Regulatory Update...

GOVERNMENT REGULATIONS RELATED TO PLASTICS INDUSTRY

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INDIRECT FOOD ADDITIVES: FDA has amended the food additive regulations to provide for the safe use of the ammonium salt of butanedioic acid, sulfo-1,4-diisodecyl ester, as a surface active agent in adhesive formulations, and in components of paper and paperboard intended to contact food. This action is in response to a petition filed by Troy Corp. 66 FR 13653-13655 (03/07/01).

Nalco Chemical has withdrawn, without prejudice to a future filing, a food additive petition (FAP 2B3627) proposing that the food additive regulations be amended to provide for the safe use of 2-(4-thiazolyl)benzimidazole as a component of adhesives and paper and paperboard. 66 FR 15496 (03/19/01).

MAINE HOSPITALS CUT PVC: Maine's 39 hospitals have voluntarily pledged to cut their use of PVC in medical supplies and eliminate mercury-bearing products. The agreement -- announced March 7^th by the Maine Hospital Association, the Maine Department of Environmental Protection and the Natural Resources Council of Maine on behalf of environmental coalition Health Care Without Harm -- calls for eliminating mercury by 2005, and for a 50% reduction of the overall volume of hospital waste by 2010. The agreement encourages hospitals to urge manufacturers to develop less-expensive alternative products. The DEP and Health Care Without Harm will pay for a consultant who will help hospitals establish realistic goals. Plastics News, 03/12/01, p. 22; Chemical Week, 03/14/01, p. 40.

KELLER & HECKMAN LLP has launched an online site for information about the international regulation of food, drugs, cosmetics, and other packaging, at www.packaginglaw.com. Chemical Market Reporter, 03/19/01, p. 29.

CIVIL PENALTIES: FDA has issued the final guidance titled "Reduction of Civil Money Penalties for Small Entities" as required by the Small Business Regulatory Enforcement Fairness Act of 1996 and the Presidential Memorandum of April 21, 1995. The guidance may be accessed at http://www.fda.gov/ora under "Compliance References." 66 FR 15726-15727 (03/20/01).

EDUCATIONAL WORKSHOP: FDA, in cosponsorship with the Orange County Regulatory Affairs discussion group, has announced its Fourth Annual Educational Workshop intended to give the drugs, devices, and biologics industries an opportunity to interact with FDA's reviewers and compliance officers from FDA's centers and district offices. The main focus of this interactive workshop is to provide regulatory updates, guidances, and recommendations regarding new product submissions, postapproval changes, and postmarketing issues. The meeting will be held on May 21^st and 22^nd at The Irvine Marriott, 18000 Von Karman Avenue, Irvine, CA. Contact Ramlah I. Oma, Food and Drug Administration, 19900 MacArthur Boulevard, Suite 300, Irvine, CA 92612, 949-798-7611, FAX: 949-798-7656, or Peri Ann DiRocco, OCRA discussion group, PMB 624, 5405 Alton Parkway, Suite 5A, Irvine, CA 92604, voice/FAX: 949-348-9141, e-mail: sdirocco@aol.com, for information. Space is limited, so preregistration and confirmation are required. Send registration information (including name, title, firm name, address, telephone, and fax number), written material, and requests to make oral presentations directly to the OCRA Web site www.ocra-dg.org. Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Room 12A-16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10¢ per page. 66 FR 16949 (3/28/01).

REPORT ON CARCINOGENS: In 2000, the National Toxicology Programs reviewed eight nominations of agents, substances, mixtures and exposure circumstances for listing in or delisting from the Report on Carcinogens, Tenth Edition. NTP now solicits final public comments on these. The eight nominations were broad spectrum UV Radiation (UVR) and UVA, and UVB, and UVC; chloramphenicol; steroidal estrogens; methyleugenol; metallic nickel and certain nickel alloys; talc, both abestiform and non- abestiform; trichloroethylene; and wood dust. The criteria used in the review process and a detailed description of the review procedures, including the steps in the current formal review process, can be obtained from the NTP Home Page web site at http://ntp-server.niehs.nih.gov/. 66 FR 13334-13338 (03/05/01); Chemical & Engineering News, 03/12/01, p. 43.

EARLY PUBERTY STUDY FAULTED: The Endocrine Society (Bethesda, MD) and the Lawson Wilkins Pediatric Endocrine Society (Montreal) are questioning the validity of the study by Marcia Herman-Giddens (U. of North Carolina) which -- as reported last month -- found that girls may be entering puberty at an early age, possibly caused by exposure to pesticides and/or phthalates. The two societies contend that the onset of menstruation has not changed in decades and that the Herman-Giddens study did not randomly select the girls sampled. The endocrinologists say the issue is important because doctors could be misled into misdiagnosing tumors or hormonal abnormalities -- which sometime causes these changes -- as "environmental." Chemical Week, 03/14/01, p. 40.

NEW PHTHALATE STUDY: The Centers for Disease Control and Prevention (CDC) reports that many women of childbearing age are regularly exposed to diethyl phthalate (DEP) and at levels much higher than estimated by the government's National Toxicology Program last year. Animal studies suggest that large amounts of DEP, which is found in fingernail polish and other cosmetics, may disrupt normal hormone function and cause birth defects. The report noted that the phthalates widely used in plastics are not as prevalent in the body. Whether long-term exposure is harmful to humans is being studied by government agencies. However, the Phthalate Esters Panel of the American Chemistry Council said the report "contains no new information that raises questions about the safety of phthalate esters. Based on exposures indicated by the CDC's data, consumers can remain confident about using products that contain phthalates." But environmental groups, including the American Public Health Association and the National Environmental Trust, to issue their call for more funding for more testing. The CDC study does not include any new information on the health risks of exposures nor on potential routes of exposure. But it is the first study to document which environmental chemicals are found in the U.S. population and at what levels. Chemical Market Reporter, 03/26/01, p. 1; Chemical & Engineering News, 03/26/01, p. 18.

