Nanotechnology Law Report
The EPA Inspector General's Report
The task of the Inspectors General of Federal agencies is to examine "all actions of a government agency or military organization. Conducting audits and investigations, either independently or in response to reports of wrongdoing, the OIG ensures that the agency's operations are in compliance with the law and general established policies of the government. Audits conducted by the OIG are intended to ensure the effectiveness of security procedures, or to discover the possibility of misconduct, waste, fraud, theft, or certain types of criminal activity by individuals or groups related to the agency's operation."
At the end of 2011, the Office of the Inspector General (OIG) of the Environmental Protection Agency (EPA) posted Report No. 12-P-0162,"EPA Needs to Manage Nanomaterial Risks More Effectively" to the reports section of its website.
The OIG, in the Introduction to the report, states that the
. . . purpose of this review was to determine how effectively the U.S. Environmental Protection Agency (EPA) is managing the human health and environmental risks of nanomaterials.
The report notes that
EPA has the statutory authority to regulate nanomaterials. . . . EPA can regulate nanomaterials during their manufacture, formulation, distribution in commerce, use, and/or disposal through the Toxic Substances Control Act (TSCA) . . . nanomaterials in pesticides through the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) . . . . EPA can regulate nanomaterials released into the environment using the Clean Air Act; the Clean Water Act; the Comprehensive Environmental Response, Compensation and Liability Act; or the Resource Conservation and Recovery Act.
However, while EPA is armed with this authority and while EPA has shifted in recent years from depending on nanoindustries to voluntarily supply EPA with information on "production, importation, and use; exposures; risk management practices; hazards; pollution prevention; and physical and chemical properties" to a more active "regulatory approach", "to collect nanomaterials data from manufacturers of industrial chemicals", the OIG, after conducting "this performance evaluation in accordance with generally accepted government auditing standards", "identified a number of shortcomings": At least some of these shortcoming were attributable to the limitations of TSCA:
1) " . . . An absence of toxicity testing and environmental fate data, and a reliance on modeling . . . .Because EPA depends on information reported by industry, it can initially fail to identify chemical risks not self-disclosed by manufacturers."
2) "The program was limited by TSCA's requirement to protect claims of confidential business information (CBI) on industry data submissions. . . . Excessive CBI designations inhibit independent peer reviews, oversight by external parties, and information sharing across EPA offices".
Other short comings are based in structural problems:
1) "EPA doesnot have an agency-wide formal process to disseminate manufacturer data gathered from TSCA and FIFRA data calls." This data is shared between offices only via informal personal relationships (a.k.a "The Grapevine") such as can be found in any office setting. While this form of communication may work to a limited extent, its limits are obvious.
"Because of the growing number of nanomaterial products entering the marketplace and the anticipated receipt of TSCA and FIFRA data following approval of . . . requested information gathering rule changes, it will be increasingly necessary for . . .offices [in EPA] to formally share information anc coordinate their efforts."
Other short comings found by the OIG recall a line from the movie Cool Hand Luke :
Captain, Road Prison 36: What we got here is... failure to communicate.
"Through Federal Register notices, program office web pages, public presentations, and meetings EPA has sought to communicate information related to nanomaterials and to gather input from stakeholders. However, the agency as a whole has not provided a transparent overall message about nanomaterials to the general public. . . .The agency should be prepared to communicate to the public any nonconfidential risk information generated or collected through its FIFRA, TSCA, and reseach activities because nanomaterials is emerging issue, it will be important for EPA to keep the public informed on the benefits and risks, how the public might be exposed, and what regulatory approach the agency is taking."
Other short comings are based on the limitations created by (1) a lack of technology designed to detect nanomaterials or remove detected nanomaterials from the ambient atmosphere (" . . .the agency may not be able to monitor, identify, and remediate nanomaterial comtamination if it were to occur in the natural environment") and (2) resource limitations. EPA, like all Federal, State, County and Municipal agencies, constantly face the potential for budget cuts that would severely limit agency programs.
The OIG's report concludes with the recommendation that the EPA's Assistant Administrator for Chemical Safety and Pollution Prevention be tasked with developing "a formal process to assure the effective dissemination and coordination of nanomaterial information across relevant program offices."
While EPA has agreed with this recommendation and has created a "correction plan with milestone dates" to create a formal communications process and structure, other shortcomings, as discussed above, are rooted in the limitations of TSCA, FIFRa and other laws refered to above. Changes in those are outside of EPA's control, as are those caused by the vagaries of budgets and the appropriations process.
Legislation to reform and strengthen TSCA and EPA's regulatory authority have been introduced in both the Senate and the House in both the 111th and 112th Congresses. S.847, the Safe Chemicals Act of 2011, introduced by Senator Frank Lautenberg of New Jersey on April 14, 2011, is the most recent of these bills. Assigned to the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics and Environmental Health, hearings on the bill were held on November 17, 2011. No further action on the bill has occured and with elections coming in November of this year, it is unlikely that the bill will be reported out of committee and sent to the Senate floor for debate.
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