EPA's Latest Chemical Proposals Get It Half Right, Recent EPA Toxics Adviser Says

December 8, 2008


Contact:  Jennifer Andreassen, 202-572-3387, jandreassen@edf.org
(Washington, DC – December 8, 2008)  The U.S. Environmental Protection Agency (EPA) proposed one good and one bad “enhancement” to its Chemical Assessment and Management Program (ChAMP) during a public meeting today, according to Environmental Defense Fund (EDF).  EDF welcomed EPA’s proposal to require pre-manufacture notification for any chemical removed from the nation’s list of chemicals in commerce if a company decides to reintroduce it into the market.  But EDF was strongly critical of a second proposal to extend a poorly performing voluntary program for obtaining critical chemical safety information to inorganic chemicals produced in high volumes.
EDF strongly opposed the latter proposal to initiate yet another “phased, multi-year” voluntary program for high-production-volume (HPV) inorganic chemicals.
“We know from the failure of both EPA’s HPV Challenge and the industry”s half-hearted Extended HPV Program to deliver the quality data sets needed to make sound decisions that a voluntary approach doesn’t work,” said Dr. Richard A. Denison, a senior scientist at EDF, who until recently was a member of the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) that advises EPA”s toxics office.  “To extend such a flawed model to inorganic chemicals is simply throwing good money after bad.”
Despite a decade of effort under the HPV Challenge, final data sets have yet to be submitted for nearly half of the chemicals sponsored, and remaining gaps have been identified in at least a third of those data sets that have been submitted.  Several hundred HPV chemicals were not sponsored at all under the program.  And since the launch of the Challenge, many hundreds of additional chemicals have reached HPV production levels, yet most of those have not been sponsored under the Extended HPV program, and data sets have been submitted for fewer than two dozen.1
Instead of pursuing yet another voluntary program, EDF urged EPA to immediately proceed to issue mandatory test rules using its TSCA Section 4 authority for as many inorganic HPV chemicals as possible.  Only for those chemicals for which it cannot make the requisite findings to support a test rule should EPA consider other approaches, including vigorously supporting an expansion of its data generation authorities through legislative reform of TSCA.
In contrast, EPA has offered a sound proposal setting forth the rules under which it plans to remove from the Toxic Substances Control Act (TSCA) Inventory chemicals that companies indicate they are no longer producing or importing.
“EPA should be commended for thinking through the implications of ‘resetting’ the Inventory,” Denison stated.  “While a few aspects need strengthening, we strongly support the core element of EPA’s proposal: requiring pre-manufacture notification for any chemical removed from the Inventory if a company decides to reintroduce it into the market.”  [Below this release are additional comments describing needed clarifications and improvements to EPA’s proposal.]
Denison noted that EPA’s rationale for taking this approach closely mirrors an argument EDF made in comments it filed in May 2008, when EPA first proposed an Inventory reset:  it would allow EPA to assess and, where needed, control potential risks prior to allowing a chemical back into commerce.  EDF also noted that applying pre-manufacture notification (PMN) requirements to chemicals removed from the Inventory would help to minimize incentives for companies to seek removal of as many chemicals as possible to avoid reporting or other requirements that apply to Inventory chemicals.