The CDC study measured 27 industrial chemicals, pesticides and metals in the bodies of 3,800 people whose blood or urine was tested as part of the 1999 National Health and Nutrition Examination Survey. Advances in "biomonitoring" technology allowed CDC to measure chemicals directly in blood and urine samples rather than estimating population exposures by measuring air, water or soil samples. Industry officials said they support biomonitoring as a tool in assessing environmental exposures, but stressed that the CDC data alone do not identify adverse health effects or the potential for disease. Chemical Market Reporter, 03/26/01, p. 15; Chemical Week, 03/28/01, p. 16.

ENDOCRINE DISRUPTORS SCREENING: The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is planning an independent Peer Review Panel evaluation of the validation status of in vitro estrogen receptor (ER) and androgen receptor (AR) binding and transcriptional activation assays. Conclusions and recommendations from the Panel will be considered by Federal agencies in selecting and establishing minimum performance criteria for in vitro test methods used to screen chemicals for potential endocrine disrupting effects, including the EPA's Endocrine Disruptor Screening Program. At this time, NICEATM requests study results and data evaluating the performance and reliability of ER and AR binding and transcriptional activation assays, and other relevant information from the scientific community that should be considered by the Panel. NICEATM also requests nominations of expert scientists for consideration as potential Panel members. 66 FR 16278-16279 (03/23/01).

The public is invited to a meeting intended to solicit input from interested stakeholders regarding their views on the organization of the Endocrine Disruptor Methods Validation Subcommittee, to assist its Endocrine Disruptor Screening Program implementation activities. EPA is interested in obtaining input from the agrichemical and commodity chemical industries; environmental and public interest organizations; public health organizations; animal welfare organizations; Federal agencies; State, local and tribal governments; academia; consumers, and the public. The meeting will be held on April 24^th. Requests to participate in the meeting must be received on or before April 20^th. You may submit a request to participate in this meeting through the mail, in person, or electronically (mailto:oppt.ncic@epa.gov). The meeting will be held at the Holiday Inn Rosslyn at Key Bridge, 1900 Fort Meyer Drive, Arlington, VA, 22209 (telephone: 703-807-2000). You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/scipoly. To access this document, on the Home Page select "Endocrine Disruptors" which will take you to the OSCP Endocrine Disruptor Screening Program Web Site. 66 FR 16466-16467 (03/26/01).

EUROPEAN CHEMICAL REGISTRY: Chemical companies have been warned by the European Commission that they may not be able to market products that have not met proposed registration deadlines. The Commission has proposed, in a White Paper on a chemicals strategy for the European Union, registration deadlines for substances stretching from 2005 to 2012, which the chemical industry has claimed are unrealistic. All substances on the market of more than 1 metric ton in quantity will have to be registered, according to the White Paper. Chemical Market Reporter, 03/19/01, p. 7.

TOXICOGENOMICS is an emerging scientific subdiscipline that is expected to lead to cheaper, faster testing of chemicals for toxicity while reducing the use of laboratory animals. It promises to help in the prevention, diagnosis, and treatment of diseases linked to exposure to toxic chemicals, many scientists say. And it should improve the scientific basis for environmental and workplace standards for chemicals, perhaps leading to either stricter or more relaxed regulations. It involves the study of how chemicals affect the expression of genes, the function of proteins, and metabolism. This new field combines toxicology -- the study of how poisons work -- with genomics, the study of genes and their functions. The technique exposes microarrays -- small glass or plastic plates containing hundreds or thousands of DNA strips -- to chemicals and determining which genes are turned on or switched off. However, because toxicogenomics is still new, and no one has determined just how the results of microarray testing apply to risk assessment of chemicals. Also, regulators at EPA and OSHA are not yet prepared to deal with toxicogenomic data. Chemical & Engineering News, 03/19/01, pp. 33-34.

HPV TESTING: Thus far, industry has submitted only 23 plans involving the testing of less than 500 high-production-volume chemicals, although 469 companies and 187 consortia have committed to test 2,155 of the estimated 2,800 HPV substances included in the voluntary program. EPA has expressed disappointment with the slow rate of program development. As of early March, 17 of the 23 test plans the agency has received have been posted on their website, www.epa.gov/chemrtk. EPA has finished reviewing and commenting on 13 on them. For the HPV program to succeed, industry must live up to its pledge. EPA and environmental groups say they are monitoring how companies carry out their testing commitments. Chemical Week, 03/21/01, p. 13.

HAZMAT TRANSPORT RISKS: According to a new study by the Argonne National Laboratory for the Transportation Department, the transportation of six hazardous chemicals by truck and rail poses an estimated risk of two fatalities and 85 injuries per year. The study concludes that these risks are relatively low compared with other types of transportation. However, the potential remains for serious accidents involving large numbers of injuries and deaths from chemicals that pose inhalation dangers. The study analyzed the risk of highway and rail shipment of six bulk chemicals -- chlorine, ammonia, sulfur dioxide, hydrogen fluoride, fuming sulfuric acid, and fuming nitric acid. Together, these substances account for nearly all of the risk posed from the transportation of substances that are toxic by inhalation. Chemical & Engineering News, 03/05/01, p. 28; Chemical Market Reporter, 03/12/01, p. 32.

HAZWASTE TREATMENT: The Agency for Toxic Substances and Disease Registry has announced the availability for public comment of the draft document, Public Health Reviews of Hazardous Waste Thermal Treatment Technologies. The document is available by contacting the Chief, Program Evaluation, Records, and Information Services Branch, Agency for Toxic Substances and Disease Registry, 1600 Clifton Road (E-56), Atlanta, GA 30333. Please submit written comments relating to the document to the same location. ATSDR reserves the right to provide only one copy of this draft document free of charge. The document may also be accessed at the ATSDR Home page News section at www.atsdr.cdc.gov. 66 FR 16248-16249 (03/23/01).

