8266 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

§ 180.568 Flumioxazin; tolerances for 

residues. 

(a) * * * Tolerances are established 

for residues of flumioxazin, 2-[7-fluoro3,4-dihydro-3-oxo-4-(2-propynyl)-2H1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro1H-isoindole-1,3(2H)-dione, including 

its metabolites and degradates, in or on 

the commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only flumioxazin. 

Commodity Parts per million 

* * * * * 

Hop, dried cones .................. 0.05 

Leaf petioles subgroup 4B ... 0.02 

* * * * * 

Vegetable, cucurbit, group 9 0.03 

* * * * * 

* * * * * 

[FR Doc. 2010–3166 Filed 2–23–10; 8:45 am] 

BILLING CODE 6560–50–S 

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 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 


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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 

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, 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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8268 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

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 


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Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 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) 


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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 

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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Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 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 


cprice-sewell on DSK2BSOYB1PROD with RULES
8272 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

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 

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 

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). 

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: http:// 

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 http:// 

www.regulations.gov, including any 

personal information provided. 

FOR FURTHER INFORMATION CONTACT: 

Ms. Meredith Murphy, 703–602–1302. 

SUPPLEMENTARY INFORMATION: 

A. Background 

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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