American Chemistry Council Identifies Serious Deficiencies in EPA's HPV Rulemaking
April 25, 2001
OPPT Document Control Office (DCO)
The American Chemistry Council (the Council) is pleased to submit the attached comments in response to EPA's proposed test rule on High Production Volume (HPV) chemicals (65 Fed. Reg. 81657, Dec. 26, 2000).
The Council's comments express clear support for the voluntary HPV Challenge Program, and commend the Agency for its willingness to explore new and creative approaches in exercising its authority under TSCA. The comments also offer constructive suggestions, including that EPA accept and use all types of relevant existing data, elaborate how HPV data will be integrated into risk-based programs, encourage sponsors to provide use and exposure information, and state how EPA plans to utilize use and exposure information when submitted.
The comments also suggest that EPA adopt an equitable approach to determining Apersons required to test," make the "small quantity" threshold consistent with other reporting levels, apply section 12(b) provisions in a way that makes sense and does not impose undue burdens, and revise its burden estimate to better reflect actual aggregate costs. Finally, the comments urge EPA to reconsider and amend the approaches to section 4 "A" and "B" findings in a way that we believe would produce better testing decisions.
The Council appreciates the opportunity to provide these comments, and looks forward to working with EPA to ensure successful completion of the voluntary HPV Challenge Program.
cc: HPV Subteam
65 Fed. Reg. 81657 (Dec. 26, 2000)
Docket No. OPPTS-42213A
The American Chemistry Council (ACC, or Council) represents the leading companies engaged in the business of chemistry. Council members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. The Council is committed to improved environmental, health and safety performance through Responsible Care®, common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The Council's member companies have a great deal of experience and interest in product testing, including testing pursuant to section 4 of the Toxic Substances Control Am (TSCA). The Council represents companies potentially affected by the proposed testing requirements, and as such has a considerable interest in proposals that may set a precedent for EPA action under section 4.
ACC is pleased to comment on EPA's proposal under TSCA section 4(a)(1)(B) for the Testing of Certain High Production Volume (HPV) Chemicals, 65 Fed. Reg. 81657 (Dec. 26, 2000). The Council has commented previously on virtually every testing proposal promulgated under TSCA section 4. However, the HPV Chemical Challenge Program is truly unique, and we hope it represents a new approach that EPA and the businesses it regulates can use and build upon in the future. The Council and its members support the Challenge Program, and are committed to working with all stakeholders to ensure that it is implemented fairly, that it is fully completed, that our work plans and evaluations are scientifically valid and sensitive to animal welfare concerns, and that the results are used to support risk-based chemicals management decisions.
We commend the Agency for its vision and willingness to explore new and creative approaches to carrying out its statutory responsibilities. We appreciate that new approaches can present unforeseen problems, and can pose significant process questions and administrative challenges. Nevertheless, we believe that in many cases the Agency will be able to accomplish its objectives faster, easier and with fewer resources by pursuing voluntary approaches.
While we support the voluntary HPV Challenge Program, we also offer constructive comments and suggestions here for improving this particular proposal. For example, we urge the Agency to: support the concept of "viable commitments" and clarify the consequence of making them; use and accept all types of relevant existing data; better elaborate how HPV data will be used and integrated into risk-based programs; develop incentives for sponsors to provide use and exposure information; and elaborate how it plans to utilize use and exposure information when submitted. We also reiterate several key requests made in previous proposed TSCA section 4 test rules, including that the Agency adopt a flexible and equitable approach to determining "persons required to test," make the "small quantity" threshold consistent with other reporting levels, and apply section 12(b) provisions in a way that makes sense and does not impose undue burdens.
Finally, we urge EPA to reconsider and amend the approaches to section 4 "A" and "B" findings in ways that we believe would produce better testing decisions. For example, in the final "B Policy" EPA states that when determining the adequacy of existing data and the necessity of further testing, the Agency "has always" considered the level, duration and frequency of exposure, yet that has not been done here nor, to our knowledge, has that been done in other test rules. We continue to believe that TSCA provides a sound basis for chemical testing programs, but we also believe that improvements in efficiency and cooperation could be achieved with attention to the suggestions made below.
ACC supports the HPV Challenge Program for several reasons. First, the Council has long advocated for flexible, voluntary approaches, particularly where such approaches provide the same information or achieve the same objectives faster or with fewer resources, where they achieve more equitable results, or where they lead to better-risk-based decisions. The HPV Challenge Program, while not perfect, appears to provide all of these benefits. Collaborative approaches also foster increased communication and understanding among stakeholders worldwide. Increased communication, in turn, leads to creative ideas and solutions that might not be possible, or even considered, when parties are in a potentially adversarial posture.
ACC also supports the HPV Challenge Program because the overall guidance and information sought are consistent with the approach for screening HPV chemicals developed under the Organization for Economic Cooperation and Development (OECD). We believe that the OECD's Screening Information Data Set (SIDS) is one (though not the only) fair and reasonable approach to the screening and initial evaluation of existing HPV chemicals. Pursuant to ACC Board approval, our members have supported EPA by contributing resources, data and initial assessments to that program for more than a decade.
Our support also rests on a third principle - we believe that screening information on HPV chemicals should be a matter of public record. Separate studies by the Council, EPA and Environmental Defense in 1997 and 1998 used different methods but reached a common conclusion: little "SIDS-level" test data currently exists in publicly searchable databases. When presented with that information, the Council and its members agreed to address it at an unprecedented pace. The level of commitment to the voluntary HPV Challenge Program is itself a milestone: 469 companies, alone or in one of 187 consortia, have made public commitments to provide SIDS-level hazard data and information on 2,155 chemicals by the end of 2004. More information will be provided voluntarily in six years than has been generated by regulation in the past 25. Clearly, voluntary approaches can work.
