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COLOR PIGMENTS MANUFACTURERS ASS"q,. Pl~ ,INC . . a~ . 

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February 23, 2012 

VIA FEDERAL EXPRESS 

Mr . Kenneth Moss 

Director, Chemical Control Division 

United States Environmental 

Protection Agency 

1200 Pennsylvania Avenue N .W . (Mail Code 7405M) 

Washington, D .C . 20460 

Re : Comments of the Color Pigments Manufacturers 

Association Inc. on the Proposed Significant New Use 

Rules on Rutile, Tin Zinc, Calcium-Doped, Chemical 

Abstracts Service Number ("CAS") 389623-01-2 and 

Rutile, Tin Zinc, Sodium-Doped CAS Number 

389623-07-76, 76 Fed . Reg. 81441 

Docket No . EPA-HQ-OPPT-2010-1075 

Dear Sir or Madam : 

I am writing on behalf of the Color Pigments Manufacturers 

Association, Inc . ("CPMA") regarding the Proposed Significant New Use Rules 

for Rutile, Tin Zinc, Calcium-Doped, Chemical Abstracts Service ("CAS") 

Number 389623-01-2 and Rutile, Tin Zinc, Sodium-Doped, CAS Number 

389623-07-76 (collectively, the "Regulated Substances"), 76 Fed. Reg. 81441 

(the "Proposed Rule") . 

The Significant New Use Rules for the Regulated Substances were first 

published on October 5, 2011 as Direct Final Rules at 76 Fed . Reg . 

61566-61587 . On November 2, 2011, CPMA submitted a written Notice of 

CONTAINS NO CBI 

300 North Washington Street, Suite 105 " Alexandria, Virginia 22314 " USA 

Phone: (703) 684-4044 " Fax: (703) 684-1795 " e-mail : cpma@cpma.com 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 2 

Intent to Submit Adverse or Critical Comments (the "CPMA Notice") Regarding 

the Regulated Substances . On December 5, 2011, in response to the November 

2, 2011 CPMA Notice, EPA published a Withdrawal of the Significant New Use 

Rules for the Regulated Substances pursuant to 40 CFR § 721 .160 (c) (3) and 

40 CFR § 721 .170 (d) (4) at 76 Fed . Reg . 75794 . The Significant New Use 

Rules for the Regulated Substances were published for public comment in 

the Proposed Rule on December 27, 2011 at 76 Fed. Reg . 81441 . On December 

29, 2011, CPMA submitted a letter requesting an extension of the comment 

period for the Proposed Rule . 

CPMA's request for extension of the comment period was based on the 

EPA release on December 21, 2011 of the bulk of the record developed by 

EPA to support the Proposed Rule . It should be noted that there remain 

issues as to serious redactions of these materials and failure to provide 

sixteen pages due to EPA copyright problems, despite the fact that 

rulemaking relies upon these materials . Since the information was not 

available in the docket and to some extent is still not, an additional 30 

days for comment was requested to facilitate a reasonable and complete 

opportunity for the CPMA to obtain and review all of the materials . 

EPA granted the request for extension of the comment period on January 

25, 2012 at 77 Fed . Reg . 3725 . Comments on the Proposed Rule are now due 

February 26, 2012 . 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 3 

Introduction 

The CPMA is an industry trade association representing color pigment 

companies in Canada, Mexico and the United States . CPMA represents small, 

medium and large color pigments manufacturers throughout Canada, Mexico, 

and the United States, accounting for the bulk of the production of color 

pigments in North America . Color pigment manufacturers located in other 

countries with sales in Canada, Mexico, and the United States, and suppliers 

of intermediates to the pigments industry are also members of the 

Association . 

