The Color Pigments Manufacturers Association Comments on EPA's HPV NPRM: A CRE Review
VIA FEDERAL EXPRESS
Environmental Protection Agency
Dear Sir or Madam:
I am writing on behalf of the Color Pigments Manufacturers Association, Inc. ("CPMA"). These comments are provided in response to the Proposed Rule and Notice, Testing of Certain High Production Volume Chemicals; Data Collection and Development on High Production Volume ("HPV") Chemicals, 65 Fed. Reg. 81658. December 26, 2000, (the "Proposed Rule").
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 United States, accounting for 95 & of the production of color pigments in North America. Color Pigments are widely used in product compositions of all kinds, including paints, inks, plastics, glass, synthetic fibers, ceramics, colored cement products, textiles, cosmetics, and artist's colors. Color pigments manufacturers located in other countries with sales in Canada, Mexico, and the United States, and suppliers of intermediates to the color pigments industry are also members of the Association.
Color Pigments Background
The CPMA has defined pigments as "Colored, black, white, or fluorescent particulate organic or inorganic solids which usually are insoluble in, and essentially physically and chemically unaffected by, the vehicle or substrate in which they are incorporated. They alter appearance by selective absorption and/or by scattering of light. Pigments are usually dispersed in vehicles or substrates for application, as for instance in the manufacture of inks, paints, plastics, or other polymeric materials. Pigments retain a crystal or particulate structure throughout the coloration process."
A critical characteristic of color pigments, therefore, is stability and insolubility in the substrate which makes up the final use of the color pigment. Indeed. this characteristic defines in large part the quality and value of a color pigment in the marketplace. The more stable a color pigment remains in harsh environments, including outdoor applications, the more valuable that pigment will be in the marketplace. Such stability has environmental benefit since stable coloring does not require re-coloring or replacement of the colored product.
With only a few recognized exceptions, color pigments, both organic and inorganic, are extremely insoluble in water. As an example, copper phthalocyanine organic pigments have a maximum solubility of less than a part per trillion. A solubility in water could not be calculated for chrome antimony titanate, an inorganic pigment, since the pigment cannot be dissolved sufficiently in boiling sulfuric acid to create a calibration curve. Color pigments are not, therefore, a threat to the environment when disposed of with solid waste in appropriate lined landfills. Color pigments are further protected from leaching into groundwater by the plastics, paints and inks that make up the final products incorporating color pigments.
Toxicity of Organic Pigments
Organic pigments are extremely insoluble. As a result, these compounds are non-toxic and very low in bioavailability. In the literature, there are three published summaries concerning the acute toxicity of pigments.1 The vast majority of these LD50 values are above 5000 mg/kg and no LD50 values for pigments are known to be below 2000 mg/kg. As such, when compared to other compounds, organic pigments are not, and should not, be assigned a high regulatory priority based on toxicity. Since these compounds have been found to be safe in extremely high doses, priorities and resources should be directed toward compounds which raise concerns.
Therefore, due to their extremely low solubility, in both lipids and water, organic pigments are not bioaccumulative nor do they bioconcentrate in the food chain. This has been shown by extensive tests which have indicated that, even though log P values for organic pigments may be calculated at levels that would signal concern, in actual tests, organic pigments do not exhibit any potential to bioaccumulate.
We have a number of concerns with the Proposed Rule: These concerns include:
Mandatory testing, apart from the Voluntary program. should be phased in after a careful examination of the subject chemical and discussions with the manufacturers and users of the chemical proposed for this type of rulemaking.
Test rules of this type, involving long established products in the marketplace, should be carefully phased in only after discussions with the industries making and using the subject chemical. The assumption implicit in the HPV program as it has developed appears to be that nothing is actually known of the subject chemicals and there is little understanding of toxicity characteristics. We cannot agree with this assumption. Certainly, for color pigments this assumption is not correct. EPA appears to have adopted, with considerable pressure from all sides, a one size fits all program. For example, there are obviously compounds for which many of the SIDS endpoints EPA has adopted do not apply. It is now well known in the literature that Log 1Cor bioaccumulation predictions are meaningless for many stable, highly hydrophobic substances and highly stable inorganic substances such as titanium dioxide. EPA's Science Advisory Board has on several occasions expressed concern over assumptions that such compounds are bioaccumulative due to inapplicable modeling estimations. As discussed above, these estimations do not fit for organic pigments. We strongly believe that the best way to avoid unnecessary and redundant testing of existing products is to review products on the market carefully with the industry in order to determine which tests, if any, are required to characterize the substance based on that review, which should include an understanding of the experience gained from years of production, use and disposal.
Experience and an understanding of the physical properties of the subiect chemicals, especially extremely stable compounds such as color pigments, should be built into the EPA program.