Last but not least, we support the HPV Challenge Program because it is consistent with our members' commitments to the Product Stewardship provisions of Responsible Care®. Through Product Stewardship, companies commit to develop and communicate information on the hazards and risks of their products. Adherence to Responsible Care® is an obligation of membership in the Council. While there are many ways this commitment can be met, we believe that the Challenge Program presents a reasonable and appropriate approach in the context of screening HPV chemicals.
The proposed rule cites different "data availability" studies conducted by the ACC, EPA and Environmental Defense. Unfortunately, the actual conclusions from the "data availability" studies credited with initiating the HPV program are frequently misrepresented. The most misleading of such statements are that "little is known about the hazards of HPV chemicals." As the data already being provided under this program demonstrate, this is absolutely not the case.
Each data availability study examined only select electronically searchable databases, and even then for only specific animal test data. In some, the lack of data for a single endpoint resulted in a chemical being considered as having no information for hazard classification. Moreover, EPA and all stakeholders in this process have acknowledged that these data are not the only kind of information relevant to hazard and/or safety assessments of chemicals. Non-animal (in vitro ) methods, structure-activity relationship (SAR) and "read across" analyses, category approaches, human experience, scientific appropriateness due to physical/chemical properties, as well as the likelihood, level and duration of exposure are ALL important considerations in determining whether a particular test or data element is even needed. Because not one of these elements was included in any of the three studies, they can not appropriately be determinative of how much is, or is not, known about the hazards or risks of HPV chemicals.
We urge the Agency, and all stakeholders, not to overstate what these studies represent. ACC member companies have a demonstrable history of making chemical testing and other information available to government agencies, voluntarily and by regulation. For example, the Council's CHEMSTAR "panels" have for nearly 25 years voluntarily provided copies of each and every final study report they generate to relevant government Agencies. In addition, since 1977 companies have provided EPA with literally tens of thousands of reports under TSCA, including "PAIR" reports under Section 8(a), health and safety studies under Section 8(d), and information from any study that shows a "substantial risk" under Section 8(e). This is by no means the first time companies will make test data available.
What the studies do tell us is that publicly available databases cannot currently give us a clear or complete picture of the safety or hazards of a particular chemical. To address that, ACC member companies and others have agreed to gather the necessary data on HPV chemicals, plus other information and analyses, and make it all available to the public. Moreover, the information will be provided in uniform summaries in order to allow easier electronic searching, sorting and management.
To be sure, in most cases the HPV Challenge Program will not provide the complete picture. It is designed and intended to be a screening program, not a full assessment. And perhaps most importantly, hazard information provides only one part of the picture. Without information on chemical uses and exposure, conclusions about the risks from a particular chemical are not possible, and risk management actions will generally be premature.
The proposed rule provides companies that did not previously make timely HPV commitments with an opportunity to make a "viable" commitment before the close of the comment period. (65 Fed. Reg. 81662.) However, the language describing the differences between the two approaches is somewhat confusing. As we understand it, the primary differences between a voluntary commitment and a viable commitment appear to be that: (1) viable commitments must produce full study reports as well as robust summaries of all new and existing data, (2) the chemical will continue to be covered by a "proposed rule" during the course of the data generation, (3) ongoing assurances that work is underway must be provided, and (4) work must be completed in the time specified in the proposed rule, rather than in a time frame selected by the sponsor.
Although as a practical matter it will be too late for companies seeking to make viable commitments under this proposal, ACC urges the Agency to revise this section of the proposed rule to provide greater clarity. Examples of areas needing further clarity include: whether, and if so how, EPA intends to make information about these commitments public; how the Agency will handle commitments received from this point forward for un-volunteered chemicals not on this proposed rule; and how listed chemicals will be treated if the sponsor volunteers them for the ICCA Initiative, or if they are selected by another country for review in the OECD SIDS program.
The Council is pleased that the proposal recognizes and encourages companies "to make maximum use of scientifically adequate existing data" in developing their test plans, recognizing that further animal testing in these cases would be "unnecessary" and "duplicative." We agree. However, the key to actually making maximum use of existing data will depend on the degree to which the Agency's staff is empowered to determine that a study that differs from a test guideline is nevertheless "scientifically adequate." Although the guidance documents on literature searches and data adequacy are a helpful start, they should be more specific and use more examples of adequate and inadequate studies. We urge the Agency to review these guidance documents with this in mind, and to work with stakeholders to improve them. We also urge the Agency to ensure that those reviewing and commenting on work plans are aware of the guidance documents and know how to apply them.
To demonstrate its willingness also to consider studies that might not conform exactly to each and every EPA or OECD guideline, the Agency should articulate in the Final Rule that it intends to pursue a weight-of-evidence approach to determining data adequacy and data significance. That approach should include, at least, consideration of the quality of the data, the resolving power of the studies, the number and types of endpoints examined, the relevance of the dose levels, route, timing and duration of exposures, the appropriateness of dose selection, the replication of effects, statistical and/or biological significance of effects, and quality assurance/quality control information. Expert judgment is essential for understanding and interpreting specific toxicological effects, and this is the foundation for the weight of evidence evaluation.
Making maximum use of existing data also may involve consideration of in vitro , epidemiological, non-traditional data, or other data not necessarily listed as among the SIDS data elements. We urge EPA to remain flexible in receiving, interpreting and applying the results of such information when reviewing test plans. Since the ultimate goal of the HPV challenge is to provide information sufficient to conduct an initial screening level hazard assessment, and not to blindly "check boxes," EPA should take a positive and proactive posture on this issue, especially with those charged with reviewing test plans in the voluntary program.