The Proposed Rule indicates that, prior to its publication, EPA 

entered a Consent Order for the manufacture of the Regulated Substances 

under the Toxic Substances Control Act ("TSCA") sections 5 (e) (1) (A) (I) and 

5(e)(1)(A)(ii)(I), which regulate the inventory of substances which can 

be manufactured, imported, processed and sold in the United States (the 

"Inventory") . The Proposed Rule is intended to establish requirements 

similar to those contained in the terms of the Consent Order and apply those 

requirements to all manufacturers which presently produce or import the 

Regulated Substances or begin producing the Regulated Substances in the 

future . 

The Safety of the Regulated Substances 

The background documents placed in the electronic docket on December 

21, 2012 by EPA contain EPA's Risk Assessment for the Regulated Substances . 

EPA's Risk Assessment states that there is no exposure expected to the 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 4 

Regulated Substances, and therefore no exposure to titanium dioxide or 

other ingredients, from the Regulated Substances in finished form . 

EPA concluded that : 

"Human Health Effect s Summary : 

Absorption : If calcined, absorption is expected to be nil 

via all routes based on physical/chemical properties . 

But if the PMN substances are not calcined, then absorption 

is expected to be nil via the skin based on 

physical /chemical properties, and poor through the lungs 

and GI tract based on analog data ." EPA Consent Order and 

Determinations Supporting Consent Order, Section IV, 

EPA's Assessment of Risk . 

Since EPA has concluded that absorption is nil via all relevant routes 

for the calcined product, EPA has determined that there can be no risk 

warranting regulation under the Proposed Rule . Without calcining, the 

Regulated Substance would consist of a mixture of metal oxides of titanium, 

tin and zinc . These metal oxides are established on the TSCA Inventory 

and have established workplace control limits where warranted . The 

Regulated Substances can only be formed in the sustained high temperatures 

used in the calcining process . The calcining process for manufacturing 

complex inorganic color pigments is described as : 

"Complex Inorganic Color Pigments ("CICPs") are made by 

calcination (strong heating in air) of blends of metal 

oxides and/ or oxide precursors such as metal salts, 

hydrates, and carbonates . Calcination temperatures 

typically range from 650 degrees to 1300 degrees 

centigrade . At relatively low temperatures, all of the 

raw ingredients decompose to form metal oxides at higher 

temperatures, this oxide mix becomes reactive . Metal and 

oxide ions become mobile and interdiffuse to create a 

homogeneous solid . The ions in the solid then rearrange 

to a stable crystalline structure that is determined by 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 5 

the metals present, the oxide to metal ratio, and the 

calcining temperature . This new structure is the color 

pigment ."' 

There is no known alternative industrial process for making finished 

products such as the Regulated Substances or similar complex inorganic 

color pigments . 

substances such 

Therefore, without a calcining process in which 

as the Regulated Substance are formed, the finished product 

does not exist ; with the calcining process, there is no purpose for 

Proposed Rule . 

the 

Only the calcined form of the Regulated Substance can 

exist, and the calcined substance poses no exposure and, therefore, no risk . 

CPMA members manufacture numerous products similar to the Regulated 

Substances . For over fifty years these similar products have provided 

safe, effective, permanent color in thousands of plastic, glass and coating 

products . Therefore, based on our review of the Risk Assessment for the 

Regulated Substances and the extensive experience of our members with 

similar products, we find no risk associated with the Regulated Substances 

substantiated in the record for the Proposed Rule . CPMA objects to the 

Proposed Rule and the 

Substances . 

necessity for any restrictions on the Regulated 

"High Performance Pigments", Second, Completely Revised and 

Extended Edition, edited by Edwin B . Faulkner and Russell J. Schwarz, 

Wiley VCH, Weinheim, Germany, 2009 . Chapter 5, p.44, on Complex 

Inorganic Color Pigments written by James White, Ph .D . of Shepherd 

Color Company. 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 6 

EPA Relied on A Recommended Exposure Level ("REL") Value 

From a Draft National Institute of Occupational Safety and 

Health ("NIOSH") Report . The Validity and Relevance of 

EPA's Risk Assessment Must be Reviewed In Light of the 

Value Contained in the Final NIOSH Report 

In the Proposed Rule, EPA restricts uncontrolled exposures to the 

Regulated Substances to levels of 1 . 5 mg per cubic meter air (,,Mg/M311) 

