Peter Mayberry05.05.15
The U.S. Environmental Protection Agency (EPA) has issued a proposed rule that would make nanoscale materials subject to the Toxic Substances Control Act (TSCA) which, in turn, would potentially require reporting and listing of all nanoscale materials used by the nonwovens industry as potentially toxic substances just as this new technology is emerging.
Indeed, a simple Google search of the combined terms “nanoscale” and “nonwovens” yields an amazing 1,580,000 hits. Last year alone there were more than a dozen articles published on the use of nanoscale materials for such things as surgical masks, filtration media, and wearable supercapacitors.
Under the EPA proposal – which was released in early April – certain chemical substances would be subject to reporting and recordkeeping requirements under TSCA when manufactured or processed at the nanoscale. These requirements would also apply to imported materials.
Included in the reporting requirements are chemical substances with an approximate size range of 1-100 nm as used by the NNI for defining nanotechnology.
Specifically, the EPA would require persons that manufacture, import, or process—or intend to manufacture or process-chemical substances at the nanoscale to report the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects. This information would have to be filed electronically and would be publicly available, free of charge, through an EPA database by searching any combination of chemical name or CAS number, facility site name, registry ID or geography.
The proposal involves one-time reporting for existing nanoscale materials and one-time reporting for new discrete nanoscale materials before they are manufactured or processed. According to the EPA, this information would facilitate the agency’s evaluation of the materials and determinations as to whether further action is needed.
Potentially affected by this action are those who manufacture, process, or intend to manufacture or process nanoscale forms of certain chemical substances including entities involved in chemical manufacturing or processing (NAICS codes 325); synthetic dye and pigment manufacturing (NAICS code 325130); other basic inorganic chemical manufacturing (NAICS code 325180); home furnishing merchant wholesalers (NAICS code 423220); roofing, siding and insulation material merchant wholesalers (NAICS code 423330), and R&D organizations involved in physical, engineering, and life sciences (NAICS code 541712).
Excluded from reporting requirements are the following materials: zinc oxide; nanoclays; chemical substances manufactured at the nanoscale as part of a film on a surface; DNA; RNA; proteins; and chemical substances which dissociate completely in water to form ions that are smaller than one nanometer.
The EPA notes that this proposed rule—and its accompanying discussion of potential risks associated with nanoscale materials – is not intended to conclude that these materials “necessarily give rise to or are likely to cause harm to people or the environment,” but information gathered through the TSCA will be used by the agency to determine if further action is needed.
Why is the EPA proposing this rule? According to the agency, TSCA reporting and recordkeeping requirements would “assist EPA in its continued evaluation of chemical substances manufactured at the nanoscale, informed by available scientific, technical and economic evidence.” The EPA states that the proposed rule is not intended to indicate that restrictions on these substances are needed or draw any specific conclusions about the risks of chemical substances manufactured at the nanoscale in general.
Rather, as the agency further notes, TSCA reporting/recordkeeping requirements would “facilitate EPA’s evaluation of nanoscale chemicals and its determination of whether any further action under TSCA is needed.”
That said, however, the EPA also notes that the National Institute of Occupational Safety and Health (NIOSH) issued a report in 2009 that summarized scientific information about nanoscale materials available at the time. In its report, EPA says that NIOSH identified several potential health and safety issues including the observation that “Nanomaterials have the greatest potential to enter the body through the respiratory system if they are airborne and in the form of respirable-sized particles (nanoparticles). They may also come into contact with the skin or be ingested.’’
The NIOSH report further notes that “Experimental studies in rats have shown that equivalent mass doses of insoluble incidental nanoparticles are more potent than large particles of similar composition in causing pulmonary inflammation and lung tumors. Results from in vitro cell culture studies with similar materials are generally supportive of the biological responses observed in animals.’’ And, “Studies in workers exposed to aerosols of some manufactured or incidental microscopic (fine) and nanoscale (ultrafine) particles have reported adverse lung effects including lung function decrements and obstructive and fibrotic lung diseases. The implications of these studies to engineered nanoparticles, which may have different particle properties, are uncertain.’’
Under the proposed rule, the industry is conservatively estimated to incur a burden of approximately 206,098 hours in the first year and 22,755 hours in subsequent years, with costs of approximately $13.9 million and $1.5 million, respectively. Additionally, the EPA is expected to use approximately 6,539 hours in the first year and 723 hours in subsequent years, with costs of approximately $0.51 million and $0.06 million respectively. Discounted over a 10-year period at 3% and 7%, total annualized costs are estimated to be approximately $2.8 million and $3.08 million, respectively.
The EPA is taking comment on this proposal until July 6, 2015, and is specifically requesting comment on whether any information collected under the proposed rule is duplicative of information collected under other federal statutes and, therefore, ought to be excluded. There are six other areas of requested comment included in the preamble to the proposed rule as well.
More information about the proposed rule—and procedures for filing comment – can be found online at www.regulations.gov and searching under docket number EPA-2010-0572, or by contacting Jim Alwood in the Chemical Control Division of the EPA’s Office of Pollution Prevention and Toxics. Mr. Alwood can be reached by telephone at 202-564-8974 or via email at alwood.jim@epa.gov.
General information about TSCA and TSCA reporting is also available through the TSCA-Hotline which can be reached by telephone at 202-554-1404 or via email at TSCA-Hotline@epa.gov. n
Peter Mayberry is President of Mayberry & Associates in Washington, DC. Peter is a third-generation Washingtonian and government relations professional whose career spans more than three decades. He served as INDA’s Director of Government Affairs from 1989-2009 and has a deep understanding of legislative and regulatory issues facing our industry. Peter is also the author of nonwovensregs.com and can be reached via e-mail addressed to peter@mayberryandassociates.com.
