Public Comment Sought Regarding Human Testing Data

May 16, 2003
On May 7, EPA published an Advance Notice of Proposed Rulemaking (ANPR) in the Federal Register to solicit public comment about criteria and standards the Agency would use in deciding the extent to which it will rely on certain kinds of human research to support its actions to protect public health and the environment. This notice begins a process to establish rigorous scientific and ethical standards that EPA would apply in its analysis of various types of research involving people exposed to toxicants to identify or quantify their effects. The Agency will particularly focus on "third-party intentional dosing human studies," but recognizes that standards applicable to these studies may also be applicable to other types of studies. "Third party studies" refers to research not conducted or supported by EPA or other federal agencies, and therefore not governed by the Common Rule to ensure that human test subjects have adequate protections.

The Agency is seeking public comments on how to determine the extent to which it will consider or rely on results from particular types of studies involving human subjects, and how EPA might be able to establish robust standards for the protection of human subjects, in preparation for developing a rule or policy on this issue. The Agency's focus in developing a future policy or rule must be protection of the welfare of human research subjects and adherence to the most rigorous ethical and scientific standards. Along with public comments, EPA will also carefully consider advice expected later this year from the National Academy of Sciences. This process will allow EPA to review its approach to human subjects research and develop a rule or policy in a transparent and participatory manner.

Comments on this ANPR will be accepted for 90 days. The Federal Register notice can be found at

EPA Finalizes Changes to the MACT Hammer Rule

EPA has revised two rules contributing to its efforts to reduce national emissions of toxic air pollutants. The first action amends a rule known as the "General Provisions" which establishes a common set of requirements for developing rules or standards to regulate emissions of toxic air pollution. In the second action, EPA is amending its rule known as the "Section 112(j) or MACT Hammer rule." This rule currently affects over 40 categories of industry for which EPA has yet to issue national air toxics emissions standards.

The 1990 Clean Air Act charged EPA with a very large task – in just 10 years the Agency was to issue regulations that would reduce air toxic emissions from over 170 categories of industries. To date, the Agency has issued rules to control emissions of air toxics from 112 of the 154 categories of industries currently listed for control. Sixteen of the original categories have been delisted or are included within other categories. EPA is committed to completing the remaining emissions standards by the deadlines agreed to in a March 2003 settlement agreement with the Sierra Club – all will be completed by June 14, 2005. These amendments include a backstop to insure that emissions reductions will occur by requiring states to set emission limits on a facility-by-facility basis should EPA not be able to finalize the remaining air toxics standards as agreed.

EPA Proposal Outlines Implementation of New Air Quality Standards for Ground-Level Ozone

EPA is proposing a rule that outlines steps certain polluted areas would have to take to clean up their air. The proposed rule would establish guidelines for state and tribal authorities to implement the 8-hour national air quality standard for ozone, first enacted by EPA in 1997 and upheld by the U.S. Supreme Court in 2001. The proposal seeks public comment on options for planning and control requirements for states and tribes, as well as on options for making the transition from the 1-hour ozone standard to the 8-hour standard. The proposed rule describes options for classifying nonattainment areas; however, the proposal does not make any attainment designations.

A nonattainment area violates the ozone standard or contributes to violations of the standard in a nearby area. Designations for nonattainment areas will occur by April 15, 2004 under a separate process.

EPA will take comments on this proposed rule for 60 days following publication in the Federal Register. The Agency will also hold three public hearings across the country on the proposed rule: Dallas, Texas on June 17; San Francisco, Calif. on June 19; and Alexandria, Va. on June 27. More information is available at .

EPA Publishes Report on Hazardous Waste Treatment Technologies

The National Risk Management Research Laboratory, under EPA's Office of Research and Development, has published the "The Superfund Innovative Technology Evaluation (SITE) Program Annual Report to Congress Fiscal Year 2001."

The SITE Program provides environmental decision-makers with data on new treatment technologies that perform better and cost less than existing technologies. Since the program's inception in 1986, it is estimated that cleanup of contaminated sites through the use of SITE technologies has resulted in cost savings of more than $2.6 billion. This program was established in response to the 1986 Superfund Amendments and Reauthorization Act, which recognized the need for new treatment technology research. Treatment tools and technologies developed under SITE prevent and control pollution of air, land, water; protect public water systems; remediate contaminated sites and ground water; and prevent and control indoor air hazards. New technology is field-tested on hazardous waste materials, and engineering and cost data are collected so potential users can assess the technology's applicability to a particular site.

The report discusses the SITE program's cost savings and vendor benefits through the promotion of innovative, cost-effective technologies. More information on the SITE program is available at

EPA Launches New Compliance Assistance Center for Auto Recyclers

EPA has introduced a new web-based Compliance Assistance Center to help automotive recyclers comply with federal and state environmental regulations. The new center, the Environmental Compliance for Automotive Recyclers – or ECARcenter – is a cooperative effort between the Automotive Recyclers Association (ARA) and the National Center for Manufacturing Science, and is funded by EPA. In addition to explaining federal and state environmental requirements applicable to the automotive recycling industry, ECARcenter gives users the latest industry news from U.S. and international publications. The ECARcenter can be found on-line at

ECARcenter is the second of two new Compliance Assistance Centers launched recently by EPA. On May 1, Administrator Christie Whitman introduced the new Construction Industry Compliance Assistance Center, partnering with industry, academic institutions, environmental groups, and other agencies to develop thirteen sector-specific Compliance Assistance Centers so far. Other Centers include agriculture, auto repair, chemical, federal facilities, local government, metal finishing, painting and coatings, printed wiring board, printing, transportation, and U.S. / Mexican border environmental issues. EPA surveys suggest that the Centers are serving their intended purpose: to provide access to current information and an increased understanding of applicable regulations. At least 73 percent of the respondents took one or more actions (e.g., conducted a self audit, changed a process or practice) from Center use. Furthermore, 69 percent of the survey respondents reported a cost savings from these actions and 85 percent of respondents reported an environmental improvement. To visit all Compliance Assistance Centers, see