. The 

Proposed Rule cites a draft 2006 National Institute of Occupational Safety 

and Health ("NIOSH") Intelligence Bulletin for the Recommended Exposure 

Level ("REL") of 1 .5 Mg/M3 to fine titanium dioxide as the source of this 

standard . EPA based its New Chemical Exposure Limit on the draft REL cited 

in the Draft Intelligence Bulletin at a level of 1 . 5 mg/m3 proposed by NIOSH . 

The Final NIOSH Intelligence Bulletin was issued in 2011 and set a higher 

REL of 2 .4 mg/m3 for exposure to fine titanium dioxide . The 2 .4 

Mg/M3 level represents a significantly higher standard which compares with 

standards often cited for inert nuisance dusts . The final NIOSH limit also 

confirms the general safety of titanium dioxide at all but the most extreme 

dust levels . Given the value and cost of producing synthetic substances, 

such as the Regulated Substances, which mimic natural minerals and 

gemstones and comprise large, non-nano-sized particles, there is little 

or no potential for workplace exposures to approach such high 

concentrations . Unlike the natural occurring minerals, the Regulated 

Substances are substantially free of soluble heavy metal salts . 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 7 

Furthermore, to the extent that such extreme exposure could occur, 

these exposures would be regulated, since they are at present regulated 

by the inorganic metal dust permissible exposure limits and restrictions 

on airborne nuisance dusts . The existing exposure standards applicable 

to the metal oxides used in production and existing requirements for 

workplace safety such as the confined space entry standard also regulate 

the use of the Regulated Substances in the workplace . 

Therefore, even if the risk assessment based on titanium dioxide were 

relevant to the Regulated Substances, EPA would have to significantly 

revise the risk assessment to incorporate a much higher REL . In the process 

of analyzing the risk posed by the higher concentration level, the relevance 

and utility of the Proposed Rule must be questioned and reviewed by EPA . 

The Regulated Substances are Restricted Under Existing 

Workplace Permissible Exposure Limits . As a Result, 

There is No Need, No Benefit And a Conflict With EPA Policy 

in EPA Establishing Another Workplace Exposure Limit in 

the Form of a New Chemical Exposure Limit in the Proposed 

Rule 

The Regulated Substances contain tin as an ingredient in sufficient 

concentration to warrant including the word "Tin" in the name of the 

Regulated Substances . Therefore, the Regulated Substances are classified 

as "Inorganic Tin Compounds" . There is an existing, enforceable workplace 

exposure standard covering all exposures to Inorganic Tin Compounds . In 

addition, there is a separate standard applicable to all inert dust 

particles in the air, with a limit for all exposures of no more than 5 mg/m3 . 

The standards are codified in the regulations of the Occupational Safety 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 8 

and Health Administration (OSHA") at 29 CFR §1910 .1000, Subpart Z, Table 

Z-1, Limits for Air Contaminants, and Table Z-3, Mineral Dusts . Inorganic 

Tin Compounds, other than specific Tin Oxides, are restricted to exposures 

no higher than 2 .0 mg/m3 as tin, as an eight hour time weighted average . 

Since the Regulated Substances are Inorganic Tin Compounds, exposure to 

the Regulated Substances is regulated by the existing standards . 

