Addition of National Toxicology Program Carcinogens
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Rule Summary
On November 26, 2010, EPA finalized a rule to provide communities with additional information about toxic chemicals being released to the environment. The rule adds 16 chemicals to the TRI list of reportable chemicals. Each chemical has been classified as "reasonably anticipated to be a human carcinogen" by the National Toxicology Program (NTP) in their Report on Carcinogens (RoC) document. EPA has concluded, based on a review of available studies, that these 16 chemicals could cause cancer in humans and therefore meet the EPCRA section 313(d)(2)(B) statutory listing criteria.
Four of the chemicals are being added to TRI under the polycyclic aromatic compounds (PACs) category. The PACs category is 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.
Rule History
Chemicals Included in the Final Rule
| Individual Listings | Polycyclic Aromatic Compounds (PACs) category | ||
|---|---|---|---|
| Chemical Name | CAS# | Chemical Name | CAS# |
| 1-Amino-2,4-dibromoanthraquinone | 81-49-2 | 1,6-Dinitropyrene | 42397-64-8 |
| 2,2-bis(Bromomethyl)-1,3-propanediol | 3296-90-0 | 1,8-Dinitropyrene | 42397-65-9 |
| Furan | 110-00-9 | 6-Nitrochrysene | 7496-02-8 |
| Glycidol | 556-52-5 | 4-Nitropyrene | 57835-92-4 |
| Isoprene | 78-79-5 | ||
| Methyleugenol | 93-15-2 | ||
| o-Nitroanisole | 91-23-6 | ||
| Nitromethane | 75-52-5 | ||
| Phenolphthalein | 77-09-8 | ||
| Tetrafluoroethylene | 116-14-3 | ||
| Tetranitromethane | 509-14-8 | ||
| Vinyl Fluoride | 75-02-5 | ||
The National Toxicology Program and the Report on Carcinogens
The National Toxicology Program 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.
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."
Advantage of Using the 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."
EPA's Review and Selection of 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.
Additional Resources
Read the final rule (PDF) (8pp, 175 K, About PDF)
Compliance
EPA estimates that 175 facilities will be affected by this final rule. These 175 facilities are expected to file 186 reporting forms containing release and waste management data for the 16 chemicals being added.
The majority of the facilities expected to file reporting forms are from industry sectors that manufacture basic organic chemicals, dyes, pigments, plastics and resins. Reports are also expected from petroleum refineries.
The final rule is effective for the 2011 reporting year with the first reports due July 1, 2012.