There is no substitute for experience. The testing protocol for HPV substances should begin with an understanding of the subject chemicals. Without such analysis much of the proposed testing may be unnecessary, wasted effort and resources, merely proving characteristics previously identified and wellunderstood within the industries that manufacture or use the subject compound. In the case of the color pigments identified in the HPV program, this background could be very important. Many of the subject color pigments have been in use for fifty to one hundred years. These products have been used for color printing inks, paints, plastics and other applications. It would appear likely that if there were hidden. previously unknown, toxicological characteristics or properties, which cause some concern in disposal and waste systems in the exterior environment, such concerns would have been identified by now. Since many of the pigments EPA identified in the HPV program are classical ink pigments, these pigments are produced almost universally around the world for colored printing ink in three color processes. Mysterious, previously unknown risk characteristics appear highly unlikely.
EPA states in the proposed rule that:
"In addition participants in the voluntary HPV Challenge Program may conclude that certain endpoints need not be tested if, given the totality of what is known about a chemical, including human experience, there is sufficient existing data that is consistent with the Agency's guidance on determining the data adequacy." 65 Fed. Reg. 81690
The EPA does not, however, substantiate this statement. We find no reasonable method by which human experience could meet the data adequacy as such is now defined and enforced by EPA in its comments on robust summaries filed to date.
Will EPA recognize HPV-Screening Inventory Data Set ("SIDS") Dossiers assembled under the Organization for Economic Cooperation and Development ("OECD") SIDS program with sponsorship of member countries?
As we have just discussed, organic pigments, especially the classic organic ink pigments, are produced in countries throughout the world for basic three-color printing processes. As a result, many if not most of these pigments have been or are being tested under the DECD-SIDS program. Indeed, if structural analog analysis is used for the limited number of pigments that are not covered by the OECD program, there will be no additional testing of classical ink pigments required under the HPV program. Since the OECD program is the predecessor of the U. S. program and the U. S. has adopted the SIDS dossier as its model, we assume that chemicals analyzed under the international program with sponsorship by member countries will satisfy EPA's program. 65 Fed. Reg. 81690. If that is not the case we request an explanation of EPA's procedures.
We do not believe it was appropriate for EPA to issue final testing guidance rules without reasonable notice and public conunent procedures.
In EPA's Final Rule dated December 15, 2000, entitled "Toxic Substance Control Act Test Guidelines"; (the "Final Rule") EPA has issued a Final Rule creating a significant burden to many industries without reasonable notice and public comment procedures.
EPA states that:
"Establishment of the guidelines provides a series of standardized test procedures and is necessary to ensure enforceable test standards in test rules promulgated under Section 4 of TSCA. Codification of this series of TSCA test guidelines does not by itself impose obligations upon any person. Obligations are only imposed when these guidelines are crossreferenced in a test rule promulgated under Section 4 of TSCA. " 65 Fed. Reg. 78746
We strongly disagree with this statement. These TSCA test guidelines, published two weeks before the Proposed Rule, create, in effect, a required standard that must be met by the hundreds of companies who, through sponsorship or later proposed test rules, will apply these procedures or compare existing data to these procedures. EPA states in the preamble to the rule that all manufacturers and all importers are potentially affected entities.
In issuing the Final Rule as EPA has done, EPA has attempted to foreclose any comment on the actual tests and procedures included in the tests that are required under a TSCA test rule. When the test rule is published, the impacted entity only has one option, to comment, argue or contest the test rule itself. The Final Rule prevents the impacted entity from making any meaningful comment on whether the standard test procedures in the Final Rule are appropriate.
A plain reading of the TSCA statute would indicate that the Administrator must first determine that a chemical requires testing before determining how the chemical is to be tested. 15 U.S.C.A. '2603(a) and (b). Many of the tests described in the Final Rule are very costly, ranging from hundreds of thousands of dollars to well over one million dollars. The TSCA developmental neurotoxicity and chronic toxicity protocol are two examples of extremely expensive tests with controversial requirements. To state that a Final Rule such as this poses a burden on no-one and therefore does not deserve a reasonable notice and public comment rule making process is obviously not true.
The endpoint parameters which EPA has requested for Alkali Blue Pigment CAS Number 132476-1 do not appear appropriate given the background and experience in use for this important pigment.
As discussed in our comments above, we believe that EPA should first make some reasonable investigation into the need for new studies before requiring such tests. Merely checking a public database for available studies is not sufficient. Alkali blue is an extremely safe, stable pigment commonly used in many applications including printing inks. This pigment has been produced and sold for use in ink products for decades. Certainly, with a product such as this it would make more sense to collect available data on the physical properties of the product and then discuss what additional screening tests, if any, are warranted. Given its lack of water solubility or toxicity, there would not appear any rational reason to immediately undertake involved mammalian toxicity tests on alkali blue. Certainly any such test should only be planned after other parameters such as mutagenicity are reviewed. Given the very large production and use of this pigment, if it were the case that alkali blue posed an unknown risk to humans, including workers, we would know that at this point.
The batch manufacturing chemical industry has disproportionately more of an economic burden in responding to the HPV program.