In addition to maximizirig use of existing data, the proposal also urges sponsors to make maximum use of scientific techniques and rationale to provide "information" that is scientifically equivalent to test data. However, as with the determination of whether existing data are "scientifically adequate," the determination of whether information can be provided in lieu of data can be a matter of scientific judgment. In our experience to date, the Agency's strong support for these approaches is not applied with equal conviction by those actually reviewing the test plans.
We fully recognize that honest scientific differences on whether such approaches are appropriate in a particular case can exist. Nevertheless, it also is apparent that there is less than full endorsement for these approaches in some parts of the Agency. In order to increase consistency in application and acceptance of these approaches, and to increase the quality of the proposals for their use, we urge the Agency to: (1) make unambiguous in the final rule its willingness to consider and even accept appropriate information in lieu of data; (2) conduct targeted technical outreach to the staff reviewing work plans; and (3) review the current guidance documents, based on experiences to date, to find additional examples of where others have made successful use of these approaches.
Maximizing use of existing data is, in many instances, the key to successfully reducing the number of test animals used. And while achieving reductions in animal use is a major factor in testing decisions, there are other important considerations in the decision of whether to conduct a new test, which test to conduct, and the test substance to use. These factors include but are not limited to the product's use and likelihood of exposure; global acceptance of the proposed test method; cost; whether "higher tier" tests may later be required under another Agency program; the relative availability of test data on surrogates or analogues; and the predictability and reliability of the method for the endpoint being studied. (See also section III(C)4 below, Findings Concerning the Sufficiency of Existing Data and the Necessity of the Proposed Testing, p. 19.)
ACC members remain committed to reducing the number of test animals where possible, replacing methods when acceptable alternatives are available, and refining existing methods. HPV sponsors also have received the October 14, 1999 letter from EPA requesting significant changes to the Challenge as originally received. Where possible and appropriate Council members have and will continue to modify their work plans to accommodate EPA's requests. However, we believe that the single most important step in actually reducing the number of animals used will be for the Agency to establish a scientifically grounded approach that considers all types of data and other information.
Finally, we note that in at least one place the Agency appears, perhaps inadvertently, to create a disincentive for non-sponsors to voluntarily provide previously unpublished data. The proposed rule states:
"To the extent that additional data relevant to the HPV chemicals are known to exist, EPA is Interested in receiving this information under the voluntary HPV Challenge Program. In addition to submitting the full citation for published studies, and full copies of any unpublished studies, commenters under the HPV Challenge Program ... who wish to submit any additional relevant studies are encouraged to also prepare a robust summary..." (Id. at 81688, emphasis added.)
While we understand that full study copies and robust summaries may be preferable from an administrative perspective, preparing a robust summary is not without cost. The Agency should adopt policies that encourage the submission of all relevant information, and remain flexible as to the format used to submit the information.
Given the scope and data-management consequences of the HPV Challenge Program, we had hoped that the Agency would articulate in the proposed rule a clear plan for using the International Uniform Chemical Information Database (IUCLID) for receiving, storing, managing and making public the massive amount of data, analyses, rationale and other types of information that will be provided. Because most information will be provided in similarly formatted robust summaries that can be entered, shared, sorted and printed using IUCLID, the Agency has a golden opportunity to enhance its data storage and management systems, and to make them consistent with the systems utilized throughout Europe, and within the OECD. In this regard, we urge the Agency to clarify in the final rule precisely how IUCLID will be used to manage data submitted in the US HPV Challenge Program.
We also suggest that EPA clarify within its own staff that data will be accepted when submitted using the IUCLID format. Although certain Agency staff and a few HPV sponsors are aware of this capability, we believe that a statement on the acceptability of IUCLID formatted data would be very helpful. IUCLID was recently upgraded to allow several functions suggested by both US EPA and industry, so many US sponsors are anxious for EPA to clarify whether IUCLID formatted data is acceptable, and the degree to which EPA intends to integrate that data management system into its own.
It is clear from statements in the proposed rule that EPA envisions several potential uses from the HPV data developed by sponsors. The proposed rule describes HPV screening information as "fundamental" to achieving its mission and goals of "risk assessment and risk management" (Id . at 81664), using HPV screening information to "support the development of preliminary hazard and risk assessments for these HPV chemicals" (Id .), and also to "set priorities for further testing that will produce hazard information ... needed by EPA ... to support adequate risk assessments." (Id .) One of our principal concerns throughout this effort has been that EPA or others will confuse hazard data or assessments with risk, and immediately seek to initiate inappropriate or unnecessary risk management or chemical controls without providing a real opportunity to put identified hazards in a risk context. EPA should describe at the first opportunity precisely what steps it will take to prevent this from occurring.
We strongly support development of risk-based activities and programs that consider and build on the information provided under the HPV Challenge Program. However, to date we see little evidence that the activities described in the previous paragraph are actually underway. To the best of our knowledge, the Agency has not yet articulated an overall approach to risk assessment, at least not since initiation of the HPV Chemical Challenge Program. To build on the cooperation that led to the successful voluntary generation of hazard data, we urge the Agency to consult broadly with a variety of stakeholders to determine whether there are information sources, programs, processes or approaches to risk assessment that could be cooperatively designed and implemented.
The proposed rule states that although EPA supports category and SAR approaches in the voluntary program, they are not available in the proposed rule, in part because they would be "time consuming, complex and involve resource intensive procedural steps." (Id. at 81662.) The proposal then notes that in reviewing the chemicals listed in the proposed rule EPA has not identified any possibilities that will allow inclusion of those approaches. (Id.) The principles of EPA's October 14, 1999 letter compel companies to identify category/SAR approaches and opportunities where scientifically appropriate, including reference to substances outside the test rule. The same principles compel EPA to consider that information, if it is provided. For this reason, we believe it is appropriate to provide a reasonable and timely opportunity for companies to describe how these approaches might apply to a given chemical.