Additional comments and needed enhancements to EPA’s proposal to reset the TSCA Inventory
  • Any Inventory resetting must be done using a reporting mechanism that tracks production/import over a significant period.  EPA”s experience with reporting of production and import data under its Inventory Update Rule (IUR) – which entails the reporting of only one year”s volume once every five years (recently raised from every four years) – shows that there is enormous fluctuation from one reporting cycle to the next that must reflect underlying changes in chemical supply and demand dynamics and production and use patterns.2  These data demonstrate that infrequent and time-limited reporting yields a highly inaccurate picture of which chemicals are in commerce, as well as their actual manufacturing levels over time. 
    • Given experience with IUR reporting, EDF is concerned that use of only a 3-year window as suggested by EPA could significantly underestimate the number of chemicals in commerce. 
    • EPA needs to carefully consider the length of the reporting period it uses to reset the Inventory, and should require reporting of any production or import that has taken place at any time during the reporting window. 
    • While we are concerned that some companies might be able to “game the system” if a too-short reporting window is employed, this concern will be alleviated considerably as long as EPA requires (as it has proposed) that any chemicals removed from the Inventory be subject to PMN notification prior to their reintroduction.
    • We support EPA’s proposal to conduct a reset on a periodic basis, a measure that would also help to alleviate our concerns that a reset with too short a window could miss many chemicals in commerce.
  • No lower threshold should apply to the reporting used to reset the Inventory.  Production or import of a chemical in any amount at any time during the reporting window should trigger its retention on the Inventory if its original purpose is to be retained.
  • Exemptions available from reporting conducted under TSCA Section 8(a) should not apply.  Numerous classes of chemicals have been granted full or partial exemptions from IUR reporting by EPA, some of which are based on presumptions of low environmental or health concern.  Because the purpose of the Inventory is to list chemicals in commerce independent of any sort of risk consideration, such exemptions are wholly inappropriate.  Specifically, EPA should not provide Inventory reset exemptions for:
    • Polymers (exempted from IUR reporting under CFR 710.46(a)(1))
    • Microorganisms (CFR 710.46(a)(2))
    • Naturally occurring substances (CFR 710.46(a)(3))
    • Certain forms of natural gas (CFR 710.46(a)(4))
    • Petroleum process streams (CFR 710.46(b)(1))
    • Specific exempted chemical substances (CFR 710.46(b)(2))
Also inconsistent with the Inventory’s purpose would be providing exemptions for small manufacturers; for this reason, EDF supports EPA’s proposal to conduct the Inventory reset using its Section 8(b) rather than Section 8(a) authority.
  • A publicly available list of all chemicals removed from the Inventory must be maintained.   Many such chemicals, even if not in active production, may nevertheless still be stockpiled, present in products as ingredients, byproducts or residuals, or present as pollutants in air, water, soil, sediment or waste sites.  And of course, they may return to active production in the future.  Maintenance of a public list of all chemicals removed from the Inventory would serve as a compliance tool (see more on compliance below).  It is critical, therefore, that EPA retain — and the public still have access to — an inventory of, and any and all information available on, any chemicals removed from the Inventory.
  • Any chemicals removed from the Inventory must be subject to TSCA Section 5 notification requirements.  As discussed at length in our May 2008 comments and noted above, we strongly support EPA’s proposal in this regard.  We support EPA’s “clean” reset option, under which EPA would set forth this requirement as unambiguous policy via a Federal Register notice:  As has been the case historically, any chemical not on the Inventory is subject to Section 5 requirements. 
  • We do not support the alternative EPA discusses of seeking to issue a Significant New Use Rule (SNUR) to cover such chemicals.  This approach would be more cumbersome and not offer any advantages over the more direct proposed approach.
  • Processors should be included in the Inventory reset.  The language of Section 8(b) is unambiguous:  EPA is required to “compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the United States.”  We see no basis or rationale for excluding processors from certification under an Inventory reset.
  • EPA should not allow companies to certify “future” manufacture or production as a means to retain a chemical on the Inventory.  Such an approach would necessarily be based on speculative or uncertain information that could easily change, leaving chemicals listed on the Inventory that are not actually in commerce, thereby frustrating the entire purpose of the reset.  This approach could also create a perverse incentive for companies to seek to retain listings for chemicals not currently in production so as to avoid Section 5 notification and review requirements, thereby frustrating what we see as a key advantage to the core element of EPA’s proposed approach.
  • EPA needs to require, not merely invite, certification and take additional steps to ensure compliance.  We are troubled by EPA’s statement that it would merely “invite” companies to certify their production or import (73 FR 70642; paragraph 3 of the Inventory reset background document).  Elsewhere EPA more appropriately refers to “requiring certification” (paragraph 9(a) of the Inventory reset background document).  If the Inventory reset exercise is to be – and be perceived as – credible, it must include all reasonable steps to ensure compliance by all companies that produce, import or process chemicals:
    • EPA must require companies to certify as to which chemicals they produce, import or process.  Such a certification should be signed by a senior officer and be legally binding.
    • EPA should also require that a company certification indicate that the chemicals it identifies are the only chemicals listed on the Inventory that it produces, imports or processes.
    • EPA should commit to undertake additional steps to assess the extent of compliance achieved under the reset, and to promptly initiate actions, including robust enforcement, to address any non-compliance.  EPA should cross-check its reset Inventory chemical lists with other sources of reported information (e.g., IUR and other Section 8 reporting; PMN submissions, etc.) as one means to identify discrepancies.  It should use its enforcement authorities (access to company records, audits, inspections, etc.) on at least a spot basis to ensure full compliance.
    • EPA should provide public access to up-to-date versions of both the reset Inventory and the list of removed chemicals.  As proposed by EPA, these lists should also include entries for any chemicals with identities claimed as confidential business information, providing as much identifying information as possible consistent with allowed protections for legitimate CBI.
1 See EDF’s recent report on the HPV Challenge and Extended HPV Program, High Hopes, Low Marks, available at www.edf.org/hpvreportcard.
2 USEPA, National Pollution Prevention and Toxics Advisory Committee (NPPTAC), Broader Issues Work Group, “Initial Thought-Starter: How can EPA more efficiently identify potential risks and facilitate risk reduction decisions for non-HPV existing chemicals?” Draft dated October 6, 2005, pp. 3-4, at www.epa.gov/oppt/npptac/pubs/finaldraftnonhpvpaper051006.pdf; and Environmental Defense comments on Proposed Rule, TSCA Inventory Update Reporting Revisions (70 Fed. Reg. 3658, 26 January 2005), Docket ID No. EPA-HQ-OPPT-2004-0106, accessible at www.regulations.gov (search for docket number).