The CPMA is an association of small, medium and large batch manufacturers. We find that the HPV program generally has been tailored much more for commodity chemical manufacturers.
CPMA member companies produce hundreds of color pigment products on a custom batch basis. Additionally, there can be many variations in each color pigment in terms of physical properties such as particle size to adjust performance characteristics. While many of our members may make an HPV chemical, such chemicals are not produced in continuous processes. In most cases an HPV pigment product is only a small fraction of a facility's total production of pigments. Economically, it is far more difficult for the batch producer to fund extensive studies for any one product among hundreds. This is due to the fact that isolated individual products are simply not a sufficient portion of total sales to warrant such expenditures. Furthermore, the color pigment business allows for manufacturers, and in particular importers, to take steps to avoid these testing products by simply shifting production to similar, though not precisely the same, color pigments. The HPV pigment then is not being sold and therefore not funded by the importer. The importer can vary products many times over a period of eight to ten years as new HPV compounds are identified from inventory update processes. We believe strongly that EPA should amend the voluntary program to allow for more flexibility in analyzing batch products over a more reasonable period of time.
The timetables for testing outlined in the Proposed Rule and the timetables for consortia to provide robust summaries and test plans are not sufficient to produce good thorough assessments without placing undue burdens on manufacturers.
The timetable allotted by EPA in the Proposed Rule is not adequate. The timetable will force precipitous action and animal testing which may not be needed or efficient. By definition, it takes considerable time to identify all manufacturers and importers of a specific product. It takes more time to reach agreements on testing and begin the testing process. EPA's own descriptions in the Proposed Rule indicate that a specific order should be followed in undertaking these types of tests with physical parameters and estimations preceding more involved analysis. That process takes considerable time.
In particular, this timetable will be an excessive burden for batch manufacturers. Very few batch manufacturers have in-house toxicology and environmental experts available to do this coordinating work. Costly consultants with expertise in the industry must be identified and retained. Legal agreements may be required among consortia members, all of this activity requires considerable time before draft reports are even prepared for initial review. The thirteen months EPA has indicated in the Proposed Rule for completing all of these tasks is simply not enough time. Furthermore, the requirement that all consortia report within the first year of the voluntary program is similarly unreasonable. At a minimum several years should be allocated for these tasks. Many color pigments and many analogs of HPV color pigments have been and are being tested for various properties in laboratories around the world. It is extremely difficult and time-consuming to locate and collect all such data for products that in some cases have been manufactured for between fifty and one hundred years. The schedules for response in the voluntary program should also be extended several years to allow for a reasonable and thorough search of existing data and to plan efficient testing procedures.
EPA's public criticism of HPV test plans and summaries submitted to date have been in many cases unreasonablv restrictive with many requested responses acting only to raise costs in rewriting reports which are otherwise found reasonable.
We have reviewed the criticism EPA has publicly posted on HPV test plans and robust summaries posted to date on the internet. In most cases the remarks, invariably rejecting the submission without extensive revision, appear to be unnecessarily restrictive interpretations. These remarks appear to fall into a pattern of always wanting more data on existing study reports, after which EPA informs the submitter that only sixty days will be allowed for the correction of all deficiencies in the "voluntary" program. Both the criticism and the response time appear to be completely unreasonable. When studies of toxicological characteristics are undertaken many companies do not necessarily archive every record created in the course of the analysis. Indeed, very often all that survives is the final summary report of the study. Recently, we have noted that this is also true for the Federal government. Detailed protocols of all National Cancer Institute examinations are not in all cases available. Only final reports are available. To force repeating tests because stacks of laboratory backup data and long-forgotten detailed protocols are not available is not reasonable. This is especially true where premier laboratories and even government institutions are involved in completing the study.
We strongly believe that both the Proposed Rule for HPV testing and the Voluntary Program should be revised to allow for more time and flexibility in assessing chemicals and determining what tests, if any, should be undertaken. This should involve detailed discussions with industry to understand the properties, risks and exposures chemicals pose before new studies are undertaken. The analysis should be sufficiently flexible to incorporate experience with the subject chemical in a meaningful context.
We hope these comments help EPA in revising the HPV program to be more responsive and flexible.
Please call if we can be of further assistance or if you have any questions or comments.
EPA docket\01 April 23 HPV
1. ETAD published a summary concerning 4000 separate colorants, Clarke, E. A. and Anliker, R., "Organic Dyes and Pigments. "The Handbook of Environmental Chemistrv, Volume 3, Part A, 0. Hutzinger, Editor, Springer-Verlag, Berlin.), the National Printing Ink Research Institute ("NPIRI') tabulated LD50 data for 108 organic pigments (NPIR Raw Materials Data Handbook), Volume 4, Pigments, Francis MacDonald Sinclair Memorial Laboratory 7, Lehigh University, Bethlehem, PA 18105, 1983. 1983), and a NiFab Symposium lecture reviewed 194 pigments (Leist, K. H., "Toxicity of Pigments." NiFab Symposium in Stockholm, May 1980).