The approaches suggested in the proposed rule (an application for modification after issuance of a final rule, or a multi-phase rulemaking) are not sufficient. A final rule carries with it significant regulatory and marketing disadvantages which would not be imposed upon a single chemical that sought to make a "viable commitment." We see no reason why a chemical that is a candidate for category or SAR approaches should receive less favorable regulatory treatment than a single chemical.
In response to the Agency's request for alternative approaches, we suggest that if EPA receives a viable commitment for a chemical which involves a proposal to use category or SAR approaches, then the proposed rule should be left "open" for that particular chemical (and later, if necessary, severed from the initial proposal) until the appropriateness of the approach for that chemicals can be determined. If the proposed category/SAR approach is deemed appropriate, the sponsor could submit for EPA approval a revised approach similar to an Enforceable Consent Agreement. If the proposed category/SAR approach is not deemed appropriate, the rule could be finalized as it was originally proposed. This would avoid the unnecessarily complicated modification process and eliminate unfair treatment of chemicals that are candidates for category or SAR approaches (compared to single chemicals).
Over the past few years EPA has proposed numerous new test rules, testing initiatives and reporting requirements in addition to the HPV Challenge Program. These initiatives often overlap in terms of chemicals and timing, and many have been proposed to begin in one or more of the "sign up" years for the voluntary HPV program. ACC is not aware of any serious or sustained effort to coordinate these activities, or to consider how the results of one initiative might be used to the benefit of another. These initiatives include the: Endocrine Disruptor Screening and Testing Program; Voluntary Children's Chemical Evaluation Program; Inventory Update Rule; a Reproductive / Developmental Toxicity Test Rule; Hazardous Air Pollutants Test Rule; Dermal Absorption Test Rule; ATSDR/Superfund Test Rule for Chronic Studies; PAIR Rule for nonylphenol ethoxylates; OPP Data Call In on FIFRA Inerts (many of which are HPVs); and an ITC data call in for use and exposure information on 392 chemicals with potential PBT characteristics (34 are HPVs).
Together, these programs pose a significant potential for overlapping requirements, duplication, and other inefficiencies. To avoid these outcomes ACC has previously urged EPA to undertake a program to "integrate" its data and information requests in such a way that each request considers and, if appropriate, incorporates the work of one initiative into the work of another in a timely manner. The five elements of our previous request are summarized here for convenience:
The HPV Challenge Program does not require the submission of use or exposure information; sponsors that submit only work plans and hazard information will have fully met their commitments. Nevertheless, participants in various voluntary HPV programs have expressed the intent to submit use and exposure information along with the required hazard data as a means of helping put any identified hazards into a risk context. Where sponsors agree to provide this information, it is important that the Agency commit to post it, along with the hazard information, and to make the use and exposure information equally accessible.
Indeed, EPA already handles use and exposure information on HPV chemicals in the context of the OECD SIDS program. In that program sponsors provide production volume, use functions and categories, form of the marketed product, and likely sources of potential exposure, along with any other relevant and existing exposure information that may be available. That information is provided and published along with the hazard information in both the SIDS Profile and Initial Assessment Report. Given that the Agency has agreed to receive and provide this information with hazard data in the SIDS context, it should provide no less in the Challenge Program.
The proposed rule acknowledges that the Agency plans to use the data provided to EPA under the US Challenge "to conduct initial assessments of hazards and risks of HPV substances," and to combine it with "information on exposure and uses to allow [EPA] to evaluate and prioritize health and environmental effects" (Id. at 81664). Clearly, EPA anticipates receiving various types of use and exposure information. However, at this point it appears that the Agency has not thought strategically about how it will manage or use the information that will be submitted. There has even been resistance among some staff to receiving this information since it falls outside of the original scope of the Challenge Program. We urge the Agency to ensure that its staff develops a consistent position on this issue. The Agency also might want to consider how to provide incentives designed to encourage companies to participate in use/exposure information gathering activities. Inasmuch as the consortia already are formed, and the data are understood to be useful to the Agency, this would seem a perfect time to match mutual interests.
The proposed rule suggests that aquatic testing requirements be determined based on the test substance's log Kow, and uses a cutoff value of 4.2 to conduct acute (Test Group 1) versus chronic (Test Group 2) aquatic toxicity testing (Id. at 81669-70). This requirement is not, to the best of our knowledge, mentioned in any of the HPV guidance documents, and has not been discussed previously with HPV stakeholders. Although this may be an attempt to provide consistency with TSCA section 5 policy on PBT chemicals, a cut-off value of 4.2 will not necessarily be appropriate for all chemicals in the context of an HPV screening program. We urge EPA to state the basis for this new proposal, and allow industry the flexibility to propose aquatic toxicity test plans that consider the potential for long-term effects on a chemical-by-chemical basis, rather than set against specific log Kow criteria.
After reviewing EPA's Economic Analysis of this proposed rule,1 we are concerned that it does not adequately characterize the scope and scale of EPA's testing initiative. Even in the context of a test rule designed to obtain screening level hazard information, we believe these are important issues. We offer the following points.