WASTE TREATMENT WORKSHOPS: EPA is conducting two workshops on the final effluent limitations guidelines, pretreatment standards, and new source performance standards for the Centralized Waste Treatment (CWT) Industry. The agency is holding these workshops on March 27^th in Chicago and on April 26^th Washington (EPA's Auditorium, Waterside Mall, 401 M Street, SW). During each of these workshops, EPA plans to provide an overview of the final CWT effluent limitations guidelines, pretreatment standards, and new source performance standards and guidance on their implementation. The agency will also devote considerable time for questions and answers during this workshop. The final CWT rule and related documents are available on the Internet at http://www.epa.gov/ost/guide. For further information, contact Ms. Jan Matuszko at (202) 260-9126 or Mr. Timothy Connor at (202) 260-3164 or by E-mail: matuszko.jan@epa.gov or connor.timothy@epa.gov. 66 FR 15117-15118 (03/15/01).

SUPERFUND REFORM could be thwarted by current congressional efforts to push brownfields legislation. Although industry supports the bipartisan effort to speed and ease the redevelopment of brownfields, attention is deflected from the overall aim to revamp Superfund law completely and clarify EPA's authority in cleaning up priority sites. The brownfields bill contains no Superfund language. Chemical Week, 03/07/01, p. 46.

Although it is a "stand-alone" measure, the American Chemistry Council no longer opposes brownfields legislation aimed at spurring the cleanup and redevelopment of abandoned industrial sites. Chemical industry supports most elements of the bipartisan brownfields revitalization bill that is on a fast-track toward Senate passage. The Senate Environment and Public Works Committee passed the measure 15 to 3 early this month, and a Senate floor vote could occur by the end of the month. In the past, industry officials have maintained that the cleanup and restoration of moderately contaminated brownfield sites should be handled within the context of comprehensive legislation to reform the Superfund toxic waste law. The industry had argued that passing "piecemeal" reform bills that address only a single issue -- such as brownfields remediation or liability relief for small business -- would take pressure off Congress to pass broader changes in the Superfund law. Chemical Market Reporter, 03/12/01, p. 1; Chemical Week, 03/14/01, p. 5.

ACCIDENTAL RELEASES: EPA has withdrawn the notice of January 17, 2001 (66 FR 4021) describing draft plans for providing additional access to information about the potential off-site consequences of accidental chemical releases from industrial facilities. As part of the Administration's review of recent Federal agency actions, the agency is evaluating the draft plans. When the review is completed, the agency will make its plans for providing additional access available for public review. 66 FR 15254 (03/16/01).

WORST-CASE SCENARIOS: According to a Greenpeace analysis of worst-case accident data that companies are required to file with the EPA, more than one million people are at risk from accidents at chemical plants in Louisiana. The Greenpeace study said one Dow Chemical plant in Plaquemine projected 370,000 people are at risk from a worst-case leak of hydrogen chloride, and said a smaller leak of chlorine would put 31,000 people at risk. Greenpeace said it collected the information from reports filed by 50 chemical companies at the EPA's "reading room" in Washington, and said the data includes only worst-case scenarios in which the companies said more than 100,000 people are at risk. Concerns that terrorists would use the information prompted Congress to limit access, and Greenpeace said its study is the first time the information has been widely available. The organization said it plans to post the accident scenarios at its Web site, www.greenpeaceusa.org/toxics. Plastics News, 04/02/01; Chemical Market Reporter, 04/02/01.

Among regulations recently withdrawn by the Bush Administration is a draft plan to provide limited public access to off-site consequences of potential chemical company accidents. The draft was an attempt to overcome opposition by industry and Justice Department officials to broad access to so-called worst-case scenarios. It is unclear when another draft will be issued. Chemical & Engineering News, 03/26/01, p. 27; Chemical Week, 03/28/01, p. 46.

ACID RAIN PERMITS RULE: EPA has taken direct final action to remove the provision for the industrial utility-units exemption in the regulations for the Acid Rain Program under title IV of the Clean Air Act. The purpose of the Acid Rain Program is to significantly reduce emissions of sulfur dioxide and nitrogen oxides from utility electric generating plants in order to reduce the adverse health and ecological effects of acidic deposition (or acid rain) resulting from these emissions. In January 1993, EPA issued rules implementing the program, including the permits rule. In October 1997, EPA revised the permits rule in order to add, among other things, a provision establishing a limited exemption from the program for certain industrial boilers (referred to as "industrial utility-units"). One party filed a petition for review challenging the industrial utility-units exemption. On August 23, 2000, EPA and the petitioning party signed a settlement agreement addressing the exemption provision. EPA is thus removing the industrial utility-units exemption based on a review of the record. This action is consistent with the August 23, 2000 settlement. 66 FR 12973-12978 (03/01/01). Proposed rule, 66 FR 12979 (03/01/01).

OZONE AND PARTICULATE MATTER: The chemical industry expressed disappointment last week in the Supreme Court's decision in a case that had challenged the extent of EPA's authority to regulate ozone and particulate matter throughout the country. In a unanimous 9-0 ruling, the nation's highest court found that EPA did not usurp lawmaking power from Congress when it set strict new standards for low-level ozone and particulates in 1997. The justices also upheld how the federal government sets air pollution standards, rejecting industry arguments that public health benefits should be weighed against compliance costs. The American Chemistry Council was not completely surprised by the decision, stating that it "was fairly apparent after the oral arguments that it would be an uphill battle on the unconstitutional delegation issue as well as the cost issue." Chemical Market Reporter, 03/05/01, pp. 1 and 13; Chemical & Engineering News, 03/05/01, p. 9; Chemical Week, 03/07/01, p. 9.

The National Association of Manufacturers and the U.S. Chamber of Commerce nation's have called for Congress to act in the wake of the Supreme Court's ruling. Senator George Voinovich (R-OH), chairman of the Senate Clean Air Subcommittee, responded by announcing plans to introduce legislation requiring new rules to be rooted in sound science and subject to cost-benefit analyses, risk assessment and peer review. Chemical Market Reporter, 03/12/01, p. 24.

