, e.g.,
determining that a substance reported as A is actually C or that a
substance reported as D is actually a mixture of E and F.'')
Manufacturers' failure to report activated phosphors for the TSCA
Inventory under the first category is covered by none of the four
eligibility criteria listed in this unit, which cover improved
information about a previously reported chemical rather than failure to
report it. Neither the second nor the third category is applicable
here.
Under these guidelines, a blanket exclusion from TSCA section 5
reporting, and inclusion on the TSCA Inventory by correction, for all
activated phosphors including those first manufactured subsequent to
the reporting period for the Initial TSCA Inventory, would be
inappropriate. EPA believes such an exclusion would prevent these
materials from receiving the environmental, workplace safety, and
consumer safety review contemplated by TSCA.
2. Comment. Commenter Color Pigment Manufacturers Association
(CPMA) stated that because the EPA made its initial error in 1978, when
materials were being entered into the TSCA Inventory by survey, EPA
should allow for listing of the materials which are the subject of the
action by survey and correction to the TSCA Inventory.
Response. CPMA has raised three issues here: Addition to the TSCA
Inventory by survey for materials which were first manufactured before
the end of the Initial TSCA Inventory reporting period, addition to the
TSCA Inventory by survey for materials which were first manufactured
after the end of the Initial TSCA Inventory reporting period, and use
of the TSCA Inventory correction mechanism to enter non-TSCA Inventory
materials onto the TSCA Inventory. CPMA's comment provides no apparent
rationale for allowing survey addition to the TSCA Inventory for
materials first manufactured after the Initial TSCA Inventory reporting
closed in 1979. We have responded to the suggestion that the
corrections procedure be used for activated phosphor materials in our
response to the comment by OSRAM Sylvania, in Unit III.D.1.
In regard to materials which were in commerce already before the
end of the Initial TSCA Inventory reporting period in 1978, the Initial
TSCA Inventory has been closed to survey reporting since the end of
TSCA Inventory reporting in 1979, with the only mechanism for changing
the Initial TSCA Inventory listings and compilation having been TSCA
Inventory corrections. Although there may have been some persons
manufacturing activated phosphors during the Initial TSCA Inventory
reporting period for TSCA who were confused by EPA guidance at that
time, irrespective of the guidance, those persons should have reported
for the Initial TSCA Inventory in some manner to account for their
manufactured activated phosphor products. For example, in their Initial
TSCA Inventory reporting, some persons may have identified their
phosphor compounds without including the activators (dopants) in the
chemical names. Others may have viewed their activated phosphors to be
mixtures of two chemical substances (i.e., the activator and the
phosphor host material), and reported both of their perceived mixture
components.
EPA believes that a survey process for adding certain activated
phosphors which may have been in commerce before 1978 to the TSCA
Inventory at this late date would not be warranted. TSCA section 5
reporting for all activated phosphors not on the TSCA Inventory (and
for which a TSCA section 5(h)(4) exemption has not been granted) and
which are to be manufactured on or after the effective date of this
clarification is a practical way to enable the affected manufacturers
to come into compliance without undue disruption; it will facilitate
the safety and environmental impact review for these materials intended
in the statute; and the criteria used to assess these materials will be
uniform.
3. Comment. Commenter American Chemistry Council (ACC) stated that
this is more than a 'clarification', but that it is a reversal of a
position held for 20 years. Therefore, a public review and comment
period, and consultation with stakeholders, is in order.
Response. Rather than having stated a consistent position, EPA's
guidance has been inconsistent, as noted in the proposal. This
clarification provides the guidance necessary to go forward with one
policy about the activated phosphor materials. A significant number of
manufacturers have in fact submitted PMNs and exemption notices
covering over 200 activated phosphors (this includes reporting forms
for the Initial TSCA Inventory) and the Initial TSCA Inventory
reporting form and PMN substances have been given TSCA Inventory
listings. The Agency has provided an opportunity for stakeholder input
in the comment process via the proposed clarification, and met with one
manufacturer before the clarification was written and one during the
comment period.
