Office of Pollution Prevention and Toxics
Environmental Protection Agency
1200 Pennsylvania Ave. NW
Washington DC 20460-0001
Subject: Environmental Working Group’s Comments on TSCA Inventory Update Reporting ; Modifications; Proposed Rule
Docket ID: EPA-HQ-OPPT-2009-0187
Environmental Working Group (EWG), a non-profit public health research and advocacy organization, submits these comments regarding the proposed rule strengthening the Inventory Update Reporting (IUR) requirements of the Toxic Substance Control Act (TSCA).
EPA’s proposed modifications of the IUR are a critical and necessary step forward toward reducing the secrecy that surrounds many chemical industry operations. In the preamble to its proposed rule, EPA has done an admirable job summarizing the need for more accurate and timely reporting of chemical production information. EWG supports nearly all the proposed modifications, but we have identified a number of shortcomings and recommend a number of other changes to further strengthen protection of public health. Our suggested modifications to the proposed rule include:
- Collect and publicize IUR data annually.
- Apply the volume threshold for reporting by company, not by geographic site.
- Lower the annual reporting threshold to no more than 2,000 lbs.
- Require reporting of ports of entry, storage facilities and final destinations for all imported chemicals.
- Require identification of all chemicals that may pose a risk to children, not just those in “products intended for use by children.”
- Make IUR information publicly accessible within two months of the end of the reporting cycle.
- Apply the same requirements to engineered nanomaterials, with no exemptions for small business.
TSCA places strict limits on the EPA’s authority to ensure that human health and the environment are protected from the harmful effects of industrial chemicals. EPA has little or no authority to ban chemicals or to require basic safety studies for compounds widely used in consumer products.
Despite its many gaps, TSCA does give EPA one key authority, and the agency has failed to implement it fully:
“The Administrator shall compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the United States.” [TSCA Section 8(b), 15 U.S.C. 2607(b)]
EPA’s half-hearted attempts to collect this information have left the agency with an incomplete and out-of-date accounting of chemicals manufactured in or imported into the U.S. The inadequacy of this data hinders the agency’s ability to effectively protect human health and the environment. Without knowing the scope of the chemical inventory in manufacturing facilities, warehouses, and, ultimately, in consumer products and the environment, the agency lacks the most basic information it needs in order to fulfill its core responsibilities to the public.
In 1977, EPA compiled a chemical inventory of 62,000 chemicals registered for use in the U.S. under TSCA’s Inventory Reporting Rule (EPA 1977). Since then, the agency has added hundreds of newly invented chemicals each year, for a current total of 86,000 chemicals. The sheer number of compounds sounds impressive, but the list has become a poor reflection of the current market – and, therefore, a poor tool with which to assess potential risks. Since publication of the original 62,000-name list, EPA has never reassessed which chemicals are still in use (EPA 1980, EPA 1982, EPA 2008). This means that the number of chemicals in actual use is entirely unknown, even though the TSCA inventory is very often misrepresented as a list of chemicals in commerce (Kristof 2010).
The 86,000-chemical list includes both those currently manufactured and those no longer in use, with no way for EPA to know the difference. In 1986, the agency adopted the Inventory Update Reporting Rule in an effort to fill this data gap by periodically collecting production and importation information for medium- and high-volume chemicals. However, information currently collected under the IUR contains no production information at all for chemicals manufactured or imported in amounts less than 25,000 pounds per year at any given facility, nor for chemicals, including those made in large amounts, produced in the four-year span between each reporting year -- which occurs every five years. In addition, the list contains no information at all on several enormous classes of chemicals, including polymers, naturally occurring substances, most nanomaterials, and chemicals produced by small businesses.
Below we detail the proposed changes in EPA’s draft IUR update that EWG supports, those that we believe could be improved, and those that we cannot support in their current form.
