

[Federal Register: January 16, 2008 (Volume 73, Number 11)]
[Proposed Rules]               
[Page 2854-2859]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja08-24]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 704, 720, 721, and 723

[EPA-HQ-OPPT-2007-0392; FRL-8131-8]
RIN 2070-AJ21

 
Proposed Clarification for Chemical Identification Describing 
Activated Phosphors for TSCA Inventory Purposes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed clarification.

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SUMMARY: This document proposes a clarification under which activated 
phosphors that are not on the Toxic Substances Control Act (TSCA) 
section 8(b) Chemical Substance Inventory (TSCA Inventory) would be 
considered to be new chemical substances under TSCA section 5, thus 
would be subject to the notification requirements under TSCA section 
5(a) new chemical notification requirements. In certain letters and 
other interpretations issued by EPA from 1978 to 2003, it appears that 
the Agency erroneously indicated that activated phosphors constitute 
solid mixtures for purposes of the TSCA Inventory, and thus that they 
were not separately reportable as chemical substances under TSCA 
section 5(a) new chemical notification requirements. This proposed 
clarification is necessary because EPA's interpretations in this area 
have not been consistent. Given this past inconsistency, EPA is seeking 
comment on its proposed clarfication.

DATES: Comments must be received on or before March 17, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2007-0392, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2007-0392. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0392. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 

provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 

Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, will be publicly available only in hard copy. Publicly 
available docket

[[Page 2855]]

materials are available electronically at http://www.regulations.gov, 

or, if only available in hard copy, at the OPPT Docket. The OPPT Docket 
is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West 
Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public 
Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding Federal holidays. The telephone number of the 
EPA/DC Public Reading Room is (202) 566-1744, and the telephone number 
for the OPPT Docket is (202) 566-0280. Docket visitors are required to 
show photographic identification, pass through a metal detector, and 
sign the EPA visitor log. All visitor bags are processed through an X-
ray machine and subject to search. Visitors will be provided an EPA/DC 
badge that must be visible at all times in the building and returned 
upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: 
TSCA-Hotline@epa.gov.

    For technical information contact: David Schutz, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9262; e-mail 
address: schutz.david@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are, or may in the future 
be, a manufacturer or importer of an activated phosphor that requires 
submission of a premanufacture notification (PMN) or exemption request 
under TSCA section 5. Special procedures would apply to persons who 
manufactured these chemicals after the publication of the Initial TSCA 
Inventory and before a date 12 months following the publication of a 
final chemical identification clarification document in the Federal 
Register. Potentially affected entities may include, but are not 
limited to:
     Chemical manufacturers or importers (NAICS codes 325, 
3251), e.g., anyone who manufactures or imports, or who plans to 
manufacture or import, an activated phosphor for a non-exempt 
commercial purpose.
     Electric Lighting Equipment Manufacturing, Electric Lamp 
Bulb and Part Manufacturing (NAICS codes 3351, 33511), e.g., anyone who 
manufactures or imports, or who plans to manufacture or import, 
lighting equipment containing an activated phosphor for a non-exempt 
commercial purpose.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM 
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and 
then identify electronically within the disk or CD-ROM the specific 
information that is claimed as CBI. In addition to one complete version 
of the comment that includes information claimed as CBI, a copy of the 
comment that does not contain the information claimed as CBI must be 
submitted for inclusion in the public docket. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    This action proposes a clarification in the approach used for the 
chemical identification of activated (doped) phosphors for purposes of 
listing on the TSCA Inventory. A doped or activated phosphor is a 
substance resulting from the chemical combination of a mixture of metal 
oxides, carbonates, phosphates or acid phosphates, chlorides, and/or 
fluorides, most frequently by sintering, along with a small amount of 
one or more dopants. Dopants can include such chemical substances as 
antimony, europium, gallium, germanium, magnesium, manganese, 
strontium, or yttrium. When this material is electrically excited, it 
emits light. The color and electrical efficiency of light emission is a 
function of the parent phosphor and of the dopant which is present.
    EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to 
compile and keep current an inventory of chemical substances 
manufactured, imported, or processed for commercial purposes in the 
United States. This inventory is known as the TSCA Chemical Substances 
Inventory (TSCA Inventory). In 1977, EPA promulgated a rule published 
in the Federal Register issue of December 23, 1977 (42 FR 64572) under 
TSCA section 8(a), 15 U.S.C. 2607(a), to compile an inventory of 
chemical substances in commerce at that time. In 1983, and building on 
several earlier interim policies, EPA promulgated a rule published in 
the Federal Register issue of May 13, 1983 (48 FR 21722) under TSCA 
section 5, 15 U.S.C. 2604, to keep the TSCA Inventory up-to-date 
through a procedure for the submission, receipt, and health and safety 
review of PMNs covering chemical substances not yet in commerce from 
their intending manufacturers and importers.
    Manufacturing, importing, or processing of a new chemical is 
illegal prior to the expiration of the PMN review period. Once EPA 
receives a PMN, the Agency has 90 days to review the notice (unless for 
good cause EPA extends the review period). During the review period, 
EPA may act under TSCA section 5(e) or 5(f) to regulate the