First, the proposed test rule covers only a subset of chemicals potentially subject to HPV testing requirements under TSCA section 4. EPA has identified approximately 2,800 chemicals as candidates for evaluation under the H13V Challenge Program (65 Fed. Reg. 81664). Sponsors have come forward thus far for approximately 2,155 of these compounds, leaving roughly 400 to 450 test rule candidates, after low priority chemicals are subtracted. Though EPA estimates the cost of the proposed test rule at between $268,000 and $283,000 per chemical, we believe the average cost of testing (including administrative costs) likely will be considerably higher. Thus, at the end of the day, we believe the full cost of this testing initiative, not including chemicals sponsored under the HPV Challenge Program, could be as high as two hundred million dollars- an amount far above the costs projected by EPA for the 37 chemicals included in this initial proposed test rule.
Second, for purposes of its economic analysis, we believe EPA should have considered all HPV chemicals potentially subject to the testing requirements in this proposed rule as a single group, as we have done in the preceding paragraph. While breaking the entire package into more manageable pieces certainly makes the task of scheduling HPV testing requirements much easier, both for EPA and test sponsors, it is generally agreed that dividing an economically significant or major rule into a collection of more manageable parts does not fundamentally alter its economic significance or major character. Therefore, we believe EPA should have aggregated all HPV test rules for purposes of its economic analysis.
Third, we believe an aggregate economic analysis is important for at least three reasons: (1) it meets legal requirements; (2) it permits interested parties to understand the full magnitude of the proposed testing program; and (3) it invites EPA to design its regulations (in this case, the testing program) in the most cost-effective manner to achieve the regulatory objective, considering all relevant factors, including cost, the necessity of the testing, the viability of alternative approaches (e.g. , use of categories and SAR), and animal welfare concerns.
These are considerations ACC has emphasized from the outset of the HPV program. We have sought a cost-effective approach to chemical testing - one that invites innovation in the context of a consistent and predictable system for addressing legitimate data needs. We recognize that elsewhere in the proposed rule EPA has embraced many of these concepts, but we believe a sound economic analysis would provide strong reinforcement for the sound scientific principles embodied in these concepts.
We understand that an accurate economic analysis requires reliable information pertaining to various underlying factors, including the likely costs of the testing and administrative support. ACC stands ready to assist EPA with the gathering of reliable information to support its economic analyses. We believe this effort is important to producing sound and cost-effective regulatory decisions. We offer these comments with that objective in mind.
EPA has divided persons who would be subject to the test rule into two groups: persons initially required to comply (Tier 1) and persons not initially required to comply (Tier 2). Tier 1 includes all persons who manufacture a test substance and are not listed in Tier 2. Tier 2 includes:
Persons who process or intend to process a test rule substance.
Persons in Tier 2 are subject to the rule and responsible for providing reimbursement to persons in Tier I who conduct the testing, but they have an automatic conditional exemption from testing and are not required to take any action unless notified by EPA (which would occur only if no persons in Tier 1 came forward to test). EPA has solicited comment on this approach, and specifically on whom should be included in Tier 1 and Tier 2. EPA also has solicited comment on whether the 500 kg (1100 lb) small quantity threshold should be increased. ACC offers the following comments on these issues.
First, we agree with the placement of processors in Tier 2, as has been EPA's consistent practice under TSCA section 4.
Second, concerning manufacturers, our basic premise is this: producers whose activities contribute in a significant way to the need for testing should be in Tier 1. In this case, EPA's proposed placement of persons in Tier 1 and Tier 2 may be appropriate for all or most of the HPV substances, but if the producers in Tier 1 are able to demonstrate in any given case that the activities of persons in Tier 2 contribute in a significant way to the need for test data, then EPA should place those persons in Tier 1 for that substance. EPA need not take the same approach for every compound, nor in every section 4 test rule. Rather, fundamental principles of equity should be the Agency's guide in each case. The Council would be pleased to work with the Agency and other stakeholders to evaluate and propose the most efficient means of collecting this information early or immediately prior to the proposed rulemaking.
By law, test rules under TSCA apply to persons who "manufacture" or "process" the chemical that is the subject of testing. TSCA section 4(b)(3)(B). The statute, however, grants EPA discretion to specify the classes of manufacturers and processors subject to a test rule based on its rationale for requiring testing. Id . Thus, for example, if in a particular test rule air emissions are a primary reason for requiring testing and the activities of byproduct or impurity producers contribute significantly to those air emissions, then those persons should be moved to Tier 1. Further, while EPA may want to consider establishing threshold triggers for moving persons to Tier 1, such as a production volume threshold or a concentration-based cut-off, EPA should be careful not to set any such triggers in a way that undermines the goal of placing in Tier 1 all persons whose activities contribute significantly to the need for testing. EPA should be particularly wary about applying concentration-based cutoffs to persons who produce a test substance as a byproduct, impurity or component of a Class 2 substance, to make sure that persons are not excluded from Tier 1 if their activities (total production, emissions, worker exposures, etc.) warrant their inclusion. Further, EPA should recognize that a concentration-based cut-off that seems reasonable in most cases may not be reasonable in all cases.
Finally, concerning the current 500 kg (1100 lb) small-quantity threshold, ACC supports raising this threshold to 10,000 pounds. This higher figure has several advantages: it matches the reporting threshold under the TSCA Inventory Update Rule (IUR); as a practical matter, the activities of smaller producers will rarely be a significant factor in EPA's decisions to require testing; test sponsors are unlikely to seek reimbursement from such small-quantity producers in most cases; and EPA will be spared the burden of processing exemption requests from these producers. It may be appropriate at a later date to consider an even higher small-quantity threshold, but for now ACC supports using 10,000 pounds as the cutoff.
