Additions to the Master Testing List - Categories
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
The following categories have been targeted by EPA for testing needs and/or testing action development; the categories that are currently on the MTL (including those that have been added to the MTL since 1992) are as follows:
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1. Persistent Bioaccumulators
Many chemicals that possess persistent and bioaccumulative properties have been found to present significant environmental problems. Emerging concerns in EPA, especially in the Office of Water, focus on sediments contaminated with chemicals having these characteristics. OPPT plans to require the development of environmental fate and ecotoxicity test data on these chemical substances to support a more comprehensive risk assessment. OPPT is in the process of identifying the set of chemicals that will be addressed under this effort and the types of testing needed.
2. New Chemicals Program "Chemical Categories"
EPA's New Chemicals Program has established 47 chemical categories for
which TSCA section 5(e) risk determinations have been made based upon
health or environmental concerns identified through structure-activity
relationships (SAR). These chemical categories were established to facilitate
the TSCA Section 5 "Pre-Manufacture Notice" (PMN) review/regulatory
process and represent part of a general effort by EPA to promote development
of safer chemicals. EPA is continuing to refine the boundaries and definitions
of such categories and engage the chemical industry in dialogue directed
toward development of focussed testing programs on commercially promising
new chemicals and/or structurally-related existing chemicals. The resulting
test data are valuable to EPA as well as the industry for hazard identification,
risk management, and the design of safer substitutes. Properly conducted,
strategic testing of one or more members of a category can often be used
to evaluate the toxicologic potential of an entire class of commercially
promising compounds from that category. The following discussion provides
a brief overview of the OPPT New Chemicals Program "categories"
that are now listed on the MTL, namely: Chlorofluorocarbon Substitutes,
Acrylates/Methacrylates, Vinyl Esters, Fluorescent Whitening Agents, and
a. CHLOROFLUOROCARBON SUBSTITUTES
Since 1989, OPPT's New Chemicals Program has been working closely with EPA's Office of Air and Radiation (OAR) to 1) coordinate identification of and provide a more thorough and consistent EPA review of health and environmental effects of "new" chemical substances that can be used as substitutes for ozone-depleting chlorofluorocarbons (CFCs); and 2) develop regulatory strategies for controlling commercial introduction of these substitutes in order to address toxicological concerns as well as OAR issues such as ozone depletion and global warming. OAR participates in OPPT's New Chemicals Program process at the earliest review stages and regulatory strategies are developed to meet the requirements of both the Toxic Substances Control Act (TSCA) and the Clean Air Act (CAA). Among the regulatory tools used by OPPT in dealing with "new" CFC substitutes are "Consent Orders" issued under Section 5(e) of TSCA. Section 5(e) Consent Orders are developed to require the manufacturer or importer of a new CFC substitute to control exposure to that chemical and/or conduct additional testing on that material. Another TSCA regulatory tool that is used is the Section 5 "Significant New Use Rule" which covers potential additional producers/importers and users of that CFC substitute and may subject "new" uses of the chemical to further EPA review and/or control. Interactions between OPPT and OAR have reduced duplicative review efforts resulting in substantial resource savings for EPA while industry benefits from a coordinated regulatory program that simultaneously addresses the concerns of both EPA offices. In order to supply EPA with needed toxicological data to assess the potential hazards that may be posed by exposure to CFC substitutes, and in addition to conducting toxicity studies that are required by EPA via TSCA Section 5(e) Consent Orders on 3 "new" CFC substitutes, the chemical manufacturers who are members of the international Program for Alternative Fluorocarbon Toxicity (PAFT) agreed in the late 1980's to conduct a comprehensive voluntary testing program on two existing chemical substitutes (namely, 1,1,1,2-tetrafluoroethane [HFC-134a] and 2,2-dichloro-1,1,1- trifluoroethane [HCFC-123]). The PAFT testing program was reviewed and accepted internationally by authorities in the U.S., the European Union and Japan. This understanding provided additional certainty to industry developing these chemicals. PAFT's voluntary testing program is still underway and includes studies designed to develop data on genotoxicity, acute toxicity, subacute toxicity, subchronic toxicity, neurotoxicity, reproductive/developmental toxicity, and oncogenicity. In addition to conducting these toxicological studies on a voluntary basis, PAFT has been distributing copies of the study reports publicly on a world-wide basis.