[[Page 2856]]

new chemical substance. If EPA has not prohibited manufacture or import 
of the chemical substance during the review period, these activities 
may begin subject to any restrictions or testing requirements imposed 
upon the submitter during the review period (these restrictions may be 
imposed upon others via a Significant New Use Rule (SNUR) and 
subsequent action under TSCA section 5(e) or 5(f) taken in follow-up to 
a significant new use notification (SNUN)). When manufacture or import 
begins, the notice submitter must provide a notice of commencement, 
after which EPA adds the chemical substance to the TSCA Inventory. If 
the Agency receives a PMN submission for a chemical substance which EPA 
determines is excluded from consideration as a chemical substance under 
TSCA (generally because it meets the criteria for one of the excepted 
categories at TSCA section 3(2)(B), which include mixtures, pesticides, 
tobacco, food, drugs, etc.) it will not accept the PMN. A similar 
practice was followed as well during the period 1978-1979, when the EPA 
was accepting submissions for the Initial TSCA Inventory, and during 
1979-1983, prior to promulgation of the May 13, 1983 PMN rule.
    Partly as a result of the Agency's incomplete information and 
understanding of the chemistry involved in manufacturing activated 
phosphors, from 1978 through 2003 EPA has been inconsistent in its 
interpretation to potential submitters and in its actions regarding 
whether activated phosphors are considered distinct chemical substances 
for purposes of the TSCA Inventory. During the period 1978-1979, when 
EPA received submissions for the Initial TSCA Inventory, it accepted a 
number of doped phosphors for listing, but in other cases it sent 
``problem letters'' to the manufacturers of doped phosphors indicating 
that they were mixtures.
    In October 1979, the Agency wrote to a lighting manufacturer and 
stated that such listings could be ``unnecessary'' and that their 
continued inclusion on the TSCA Inventory would be ``closely 
examined.'' In January 1980, a lighting manufacturer wrote to the 
Agency to challenge problem letters it had received. The manufacturer 
stated that the materials it manufactured should be excluded from 
mixture status because they had characteristic crystal structures and 
that volatile reaction products given off during their manufacture 
showed that chemical synthesis was occurring. In March 1982, the Agency 
wrote to a lighting manufacturer and suggested that activated phosphors 
could be regarded either as physically altered chlorophosphates or as 
mixtures, thus not subject to PMN. In August 1983, the Agency wrote to 
the lighting manufacturer which had challenged the problem letters and 
informed it that the materials had, in fact, been placed on the TSCA 
Inventory, and in addition that a PMN was appropriate for another 
activated phosphor but that ``low levels'' of an activator would not 
require separate PMN.
    In January 1993, a lighting manufacturer submitted a Low Volume 
Exemption (LVE) Application for an activated phosphor with a letter 
referencing much of the history as described in this unit and asserting 
that, based on Agency positions, no submission should be necessary, but 
the Agency did accept the application and granted the LVE. After that 
LVE was granted, the manufacturer submitted a letter making the case 
that activated phosphors should, in fact, be considered to be mixtures 
and requesting that the Agency issue a clarifying statement. In 
response, the Agency met with the manufacturer on the issue and 
indicated that activated phosphors should be considered chemical 
substances instead of mixtures, but did not issue a written 
clarification.
    In 1995, EPA issued the publication entitled Toxic Substances 
Control Act Inventory Representation for Products Containing Two or 
More Substances: Formulated and Statutory Mixtures (Formulated and 
Statutory Mixtures), available at http://www.epa.gov/opptintr/newchems/pubs/mixtures.txt
), which interpreted the mixture definition given at 