INTERSTATE SMOG: The Supreme Court has also let stand an EPA rule to control smog that blows across state lines in the eastern part of the country. The high court denied one request by industry and another by two upwind states -- Michigan and Ohio -- to review the 1998 EPA regulation. That rule requires 22 states and the District of Columbia to submit implementation plans indicating what sources in each state will curb emissions of nitrogen oxides (NO_x), which are precursors to smog, with the goal of improving air quality in downwind areas. The primary targets of the Clean Air Act regulation are older, coal-burning power plants in the Midwest and Southeast. A year ago, a Federal appeals court upheld the regulation but said all of Wisconsin and parts of Georgia and Missouri should be exempt from the rule. Meanwhile, electric utilities have filed a case in Federal appeals court challenging how EPA determined NO_x emissions limits for each state affected by the rule. Chemical & Engineering News, 03/12/01, p. 43; Chemical Week, 03/14/01, p. 13.

SMOKE AND OZONE: Smoke aerosol and ozone are both produced by biomass burning. A strong link between elevated tropospheric ozone and biomass burning has been shown particularly for southern Africa, but other studies have indicated that tropospheric ozone is driven by large-scale atmospheric dynamics and by lightning. Researchers have analyzed daily satellite measurements of aerosol and ozone in the troposphere for August 1996 to December 1998. They show that tropospheric ozone increased well before the large fires in Indonesia connected with El Niño. Comparison of these data with earlier records from the 1980s shows that smoke and ozone signals were generally decoupled, indicating that biomass burning is only one factor determining tropical tropospheric ozone. Science, Vol. 291, No. 5511, 16 March 2001, pp. 2128-2132.

NAFTA CAUSES AIR POLLUTION: Increased trade due to the North American Free Trade Agreement (NAFTA) contributes significantly to air pollution along the U.S.-Canada and U.S.-Mexico borders. A new study conducted for the Commission on Environmental Cooperation, a trinational group established in conjunction with NAFTA, found that increased trade among the U.S., Canada, and Mexico is a significant source of nitrogen oxides -- which are linked to smog formation -- and fine soot particles in border areas. Most of these emissions are from trucks, but some come from locomotives, the study found. Trucks also contribute to carbon monoxide pollution as they idle while waiting to make border crossings. However, the study estimated that, because of regulations requiring low-sulfur diesel fuel and cleaner diesel engines, trade-related emissions from trucks will remain stable during the next two decades even as NAFTA-related trade increases two- to four fold. Chemical & Engineering News, 03/19/01, p. 25.

MERCURY EMISSIONS from chlor-alkali plants will be targeted by EPA in their effort to reduce children's health risks, although few -- only eleven -- U.S chlor-alkali processors use the old mercury cell processes. This is 15% of the nation's chlorine industry. The proposed restrictions would compliment the strategy proposed by EPA last fall to control Hg emissions from coal-fired electrical power plants. Chemical Week, 03/07/01, p. 45.

More than half of the European industry's chlorine producers are still using mercury-cell technology. In Barcelona last month, at its fifth triennial technical seminar, the European chlorine industry tackled the topic of "a sustainable future for chlorine," with a focus on improving health, safety, and environmental performance. The industry is inexorably converting or closing its mercury-cell plants, but the timetable is not yet clear. The deadline for the total change will be either 2010, as recommended in 1990 by an international convention, or 2020, as argued by the industry. The newer membrane-process capacity has risen from 11% of the total 1995 capacity of 10.8 million metric tons to 22% of the capacity in 2000 of 11.5 million metric tons. The capacity represented by diaphragm technology has held steady -- 24% in 1995 and 23% last year. That leaves mercury-cell capacity as the largest segment at just under 55%, although that share is down from the 65% of five years ago. Chemical & Engineering News, 03/12/01, pp. 21-24; Chemical Week, 03/14/01, p. 41.

MERCURY LEVELS in the bodies of about 10% of U.S. women are near harmful levels, according to a recent study by the Centers for Disease Control & Prevention. The primary mercury health impact is to children exposed to high levels in utero, mainly from the consumption by the mother of methylmercury in fish or seafood. Overall, the study found that mercury levels in children and women of childbearing age were below amounts considered hazardous. But the significant number of women with mercury near hazardous levels demonstrates a narrow margin of safety, according to the study. A breakdown by region, amount of fish consumption, and race/ethnicity will be available in two years, CDC says. The report follows others that have raised concerns about mercury in the environment. It is available on the Internet (http://www.cdc.gov/publications.htm). Chemical & Engineering News, 03/12/01, p. 43.

ETHYLENE OXIDE EMISSIONS: EPA has proposed to amend the emission standards for sterilization facilities by eliminating maximum achievable control technology (MACT) requirements for chamber exhaust vents. This action is being proposed to eliminate safety problems associated with the existing requirements. This proposal also amends testing and monitoring requirements for sterilization chamber, aeration, and chamber exhaust vents. Specific testing and monitoring requirements are being removed or simplified to correct technical problems associated with the existing requirements. 66 FR 13464-13473 (03/06/01).

GLOBAL WARMING: The White House is reviewing its strategy on global warming and will not be bound by positions taken by the Clinton administration in previous negotiations on the future of the Kyoto Protocol. Although she denies that the Bush administration is backing away from Kyoto, EPA administrator Christie Whitman is reviewing the implementation strategy. Mrs. Whitman called global warming "one of the greatest environmental challenges we face, if not the greatest." But she heavily qualified the Bush administration's acceptance of the UN pact under which industrialized nations agreed to curb their greenhouse gas emissions. Mrs. Whitman indicated that the US would not necessarily be bound by the target of reducing greenhouse gases by 7%, as agreed to four years ago by former President Bill Clinton. The last round of negotiations on implementing the climate accord broke down after a two-week session last November in The Netherlands. The talks are scheduled to resume in July. Chemical Market Reporter, 03/12/01, p. 7.