EPA has established a policy of deferring to the OSHA PEL in cases where 

an OSHA PEL is promulgated for any substance subject to a New Chemical 

Exposure Limit ("NCEL"), such as the Regulated Substances . In its Response 

to External Comments On New Chemical Exposure Limits In TSCA 5 (e) Orders, 

EPA stated that : 

"EPA has added an explicit sunset provision to its 5(e) 

Orders which states that the NCEL and respirator 

requirements are automatically nullified if OSHA 

promulgates a PEL for the same substance ." EPA Response 

to Comments, p . 13 of 54 

Since OSHA standards for the Regulated Substances exist and are 

protective of any concern raised in the risk assessment for respirable, 

inert, low soluble dusts, there is no benefit to EPA establishing another 

exposure limit . Indeed, the establishment of an EPA limit conflicts with 

the policy EPA set in these circumstances, as stated above . 

NIOSH and the American Conference of Governmental Industrial 

Hygienists ("ACGIH") have also established recommended exposure levels for 

all forms of Inorganic Tin . In both cases, the recommended exposure limit 

is 2 mg/m3 of air . The existence of the OSHA permissible exposure limits, 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 9 

the NIOSH Threshold Limit Value and the ACGIH exposure limit automatically 

generate an obligation on the part of manufacturers and importers to notify 

downstream users through the existing Hazard Communication Standard, 29 

CFR §1910 . The analytical monitoring techniques relevant to the Inorganic 

Tin Compounds standard and for analysis for inert dust particles are well 

established and readily available from OSHA . There is no need for EPA to 

require the development of additional and different regulatory monitoring 

techniques for the Regulated Substances . 

The risk assessment for the Regulated Substances refers to a potential 

risk due to exposure to the Regulated Substances in quantities sufficient 

to cause a potential overload of inert particles . (See for example EPA 

Structure Activity Team Report, October 28, 2005, Case Number P06-0036, 

Docket Number, EPA-HQ-OPPT-2010-1075-0002, p . 4 of 106) The risk of such 

a lung overload is more than adequately controlled by the existing, 

enforceable OSHA standard for exposure to Inorganic Tin Compounds . Since 

the only identified risk is controlled by an enforceable regulation, there 

is no benefit to the establishment of another New Chemical Exposure Limit 

pursuant to the Proposed Rule . Further action on this issue from the EPA 

would be redundant, confusing and unnecessary . 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 10 

EPA's Health Risk Analysis Based on Structural Analogs 

Does Not Evidence a Risk Warranting Regulation Because the 

Regulated Substances Do Not Exhibit the Properties of 

Constituent Metals and Do Not Represent an Unregulated 

Dust Exposure 

In the record for the Proposed Rule, EPA raised concerns regarding 

the toxicity of the Regulated Substances based on a structural activity 

relationship analysis derived from the use of titanium dioxide, the 

potential bioavailability of constituent metals and the potential for 

inhalation exposure due to dust overload . The Structural Activity Team 

report of October 28, 2005 contains a significantly redacted analysis of 

the primary concerns raised by the EPA analysis of the Regulated Substances 

using analog comparison . Docket No . EPA-HQ-OPPT-2010-1075-0002, pp . 4-7 

of 106 . However, despite the redactions, sufficient information is 

presented in the Structure Activity Report and the record to identify the 

concerns raised by EPA in its overall health risk analysis . 

The concerns cited by EPA in the Structure Activity Report are : 

1 . Concern for immunotoxicity and reproductive 

toxicity if a constituent metal is 

bioavailable . 

2 . Concern forimmunostimulation, neurotoxicity, 

developmental toxicity and mutagenicity if a 

constiuent metal is bioavailable . 

3 . Concern for mutagenicity and lung toxicity if 

a constituent metal is bioavailable . 

4 . Concern for metal fume fever from inhaled 

exposure . 

5 . Respiratory tract toxicity from inhalation 

exposure to titanium dioxide . 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 11 

6 . Concern for lung toxicity from lung overload 

and fibrosis of respirable particles are 

inhaled . Concern for pulmonary oncogenicity 

due to crystalline nature of the Regulated 

Substances . 

Docket No . EPA-HQ-OPPT-2010-1075-0002, pp . 

4-7 of 106 . 

