
[Federal Register: February 24, 2010 (Volume 75, Number 36)]
[Rules and Regulations]               
[Page 8266-8272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe10-11]                         

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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.

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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 http://
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 http://www.regulations.gov, or, if only available in hard 
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., 
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation 
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 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 http://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

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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 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

