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Addition of ortho-Nitrotoluene: Final Rule
On November 7, 2013, EPA published a final rule adding o-nitrotoluene to the TRI list of reportable chemicals. This rule is part of the Agency's ongoing efforts to examine the scope of TRI chemical coverage and provide communities with more complete information on toxic chemical releases to the environment.
o-Nitrotoluene has 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 o-nitrotoluene meets the Emergency Planning and Community Right-to-Know Act (EPCRA) Section 313(d)(2)(B) statutory listing criteria because it can reasonably be anticipated to cause cancer in humans.
- Read the proposed rule (PDF) (8 pp, 277 K, About PDF)
- Read the final rule (PDF) ( 4 pp, 253 K, About PDF)
What is the basis for adding o-nitrotoluene?
o-Nitrotoluene has been classified by the National Toxicology Program (NTP) in their Report on Carcinogens (RoC) as "reasonably anticipated to be a human carcinogen." EPA determined that o-nitrotoluene meets the statutory listing criteria because it can reasonably be anticipated to cause cancer in humans. EPA also expects o-nitrotoluene 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 the toxicity data for o-nitrotoluene?
EPA reviewed the NTP RoC chemical profile and supporting material for o-nitrotoluene. 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 o-nitrotoluene 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 proposed rule and what are they required to do?
EPA estimates that 22 facilities will be affected by this proposed rule. These 22 facilities are expected to file 22 reports containing release and waste management data for o-nitrotoluene.
When does the final rule take effect?
The final rule is effective for the 2014 TRI reporting year with the first reports due July 1, 2015.
For further information contact:
You can contact Daniel R. Bushman (email@example.com) at 202-566-0743. By mail: Environmental Analysis Division, Office of Information Analysis and Access (MC #2842T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460.