Addition of ortho-Nitrotoluene
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On November 7, 2013, EPA published a final rule adding o-nitrotoluene to the TRI list of reportable chemicals. 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.
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 EPCRA Section 313(d)(2)(B) statutory listing criteria because it can reasonably be anticipated to cause cancer in humans.
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. This includes evaluating 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 of 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.
Final Rule (PDF)(4 pp, 253 K, About PDF)
Proposed Rule (PDF)(8 pp, 277 K, About PDF)
EPA estimates that 22 facilities will be affected by this proposed rule. These facilities are in industry sectors including hazardous waste treatment and disposal, chemical manufacturing, and solid waste combustors and incinerators. These 22 facilities are expected to submit 22 TRI reporting forms containing release and waste management data for o-nitrotoluene. The final rule is effective for the 2014 TRI reporting year, with the first forms due by July 1, 2015.