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Addition of National Toxicology Program Carcinogens Proposed Rule
On April 6, 2010, EPA took an important step toward providing communities with additional information about toxic chemicals being released to the environment. The Agency announced that it is proposing to add 16 chemicals to the TRI list of reportable chemicals. The Agency's proposal is part of its ongoing efforts to examine the scope of TRI chemical coverage and provide communities with more complete information on toxic chemical releases, and is the first TRI program chemical expansion in over a decade.
The chemicals that EPA is proposing to add have been classified as "reasonably anticipated to be a human carcinogen" by the National Toxicology Program (NTP) in their Report on Carcinogens (RoC) document. Based on a review of the NTP RoC data, EPA believes that these 16 chemicals meet the EPCRA section 313(d)(2)(B)statutory listing criteria because they can reasonably be anticipated to cause cancer in humans. Additionally, four of the chemicals are being proposed for addition to the polycyclic aromatic compounds (PACs) category. The PACs category is a category of special concern, because PACs are persistent, bioaccumulative, toxic (PBT) chemicals, and as such, they are likely to remain in the environment for a very long time, are not readily destroyed, and may build up or accumulate in body.
- View the proposed rule (PDF) (17 pp, 205 K)
Submit your comments by one of the following methods:
Identified comment by Docket ID No. EPA-HQ-TRI-2010-0006; FRL-9134-1
- www.regulations.gov: Follow the on-line instructions for submitting comments.
- Email: email@example.com
- Mail: Office of Environmental Information (OEI) Docket, Environmental Protection Agency, Mail Code: 28221T, 1200 Pennsylvania Ave., NW, Washington, DC 20460.
- Hand Delivery: EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC 20460. Such deliveries are only accepted during the Center's normal hours of operation.
What chemicals are included in the proposed rule?
What is the basis for adding these chemicals?
These 16 chemicals have been classified by the National Toxicology Program (NTP) in their Report on Carcinogens (RoC) as "reasonably anticipated to be a human carcinogen." EPA believes that the 16 chemicals being proposed for addition meet the statutory listing criteria because they can reasonably be anticipated to cause cancer in humans. EPA also expects that these chemicals will meet or exceed the TRI reporting thresholds resulting in reports being filed.
What is the NTP?
The National Toxicology Program (NTP) is an interagency program within the Department of Health and Human Services (DHHS) headquartered at the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH). The mission of the NTP is to evaluate chemicals of public health concern by developing and applying tools of modern toxicology and molecular biology. The mission of the NTP includes the evaluation of chemicals for their potential to cause cancer in humans.
What is the RoC?
As part of their cancer evaluation work, the NTP periodically publishes their Report on Carcinogens (RoC) document. The RoC was mandated by the U.S. Congress, as part of the Public Health Service Act (Section 301(b)(4), as amended). The RoC is an informational scientific and public health document that identifies chemicals that may pose a carcinogenicity hazard to human health. The NTP RoC classifies chemicals as either "known to be a human carcinogen" or "reasonably anticipated to be a human carcinogen."
What is the advantage of using the NTP RoC assessments?
By using the NTP RoC assessments EPA is taking advantage of readily available, high quality assessments that provide strong evidence to support adding a chemical to the TRI list. The NTP RoC review process includes evaluations by scientists from the NTP, other Federal health research and regulatory agencies (including EPA), and nongovernmental institutions. The RoC review process includes external peer review and several opportunities for public comment. The specific data used by the NTP to determine whether a chemical is "Known To Be Human Carcinogen" or "Reasonably Anticipated To Be Human Carcinogen" are consistent with data used by EPA to evaluate chemicals for their potential to cause cancer and classify chemicals as either "Carcinogenic to Humans" or "Likely to Be Carcinogenic to Humans".
How did EPA review and select the NTP RoC chemicals being added?
EPA reviewed the NTP RoC chemical profiles and supporting materials for each chemical being considered for listing on the TRI. Given NTP's extensive reviews and expertise, EPA's review focused on ensuring that there were no inconsistencies with how the Agency would consider the available data. EPA also reviewed available production and use information for each chemical to determine whether it is expected to be manufactured, processed, or otherwise used in quantities that would exceed TRI reporting thresholds.
How many facilities are expected to be affected by this rule and what are they required to do?
EPA estimates that 175 facilities will be affected by this proposed rule. These 175 facilities are expected to file 186 reports containing release and waste management data for the 16 chemicals being proposed for addition. The final rule is effective for the 2011 reporting year with the first reports due July 1, 2012.
For further information contact:
Daniel R. Bushman, Environmental Analysis Division, Office of Information Analysis and Access (2842T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: 202-566-0743; fax number: 202-566-0677; e-mail:firstname.lastname@example.org, for specific information on this document.