Based on cancer concerns, "new" chemical substances in the category of acrylates (including methacrylates) are being regulated by EPA under Section 5 of TSCA. Following discussions with OPPT staff regarding these regulations, the industry members of the Specialty Acrylates Manufacturers (SAM) offered to conduct a voluntary testing program on 13 "existing" acrylates in exchange for some concessions by EPA in regulating new acrylates under Section 5. As the result of negotiations with SAM, OPPT agreed not to require a cancer warning on product labels for new acrylates regulated by EPA; however, cancer warnings, would still appear on the Material Safety Data Sheets (MSDSs) for these chemicals. For its part, SAM agreed in 1990 to conduct a voluntary testing program involving physical/chemical properties and metabolism/pharmacokinetics testing on 13 existing acrylates and cancer bioassays on 2 of those chemicals. SAM's voluntary testing program was completed in September of 1995 and the results of the tests are currently under review by OPPT.
c. VINYL ESTERS
A vinyl ester is a carboxylic acid ester with at least 1 vinyl group (CH2=CH-) attached to an organic acid radical (RCOO-). In 1992, the chemical industry initiated a testing program designed to evaluate a new generation of vinyl esters submitted to EPA's New Chemicals Program under Section 5 of TSCA. These vinyl esters are being developed to replace lower molecular weight acrylates (preceding discussion on Acrylates/Methacrylates). The testing program includes glove permeation, hydrolysis, non-protein sulfhydryl ("GSH") depletion, subchronic toxicity, and developmental toxicity studies as well as cancer bioassays. EPA responded to this industry initiative by agreeing not to require cancer warnings on product labels for new vinyl esters regulated by the Agency under TSCA Section 5 (although cancer warnings still appear on the Material Safety Data Sheets (MSDSs) for these chemicals).
d. FLUORESCENT WHITENING AGENTS
In EPA's TSCA Section 5 New Chemicals Program, fluorescent whitening agents fall under the general chemical category of water soluble (sulfonated) derivatives of 4,4-bis(triazin-2-ylamino)stilbene. Testing program negotiations are currently underway with members of the Ecological and Toxicological Association of Dyestuffs and Organic Pigments Manufacturers (ETAD) to conduct needed developmental and reproductive toxicity studies on at least 2 representative stilbene-based fluorescent whitening agents.
A molecule containing one or more of the following functional groups is considered by the TSCA Section 5 New Chemicals Program to be a member of the "peroxides" category: dialkyl peroxide, alkyl hydroperoxide, peroxy ester, diacyl peroxide and peroxy acid. The typical "new" peroxide is a discrete (Class I) chemical with a molecular weight of less than 500. The chemical industry is currently developing and conducting a number of short term tests to predict/assess potential tumor promoting and/or carcinogenic activities of 10 organic peroxides. The test systems being developed are: (1) test tube (in vitro) assays for detecting free radical formation, and (2) mouse skin assays for sustained inflammatory/hyperplastic response. In addition to the test tube assays, EPA has suggested use of a human skin cell culture to look for evidence of free radical formation. A series of structurally different new and existing peroxides are being studied in this voluntary testing program and the results are expected to allow correlation of the types and levels of free radicals formed and how damage caused by free radicals may relate to either tumor promoting and/or carcinogenic activity or inactivity.
3. EPCRA Section 313 ("TRI Screening")
The Toxics Release Inventory (TRI) was established under section 313 of the "Emergency Planning and Community Right-to-Know Act" (EPCRA). Under a voluntary cooperative effort with the Chemical Manufacturers Association (CMA) and possibly other chemical trade associations, a subset of at least 10 TRI chemicals produced and released in high volumes will be evaluated and screening level testing developed using the Organization for Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) model. Thus far, the U.S. chemical industry has agreed to conduct SIDS testing on 4 TRI chemicals. EPA has asked the industry to complete its commitment by selecting at least 6 more "high production/high release" TRI chemicals for SIDS testing.
