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# 3~2 .1~8 / 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 NewUse 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 

# CONTAINSNOCBI 300NorthWashingtonStreet,Suite105"Alexandria,Virginia22314"USA Phone:(703)684-4044"Fax:(703)684-1795"e-mail:cpma@cpma.comMr . Ken Moss United States Environmental Protection Agency

Docket No. EPA-HQ-OPPT-2010-1075 February 23, 2012

Page 2 Intent to SubmitAdverse or Critical Comments (the "CPMANotice") Regarding the Regulated Substances. On December 5, 2011, in response to the November 2, 2011 CPMA Notice, EPApublished a Withdrawal of the Significant NewUse 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 NewUse 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 reviewall of the materials. EPAgranted the request for extension of the comment periodonJanuary 25, 2012 at 77 Fed. Reg. 3725. Comments on the Proposed Rule are nowdue 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 CPMAis an industry trade association representing color pigment companies in Canada, Mexico and the United States. CPMA represents small, mediumand 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 countrieswithsales in Canada, Mexico, and the United States, andsuppliers 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 EPAcontain EPA's Risk Assessment for the Regulated Substances. EPA's Risk Assessment states that there is no exposure expected to theMr. 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, fromthe Regulated Substances in finished form . EPA concluded that: "Human Health Effects Summary: Absorption: If calcined, absorption is expected to be nil via all routes based on physical/chemical properties. But if the PMNsubstances 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." EPAConsent Order and Determinations Supporting Consent Order, Section IV, EPA's Assessment of Risk. Since EPAhas 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 ofmetal 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 lowtemperatures, all of the rawingredients decompose to formmetal oxides at higher temperatures, this oxidemixbecomes 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 byMr. 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 newstructure 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 finishedproduct does not exist; with the calcining process, there is no purpose for Proposed Rule. the Only the calcined formof the Regulated Substance can exist, and the calcined substanceposes noexposure and, therefore, no risk. CPMAmembers 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 reviewof the Risk Assessment for the Regulated Substances and the extensive experience of our members with similar products, we find no risk associatedwith 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 ARecommended Exposure Level ("REL") Value FromaDraftNational 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 1.5mg per cubicmeter 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 titaniumdioxide as the source of this standard. EPAbased its NewChemical Exposure Limit on the draft REL cited inthe Draft Intelligence Bulletin at a level of 1 .5mg/m3proposed 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 titaniumdioxide. The 2.4 Mg/M3 level represents a significantly higher standard which compares with standards often cited for inert nuisance dusts. The final NIOSHlimit also confirms the general safety of titaniumdioxide 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 titaniumdioxide were relevant to the Regulated Substances, EPA would have to significantly revisethe riskassessment to incorporate a much higherREL. Intheprocess ofanalyzing the riskposedby 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, NoBenefitAnda ConflictWith EPAPolicy in EPA Establishing Another Workplace Exposure Limit in the Formof 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 "InorganicTin 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 5mg/m3. The standards are codified in the regulations of the Occupational SafetyMr . 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 forAir Contaminants, andTable 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 NewChemical Exposure Limit ("NCEL"), such as the Regulated Substances. In its Response to External Comments On NewChemical 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, lowsoluble 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 InorganicTin. 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 NIOSHThreshold Limit Value and the ACGIHexposure limit automatically generate an obligation on the part of manufacturers and importers to notify downstreamusers 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 fromOSHA. There is no need for EPAto require the development of additional and different regulatory monitoring techniques for the Regulated Substances. The risk assessment for the Regulated Substances refers toa 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 TeamReport, 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 NewChemical Exposure Limit pursuant to the Proposed Rule. Further action on this issue fromthe 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 NotEvidence aRiskWarranting 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 EPAanalysis 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 titaniumdioxide.Mr . Ken Moss United States Environmental Protection Agency

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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 productionof 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 bioavailabilityof 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 concernexpressed in the StructureActivity Report ismetal 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 thisMr. 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 fromthe 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 whichwouldprevent 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 newstandard, and no unregulated overexposure that requires EPA regulation of the Regulated Substances.

TitaniumDioxide Is Not an Analog Surrogate for the Regulated Substances EPA claims that titaniumdioxide represents a similar, respirable, poorly solubleparticle. (EPAChemical Categories Report .) This conclusion is unsubstantiated for the Regulated Substances. The Proposed Rule is premised onEPA'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 titaniumdioxide 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 titaniumdioxide, zincoxide and tin oxide, based onthepublished 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 chromiumoxide, titaniumdioxide and iron oxide, as coloringMr. 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 andphysiological properties, since theyno 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 termoutdoor 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 evaluationof the Regulated Substances and complex inorganic pigments should be based on the finished crystal formof 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 showany allergic reaction.2 These findings have alsobeen shown inanimal studies of complex inorganic titanate pigments. For example, in a Japanese study, nickel-titaniumyellowwas 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 frommetal 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 inwater, 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. maximumfastness 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 followingTitanate Pigments: C.I . Pigment Yellow53 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 termis generally defined by various international jurisdictions, including the EPA. The average particle size for this pigment in use would be greater than 100nanometers. 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 newformulated products. Newenergy 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. Ifthe RegulatedSubstances are regulatedaspublished inthe ProposedRule, customers are unlikely to incur the compliance costs required for use of the Regulated Substances. The result is a loss of important newproducts 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 theMr. 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 newuse" the absence of these "protective" measures. If triggered by the import or manufacture of the Regulated Substance for a Significant NewUse, EPA would require the importer or manufacturer to notify EPAof the newuse 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 EPAEconomic Assumptions Regarding the Proposed Rule Pursuant to the Regulatory FlexibilityAct 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 substantialMr. Ken Moss United States Environmental Protection Agency

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Page 19 number of small entities. The requirement to submit a [Significant NewUse 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 frommanufacturing 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 fromTSCAand, therefore, exempt fromthe Proposed Rule. As a result, foreign manufacturers of finished products will be able to use the Regulated Substances in paints andplastics whichare incorporated into finishedproducts 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

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February 23, 2012

Page 20 Chapter 6of the Book Entitled "HighPerformancePigments" Regarding "Titanate Pigments: Colored Rutile, Priderite, and Pseudobrookite Structured Pigments"

CPMAsubmitted information to describe for EPAthe 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 titaniumpigments 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, 2009Mr . 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 rawmixtures 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 andmetal oxide compounds. The Regulated Substances, the titanates discussed in the enclosed Chapter 6and the blendedmixtures ofmetal 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 formof the Regulated Substance fromthe Proposed Rule. Since there is no other formof 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 bewithdrawn. 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