The EPA risk assessment, which concludes that absorption of the 

Regulated Substances is nill via all routes provided that the Regulatory 

Substances are calcined, addresses any remaining concern with bioavailable 

metals . (See the above discussion regarding the "Safety of the Regulated 

Substances" which includes a detailed description of the calcining 

process .) The calcining process, which is a necessary part of the 

production of the Regulated Substances, eliminates any concern for exposure 

to bioavailable metals from the Regulated Substances . Therefore, the 

concerns raised by EPA's Structure Activity Report, and repeated as points 

1 . to 3 . above, are all contingent on the bioavailability of the constituent 

metals in the Regulated Substances . Since the constituent metals are not 

bioavailable, there can be no concern for exposure to bioavailable metals . 

The fourth concern expressed in the Structure Activity Report is metal 

fume fever, presumably associated with molten tin or zinc . Metal fume 

fever cannot be a concern for the Regulated Substances . Again, the 

calcining process, used to manufacture these pigments at temperatures of 

approximately 1000 degrees centigrade, generates a finished product with 

very high heat stability . Only an equal amount of heat could release 

constituent metals in the environment or the workplace . Since this 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 12 

temperature is well above any working temperature used in a colored 

application such as paint or plastic, there is no potential for the release 

of constituent metals as metal fume from the use of the finished Regulated 

Substances . 

EPA's concern, as noted above in items 5 . and 6 ., with respiratory 

tract exposure involving a dust or particle exposure to the finished 

Regulated Substances is at best overstated and, in any event, is already 

regulated under existing exposure limits . The existing and enforceable 

standard for exposure to inorganic tin compounds requires warning of 

downstream users on Material Safety Data Sheets under the Hazard 

Communication Standard and restricts air exposure in the workplace to a 

level which would prevent significant overexposure to inert dust consisting 

of the Regulated Substances . Since an exposure of this magnitude is 

automatically regulated under the existing regulation, there is no need 

for EPA to assign a new standard, and no unregulated overexposure that 

requires EPA regulation of the Regulated Substances . 

Titanium Dioxide Is Not an Analog Surrogate for the 

Regulated Substances 

EPA claims that titanium dioxide represents a similar, respirable, 

poorly soluble particle . (EPA Chemical Categories Report .) This conclusion 

is unsubstantiated for the Regulated Substances . 

The Proposed Rule is premised on EPA's determination that the Regulated 

Substances may present an unreasonable risk of injury to human health . 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 13 

This determination is not substantiated by the risk assessment published 

by EPA in support of the Proposed Rule . In the Proposed Rule and 

supporting materials, EPA based its risk to human health on the 

determination that the Regulated Substances may cause lung overload and 

fibrosis in workers exposed by the inhalation route . 

Although titanium dioxide is used as an ingredient in the manufacture 

of the Regulated Substances, the calcined synthetic mineral, gemstone-type 

structure of the Regulated Substances does not exhibit the properties of 

the incorporated metal oxides . The safety of the calcined, finished 

Regulated Substance is recognized in the background documents and risk 

assessment for the Proposed Rule . Therefore, since the finished Regulated 

Substance does not exhibit the properties of the component metal oxides, 

including titanium dioxide, zinc oxide and tin oxide, based on the published 

Regulated Substance names, these oxides are not surrogates for the 

Regulated Substances . 

Structure and Composition of the Regulated Substances and 

Complex Inorganic Color Pigments 

The Proposed Rule indicates that the Regulated Substances are 

intended to be used as pigments . The Regulated Substances are similar in 

structure and proposed use to complex inorganic color pigments . Like the 

Regulated Substances, the crystalline lattice which makes up complex 

inorganic color pigments incorporates individual metal oxides, such as 

trivalent chromium oxide, titanium dioxide and iron oxide, as coloring 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 14 

components . The incorporated oxides completely lose their original 

chemical, physical and physiological properties, since they no longer exist 

as separate chemicals in the mixed phase crystalline lattice . These 

crystal structures are synthesized to mimic natural colored minerals and 

gemstones . These structures include zircons, corundums, spinels, 

rutiles, titanates and hematites . The complex inorganic structures lend 

extreme light and weather stability to complex inorganic color pigments . 