Proposed changes EWG supports
Require reporting of production and importation quantities for all years. EPA has proposed that IUR submissions include production information for all years of each five-year reporting cycle, not just for the fifth year as at present. This will keep manufacturers from disguising their actual output by producing certain specialty chemicals only in years that are not currently subject to IUR reporting. EPA noted in drafting the proposed rule that there have been large fluctuations in production, such that chemicals were dropped from the high production volume challenge program because volume fell below 1 million pounds in one IUR reporting cycle, only to soar well above 1 million pounds in subsequent cycles (EPA 2010). EWG’s analysis of IUR data from 1986 to 2006 identified more than 2,250 chemicals that were reported during one cycle – omitted in the next one – and then reported once again in a later IUR. For 45 percent of these chemicals, production before or after a non-reporting cycle was greater than 500,000 lbs., indicating that many medium and high production volume chemicals may not be produced every year.
Require upfront substantiation of CBI claims. EPA is now requiring that Confidential Business Information (CBI) claims on information submitted to the agency be substantiated, shifting the burden of proof to the submitters. The overuse of confidentiality comes at a great cost to both the public and EPA. EWG’s research has shown that the TSCA inventory contains about 17,000 chemical substances whose very identity is claimed confidential (EWG 2010). In 2005, the number of chemicals cloaked by confidentiality claims in IUR reporting increased to more than 1,100 (EWG 2010). Since then, EPA has released the names of 530 of these substances because the chemical identity was publicly available or had not been claimed confidential by at least one submitter (EPA 2009a). With confidentiality claims hiding a large portion of the data submitted in IUR reporting it is critical that these claims are substantiated.
Require IUR reporting for all chemicals subject to EPA rulemaking. EPA has proposed that all chemicals subject to rulemaking (section 4 - requiring the generation of more test data, section 5(b)4 - presence on the EPA chemical concern list, section 6 - chemicals that present an unreasonable risk, or section 5(e) - chemicals subject to a consent order) be required to submit production and importation data. This critical action will provide relevant data on chemicals that are by definition of higher concern to EPA and the public. The absence of production and importation information on hazardous substances is a huge gap that is critical for understanding population and ecosystem exposures.
Eliminate the 300,000 lb threshold for reporting. EPA is proposing that process and use information be submitted for all chemicals subject to the IUR rule, not just those produced at more than 300,000 lbs at a single site. This is a very important step toward increasing the information available to make risk management and exposure assessments necessary for the protection of public health.
Require electronic submission of all documentation. EPA has proposed that it will no longer accept fax and postal mail submission of IUR information and will rely entirely on web-based submissions. Under the current IUR program, a company that started producing 1 million pounds a year of a previously unreported chemical in 2001 did not have to submit this information to EPA until March 2007 (assuming production continued in 2005). EPA did not make the 2006 IUR data available until the last weeks of 2008, and even then it noted an error rate of 5 percent (EPA 2009a, EPA 2010). Thus industry could have commenced production of a high volume chemical in January 2001 and the information would not have been made public for 7 years and 11 months.
Making IUR information available to the public and within EPA in a timely manner is contingent upon receiving accurate submissions. Online data submission should increase reporting speed and accuracy and should reduce the reporting burden on industry and error-checking burden on EPA.
Require reporting of chemical identity as listed on the TSCA inventory. EPA has proposed that all submissions must include the chemical name as listed on the TSCA inventory to reduce errors in data collection. Along with electronic submissions, this proposed change in chemical nomenclature should aid in reducing the large number of errors in submissions and speed the process of making the information publicly available.
Require more use information. EPA’s proposed changes include stronger language to address the inadequate information provided to EPA on chemical use. The processing and use information in many industry submissions is incomplete. EPA noted that “almost half contained no commercial or consumer use information” and that “EPA believes that companies routinely have more information about how their chemical substances are processed and used than is reflected in the 2006 IUR data” (EPA 2010a). EWG noted the high frequency of chemical uses classified as "other" and "not readily obtainable" also occurred for chemicals with the identity claimed confidential on the 2006 IUR (EPA 2009b, EWG 2010).
Proposed changes EWG believes should be improved
Production and importation data should be reported and published at least annually. EPA is proposing a change in reporting frequency from every five years to every four years, as was standard practice from 1986 to 2006. EPA “is considering further increasing the frequency to every 3 years, biennially or annually. (See Ref 15 for burden and cost information)” (EPA 2010). The proposed time frame remains too long. Production and importation information should be reported at least annually, and the more detailed use and exposure information should be reported annually.