40 CFR 710.3(d) and 720.3(u):

    Mixture means any combination of two or more chemical substances 
if the combination does not occur in nature and is not, in whole or 
in part, the result of a chemical reaction; except ``mixture'' does 
include (1) any combination which occurs, in whole or in part, as a 
result of a chemical reaction if the combination could have been 
manufactured for commercial purposes without a chemical reaction at 
the time the chemical substances comprising the combination were 
combined, and if all of the chemical substances comprising the 
combination are not new chemical substances, and (2) hydrates of a 
chemical substance or hydrated ions formed by association of a 
chemical substance with water, so long as the nonhydrated form is 
itself not a new chemical substance.

    Formulated and Statutory Mixtures discusses common examples of 
mixtures, including paints, blended fuels, and solvent combinations. 
``Mixture'' can include, as well, solid solutions--homogeneous 
crystalline phases composed of several distinct chemical species. 
Alloys are solid solutions, and are considered mixtures. For the 
purposes of TSCA, multi-component blends or formulations of chemical 
substances, or certain reaction product combinations which can be 
completely characterized as consistently formed sets of their 
constituent chemical substances, are considered to be mixtures of 
chemical substances. Mixtures are not reportable, although their 
constituent chemical substances are. Most important in the context of 
this clarification, a mixture can often provide its function over some 
range of constituent ratios, consequently it is unusual if the ratios 
of chemical substances which comprise a mixture are necessarily 
definite or stoichiometric, and if the mixture components are 
deliberately reacted together to manufacture a chemical substance, this 
reaction product cannot be considered a mixture for TSCA purposes 
except in very specialized circumstances which are not present in the 
case of the activated phosphors.
    In June 1998, a lighting manufacturer wrote to the Agency and 
stated that, in the absence of any negative response by the Agency 
within 60 days of the letter, it intended to rely on the interpretation 
in Formulated and Statutory Mixtures, and that it believed that that 
interpretation precluded TSCA Inventory listing for activated 
phosphors. The Agency did not respond to that letter. Based on a 2003 
request from a lighting manufacturer, and cognizant of the history 
described in this unit, EPA held a meeting with the manufacturer in 
September 2003 and as a result has reexamined some earlier 
assumptions--particularly about non-stoichiometry and non-reaction 
between chemical substances used to make activated phosphors--which may 
have led it to believe that activated phosphors could be considered 
mixtures.
    The result of this reexamination is this clarification that 
individual activated phosphors should be considered to be distinct 
chemical substances under TSCA. EPA's clarification on the potential 
need to report activated phosphor materials is based on its updated 
understanding about reactions and stoichiometry in activated phosphors, 
as follows: Activated phosphors are in general synthesized by means of 
a solid state reaction at high temperature and using precise quantities 
of the precursor chemical substances, both for the base materials and 
for the dopants which control the quality of light emitted. Precise 
ratios of component materials are used to maintain strict stoichiometry 
in the end product, and component