Mrs. Whitman made her remarks at the Group of Eight (G-8) industrial nations meeting in Trieste, Italy, where she also approved and signed a communiqui that commits those nations to reaching agreement on outstanding issues in the Kyoto protocol on climate change. This raised hopes that at the upcoming climate-change meeting, scheduled for July in Bonn, nations can resolve conflicts that led to the collapse of negotiations last November in The Hague. The communiqui says, among other things, nations should achieve the majority of their greenhouse gas emissions reductions domestically rather than through emissions trading or through sponsorship of clean energy projects in developing countries. Whether most of the emissions reductions should be achieved domestically was a major sticking point in The Hague. Chemical & Engineering News, 03/12/01, p. 11.

Citing a national energy crisis and reversing a campaign pledge he made in September, President Bush has announced that he would not regulate power plants' emissions of carbon dioxide. Vice President Dick Cheney -- who is directing energy policy oversight for the administration -- told Republican senators that promising to regulate carbon dioxide "was a mistake" because of a national energy crisis and high electricity prices. The Global Climate Coalition, a group of industry associations which includes the American Chemistry Council, and opposed to mandatory CO₂ emissions cuts, expressed support for the President's decision. Chemical Market Reporter, 03/19/01, p. 5 and 03/26/01, p. 21; Chemical & Engineering News, 03/19/01, pp. 10 and 25; Chemical Week, 03/21/01, p. 7 and 03/28/01, p. 46.

Elsewhere, a United Nations report concludes that greenhouse gas emissions can be reduced at a lower cost than previously believed. The UN report prepared by the Intergovernmental Panel on Climate Change is the final study in a series of three. The first two reports released earlier this year concern the causes and impacts of climate change. This final report concludes that, in 1990, global greenhouse gas emissions totaled 6.9 billion to 8.4 billion metric tons (bmt) in carbon equivalents and that emissions could be cut by 3.6 to 5.1 bmt annually by 2020 from a projected total of 12 bmt. Significant progress in technologies that reduce emissions of greenhouse gases will make cutting emissions cheaper than expected. Examples include advances in wind turbines, efficient hybrid-engine cars, fuel-cell technologies, and carbon removal from fuels or flue gas and storage in deep underground aquifers. The Global Climate Coalition, a business group whose members include the American Chemistry Council, says a the report "reinforces the need to develop a voluntary program for developing new technologies for the worldwide reduction of greenhouse gas emissions." Chemical & Engineering News, 03/12/01, p. 11; Chemical Market Reporter, 03/19/01, p. 28.

The U.N. climate conference in The Hague in November 2000 was adjourned without agreement. In a Policy Forum piece in Science magazine, Klaus Töpfer, the Executive Director of the United Nations Environment Program, looks ahead to the forthcoming meeting scheduled from 16^th July 2001 in Bonn. To meet the objectives of the Kyoto Protocol, industrialized nations must lead the way. Emission and sequestration policies must be agreed and implemented within a framework of transparent environmental standards that promote long-term benefit. Technology innovation and transfer to developing nations must be complemented by domestic action in the industrialized nations, and adaptation funds for developing countries must be made available. Science, Vol. 291, No. 5511, 16 March 2001, pp. 2095-2096.

A study based on direct observations from satellites shows an increase in Earth's greenhouse effect between 1970 and 1997 [Nature, 410, 355 (2001)]. John E. Harries, an atmospheric physicist at Imperial College, London, and colleagues analyzed two sets of spectra of Earth's outgoing long-wave radiation, which is a measure of how much heat Earth radiates into space. The first set of spectra was obtained by NASA with a spectrometer on the Nimbus 4 spacecraft between April 1970 and January 1971. The second set was recorded by a spectrometer aboard a Japanese satellite in 1996-97. A comparison of the two data sets shows that the amount of long-wave radiation emitted by Earth declined between 1970 and 1997, indicating a significant increase in Earth's greenhouse effect. It also indicates long-term changes in atmospheric levels of greenhouse gases, such as CH₄, CO₂, and O₃. These new results provide the first direct observational evidence for changes in the radiative forcing (heat-trapping effect) of Earth's atmosphere over the past 27 years, says Helen E. Brindley, an atmospheric physicist at Imperial College who coauthored the study. Previous estimates of the total radiative effect of greenhouse gases were made with models. Chemical & Engineering News, 03/19/01, p. 36.

CLIMATE ACTION REPORT: In June 1992, the United States signed the United Nations Framework Convention on Climate Change (UNFCCC). Pursuant to the national communication reporting requirements of the Convention, the United States submitted the first U.S. Climate Action Report (USCAR) to the UNFCCC Secretariat in 1994 and the second in 1997. The government is currently preparing the third national communication, which is due to the UNFCCC secretariat no later than November 30, 2001. EPA therefore is notifying interested members of the public of this process and to solicit contributions and input on the issues covered in the national communication before the draft text is released for public review (in summer of 2001). Written comments should be received on or before noon, April 18, 2001. However, comments received after that date will still be welcomed and will be considered during preparation of the report. Comments should be submitted to Mr. Reid P. Harvey, U.S. Environmental Protection Agency, Office of Atmospheric Programs (Mail Stop 6204N), 1200 Pennsylvania Avenue, NW, Washington, DC 20460. Comments may also be e-mailed to harvey.reid@epa.gov or faxed to 202-565-6673. Overnight or courier deliveries should be sent to the office location at 633 3^rd Street, NW, Washington, DC, 20001. 66 FR 15470-15471 (03/19/01).

LINKS BETWEEN OZONE DEPLETION AND GLOBAL WARMING: Stratospheric denitrification -- the irreversible removal of nitric acid from the stratosphere -- facilitates the destruction of ozone by removing reactive nitrogen species that sequester atomic chlorine, the major catalyst of ozone loss. Reaching a quantitative understanding of how denitrification occurs has been an elusive goal. NASA and University of Colorado scientists have used a cloud model that simulates the formation, growth, and sedimentation of large nitric acid-containing particles, the prime suspects in denitrification, and they identify a polar freezing belt that allows denitrification to occur around both the Arctic and the Antarctic. Their results indicate that if global warming leads to stratospheric cooling, recovery from polar ozone loss will be delayed. Science, Vol. 291, No. 5513, 30 March 2001, pp. 2591-2594.