These pigments are often used in applications that require stability in 

the harshest long term outdoor environments . Due to their stability and 

lack of solubility, many of these pigments are also used in indirect food 

contact polymers and packaging . 

It is important to note that toxicological evaluation of the Regulated 

Substances and complex inorganic pigments should be based on the finished 

crystal form of the mixed phase entity, which is a solid solution, and not 

on the uncalcined metal oxides incorporated in their crystal structures . 

Although the metal oxides have been reported to trigger allergies ; it has 

been reported that workers exposed to these metal oxides as contained in 

complex inorganic color pigments for many years do not show any allergic 

reaction .2 These findings have also been shown in animal studies of complex 

inorganic titanate pigments . For example, in a Japanese study, 

nickel-titanium yellow was fed to rats in doses of 1 .5 and 10 grams per 

Endriss, H . and Rade, D. "Metal Oxide Mixed Phase 

Pigments", Kunstoffe German Plastics, Vol . 79, No .7, 1989, pp . 

618,620 . 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 15 

killogram body weight of feed without any evidence of toxicological 

effects .3 

The Regulated Substances and similar complex inorganic pigments are 

characterized by a synthetic, mineral, gemstone-type structure derived 

from metal oxides reacted in a calcining process at temperatures at or above 

1000 degrees centigrade . After the calcining process, these pigments are 

washed to remove residues of soluble salts and are ground to an acceptable 

particle size . These substances are almost completely insoluble in water, 

alkalis and mineral acids, with the exception of hot concentrated sulfuric 

acid . In the ambient environment, these pigments should not be considered 

a soluble or bioavailable source of metals . The Regulated Substances are 

characterized by the following technical performance properties : 

outstanding color, temperature and time dependent 

stability . 

maximum fastness to light and weather . 

absolute fastness to migration . 

very good chemical resistance . 

no negative effect on the mechanical properties of 

polyethylenes . 

absolute neutrality to distortion in 

polyolefins . 

The Regulated Substances are used generally in paints, plastics and 

glass applications . The large particle size and extremely hard 

Hara, et al ., "Pharmacological Studies of Titani 

Yellow with Regards to its Toxicity", Department of 

Pharmacology, Tokyo Medical College, 1963 . See also, 

organization for Economic Cooperation and Development, SIDS 

Initial Assessment Reports for the following Titanate Pigments : 

C .I . Pigment Yellow 53 and C .I . Pigment Brown 24 . 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 16 

crystalline gemstone structure of these pigments, coupled with the cost 

of production, make these pigments unsuitable for use in publication 

printing inks . 

The Regulated Substances and complex inorganic color pigments 

generally are not Nano-size particles, as the term is generally defined 

by various international jurisdictions, including the EPA . The average 

particle size for this pigment in use would be greater than 100 nanometers . 

The presence of any Nano-sized particles in complex inorganic color 

pigments or a product colored with the pigments would be incidental . 

Complex inorganic color pigments similar to the Regulated Substances 

have been tested for decades in color chip studies exposed to outdoor 

weathering in South Florida . The weather fastness of pigments, such as 

the Regulated Substances in use, is unmatched by other products . 

The Regulated Substances and complex inorganic color pigments are 

also significant pigments in architectural coatings, plastics and roofing 

materials for exterior use, due to their energy saving heat reflective 

properties . Scientists developing cool-paint and cool-roof architectural 

materials, which are designed to reflect heat and save cooling energy, 

prefer to utilize complex inorganic color pigments in their formulations . 

These pigments are valued for its their color, high heat reflective crystal 

structure and energy efficient weatherability after application . 