Indeed, a simple Google search of the combined terms “nanoscale” and “nonwovens” yields an amazing 1,580,000 hits. Last year alone there were more than a dozen articles published on the use of nanoscale materials for such things as surgical masks, filtration media, and wearable supercapacitors.
Under the EPA proposal – which was released in early April – certain chemical substances would be subject to reporting and recordkeeping requirements under TSCA when manufactured or processed at the nanoscale. These requirements would also apply to imported materials.
Included in the reporting requirements are chemical substances with an approximate size range of 1-100 nm as used by the NNI for defining nanotechnology.
Specifically, the EPA would require persons that manufacture, import, or process—or intend to manufacture or process-chemical substances at the nanoscale to report the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects. This information would have to be filed electronically and would be publicly available, free of charge, through an EPA database by searching any combination of chemical name or CAS number, facility site name, registry ID or geography.
The proposal involves one-time reporting for existing nanoscale materials and one-time reporting for new discrete nanoscale materials before they are manufactured or processed. According to the EPA, this information would facilitate the agency’s evaluation of the materials and determinations as to whether further action is needed.
Potentially affected by this action are those who manufacture, process, or intend to manufacture or process nanoscale forms of certain chemical substances including entities involved in chemical manufacturing or processing (NAICS codes 325); synthetic dye and pigment manufacturing (NAICS code 325130); other basic inorganic chemical manufacturing (NAICS code 325180); home furnishing merchant wholesalers (NAICS code 423220); roofing, siding and insulation material merchant wholesalers (NAICS code 423330), and R&D organizations involved in physical, engineering, and life sciences (NAICS code 541712).
Excluded from reporting requirements are the following materials: zinc oxide; nanoclays; chemical substances manufactured at the nanoscale as part of a film on a surface; DNA; RNA; proteins; and chemical substances which dissociate completely in water to form ions that are smaller than one nanometer.
The EPA notes that this proposed rule—and its accompanying discussion of potential risks associated with nanoscale materials – is not intended to conclude that these materials “necessarily give rise to or are likely to cause harm to people or the environment,” but information gathered through the TSCA will be used by the agency to determine if further action is needed.
Why is the EPA proposing this rule? According to the agency, TSCA reporting and recordkeeping requirements would “assist EPA in its continued evaluation of chemical substances manufactured at the nanoscale, informed by available scientific, technical and economic evidence.” The EPA states that the proposed rule is not intended to indicate that restrictions on these substances are needed or draw any specific conclusions about the risks of chemical substances manufactured at the nanoscale in general.
Rather, as the agency further notes, TSCA reporting/recordkeeping requirements would “facilitate EPA’s evaluation of nanoscale chemicals and its determination of whether any further action under TSCA is needed.”
That said, however, the EPA also notes that the National Institute of Occupational Safety and Health (NIOSH) issued a report in 2009 that summarized scientific information about nanoscale materials available at the time. In its report, EPA says that NIOSH identified several potential health and safety issues including the observation that “Nanomaterials have the greatest potential to enter the body through the respiratory system if they are airborne and in the form of respirable-sized particles (nanoparticles). They may also come into contact with the skin or be ingested.’’
The NIOSH report further notes that “Experimental studies in rats have shown that equivalent mass doses of insoluble incidental nanoparticles are more potent than large particles of similar composition in causing pulmonary inflammation and lung tumors. Results from in vitro cell culture studies with similar materials are generally supportive of the biological responses observed in animals.’’ And, “Studies in workers exposed to aerosols of some manufactured or incidental microscopic (fine) and nanoscale (ultrafine) particles have reported adverse lung effects including lung function decrements and obstructive and fibrotic lung diseases. The implications of these studies to engineered nanoparticles, which may have different particle properties, are uncertain.’’
Under the proposed rule, the industry is conservatively estimated to incur a burden of approximately 206,098 hours in the first year and 22,755 hours in subsequent years, with costs of approximately $13.9 million and $1.5 million, respectively. Additionally, the EPA is expected to use approximately 6,539 hours in the first year and 723 hours in subsequent years, with costs of approximately $0.51 million and $0.06 million respectively. Discounted over a 10-year period at 3% and 7%, total annualized costs are estimated to be approximately $2.8 million and $3.08 million, respectively.
The EPA is taking comment on this proposal until July 6, 2015, and is specifically requesting comment on whether any information collected under the proposed rule is duplicative of information collected under other federal statutes and, therefore, ought to be excluded. There are six other areas of requested comment included in the preamble to the proposed rule as well.
More information about the proposed rule—and procedures for filing comment – can be found online at www.regulations.gov and searching under docket number EPA-2010-0572, or by contacting Jim Alwood in the Chemical Control Division of the EPA’s Office of Pollution Prevention and Toxics. Mr. Alwood can be reached by telephone at 202-564-8974 or via email at alwood.jim@epa.gov.
General information about TSCA and TSCA reporting is also available through the TSCA-Hotline which can be reached by telephone at 202-554-1404 or via email at TSCA-Hotline@epa.gov. n
Peter Mayberry is President of Mayberry & Associates in Washington, DC. Peter is a third-generation Washingtonian and government relations professional whose career spans more than three decades. He served as INDA’s Director of Government Affairs from 1989-2009 and has a deep understanding of legislative and regulatory issues facing our industry. Peter is also the author of nonwovensregs.com and can be reached via e-mail addressed to peter@mayberryandassociates.com.