Under EPA's proposed rule, any person who exports one of the HPV substances covered by the rule in any form will be subject to the export notification requirements set forth in TSCA section 12(b)(1) and 40 CFR part 707, subpart D. EPA has traditionally interpreted section 12(b) as applying to all persons exporting products which contain the test substance as an impurity or minor mixture component . As applied to large volume chemicals, this approach has had the practical effect of extending section 12(b) obligations to numerous companies with minimal commercial involvement with the test chemical, greatly adding to the time and cost of section 12(b) compliance. ACC has raised this concern with EPA on a number of occasions and asked the Agency to reconsider the scope of export notification requirements for section 4 chemicals. This rulemaking represents a timely opportunity for such reconsideration.
First, section 12(b) requires the submission of export notices by persons who export "a chemical substance or mixture" for which "the submission of data is required" under section 4. ACC believes EPA should interpret this requirement to apply only where the product being exported is itself a substance or mixture subject to section 4 requirements. Under this approach, impurities or minor components of other substances, mixtures or products would be outside the scope of section 12(b) requirements.
In any event, section 12(b) requirements should only apply to persons who have testing obligations under section 4. Persons exempt from testing requirements should likewise be exempt from section 12(b) requirements. Similarly, persons outside the scope of section 4 should not be required to submit section 12(b) notices. By aligning the coverage of sections 4 and 12(b), EPA can simplify compliance and reduce paperwork while still fulfilling the purposes of both provisions of TSCA.
The language of section 12(b) gives EPA discretion to limit notification requirements to persons who have testing obligations under section 4 of TSCA. Moreover, EPA has inherent authority under well-established case law to create de minimis exemptions from statutory requirements in order to avoid irrational or counterproductive results.2 EPA has used this inherent authority under many other TSCA provisions; examples include the PMN regulations (40 C.F.R. Part 720) which exempt impurities, byproducts and other inadvertently produced chemicals from PMN requirements.
EPA has previously recognized that de minimis exemptions could likewise be created under section 12(b). In 1989, EPA proposed to amend its section 12(b) regulations because of concern about the excessive paperwork burdens being imposed on EPA and industry.3 While EPA's main focus was to allow companies to file a one-time notice for each country to which section 4 chemicals were exported, EPA's proposal discussed a cutoff level (e.g. one percent) for test substances present in exported products in low concentrations. When EPA promulgated final regulations in 1993, it declined to adopt this approach.4 Significantly, however, EPA did not maintain that it lacked statutory authority to establish a de minimis exemption under section 12(b). While agreeing that such exemptions "may be appropriate in many circumstances," EPA stated that "it is preferable to provide foreign countries 12(b) notifications so they have the opportunity to make their own determinations regarding what level of a chemical in mixtures is deemed important." EPA promised to "reexamine this option at a later time" if "further experience . . . indicates that a de minimis regulatory exemption is warranted."5 Moreover, EPA has subsequently created de minimis exemptions from export notification on a chemical-specific basis.6
In recent years, reporting burdens under section 12(b) have steadily increased as additional substances are subjected to testing requirements under section 4. Thus, EPA should use the HPV test rule to create section 12(b) exemptions for persons not initially required to comply (i.e., not in Tier 1) because: (1) export notices would continue to be submitted by persons who manufacture and export the test substance as a bulk chemical, and (2) neither EPA nor foreign governments will benefit from information about the presence of trace amounts of test substances in export shipments of other chemicals, mixtures or products.
ACC and EPA have disagreed in the past on several issues pertaining to how EPA makes its findings under section 4 of TSCA. We would like to use this opportunity to clarify our thoughts on several issues.
Fundamentally, we believe the language in TSCA section 4(a) is well-constructed to produce sound testing decisions. EPA may require testing based on a suspicion of unreasonable risk ("may present an unreasonable risk of injury to health or the environment"), or based solely on production volume and potential exposures ("substantial" production and the substance "may reasonably be anticipated to enter the environment in substantial quantities" or "there is or may be significant or substantial human exposure"). In either case, EPA also must find that existing data are insufficient to determine risks to human health or the environment from the manufacture, processing, use or disposal of the subject chemical(s), and that each of the proposed tests is necessary to develop such data.
ACC believes the statutory language outlines a sound approach for making testing decisions. Problems arise, however, if the statutorily-required findings are regarded merely as technical requirements that must be satisfied to proceed with the testing of preselected substances, using a pre-determined test batteries. When the latter approach is taken, chemical producers are often faced with testing requirements that do not pass muster ethically - a troubling circumstance for the scientists involved in the testing as well as the companies who must pay. We illustrate our point with the following examples.
EPA has consistently refused to consider the level (magnitude), duration or frequency of human or environmental exposures when making its "B" findings. Yet in 1992, in a proposed test rule for aryl phosphate base stocks, EPA stated that "it is reasonable to interpret TSCA section 4(a)(1)(B) as authorizing EPA to require testing for every substance whose environmental or human exposure is of such magnitude or type that it may need to be regulated if test data reveal adverse effects."7 EPA's "B" policy thus is not consistent with the Agency's own articulation of what TSCA section 4(a)(1)(B) authorizes, and the numerical criteria set forth in EPA's "B" policy8 do not provide a meaningful basis for making the judgment described by EPA in the aryl phosphates proposed rule.
By focusing exclusively on the size of the potentially exposed population or the quantities released to the environment, and ignoring other relevant factors such as the levels, duration, and frequency of exposures, EPA's numerical criteria permit testing even where monitoring data or modeling results using EPA-approved techniques demonstrate that exposures are essentially nil (e.g ., where exposures are infrequent and consistently below 1 ppb). Clearly the number of potentially exposed people is one of the factors which could determine the need for risk management measures if testing demonstrates adverse effects, but other factors may be of equal or greater importance, including: physical, chemical and biological properties; manner of use and release; exposure concentrations; and duration and frequency of exposure. By failing to consider these factors, EPA's B Policy can lead to comprehensive testing requirements where the possibility of harm is remote, and testing is simply not warranted.
