Curing the common chemical?

Many, if not all of us are familiar with the testing required to monitor air pollutants, wastewater and solid wastes. However, there are also countless mandated chemical tests, not related to effluent management, that are undertaken prior to the entrance of a new chemical into the market. Now, with the passing of a December 1999 deadline, toxicity testing for 2,800 chemicals currently in use is to be conducted by stakeholders who have volunteered, or who are under U.S. Environmental Protection Agency (EPA) mandate. Each of these 2,800 chemicals are manufactured or imported at a quantity in excess of 1 million pounds annually and are referred to as high production volume (HPV) chemicals. The December 1999 deadline for voluntary compliance with this testing was a milepost in a chemical right-to-know effort spearheaded by Vice President Al Gore. According to the Chemical Manufacturers Association (CMA), the initiative challenged industry to test 2,800 chemicals within three years or face testing requirements for these chemicals mandated by the Toxic Substances Control Act (TSCA) (15 United States Code Sections 2601 - 2629). Discovery of toxic characteristics in any or all of these 2,800 chemicals could alter the landscape of chemical use and regulation. For example, there is a possibility that the use of chemicals now present in everyday products may be restricted. According to Ronald S. Rogers of Chemical & Engineering News, the tests will focus on:

  • Physical and chemical characteristics, such as how quickly evaporation occurs and if the substance is soluble in body fat;
  • Fate of the chemical in the environment, including an estimate of how quickly the substance degrades in sunlight, or through biodegradation;
  • Toxicity data, including how poisonous the compound can be to plants, fish and mammals;
  • A given compound's ability to cause cell mutations, including cancer; and
  • A given compound's ability to interfere with animal and human reproduction.
  • Testing guidelines