Important uses for these pigments involve exterior architectural paints, 

colored reflective roofing materials and plastics . 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 17 

The Regulated Substances are likely to have important and valuable 

uses which are beneficial to the environment when used in new formulated 

products . New energy saving cool roof and cool paint technologies for 

buildings and automotive applications being developed in government and 

industry laboratories require color pigments with the permanent, high 

performance, heat reflective characteristics of the Regulated Substances . 

If the Regulated Substances are regulated aspublished in the Proposed Rule, 

customers are unlikely to incur the compliance costs required for use of 

the Regulated Substances . The result is a loss of important new products 

which other manufacturers would otherwise choose to produce . 

The Costs and Economic Impact of the Proposed Rule 

Are Underestimated Significantly 

Based on our experience, the overall impact of the Proposed Rule will 

be a very significant chilling effect on commerce and innovation for the 

Regulated Substances and a potentially similar chilling effect on similar 

complex inorganic color pigments in commerce . In order to avoid incurring 

the costs and risks of on-going compliance, customers will not purchase 

the Regulated Substances and will not use the Regulated Substances in new 

formulated products . Because the Regulated Substances are similar to 

numerous other products already in commerce, the Proposed Rule may have 

an unintended impact on those similar products . 

The Proposed Rule would require manufacturers of the Regulated 

Substances to incur new costs for regulatory programs, such as the 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 18 

establishment of special hazard communication warnings, mandatory 

respirator use and special recordkeeping requirements . The Proposed Rule 

would also restrict all manufacture of the Regulated Substances for which 

10 percent by weight of the substance measured contains a particle size 

less than 100 nanometers ("Nano-sized particles") . The Proposed Rule 

designates as a "significant new use" the absence of these "protective" 

measures . If triggered by the import or manufacture of the Regulated 

Substance for a Significant New Use, EPA would require the importer or 

manufacturer to notify EPA of the new use and submit toxicological testing 

data prior to manufacture or import of the Regulated Substances . 

As an example, the Regulated Substances are likely to have important 

and valuable uses which are beneficial to the environment when used in new 

formulated products . If the Regulated Substances are regulated as 

proposed, customers are unlikely to voluntarily incur the ongoing 

compliance costs required for use of the Regulated Substances . The result 

is a loss of important new products which other manufacturers would 

otherwise choose to produce . 

The EPA Economic Assumptions Regarding the Proposed Rule 

Pursuant to the Regulatory Flexibility Act Do Not Reflect 

the Current Market 

EPA states in the Proposed Rule that : 

"Pursuant to section 605(b) of the Regulatory Flexibility 

Act (RFA) (5 U .S .C . 601 et seq .), the Agency hereby 

certifies that promulgation of this SNUR would not have 

a significant adverse economic impact on a substantial 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 19 

number of small entities . The requirement to submit a 

[Significant New Use Notice] SNUN applies to any person 

(including small or large entities) who intends to engage 

in any activity described in the final rule as a 

`significant new use' . Because these uses are "new', based 

on all information currently available to EPA, it appears 

that no small or large entities presently engage in such 

activities ." 

Nearly identical structural analogs of the Regulated Substances 

previously registered on the TSCA Inventory are produced by companies 

located in the United States and abroad . The Regulated Susbtances are 

produced abroad and imported into the United States in finished articles . 

The impacted companies include CPMA members, some of which are small 

businesses . Many more small businesses may use the Regulated Substances 

to manufacture formulated plastic, paint or ceramic products . 