Most of the chemical substances subject to this clarification, and
which are reportable, were manufactured after the close of the TSCA
Inventory reporting period and new chemical notices would have been
submitted had there not been any erroneous guidance from EPA.
Therefore, the net new chemical notice reporting burden should be
little greater than if EPA had issued accurate guidance on activated
phosphors after the publication of the Initial TSCA Inventory. Those
who have already reported activated phosphors will not need to do
anything, while those who have not yet reported such chemical
substances must do so by the effective date of this document. In this
way, new chemical notices will finally have been submitted for all of
the activated phosphors initially manufactured for a non-exempt
commercial use. Due to the confusion caused by EPA's earlier erroneous
guidance, the Agency wishes to minimize any inconvenience to the
chemical industry by providing an exception to its TSCA new chemicals
program policy of a limit of six chemical substances per consolidation
notice for these chemical substances and by setting an effective date
for the consistent interpretation at 18 months after date of
publication of this document in the Federal Register.
4. Comment. Commenter ACC said 12 months is not sufficient to do
the work required to come into compliance with this clarification. ACC
noted that regulated industry is doing a good deal of ongoing work to
come into compliance with the European Union REACH program. EPA should
lengthen time to come into compliance to 18-24 months.
Response. The Agency believes that the number of new chemical
notice submissions which will be prepared to conform to the
clarification will not be large, nor will they be unusually difficult
to write. EPA's estimate of the total number of premanufacture notices
it will receive in response to this clarification is 30. After
considering this comment, however, EPA agrees that 1 year could provide
insufficient time to complete the new chemical notice review process
for all activated phosphors affected by this clarification. Therefore,
EPA has extended by 6 months the time that manufacturers and
[[Page 8271]]
importers who are currently manufacturing or importing affected
activated phosphors would have had under the proposed clarification to
complete the TSCA section 5 review process.
Under the proposed clarification, such manufacturers would have had
to submit a premanufacture notice to EPA within 6 months after
publication of the final clarification in order for EPA to have had the
entire 180 day period authorized by TSCA section 5 (90 days plus
opportunity for up to a 90-day extension under TSCA section 5(c)) to
complete the PMN review. This time frame may have been too short in
some circumstances. Under this final clarification, such manufacturers
and importers will have up to12 months to submit a PMN in order for EPA
to have the entire 180-day review period (90 days plus opportunity for
up to a 90-day extension under TSCA section 5(c)) to complete the
review of a PMN. This approach will allow such manufacturers and
importers additional time to compile the information necessary to
prepare and submit PMNs or exemption requests. However, EPA encourages
manufacturers and importers to submit PMNs or, alternatively, exemption
requests as soon as possible after publication of the final
clarification. Doing so will provide EPA with more time to complete any
consent orders and, if necessary, establish testing requirements for
those activated phosphors for which EPA may have concerns of potential
unreasonable risk to human health or the environment.
5. Comment. Commenter CPMA said this action is onerous and punitive
for CPMA members, and results from EPA's mistake. It will be disruptive
if it results in materials being unavailable for manufacture during the
PMN review process, and will be costly to small businesses.
Response. As noted in Unit III.D.1., it is the statute that imposes
the requirement for new chemical notice reporting. This document is not
punitive; rather it clarifies EPA's views with respect to the chemical
identity of activated phosphors. The commenter is correct that the need
for this action arises from the Agency's error, and EPA will make a
diligent effort to complete the new chemical notice reviews as quickly
as possible. We recommend that manufacturers submit as promptly as
possible, and well before the effective date of the clarification. As
noted in Unit III.D.4., we have lengthened the time period for coming
into conformity with the clarification to 18 months from 12 months as
proposed, and the effective date of the clarification has been chosen
to enable the reviews to be completed before the effective date. CPMA
provided no information to support the claim that there are such small
businesses and that the economic impact on them would be significant.
EPA estimates that the number of new chemical notices which may be
received from small businesses is 10. When EPA receives applications
from small business as a result of this clarification we will make
every effort to assist these submitters to navigate the process as
necessary.
6. Comment. Commenter CPMA said the Agency has not provided any
evidence in the proposed clarification that the phosphor materials
subject to the clarification pose a significant risk to humans or the
environment.