EPA's findings under section 4(a)(1)(B) also have failed to consider the relationship between a substance's exposure potential and the end-points under consideration for testing (i.e ., whether the type and duration of exposure that forms the basis for the "B" finding raises a concern about a particular testing endpoint). For example, irritation and other acute health effects typically are associated with high levels of exposure for limited periods of time. By contrast, chronic effects typically are associated with long term exposure scenarios. ACC believes EPA should take these factors into account in developing a test program. A "B" finding may be based on a pattern of exposure that is relevant to one toxicity end-point, but not for others. Once EPA has made a "B" finding, it should examine each study under consideration to determine whether the exposure warrants testing for that specific endpoint.
TSCA's legislative history underscores the need for consideration of exposure under section 4(a)(1)(B). According to the House Report:
In making the finding that there is or will be substantial production coupled with substantial environmental or human exposure to a substance or mixture, . . . [t]he duration of the exposure, the level of or intensity of exposure at various periods of time, the number of people exposed, or the extent of environmental exposure are among the considerations which may be relevant in particular circumstances.9
This paragraph confirms that Congress did not expect EPA to define "substantial" exposure solely in terms of the size of the exposed population, but expected EPA to consider all relevant factors, including the intensity, duration and frequency of exposure.
Similarly, ACC believes it is not sufficient for EPA to conclude that releases in excess of one million pounds per year are "large" and thus automatically support a finding that a compound enters the environment in "substantial" quantities. For example, releases of a chemical into the air should not be considered "substantial" if there is little potential for plants, animals, humans or other living organisms to be exposed to that chemical. The same conclusion would be required if large amounts of the substance are present in the environment because of natural sources or non-industrial releases and the additional contribution of manufacturing or processing releases is inconsequential. To find "substantial" entry into the environment, ACC believes EPA should consider not simply the total poundage released, but also persistence in the environment, typical airborne concentrations beyond site boundaries attributable to natural releases, and the likely levels of human or environmental exposure resulting from manufacturing and processing activities.
For example, in response to the proposed test rule for hazardous air pollutants (HAPs), which is still under development, we pointed out that EPA has estimated that emissions of carbonyl sulfide from natural sources (such as oceans and volcanoes) range from 11.6 to 15.4 billion pounds per year, while TRI-reported emissions were only 16.7 million pounds, or approximately 0.1 percent of that amount. In light of the vast amounts of naturally-emitted carbonyl sulfide, we believe the anthropogenic releases should not be considered "substantial," absent some additional analysis showing how those releases can reasonably be anticipated to result in significant or substantial human or environmental exposure.
EPA itself has recognized that releases to the environment do not necessarily equal human exposures, and thus do not by themselves provide evidence of a likely risk. Thus, EPA has made the following disclaimer about TRI release data:
[I]t is important to realize that the reports reflect releases of chemicals, not exposures of those chemicals to the public. Some chemicals are rapidly dispersed or transformed when they are released into the environment which completely, or nearly completely, eliminates their threat to public health or the environment .10
Fundamentally, ACC objects to EPA's B Policy because it does not provide a sound basis for making testing decisions. The modifications to the B Policy that ACC has recommended are intended to do just that - provide a sound basis for identifying compounds for which testing is warranted based on exposure potential alone. Testing that cannot be justified when the level, duration and frequency of exposure are considered should not be required.
2. The NOES Survey
EPA should exercise extreme caution when using the National Occupational Exposure Survey (NOES) database in a TSCA section 4 setting to estimate the number of workers potentially exposed to test substances. At a minimum, the Agency should not rely on that data absent some other more recent indication of reliability for a particular chemical/use scenario. As we have previously explained, this database does not provide a reliable basis for estimating the number of workers exposed to chemicals at industrial facilities.
The NOES survey was conducted by the National Institute for Occupational Safety and Health in 1981-1983.11 The survey is clearly outdated, and it covered only one percent of the 500,000 establishments listed on the Dunn and Bradstreet market identifier file as of 1980. The NOES data are based entirely on visual observations of potential exposures. The NOES field observations were recorded primarily by recent college graduates with little or no experience in occupational exposure. High turnover, particularly during the first year of the survey, further magnified the problem of inexperienced personnel. Of greatest concern, the survey did not attempt to identify the manner in which employees were exposed to the chemicals, the duration and concentration levels of exposure, or whether protective measures reduced exposure levels. All of the recorded exposures to a chemical were characterized merely as "parttime" or "full-time." Because the survey did not determine the route, duration or level of exposure, its conclusions have very limited value in determining the magnitude of workplace exposures.
Many of these concerns are presented in detail in a critique of the NOES data previously provided to EPA.12 Because of these limitations, the NOES estimates have little validity and fail to provide reasonable support for EPA's section 4(a)(1)(B) findings of "substantial human exposure" to proposed test chemicals.
At most, the NOES data should be used qualitatively to get an "order of magnitude" sense of potential worker exposure at the time the survey was conducted. EPA should make an effort to determine if uses and potential exposures have changed over time, as typically will be the case, and should ask for that information in the proposed rule. EPA should be open to receiving such information from interested parties, and should use the information More generally, NIOSH should be encouraged to conduct a new survey.