The Proposed Rule Would Not Prevent the Use of the 

Regulated Substances in United States Commerce 

While the Proposed Rule, if finalized, will prevent United States 

manufacturers from manufacturing and using the Regulated Substances in 

finished products, it must be noted that articles imported now, or in the 

future, into the United States are exempt from TSCA and, therefore, exempt 

from the Proposed Rule . As a result, foreign manufacturers of finished 

products will be able to use the Regulated Substances in paints and plastics 

which are incorporated into finished products exported to the United States 

as articles exempt from TSCA . This is inherently unfair to domestic 

manufacturers . 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 20 

Chapter 6 of the Book Entitled "High Performance Pigments" 

Regarding "Titanate Pigments : Colored Rutile, Priderite, 

and Pseudobrookite Structured Pigments" 

CPMA submitted information to describe for EPA the calcine production 

process for the manufacture of the Regulated Substances and similar 

products . In a follow up response to that submission, you requested 

additional related information from the same cited source . In response 

to your request, we have enclosed Chapter 6 of the "High Performance 

Pigments ,4 book entitled, "Titanate Pigments : Colored Rutile, Priderite, 

and Pseudobrookite Structured Pigments" for your review . Chapter 6 is 

authored by John Maloney of Ferro Corporation in Cleveland, Ohio . We note 

that, although this Chapter discusses complex inorganic color pigment 

technologies and products similar to the Regulated Substances, Mr . Maloney 

does not address the specific patent history, production and chemistry 

associated with the Regulated Substances . 

The chemistry and specific production process associated with the 

Regulated Substances was first developed in Europe by Johnson Matthey in 

the mid 1980's . At that time, the Regulated Substances were the subject 

of patents covering the chemistry and production process in Europe and the 

United States . Therefore, although the enclosed Chapter by Mr . Maloney 

discusses titanium pigments including rutile pigments, and would appear 

Second Edition of the reference book entitled, "High 

Performance Pigments", edited by Edwin B . Faulkner and Russell J . Schwarz, 

Wiley VCH, Weinheim, Germany, 2009 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 21 

to cover the Regulated Substances it does not . The Regulated Substances 

represent a unique chemistry not covered specifically by the enclosed 

Chapter . 

In general, as discussed in the enclosed Chapter, the titanate 

pigments are similar to the Regulated Substances in that the titantes are 

"only formed upon high temperature calcination" . (Chapter 6 enclosed, p . 

58, Section 6 .3 Synthesis .) Titantes generally exhibit a particle size 

for the finished product greater than 1 micron and averaging less than 5 

microns . Like the Regulated Substances, the titanates discussed in 

Chapter 6 are not Nano-sized materials, nor are the bulk metal oxides used 

to manufacture titanates Nano-sized materials, as such terms are generally 

applied to materials with a particle size below 100 nanometers . Mr . 

Maloney refers to the raw mixtures of metal oxides prepared for calcining 

as being ideally an intimately blended combination of "nano particles" . 

We note that this concept is introduced as an ideal goal . However, 

to our knowledge, this goal is not achieved in actual production . In any 

event, all such processes are controlled by existing occupational safety 

and health standards which would apply to workplace exposures involving 

metals and metal oxide compounds . The Regulated Substances, the titanates 

discussed in the enclosed Chapter 6 and the blended mixtures of metal oxides 

used to manufacture these products are not Nano-sized materials . 
Mr . Ken Moss 

United States Environmental Protection Agency 

Docket No . EPA-HQ-OPPT-2010-1075 

February 23, 2012 

Page 22 

Conclusion 

The only reasonable course of action is for the EPA to remove the 

calcined form of the Regulated Substance from the Proposed Rule . Since 

there is no other form of the Regulated Substances other than the calcined 

substance, there is no substantiated risk addressed by the Proposed Rule 

for the Regulated Substances . The Proposed Rule should be withdrawn . The 

Regulated Substances should be placed on the TSCA Inventory without 

restrictions . 

Thank you for your assistance in this matter . Please call if there 

are any further questions . 

J. Lawrence Robinson 

President 

Cc : w/Enclosure 

United States Environmental 

Protection Agency 

OPPT Document Control Office (DCO) 

EPA East, Room 6428 

1201 Constitution Avenue N .W . 

Washington, D .C . 20460