Response. TSCA compels TSCA section 5 review for new chemical
substances, regardless of what information may be available regarding
their risks. A TSCA section 5 notice presents information available to
the submitter regarding risk for review and assessment by EPA.
7. Comment. Commenter CPMA states that EPA rarely meets the
statutory 90-day review period for inorganic substances, and that a
multi-year review would impose a burden on manufacturers of these
materials. Commenter cited several cases.
Response. EPA will strive to complete the review of new chemical
notices submitted in response to this clarification promptly. For more
than 80% of submitted chemical substances, the new chemical notice
review process is completed at the EPA Focus meeting, which takes place
well before the end of the statutory 90-day PMN review period, and
without the chemical substance being restricted or regulated in any
way. For those new chemical substances for which EPA determines that
regulatory action may be necessary, the new chemical notice review
period may be suspended by the submitter to enable the Agency to
consider additional information in its review and, if necessary, to
develop and negotiate a consent order. The cases cited by the submitter
were cases in which TSCA section 5(e) consent orders, which enabled the
submitters to commence manufacture subject to certain conditions, were
signed within a year of submission. The Agency recommends that affected
manufacturers should submit their new chemical notices early in the
period following publication of this document, and that they consult
prior to submission with EPA's New Chemicals Management Branch ((202)
564-9373) in the New Chemicals Program to determine what information
will facilitate quick review.
8. Comment. Commenter CPMA said EPA has not substantiated that
activated phosphors are not statutory mixtures and this action relative
to activated phosphors is inconsistent with EPA policy on other
mixtures.
Response. EPA believes that activated phosphors are chemical
substances, not mixtures, under TSCA. These chemical substances consist
of reaction products resulting from chemical bond formation between the
activators and the host materials or precursors. As a result, the
Agency considers the activators to be chemically incorporated in the
activated phosphors, becoming part of the phosphor structure and
composition.
9. Comment. Commenter OSRAM Sylvania said the host portion, not the
activators, should be used in determining the TSCA Inventory status of
phosphors.
Response. EPA believes that an activated phosphor is appropriately
viewed as a chemical substance instead of a mixture under TSCA because
the activator species (also known as dopants) are chemically
incorporated into the structure of activated phosphors, and because the
dopants provide the essential property of luminescence to the
materials. Chemical incorporation is consistent with the wording used
by the commenter to describe activated phosphors, such as ``The
activator(s) occupies lattice points at random or interstitial
positions in the structure,'' and ``...to form the host materials with
the activators incorporated into the crystal structure,'' and is
consistent with EPA's understanding of the nature of the activators'
chemical interaction and incorporation during the manufacture of
activated phosphors.
IV. Statutory and Executive Order Reviews
This document announces a clarification of one aspect of the TSCA
Inventory chemical identification policy. This action is not a
regulatory action under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). As such, this
action does not require review by the Office of Management and Budget
(OMB) under Executive Order 12866.
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. Under
PRA, an agency may not conduct or sponsor, and a person is not required
to
[[Page 8272]]
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 EPA's
regulations 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 in certain EPA regulations is consolidated in a
list at 40 CFR 9.1.
The information collection activities related to the submission of
information pursuant to TSCA section 5 have already been 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.
This action is not subject to notice-and-comment requirements under
the APA or any other statute, and is not subject to the provisions of
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), or to
sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4). In addition, this action does not significantly or
uniquely affect small governments or impose a significant
intergovernmental mandate, as described in sections 203 and 204 of
UMRA. This action will not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, 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 (59 FR
22951, November 9, 2000).
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 this action 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 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 Low-Income
Populations (59 FR 7629, February 16, 1994), the Agency is not required
to and has not considered environmental justice-related issues.
V. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1966, does
not apply because this action is not a rule for purposes of 5 U.S.C.
804(3).
List of Subjects in 40 CFR Subchapter R
Environmental protection, Chemical substances, Hazardous
substances, Imports, Manuafacturing, Reporting and recordkeeping
requirements.
Dated: February 17, 2010.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. 2010-3675 Filed 2-23-10; 8:45 am]
BILLING CODE 6560-50-S