[[Page 2857]]

materials are thoroughly blended before reaction for uniformity of the 
product. Heat may be absorbed or released by the reactant mixture at 
certain temperatures, typically by the release of water: This is 
generally an indication of chemical substance synthesis. During the 
manufacture of activated phosphors, other volatile reaction products 
are often emitted, another indication that chemical substances are 
being formed. The phosphor and the amount of dopant added need to be 
controlled with high precision, and during sintering the doped phosphor 
undergoes oxidation state changes. Consequently, EPA believes that 
activated phosphors cannot be manufactured for commercial purposes 
without chemical reaction. Additionally, activated phosphor products 
have a different function from the material which would be produced by 
the same synthetic process in the absence of dopant, and which would 
not emit the characteristic light, which is the primary property 
sought. Because dopants provide the primary property sought from these 
materials, small or even trace amounts of dopant must be considered to 
be reactants which must be included in the chemical identity. These 
factors preclude these materials from being considered as ``mixtures.''

B. What is the Agency's Authority for Taking this Action?

    Section 5 of TSCA requires any person who intends to manufacture 
(defined by statute to include import) a new chemical substance (i.e., 
a chemical substance not on the TSCA Inventory) to notify EPA at least 
90 days in advance and comply with the statutory provisions pertaining 
to the manufacture of new chemical substances for non-exempt commercial 
purposes. Section 8(b) of TSCA requires EPA to compile, keep current, 
and publish a list of each chemical substance which is manufactured or 
processed in the United States (the TSCA Inventory). This requirement 
includes defining the scope of the listings on the TSCA Inventory.

C. Why is this Proposed Chemical Identity Clarification Necessary?

    Because activated phosphors are precluded by the factors identified 
in the last paragraph of Unit II.A. from being considered to be 
formulated or statutory mixtures, some previous EPA interpretations 
that such materials need not be reviewed through the new chemicals 
process were incorrect. As a result of certain past EPA 
interpretations, some manufacturers of activated phosphors have not 
submitted new chemical notifications under TSCA section 5 because those 
interpretations incorrectly indicated that activated phosphors were 
covered for TSCA purposes if the substances used in their manufacture 
were already on the TSCA Inventory. Other manufacturers have submitted 
notices for these materials, and they have been given TSCA Inventory 
listings in some cases. Several industry representatives have asked EPA 
to clarify the Agency's chemical identity policy for activated 
phosphors. EPA now agrees that it is necessary to add listings to the 
TSCA Inventory for activated phosphors which have been manufactured but 
not listed, and that it is possible that some existing listings should 
be altered to describe certain metal components as dopants. This 
document proposes a clarification to previous interpretations on 
chemical identity for activated phosphors. With this proposed 
clarification, activated phosphors that are not on the TSCA Inventory 
would be considered new chemical substances under TSCA section 5.
    Because some of the interpretations provided by the agency prior to 
2003 led some manufacturers to believe that the products they 
manufactured were already on the TSCA Inventory if their precursor 
substances were on the TSCA Inventory, some manufacturers of activated 
phosphor products have not submitted PMNs required under TSCA section 
5. This chemical identification problem is similar to one involving 
monomer acid and its derivatives, which was resolved through Agency-
industry dialog and a period for submission of new notices (Correction 
to Chemical Nomenclature for Monomer Acid and Derivatives for TSCA 
Inventory Purpose published in the Federal Register issue of June 27, 
2001 (66 FR 34193) (FRL-6784-6). The Agency is proposing to address 
this activated phosphor situation in a similar manner.

III. Proposed TSCA New Chemicals Program Policy for Activated Phosphor 
Chemical Identity

    EPA is proposing that the portion of EPA's earlier interpretations 
indicating that activated phosphors are mixtures rather than chemical 
substances in their own right was erroneous, and that TSCA Inventory 
listing would be required for these materials. Under this proposal, 
PMNs would be required for activated phosphors not on the TSCA 
Inventory (and for which a TSCA section 5(h)(4) exemption has not been 
granted) and which are manufactured on or after the effective date of 
the final clarification. In accordance with TSCA Inventory correction 
guidelines published in the Federal Register issue of July 29, 1980 (45 
FR 50544), activated phosphors that were never reported for the Initial 
TSCA Inventory are not eligible for TSCA Inventory correction as an 
alternative to PMN submission.