ODS EXEMPTION FOR LABS: EPA has determined that it is appropriate to provide an exemption for laboratory and analytical essential uses of certain ozone depleting substances (ODSs) for calendar year 2001 and that an allowance for laboratory and analytical essential uses, which allows for the production and import of class I stratospheric ODSs beyond the phase-out of these substances, is allowable under the Clean Air Act as a de minimis exemption. Based on specific findings, EPA has amended the regulations on import and production of ODSs to reflect this determination and is allocating a general global exemption for class I ODSs for laboratory and analytical essential uses for the year 2001. This action allows for the continued import and production of class I ODSs for laboratory uses where there are no sufficient substitutes. These laboratory uses include numerous analytical methods necessary for protecting public health and the environment. The exemption applies in Medical and Diagnostic Laboratories; Research & Development Labs in the Physical, Engineering, and Life Sciences; and Environmental Consulting Services Labs. Proposed Rule: 66 FR 14771-14772 (03/13/01); Direct Final Rule: 66 FR 14759-14770 (03/13/01).

HALON EXCHANGE: The United Nations Environment Program launched a new business-to-business Web portal to facilitate international exchange of used halons and reduce the use of newly produced halons (http://www.halontrader.org/). It is designed for companies that use halons in essential applications. Chemical & Engineering News, 03/26/01, p. 27.

NESHAP REVISIONS: EPA has proposed amendments to the General Provisions for national emission standards for hazardous air pollutants (NESHAP) and other regulatory requirements that are established under §112 of the Clean Air Act as amended in 1990 (59 FR 12408, 03/16/94) that would revise and clarify several of the current provisions. These amendments were proposed, in part, as a result of decisions reached in settlement negotiations conducted between petitioners, who filed for review of the General Provisions, and the EPA. The proposed amendments also reflect internal EPA discussions on issues regarding implementation of the General Provisions. In addition, the agency has proposed amendments to rules that establish equivalent emission limitations by permit under §112(j), which establishes requirements and procedures for owners or operators of major sources of hazardous air pollutants (HAP), and permitting authorities, to comply with §112(j). The §112(j) rule was promulgated on May 20, 1994 (59 FR 26429). An electronic copy of the proposed rule amendments will be available on the WWW through the Technology Transfer Network posted on the TTN's policy and guidance page for newly proposed or promulgated rules at http://www.epa.gov/ttn/oarpg. 66 FR 16317-16360 (03/23/01).

BROMINATED FLAME RETARDANTS are targeted for early phase-out under demands made by the environmental committee of the European Parliament and activists, seeking to more than double the number of hazardous substances earmarked for elimination under the new European Union water framework. There are currently eleven chemicals on the directive's "priority list" of substances to be phased out over the next twenty years. Parliament would expand this to 28, including lead and its compounds. Chemical Week, 03/07/01, p. 45.

IDENTIFYING WATER QUALITY STRESSORS: The Stressor Identification Guidance Document (EPA 822-B-00-025), published under the authority of §304(a)(2) of the Clean Water Act, is now available. This technical guidance document is designed to assist water quality managers in identifying unknown causes of biological impairments in any type of water body. In many cases, the cause, or causes, of these biological impairments have not yet been identified. The Stressor Identification Guidance Document provides a logical, scientific process by which water quality experts can evaluate available information to identify the stressor(s) causing the biological impairments. Paper copies of these guidelines can be obtained from the U.S. EPA, Water Resource Center by phone at: (202) 260-7786, or by sending an e- mail to the Center at center.water-resource@epa.gov, or through conventional mail by sending a letter of request to U.S. EPA Water Resource Center, Ariel Rios Building, 1200 Pennsylvania Avenue, Washington, DC 20460. Copies of the document may also be obtained from the U.S. EPA National Center for Environmental Publications and Information (NCEPI), 11029 Kenwood Road, Cincinnati, OH 45242 or (513) 489-8190. The document and fact sheet are also available on the EPA website at www.epa.gov/OST/biocriteria. 66 FR 13738 (03/07/01).

STATES SEEK TMDL RULE RELIEF: The National Governors Association has asked Congress and the Bush administration to give the states more time and flexibility to comply with the revised EPA program setting total maximum daily load (TMDL) pollution limits for water bodies. EPA defied the lawmakers last summer by implementing the revisions before Congress could act to delay them. The revisions -- taking effect in October -- require states to devise EPA-approved TMDL plans within 15 years. Chemical Week, 03/14/01, p. 40.

ARSENIC IN DRINKING WATER: In January, EPA lowered the limit of arsenic in drinking water from 50 ppb to 10 ppb (www.epa.gov/safewater/arsenic.html; 66 FR 6975-7066, 01/22/01). Now, it appears that chronic exposure to small amounts of arsenic in drinking water increases a person's risk of cancer and other diseases. Researchers believe they're now onto an explanation for the process. Arsenic acts as an endocrine disrupter, upsetting the action of hormones by blocking or mimicking them, according to researchers at Dartmouth College in Hanover, NH. Previously identified endocrine disrupters have included many pesticides, industrial chemicals, and pollutants including dioxin. This is the first time that a metal has joined the list. The researchers suggest that arsenic interferes with the action of glucocorticoids, hormones never known before to be vulnerable to endocrine disruption by pollution. Glucocorticoids belong to the same family of steroid hormones as estrogen and testosterone. Glucocorticoids are responsible for turning on many genes that may suppress cancer and regulate blood sugar. The study is reported in the March issue of Environmental Health Perspectives. Although arsenic at high doses kills cells immediately, this study shows that arsenic can be harmful even in low concentrations. Science News, 03/17/01, p. 164.