There have been rapid advances in data collection and inventory management in recent years, reducing the burden of providing this information. Chemicals are commodities, and from a business perspective, timely record keeping is necessary to ensure tracking of inventory and sales. Companies currently submit quarterly reports on chemical sales for investors under the Securities Exchange Act. Sample filings and company summaries analyzed by EWG make clear that chemical volume information is extremely important and is usually reported as a top-line finding, with volume changes attributed to specific products or product sectors (Dow 2010, DuPont 2010). Since this information is already being collected, analyzed and made public for investors, it should be utilized by the EPA and made available to the public to ensure the protection of the environment and human health.
The threshold for annual reporting should be measured by company, not by site, at 2,000 lbs a year. EPA has proposed to reduce the reporting threshold to 10,000 lbs per year per site, for the current 25,000 lbs per year per site. A threshold value of 10,000 lbs remains too high to reach the stated goal of collecting information on chemicals produced in amounts of 25,000 lbs per year or more. With a 10,000 lb reporting threshold, it is conceivable that five companies could produce a chemical at 10 sites across the country, all under the 10,000 lb reporting limit. In such a case there would be no reporting to EPA even though the national production could total 400,000-500,000 lbs a year. While a similar outcome is possible with any value, lowering the reporting threshold to 2,000 lbs a year and measuring it by company, not by site, will greatly increase the accuracy of production estimates, especially for medium- and lower-volume chemicals. Both of these actions are consistent with reporting requirements under the European Union’s REACH system of chemicals regulation (EU 2006).
Industry should identify the ports of entry of imported chemicals, storage facilities and final destinations. Reporting a company’s corporate headquarters address is not pertinent to assessing the populations that may be exposed or at risk from a chemical substance. Tracking the production and processing of chemical substances can only be accomplished with site information directly related to usage and travel, including the ports of entry, storage facilities and final destinations.
EPA should identify all chemicals that may pose a risk to children, not just those in “products intended for use by children.” Information about exposures to vulnerable populations, including children, is critical to minimizing risk from hazardous materials. Limiting the grouping of chemicals to “products intended for children” grossly underestimates potential exposures.
IUR reports should be publicly accessible within two months. During the last reporting cycle, the reported information, with its estimated 5 percent error rate, was already 24-36 months out of date when it became publicly available. Many of the proposed changes outlined by EPA, including online submission of IUR reporting, should aid in making this process much faster, less burdensome and more accurate. Information should be submitted to EPA within one month of the end of the calendar year, and EPA should make this information publicly available by the end of the following month.
Engineered nanomaterials should meet the same reporting requirements, with no exemptions. Engineered nanoscale materials should be reported under the IUR process. The lack of information on production, production location and intended usage of these materials has greatly hindered safety assessments of these materials (EPA 2010B, FIFRA SAP 2010).
Detailed analysis of CBI claims. Future IUR reports should include an analysis of the number and types of chemicals whose identity has been claimed to be Confidential Business Information. EPA’s analysis of data submitted under the 2006 IUR did not include information on chemicals claimed confidential. As a result, EWG was forced to request general information on the number of confidentiality claims masking the production volumes of chemicals reported to the IUR (EPA 2009b, EWG 2010). Each IUR report should include an analysis of the number and types of chemicals claimed confidential, their intended uses and how many are intended or reasonably anticipated to be used by children.
EPA’s proposed changes would fill a huge informational gap on what chemicals are being produced or imported into the United States each year. With production and anticipated use information, the agency will be in a better position to effectively assess risks to human health and the environment and implement measures needed to mitigate risks. The extremely long lag time in making production information available, coupled with long reporting cycles, has and will continue to reduce the value of IUR data in learning what chemicals are being produced and what are the potential exposures to people and the environment. We look forward to future action by EPA to transform IUR reporting into a timely source of information on chemical production, importation and use.
David Q. Andrews, PhD, Senior Scientist
Jane Houlihan, MSCE, Senior Vice President for Research
Environmental Working Group
1436 U. Street, Suite 100, NW
Washington DC 20009
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