    The driving force behind this broad-based program of chemical testing is TSCA. TSCA gives EPA broad authority to issue regulations regarding:
  • Health, safety and exposure information on chemical substances and mixtures;
  • Testing of chemical substances and mixtures; and
  • Exposure to chemical substances and mixtures.
  • Drugs, cosmetics, foods, food additives, pesticides and nuclear materials are exempt from TSCA. These substances are subject to control under other U.S. government statutes. For example, foods, food additives, drugs and cosmetics are regulated by the Federal Food, Drug and Cosmetic Act administered by the U.S. Food and Drug Administration (FDA). TSCA regulates chemicals already in U.S. commerce as well as "new" chemicals not yet in U.S. commerce. After the 1976 enactment of TSCA, EPA compiled an inventory of chemical substances, as required under TSCA Section 8(b) (Inventory). In 1977, EPA promulgated inventory reporting regulations (40 Code of Federal Regulations (CFR) 710) to ensure a complete and reliable chemical Inventory. At that time, several million chemicals were known to exist, challenging EPA to define the subset of commercial chemicals constituting the initial inventory. Although Congress specifically excluded pesticides, drugs, food, food additives and cosmetics from TSCA reporting requirements, EPA used the inventory reporting regulations to further narrow the scope of reporting by exempting chemical impurities and byproducts and chemical mixtures. The inventory defined chemical substances already in U. S. commerce and was a fairly extensive list of all chemicals commercially available at that point in time. These chemicals were set aside to help define the New Chemicals Program. Substances not already included in the inventory were considered "new." New chemicals were, and still are, subject to premanufacture notification (PMN) requirements that became effective on July 1, 1979. PMN requirements are part of EPA's New Chemicals Program. The New Chemicals Program, located within EPA's Office of Pollution Prevention and Toxics, is mandated by Section 5 of the TSCA. The New Chemicals Program screens new chemicals before they enter into commerce. Anyone who plans to manufacture or import a new chemical substance for an applicable commercial purpose is required by Section 5 of TSCA to provide EPA with a PMN before manufacture or import. This PMN must be submitted at least 90 days prior to the manufacture or import of the chemical. PMN submissions require the following data to be disclosed:
  • Chemical identity;
  • Production volume;
  • Byproducts;
  • Use;
  • Environmental release;
  • Disposal practices; and
  • Human exposure.
  • Should any of this data reveal adverse impact, restrictions can be applied to the production and use of the chemical. Such restrictions can include a ban on production. After review of public comments to the proposed inventory reporting regulations, EPA expanded its scope to require reporting of the plant site location and production volume data for each chemical. Newly manufactured chemicals that have completed PMN review are added to the inventory by EPA. Since 1977, the number of chemicals included on the inventory has increased from 61,000 to more than 75,000. How were the 2,800 chemical compounds to be tested selected from these 75,000 chemicals? Many of the 75,000 chemicals are produced or imported at low or negligible volumes. Other relatively unreactive chemicals on the list, such as polymers like polyethylene plastic, were viewed as unlikely to present significant toxicity risk concerns. Excluding low volume chemicals and polymers, there are about 15,000 chemicals produced or imported at levels above 10,000 pounds per year. Of these 15,000 chemicals, there are approximately 2,800 chemicals produced at levels above 1 million pounds annually, referred to as HPV chemicals. Because they have been in commerce prior to the inception of the PMN program, basic toxicity testing data is not publicly available for the majority of HPV chemicals. The lack of data in the public domain prompted action by Vice President Gore. On Earth Day in 1998, he challenged industry to supply the missing information. In October 1998, EPA, Environmental Defense (formerly the Environmental Defense Fund), and the CMA signed an agreement that mandates screening of 2,800 HPV chemicals already in use but not tested under the PMN program, for potential harm to humans and the environment. According to Jeff Johnson of Chemical & Engineering News, EPA estimates that 900 different U.S. corporations manufactured or imported these untested HPV chemicals as of the end of 1998. The deal places responsibility on the chemical industry for payment of these tests and for on-time completion. The testing program is to be wrapped up by 2004. The CMA has agreed to create an Internet site where the public can track industry's progress. According to the Environmental Defense Fund (www.edf.org/pubs/FactSheets/l_cma.html) EPA used its authority under TSCA to require testing of HPV chemicals. EPA finalized the first test rule on Dec. 31, 1999. Chemicals that a volunteer agreed to sponsor for tests by Feb. 1, 1999 were not included in the first proposed rule. Chemicals that a volunteer agreed to sponsor for tests after the rule was proposed, but by Dec. 1, 1999, were not included in the final rule. If remaining testing commitments are not met, EPA will issue additional test rules as needed. In addition, testing under the new rule will not be required for chemicals that are being tested through the Organization for Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) program. That is, chemical testing under the test rule will not be required for other countries that also make the data available to the United States, or for which all SIDS elements are already publicly available. As of January 2000, the Environmental Defense Fund reported the following time line was to be used for the HPV Chemical Testing Program:
  • 1998-2000 sign up period;
  • 2000-2003 four "start" years;
  • 2003-2004 all testing complete.
  • Sponsors whohave not have chosen to voluntarily test prior to December 1999 may choose to initiate testing of sponsored chemical(s) during one of the four "start years." In order to complete testing by the end of 2004, sponsors are encouraged to initiate tests as early as possible within the start year. Assuming voluntary commitments were secured to test five percent of HPV chemicals prior to the December 1999 deadline, the Environmental Defense Fund reports that testing goals for each start year will be as follows:
  • Year 2000 = 20 percent;
  • Year 2001 = 25 percent;
  • Year 2002 = 25 percent;
  • Year 2003 = 25 percent (maximum percentage).
  • To ensure that the year 2003 is not swamped by testing commitments, the HPV Program is to allow no more than 25 percent of chemicals to be volunteered for testing in the final start year. The other year goals are reported to be minimums. Goals may be met by conducting new individual tests, or producing existing privately held information. How many types of chemicals are represented in the list of 2,800 (refer to www.epa.gov/opptintr/chemrtk/hpvchmlt.htm#update for the entire list.)? Consider just a few - the class of compounds commonly referred to as "glycol ethers." Table 1, while not all-inclusive, describes uses of 14 specific glycol ether compounds: Table 1