In accordance with President Bush's regulatory review plan, EPA has temporarily delayed for 60 days the effective date of the above referenced arsenic regulation. That rule establishes a health-based, non-enforceable Maximum Contaminant Level Goal for arsenic of zero and an enforceable Maximum Contaminant Level for arsenic of 0.01 mg/L (10 µg/ L) for public water systems. The agency had originally said would prevent from 38 to 56 cases of cancer each year at an annual cost of $181 million. New EPA administrator Christie Whitman concluded that the cost was too high and the science too flimsy. The action leaves the United States with one of the most permissive arsenic regulations in the world. Earlier this month, the National Mining Association and the states of Nebraska and New Mexico sued to stop the Clinton administration's arsenic rule. 66 FR 16134-16135 (03/23/01); Chemical & Engineering News, 03/26/01, p. 20; Chemical Week, 03/28/01, p. 16.

When Whitman decided to withdraw new arsenic standards, she brandished scientific uncertainty as a shield against environmental protesters. But the reality is that setting safe levels of very small amounts of toxicants such as arsenic is not a question that science alone can answer. It's a judgment call, and that means a role for politics. Rocks and soils are the main source of inorganic arsenic in groundwater, although mining and other humanmade sources also contribute. People who drink water from tainted sources can eventually develop bladder and other cancers. In 1999, a National Research Council reviewed the evidence on arsenic and concluded that the current acceptable level of 50 ppb should be lowered "as promptly as possible." Although the NRC did not recommend a specific level, in January the outgoing Clinton Administration issued a final rule that would have dropped the safe level to 10 ppb. Western officials and industry objected, estimating that they would need to spend billions of dollars on treatment equipment to meet the new standard. On 20 March, Whitman sided with them, saying that she agreed with the NRC but that the Clinton plan was based on "unclear" science. "An independent review ... will help clear up the uncertainties," she added. But scientists say the evidence won't become clear anytime soon. Science, Vol. 291, No. 5513, 30 March 2001, p. 2533.

STORM WATER DISCHARGE: EPA published a new version of the NPDES Storm Water Multi-Sector General Permit (MSGP) in the Federal Register of October 30, 2000 (65 FR 64746), which replaced the first version issued on September 29, 1995 (60 FR 50804) and amended on February 9, 1996 (61 FR 5248), February 20, 1996 (61 FR 5248), September 24, 1996 (61 FR 50020), August 7, 1998 (63 FR 42534) and September 30, 1998 (63 FR 52430). This general permit authorizes the discharge of storm water from industrial activities consistent with the terms of the permit. The permit contained incorrect dates, typographical errors and omissions from any of the following: the fact sheet portion of the final MSGP from October 30, 2000, the proposed MSGP from March 30, 2000 (65 FR 17010), or the original 1995 version of the MSGP and subsequent amendments. This correction is subsequent to an initial correction notice published January 9, 2001 (66 FR 1675). 66 FR 16233-16237 (03/23/01).

EFFLUENT GUIDELINES WORKSHOP: Under the Clean Water Act, EPA is required to publish a plan every two years which, in part, identifies industry categories for new or revised effluent guidelines. EPA is convening a group of stakeholders and technical experts to participate in a two-day workshop on April 2^nd and 3^rd in Baltimore, MD. The purpose of this workshop is to evaluate processes that may be effective in providing a meaningful, transparent assessment of whether revision of existing effluent guidelines is appropriate or whether there is a new category of sources that should be regulated by new effluent guidelines. This meeting is a working session of invited participants selected to represent a broad range of viewpoints and expertise. The meeting is open to the public. The public may make oral statements on April 3, 2001 from 3:45-4:45 PM. The workshop will be held at The Admiral Fell Inn located at 888 South Broadway, Market Square at Thames Street, Baltimore, MD 21231, (800-292-4667). 66 FR 15866-15867 (03/21/01).

EPA BUDGET REDUCTION: President George W. Bush's $1.96 trillion fiscal 2002 budget proposal would reduce funding for the EPA by $500 million to $7.3 billion, a 6.4% cut from the agency's record $7.8 billion budget in fiscal 2001. Despite the cut, EPA administrator Christine Todd Whitman said her agency would still have sufficient resources to do its work. Mrs. Whitman said she is assured by the budget levels that EPA's mission would not be hindered in any way. She noted that EPA's program grants to state governments would be funded at the highest level ever, at more than $1 billion. To help reach its goals, the EPA chief said the agency will place greater emphasis on innovative approaches to environmental protection, such as market-based incentives, and will request $25 million in grant funding to help states better integrate their environmental information systems. Chemical Market Reporter, 03/05/01, p. 14; Chemical Week, 03/07/01, p. 10.

REGULATIONS ROLLBACK: A senior Democrat on the Senate Environment and Public Works Committee is expressing concern that the White House is continuing to delay implementation of public health and environmental protection rules issued in the last days of the Clinton administration. Although EPA has released its hold on final regulations requiring refiners to make drastic cuts in the sulfur content of diesel fuel, Senator Harry Reid (D-NV) voiced concern about the status of other Clinton rule makings. On January 20^th, shortly after President George W. Bush took office, White House chief of staff Andrew Card ordered that all regulations awaiting publication in the Federal Register be pulled back for review by officials of the new administration. He also ordered a 60-day delay in the effective date of final rules that had already been published. Chemical Market Reporter, 03/19/01, p. 16.

ERGONOMICS STANDARD: In a 56-44 vote, largely along party lines, the Senate opted on March 6^th to repeal the Ergonomics Standard, the Federal regulation that was aimed at protecting millions of workers from repetitive-stress injuries but would cost employers billions of dollars a year. The House of Representatives voted to repeal it as well on the next day, under strict floor rules that allow only one hour of debate. The Ergonomic Standard was published on November 14, 2000 and requires employers to take steps to reduce the incidence of workplace-induced muscle and bone disorders, such as the keyboard-instigated carpal tunnel syndrome. The regulation also requires employers to reimburse the medical costs of injured workers and to pay them at nearly full salary if they miss work. According to OSHA, about 102 million workers would be protected. Among them would be cashiers, factory-line workers, meat cutters, forklift operators, poultry-plant workers, secretaries and just about anyone who regularly operates a computer. Business groups argued that the regulation would impose huge costs on employers. OSHA estimated that the regulation would cost employers $4.6 billion a year, and industry groups said it could cost as much as $100 billion a year. However, Labor Secretary Elaine L. Chao has said that her department will review the issue of musculoskeletal diseases and possibly write a new rule that responds to industry concerns. Chemical & Engineering News, 03/12/01, p. 15; Chemical Week, 03/14/01, p. 10.