A. What is the Basis for and Scope of this Proposed Chemical 
Identification Clarification?

    EPA no longer considers to be valid the chemical identity 
interpretation that activated phosphors are mixtures rather than 
chemical substances in their own right. Thus listing on the TSCA 
Inventory established at TSCA section 8(b) is required for these 
chemical substances. The proposed chemical identity clarification would 
affect anyone who manufactures or imports, or who plans to manufacture 
or import, an activated phosphor not now listed on the TSCA Inventory.

B. What Are the Key Dates and Provisions of this Proposed Chemical 
Identification Clarification?

    The effective date for this proposed new chemical identity 
clarification, described in Unit II.B. would be 12 months following the 
date of publication of the final chemical identification clarification 
document in the Federal Register. Prior to this effective date, 
companies would be allowed to continue commercial production of non-
TSCA Inventory listed activated phosphors under the old, incorrect 
chemical identity interpretation. After the effective date, any 
manufacturer making non-TSCA Inventory listed activated phosphors for 
non-exempt commercial purposes would no longer be in compliance with 
TSCA section 5. Therefore, companies would need to submit PMNs or 
exemption applications at least 90 days before the effective date to 
ensure that Agency review is completed before this chemical 
identification clarification takes effect. Continued commercial 
production prior to expiration of the applicable review period would be 
allowed if it were during the year following the date of publication of 
the final chemical identification clarification document in the Federal 
Register and applies only to activated phosphor materials already being 
made.
    EPA will work closely with chemical manufacturers and importers to 
resolve chemical identity issues for any specific material for which 
the manufacturer believes the incorrect activated phosphor 
interpretations may still have applicability.
    To facilitate the PMN process for activated phosphors currently 
using the incorrect chemical identification, EPA

[[Page 2858]]

would allow an exception to its TSCA new chemicals program policy of a 
limit of six chemical substances per consolidation notice for these 
chemical substances. However, consistent with the Agency's chemical 
identification requirements for consolidated notices, submitters must 
use the Chemical Abstracts Service (CAS) Inventory Expert Service to 
develop correct Chemical Abstracts (CA) names for all of their reported 
chemical substances, in accordance with Method 1 as described in the 
Premanufacture Notification regulations, 40 CFR 720.45(a)(3)(i). EPA 
encourages persons intending to manufacture activated phosphors to file 
PMNs using the proper chemical identity immediately instead of delaying 
their submissions to near the effective date of this proposed document.
    PMNs filed in response to this chemical identification 
clarification should, as specified in 40 CFR 720.50, include all 
information normally included with a PMN submission, such as toxicity 
data on the PMN chemical substance that are in the possession or 
control of the PMN submitter, or known to or reasonably ascertainable 
by the PMN submitter.

C. What Are the Consequences of Not Submitting a PMN and Completing PMN 
Review on an Activated Phosphor Before the Effective Date of this 
Proposed Chemical Identification Clarification?

    Starting on the effective date of the final chemical identification 
clarification document, anyone manufacturing (includes import) for a 
non-exempt commercial purpose an activated phosphor that is not 
specifically listed on the TSCA Inventory would be in violation of 
TSCA. Penalties of $32,500 per violation per day are possible.

D. Would a PMN Be Required for Persons Who Did Not Submit One Due to an 
Incorrect EPA Interpretation, Regardless of Whether They Still 
Manufacture the Chemical Substance?

    A PMN would have to be submitted by any person who intends to 
manufacture or import an activated phosphor not on the TSCA Inventory 
for a non-exempt commercial purpose on or after the effective date of 
the final chemical identification clarification document. If future 
manufacture is not intended, no PMN need be submitted. For example, if 
you manufactured such a phosphor in 1986 but are not currently 
manufacturing nor intending to resume manufacture, you would not be 
required to submit a PMN at this time. However, if you later form an 
intention to manufacture the activated phosphor after the effective 
date of the final chemical identification clarification document, you 
would need to submit a PMN 90 days before commencing manufacture.