    Selected glycol ether compounds subject to HPV testing

    Chemical name -- Common name and uses Ethanol, 2-(2-ethoxyethoxy)-- Diethylene glycol monoethyl ether, Dowanol. This compound is used in stains for wood, in textile printing, lacquers, quick-drying varnishes and enamels, brake fluid, and in cosmetics. Ethanol, 2-butoxy-, acetate -- Ethylene glycol monobutyl ether acetate. Used in water-thinned interior paints, glass window cleaning preparations and household surface cleaners. Ethanol, 2-(2-ethoxyethoxy)-, acetate -- No recognized common name. Used for water-thinned interior and exterior primers and paints. Triethylene glycol -- Triglycol. Used in non-personal, aerosol and non-aerosol deodorants and air fresheners; disinfectants, other specialty cleaning and sanitation products, laundry starch preparations and lubricating oils. Tetraethylene glycol -- No recognized common name. Used in disinfectants and lubricating oils. Ethanol, 2-butoxy-, acetate -- Ethylene glycol monobutyl ether acetate. Used in water-thinned interior paints, glass window cleaning preparations, and household surface cleaners. Ethanol, 2-(2-ethoxyethoxy)-, acetate -- No recognized common name. Used in water-thinned interior and exterior paints and coatings. Ethanol, 2-phenoxy -- Ethylene glycol phenyl ether. Used in cosmetics, such as: blushers, mascara, eye shadow, eye liners and foundation creams; hair and scalp conditioners; soaps, including bars, liquid and paste; household surface cleaners; floor polish; paint and varnish removers and miscellaneous paint-related products; oven cleaners; and water thinned interior undercoaters and primers. Ethanol, 2-(2-butoxyethoxy)-, acetate -- Butyl Carbitol acetate. Used in water-thinned interior paints and coatings. Ethanol, 2-2-(2-butoxyethoxy)ethoxy-- Triethylene glycol monobutyl ether. Used in brake fluid, and wood stains and varnishes. Pentaethylene glycol -- No recognized common name. Used in lubricating oils. 2-Propanol, 1-butoxy -- No recognized common name. Used in water-thinned interior paints; household surface cleaners; automotive chemicals; and other specialty cleaning and sanitation products, including metal degreasers. Ethanol, 2-(2-propoxyethoxy)-- No recognized common name. Used in paint strippers. 2-Propanol, 1-2-(2-methoxy-1-methylethoxy)-1-methylethoxy-- No recognized common name. Used in household surface cleaners, polishing preparations, and oven cleaners. (Source: Environmental Defense Fund and www.scorecard.org/chemical-profiles/) In each case, CMA's Ethylene Glycol Ethers Panel (EGEP) has sponsored the testing, to begin no later than 2001. The table represents an assortment of products, ranging from automotive brake fluid to cosmetics. If any or all of these 14 glycol ether compounds are reclassified as toxic or deleterious to the environment, new scenarios for possible glycol ether contamination could become a problem. Many sewer lines convey wastewater, thought to be relatively non-toxic, from household cleaner manufacturing facilities. However, if HPV testing reveals that the glycol ether found in the cleaner is toxic, leaks in the sewer line joints could become an environmental liability, as soils surrounding the sewer could be subject to a remedial investigation for glycol ethers. Some TCE-based degreasers have been replaced by aqueous systems containing glycol ether. Rinse water from these degreasing operations is usually discharged to the municipal sewer. Should toxicity be found in the glycol ether wastewater, soils surrounding the sewer could be subject to a remedial investigation for glycol ethers. Both of the aforementioned scenarios could occur, despite complete compliance of the given wastewater discharge with municipal industrial pretreatment regulations. Both homeowners and painting contractors may use water-based paint that contains glycol ether. Paintbrushes for these water-based coatings clean easily by rinsing and these washwaters are often directed to utility sinks and floor drains of new and existing homes and buildings. Many of these facilities are serviced by septic tanks, that discharge effluent to shallow soils and ultimately to groundwater. If a given neighborhood, serviced by individual septic systems, undergoes hundreds of small and large painting tasks over a period of years, with brushes rinsed clean after each job, the potential number of glycol ether-contaminated septic systems could be astronomical. The glycol ether scenarios listed above deals with only 14 of the 2,800 