PLASTICS DIVE STICKS: The Consumer Product Safety Commission has issued a rule to ban certain dive sticks under the authority of the Federal Hazardous Substances Act. Dive sticks are used for underwater activities, such as retrieval games and swimming instruction. They are typically made of rigid plastic and stand upright at the bottom of a swimming pool. Due to these characteristics, if a child jumps onto a dive stick in shallow water he or she may suffer severe injuries. Although voluntary recalls have removed most, if not all, of these products from the market for the present time, CPSC is concerned that, without a rule banning them, they could reappear on the market. The rule will ban dive sticks that (1) are rigid, (2) submerge to the bottom of a pool of water, and (3) stand upright in water. 66 FR 13645-13652 (03/07/01); correction 66 FR 15996-15997 (03/22/01).

CLASS ACTION LAWSUITS: The American Chemistry Council and other business groups plan to mount an aggressive campaign this year to enact legislation that would transfer most state class action lawsuits to Federal courts. The U.S. House of Representatives narrowly passed a class action reform bill in September 1999 and a companion measure cleared the Senate Judiciary Committee last June. However, facing a certain filibuster on the Senate floor by Democratic opponents and a veto threat by former President Bill Clinton, the legislation failed to become law. Under the previous bill, either party in a class action case involving more than $2 million could seek a transfer to Federal court if the defendant and at least one plaintiff live in different states. Proponents of reform say the current system is fraught with abuse and allows plaintiffs' attorneys to "forum-shop" among states in search of a court that is likely to be sympathetic to their case. Federal courts are more apt to grant businesses an impartial hearing both when determining whether a suit is eligible for class action status or when the case is heard, supporters reason. Chemical Market Reporter, 03/19/01, p. 1.

TOTAL ASBESTOS LIABILITY could be as high as $50 billion, according to Credit Suisse First Boston, roughly divided among 120 defendants with varying amounts of liability. According to a study by Aetna, 27.5 million people were exposed to asbestos at work between 1940 and 1979. In a report calling for tort reform, the total number of claims filed against all defendants from the onset of asbestos litigation now exceeds 550,000. People who have been exposed to asbestos may be at risk for developing diseases including asbestosis, mesothelioma or lung cancer. The diseases often do not surface for 15-40 years. As a result, asbestos liability has continued to rise long after most manufacturers have stopped using the product. Asbestos-related lawsuits now represent the largest mass-tort litigation in U.S. history, measured by the number of cases. Bear Stearns says that unless the asbestos mess receives a legislative response, everyone can expect to see more companies seeking bankruptcy protection. Some 25 companies have filed so far because of asbestos. However, chances for comprehensive legislation are estimated at less than 50%. Plastics News, 03/19/01, p. 9.

CHEMICAL TRADE: For the past two decades, a panel of industry officials has advised the Office of the U.S. Trade Representative (USTR) on international commerce in chemicals. Environmental activists have sued to get a seat on this committee, and USTR is about to settle that suit in their favor. But now the leaders of the Industry Sector Advisory Committee for Chemicals & Allied Products (ISAC-3) want a Federal judge in the District of Columbia to stop USTR from appointing an environmental group representative to their panel. They also asked the court to allow ISAC-3 to resume its meetings, which USTR halted after the environmental activists filed their suit. It is argued that the industry sector advisory panels are technical committees that provide feedback on the plans of U.S. trade negotiators and that membership on a committee should be confined to representatives of the industry the panel focuses on. But the environmental groups maintain that the issues facing ISAC-3 are no longer parochial matters of interest only to the chemical industry. Instead, trade and environment issues have become inextricably intertwined. They note that the industry panel has advised U.S. trade officials on several global environmental treaties. An ISAC-3 meeting is scheduled for early April. Chemical & Engineering News, 03/26/01, p. 19; Chemical Week, 03/28/01, p. 12.

TRADE SECRETS: "Trade Secrets: A Moyers Report," by journalist Bill Moyers, premiered March 26^th on Public Broadcasting System stations. It was presumedly based upon what PBS described as a massive archive of secret industry documents as shocking as the "tobacco papers." The public television documentary questions whether most chemicals are tested adequately for their health effects, and is likely to increase public concern about chemicals risks. But chemical industry officials criticized Moyers for not including industry officials in the 90-minute documentary, instead relegating them to a 30-minute panel discussion airing immediately after. Chemical trade associations have launched a new website to respond to the documentary since PBS correspondent Moyers "refused to give the industry an opportunity to address allegations in the report, correct possible inaccuracies or provide balance:" www.abouttradesecrets.org/employee. Chemical Market Reporter, 03/26/01, p. 5; Chemical Week, 03/28/01, p. 5.

SAFETY & HAZARD INVESTIGATIONS: The Chemical Safety and Hazard Investigation Board (CSB) has established internal policies and procedures governing when and to what extent employees of the Board may appear as witnesses in third-party litigation or produce CSB records in third-party litigation. The intended effect of this regulation is to conserve the CSB's ability to conduct official business, preserve its employee resources, minimize involvement in matters unrelated to its mission and programs, preserve its impartiality, avoid spending public time and money for private purposes, and to help avoid needless litigation. See the information available on the CSB web site, at www.csb.gov. 66 FR 17364-17368 (03/30/01). CSB has also set forth new regulations concerning sanctions for repeated attorney misconduct, and the sequestration of witnesses and exclusion of counsel in depositions conducted under subpoena in CSB investigations. 66 FR 17363-17364 (03/30/01).