4. Clean Air Act Section 112 "Air Toxics" (Hazardous Air Pollutants)
Data are needed by EPA's Office of Air and Radiation (OAR) and Office of Research and Development (ORD) to determine the "residual risk" posed by the 189 chemicals (Hazardous Air Pollutants (HAPs)) listed under section 112 of the Clean Air Act Amendments of 1990. The MTL now includes the initial list of 23 chemicals from this category for which testing has been proposed under Section 4 of TSCA (61 FR 33178; June 26, 1996). Testing needs for other chemicals in this category are currently being determined in a cooperative effort between OPPT, OAR and ORD. EPA's primary use of the data from this testing activity will be to implement several provisions of section 112 of the Clean Air Act (CAA), including determining residual risks (e.g., assessing risks remaining after imposition of technology- based emission standards (maximum achievable control technology standards or "MACT" standards)), estimating risks associated with accidental chemical releases, and determining whether or not subject chemicals should be removed ("delisted") from the CAA section 112(b) HAPs list. Other important uses of the data obtained via this testing activity are to: 1) help in better informing communities and citizens about chemical hazards in their own localities, 2) assist state and local permitting authorities establish appropriate standards within their programs, and 3) help other EPA Program Offices and other Federal agencies in assessing chemical risks and taking appropriate action(s) within their own programs and under the Federal statutes that they administer.
5. SARA Section 104 "Priority Data Needs"
Section 104 of the Superfund Amendments and Reauthorization Act (SARA) requires EPA and the Agency for Toxic Substances and Disease Registry (ATSDR) to list chemicals frequently identified in Superfund sites. ATSDR is charged with preparing "Toxicological Profiles" for these chemical substances, identifying data gaps and research needs, and developing a testing/research program. When and where appropriate, EPA's TSCA (or Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)) authorities are to be used to obtain the necessary data. There are 250 chemicals and categories now listed under SARA Section 104 and Toxicological Profiles have been published or are being prepared by ATSDR on 215 of these chemicals and categories. ATSDR has identified priority data needs for the first subset of 13 chemicals (3 metals and 10 organics). These chemicals are listed on the MTL and testing needs/testing action development is currently underway in EPA's Chemical Testing Program.
6. Respirable Fibers
Man-made and naturally-occurring fibers with diameters less than 3.5 micrometers that can enter the small airways of the lower respiratory tract and survive in biological systems for long periods of time can present significant health concerns. EPA is assessing the potential risks associated with the production and use of synthetic and naturally-occurring respirable fibers and products made from such fibers. The testing likely to be proposed by EPA will focus on health effects via inhalation and better characterization of exposure.
7. Indoor Air Source Characterization - Carpet/Carpet-Related Products
An agreement with industry has been reached to generate the test data needed for characterization of Total Volatile Organic Compound (TVOC) emissions from carpets and carpet-related products (i.e., carpet cushion and carpet adhesives). The emissions testing program was developed via EPA's Carpet Policy Dialogue and testing was initiated in 1991 (56 FR 67317; December 30, 1991). The final results from the carpet TVOC study have been received by EPA and this entry (Carpet-TVOC) has been removed from the MTL. The voluntary testing programs for both carpet cushion and carpet adhesives are still underway.
8. Indoor Air Source Characterization - Interior Architectural Coatings
OPPT and EPA's Office of Air and Radiation (OAR) are continuing to coordinate
efforts to characterize and determine specific needs for chemical emissions
and total emissions testing for indoor air sources such as paints, varnishes
and other types of interior architectural coatings.
9. Polychlorinated Dioxins/Furans in Wood Pulp/Paper Mill Sludge
Polychlorinated dioxins and furans (D/F) are produced when wood pulp is bleached with chlorine or chlorine-derivative compounds. The sludge that results from the wastewater treatment process in pulp and paper mills has been found to be contaminated with D/F. EPA has identified concerns for possible adverse human health and environmental risks posed by the disposal of this sludge through land application and has determined that additional testing and monitoring data to evaluate such risks are needed. Under the terms of a voluntary agreement with EPA, four pulp and paper mills are evaluating their sludge for D/F concentrations and are engaged in numerous other types of product stewardship activities (e.g., labeling, modifying land application practices). Under the terms of another voluntary agreement with EPA, the American Forest and Paper Association is collecting, aggregating and submitting data from the mills to EPA and coordinating industry's outreach efforts on this voluntary testing/stewardship program.