IV. Do Certain Statutory and Executive Order Reviews Apply to this 
Action?

    No. This document presents the Agency's clarification of the TSCA 
Inventory chemical identification principles. This action is not a 
regulatory action or significant guidance document under Executive 
Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 
October 4, 1993), as amended by Executive Order 13422 (72 FR 2763, 
January 23, 2007). As such, this action does not require review by the 
Office of Management and Budget (OMB) under Executive Order 12866. In 
addition, Executive Orders 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997) and 13211, entitled Actions Concerning Regulations that 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001), do not apply to this action because it is not 
``economically significant'' as defined by section 3(f) of Executive 
Order 12866. Nor does this action establish an environmental standard 
that may have a negatively disproportionate effect on children, or 
otherwise have any significant adverse effect on the supply, 
distribution, or use of energy.
    This document does not contain any new information collection 
requirements that would require additional review and approval by OMB 
under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). The 
information collection activities related to the submission of 
information pursuant to TSCA section 5 are already approved by OMB 
under OMB Control No. 2070-0012 (EPA Information Collection Request 
[ICR] No.574). The burden for that ICR is estimated to average 100 
hours per respondent, including time for reading the regulations, 
processing, compiling, and reviewing the requested data, generating the 
request, storing, filing, and maintaining the data. Under PRA, an 
agency may not conduct or sponsor, and a person is not required to 
respond to a collection of information unless it displays a currently 
valid OMB control number, or is otherwise required to submit the 
specific information by a statute. The OMB control numbers for the EPA 
regulations that are codified in 40 CFR chapter I, after appearing in 
the preamble of the final rule, are further displayed either by 
publication in the Federal Register or by other appropriate means, such 
as on the related collection instrument or form, if applicable. The 
display of OMB control numbers for certain EPA regulations is 
consolidated in a list at 40 CFR 9.1.
    As indicated previously, this action is not subject to the notice-
and-comment requirements under the Administrative Procedure Act (APA) 
(5 U.S.C. 551 et seq.) or any other statute. As such, it is not subject 
to the provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
et seq.). Further, this action is expected to only have a limited 
impact because only entities which are now manufacturing such a 
chemical substance, and which have not already prepared and submitted a 
PMN to EPA, must submit a PMN as a result of this action if they intend 
to continue manufacturing it.
    Based on EPA's experience with review of PMNs, State, local, and 
Tribal governments have not been impacted by these activities, and EPA 
does not have any reason to believe that any State, local, or Tribal 
government would be impacted by this action. As such, this action will 
not have substantial direct effects on the States or on the 
relationship between the national government and the States or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Nor does this action significantly or 
uniquely affect the communities of tribal governments as specified by 
Executive Order 13175, entitled Consultation and Coordination with 
Indian Tribal Governments (65 FR 67249, November 9, 2000). In addition, 
EPA has determined that this regulatory action would not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
affect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4).
    This action does not involve any technical standards that require 
the Agency's consideration of voluntary consensus standards pursuant to 
section 12(d) of the National Technology Transfer and Advancement Act 
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).
    This action will not have an adverse impact on the environmental 
and health conditions in low-income and minority communities. 
Therefore, under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and

[[Page 2859]]

Low-Income Populations (59 FR 7629, February 16, 1994), the Agency is 
not required to and has not considered environmental justice-related 
issues.

List of Subjects

40 CFR Part 704

    Environmental protection, Chemicals, Confidential business 
information, Hazardous substances, Imports, Reporting and recordkeeping 
requirements.

40 CFR Part 720

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

40 CFR Part 721

    Environmental protection, Administrative practice and procedure, 
Chemicals, Hazardous substances, Imports, Labeling, Occupational safety 
and health, Reporting and recordkeeping requirements.

40 CFR Part 723

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


    Dated: January 10, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
[FR Doc. E8-681 Filed 1-15-08; 8:45 am]

BILLING CODE 6560-50-S