chemicals that require testing. Should tests conducted on any of the 2,800 chemicals reveal problems, the possibilities for claimed bodily injury or environmental impairment are almost too numerous to contemplate. Environmental managers at industrial facilities that use a broad range of chemicals should maintain a keen awareness of developments in the HPV program. New information on chemical exposures revealed through the HPV program may need to be incorporated into plant processes, engineering control of exposures and worker personal protective equipment. E-sources TSCA at Twenty: The TSCA Chemical Substance Inventory: An Historical Perspective, Henry Lau, EPA Economics, Exposure and Technology Division - www.epa.gov/opptintr/cie/issue04j.htm US High Production Volume (HPV) Chemical Tracking System (USTS) Web site - www.cmahq.com The Environmental Defense Fund's summary of the HPV program - www.edf.org/pubs/FactSheets/k_cma.html EPA's Chemical Testing and Information Home Page providing:
  • Results of chemical testing summary table;
  • Chemical hazard data availability study released; and
  • Master summary for the chemical hazard data availability table released
  • - www.epa.gov/opptintr/chemtest -EPA's Office of Pollution Prevention and Toxics New Chemicals Program - www.epa.gov/oppt/newchems/index.htm Environmental Defense Fund 2-Butoxyethanol acetate scorecard - www.scorecard.org/chemical-profiles National Institute of Environmental Health Sciences Research on Environment-Related Disease - www.niehs.nih.gov EPA Office of Pollution Prevention and Toxics New Chemicals Program - www.epa.gov/oppt/newchems/index.htm Animal activists, HPVs and the Internet Recently, five animal rights activist groups petitioned EPA - initially through a barrage of emails - to compel companies to make public unpublished health and safety studies on HPV chemicals. The activist groups are: People for the Ethical Treatment of Animals (PETA), the Physicians Committee for Responsible Medicine, the Doris Day Animal League, the International Marine Mammal Project of the Earth Island Institute and the National Anti-Vivisection Society. These activist groups claim that the regulation requiring companies to turn over unpublished studies will eliminate the need for use of animals testing for many of the HPV chemicals. According to a posting on www.epa.gov/fedrgstr/EPA-TOX/2000/January/Day-13/t850.htm, the activist groups filed their petition under Section 21 of TSCA, a little-used provision that allows the public to petition EPA to issue, change or repeal a regulation under TSCA section 4, 6 or 8. The petition must clearly state the underlying reasoning for the action requested and EPA must grant or deny the petition within 90 days of its receipt. If EPA grants the petition, it must commence the appropriate proceeding promptly. If EPA denies the petition, it must publish its reasoning for denial of the petition in the Federal Register. The petitioners may commence a civil action in a U.S. district court to compel EPA to initiate the requested rulemaking within 60 days of announcement of denial or no action. After hearing the evidence, the court can order EPA to initiate the requested action. Any of the 900 U.S. corporations described involved have a legal mandate to inform EPA about data that suggests a given chemical poses a substantial risk to health or the environment. However, the activist groups claim that many unpublished studies reveal a given chemical is non-hazardous, therefore making animal testing unnecessary. The reasoning for maintaining the confidentiality of this industry data is simple - it need not be disclosed unless EPA makes a specific request. Despite the formal Section 21 petition under TSCA, EPA turned down the activist groups' petition for a rule on health and safety data reporting. However, as noted, the activist groups can appeal the decision in federal district court. No information on an appeal by the activist groups is available at press time.

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    This article appeared in Environmental Protection magazine, July 2000, Vol. 11, No. 7, p. 53.

    This article originally appeared in the 07/01/2000 issue of Environmental Protection.

    About the Author

    Laura Stupi, MS, is an applications scientist in the Portable Elemental Analysis Division of Thermo Electron (formerly Niton), in Billerica, Mass. She can be reached by telephone at (978) 670.7460.

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