10. Endocrine Disruptors (New Category)
Endocrine disruptors are chemicals that interfere with normal hormone system functioning. These substances can have adverse impacts on growth and development, sexual differentiation, and a host of biological functions that are controlled through the endocrine system. One of EPA's primary efforts for endocrine disruptors involves the establishment of a dialogue with industry and other major stakeholders (including other Federal agencies) to formulate a cooperative screening and testing program designed to identify chemicals that can disrupt endocrine function(s) and determine the risk they may pose to health and/or the environment. In addition, Section 405(p) of the 1996 Food Quality Protection Act (FQPA) requires that EPA develop (within 2 years) and implement (within 3 years) an estrogenic effects screening program for all pesticides using validated test methods. The FQPA also gives EPA the authority to require testing of other chemicals "that may have an effect that is cumulative to an effect of a pesticide." The FQPA states that data can be obtained via Section 3(c)(2)(B) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), Section 4 of TSCA, or an "order" if it can be shown that neither FIFRA nor TSCA can be applied. Similarily the newly amended Safe Drinking Water Act (SDWA) gives EPA authority to require testing of substances found in drinking water and to which there may be substantial exposure.
11. Machining Fluid Products/Chemicals (New Category)
Machining fluids, which are also known as metalworking fluids, are used to lubricate and cool industrial equipment and the metal being shaped during a variety of machining operations. These activities include metal removal operations such as cutting or drilling and metal forming operations such as stamping or drawing. The exposure to metalworking fluids is primarily occupational and recent estimates indicate that up to 10 million workers may be exposed to these types of products, primarily via inhalation and dermal contact with mists. There may be as many as 400 different commercial products belonging to one or more of the four major metalworking fluid types: straight oils, soluble oils, semi-synthetics and synthetics. All but the synthetic fluids contain mineral oil as a component and there are no standard formulations of chemical components among commercially available machining fluids. In response to a TSCA Section 21 petition that was filed by the International Union, United Automobile, Aerospace and Agricultural Implement Workers of America-UAW (UAW), EPA formed an interagency workgroup with the National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) to identify specific testing candidates and testing needs for machining fluids. In addition, the Federal workgroup has begun discussions with the UAW, the Independent Lubricant Manufacturers Association (ILMA), and others regarding development and implementation of a testing program for machining fluid products and their components.
12. Paint Stripping Products Use Cluster (New Category)
In 1993, OPPT concluded a risk assessment on N-methyl pyrrolidone (NMP),
a methylene chloride substitute in some paint stripping products, and,
as a followup to that assessment, began a more broad- based assessment
of paint stripping chemicals/products that are commonly available to consumers.
As the result of concerns that were raised by EPA and others, and in recognition
of the tenets of product stewardship, the NMP Producers Group spearheaded
a voluntary effort by the "Ad Hoc Industry Committee for Safe Paint
Stripping" to design and conduct a glove permeability testing program.
Under this program, numerous glove types are being tested against a variety
of paint stripping formulations used by consumers and small paint stripping
shops. This voluntary testing program is designed to assess the effectiveness
of dermal protection offered by gloves of the type commonly available
to consumers through hardware stores. After the testing program is completed,
the industry plans to incorporate the results of the glove permeability
testing in improved product labels and other consumer education materials.
In addition, EPA is developing a testing action for the U.S. Consumer
Product Safety Commission (CPSC) on the following 3 dibasic esters (DBEs)
which are used as substitutes for methylene chloride in commercial paint
stripping products: dimethyl adipate, dimethyl succinate, and dimethyl
glutarate. The data from the DBEs testing program will also be used to
support OPPT's ongoing assessment of paint stripping products and their
13. Oxygenated Fuel Additives (New Category)
EPA's Office of Air and Radiation (OAR/EPA) in the administration of section 211 of the Clean Air Act (CAA), has requested OPPT to use its TSCA section 4 testing authority to obtain health effects data on a number of Oxygenated Fuel Additives (OFAs) such as ethyl t-butyl ether (ETBE) and t-amyl methyl ether (TAME)). These data are needed by EPA and others to increase understanding of the toxicity of these substances individually and in comparison to each other as well as to other OFAs such as methyl t-butyl ether (MTBE). EPA is also currently exploring options for obtaining toxicity data on diisopropyl ether (DIPE) and t-butyl alcohol (TBA) before these chemicals come into wide use as OFAs. In addition, EPA is attempting to obtain test data needed by OAR on t-butyl formate (TBF), which is a possible breakdown product of MTBE.