3. "A" Findings
EPA asserts that it need not limit the scope of required testing to the factual basis for the TSCA section 4(a)(1)(A)(i) finding ("may present an unreasonable risk"), as long as EPA makes the "insufficient data" and "necessity of testing" findings. Under EPA's approach, a possible risk of acute effects based on infrequent but high acute exposures could be used to justify chronic studies. EPA's approach, however, disregards the clear obligation under the statute to correlate suspected toxicity with suspected exposures. See Chemical Manufacturers Association v. EPA, 859 F.2d 977, 995 (D.C. Cir. 1988). ("The statutory standard requires EPA to correlate the suspected toxicity of a substance with the suspected levels of exposure.") (emphasis added). According to the Court, a section 4 test rule "is warranted when there is a more-than-theoretical basis for suspecting that some amount of exposure occurs and that the substance is sufficiently toxic at that exposure level to present an `unreasonable risk of injury to health."' Id. (emphasis added).
For example, in the HAP testing proposal, which is still under development, EPA's "A" finding for phthalic anhydride is based on respiratory sensitization, yet EPA proposes to require testing for acute toxicity, sensory irritation, subchronic toxicity, developmental toxicity, reproductive toxicity, neurotoxicity, immunotoxicity and cancer. The one endpoint for which EPA is not requiring testing is respiratory sensitization -- the endpoint on which EPA bases its authority to require testing for phthalic anhydride. EPA does the same for a number of other chemicals, including carbonyl sulfide, chlorine, ethylene dichloride, hydrochloric acid, hydrogen fluoride, maleic anhydride, methyl isobutyl ketone, naphthalene, and vinylidene chloride.
ACC believes EPA's approach is inconsistent with the clear language and intent of TSCA section 4, as confirmed by the U.S. Court of Appeals. More fundamentally, we ` believe EPA's approach fails to produce sound testing decisions.
When EPA promulgated its final "B" Policy, it stated unequivocally as follows:
For each substance-specific rulemaking under section 4, EPA must determine whether there is sufficient "data and experience" upon which to "reasonably determine or predict" the health and environmental effects of a chemical substance, and whether testing of such substance is "necessary to develop such data." In making these determinations, the Agency has always, and will continue to examine all available and relevant information concerning the substance in question, including the physical and biological properties of the substance, the manner of its use and release, the level, frequency, and duration of exposure, and any available relevant exposure and toxicity data.13
In the past, however, EPA rarely (if ever) has considered exposure information when making these findings. Instead, EPA typically has just compared existing data to the testing matrix that has been selected for the particular initiative, and the Agency usually has presumed that existing data were insufficient and testing was necessary whenever a proposed study had not already been conducted. This is not just a matter of identifying data gaps; EPA often has rejected valid studies because they did not match current testing protocols, and little or no consideration has been given to the other factors described in the quoted statement from the Final B Policy. When this occurs, an opportunity is lost to make sound testing decisions: decisions which discriminate between testing that is truly necessary, and testing that in fact is not really necessary to make sound risk management decisions.
We are encouraged by EPA's statements in this proposed test rule that it will adhere to principles articulated in an October 14, 1999 letter sent to all HPV Challenge Program participants.14 In that letter, program participants were instructed as follows:
In analyzing the adequacy of existing data, participants shall conduct a thoughtful, qualitative analysis rather than use a rote checklist approach. Participants may conclude that there is sufficient data, given the totality of what is known about a chemical, including human experience, that certain endpoints need not be tested.
ACC finds these statements encouraging, and believes they should apply to all testing initiatives under TSCA. It is critical, however, that this analysis not be reduced to a search for "equivalent data," but that it instead include consideration of all the relevant factors identified in EPA's B Policy, including "the physical and biological properties of the substance, the manner of its use and release, the level, frequency, and duration of exposure, and any available relevant exposure and toxicity data." Moreover, it is critical that EPA truly engage in a "thoughtful, qualitative analysis rather than use a rote checklist approach," as has been the case in the past.
In summary, as stated earlier, ACC believes the findings required by TSCA section 4 lead to sound testing decisions if made properly. We urge EPA to consider these comments in that light.
The Council appreciates the opportunity to provide these comments, and looks forward to continuing to work cooperatively with the Agency to successfully complete the voluntary HPV Challenge Program. We hope that these comments are received as we intend them - constructive suggestions for improving the exercise of TSCA's tools for gathering test data in a regulatory context, and for making maximum use of the considerable resources already committed to the voluntary part of the program.
1. EPA, "Economic Analysis for the Proposed Section 4 Test Rule for High Production Volume Chemicals," December 5, 2000 (hereinafter "Economic Analysis").
2. See Alabama Power v. Costle, 636 F.2d. 323, 360 (D.C. Cir. 1979) ("notwithstanding the `plain meaning' of a statute, a court must look beyond the words to the purpose of the act where its literal terms lead to `absurd or futile results."'). ACC provided an analysis of EPA's discretionary authority under Section 12(b) to EPA's Environmental Assistance Division in a letter dated November 13, 1997.
3. 54 Fed. Reg. 29524 (July 12, 1989)
4. 58 Fed. Reg. 40238 (July 27, 1993)
5. 58 Fed. Reg. at 40241.
6. See 59 Fed. Reg. 45629 (Sept. 2, 1994) (excluding TMB in refinery streams from section 12(b) requirements).
7. 57 Fed. Reg. 2138, 2144 (January 17, 1992) (emphasis added).
8. See 58 Fed. Reg. 28736, 28746 (May 14, 1993).
9. H.R. Rep. No. 1341, 94th Cong., 2d Sess. 18 (1976), reprinted in Legislative History of the Toxic Substances Control Act at 425 (emphasis added).
10. TRI 1994 Data Release: Background Information (emphasis added).
11. National Institute for Occupational Safety and Health: National Occupational Exposure Survey (NOES): Final Report by Robert Hanson, Diane Ward, John Edmonds, and Joseph Escatell (Westat, Inc.: Contract Number 210-80-6057), Cincinnati, Ohio: NIOSH, 1983.
12. See "An Assessment of the National Occupational Exposure Survey" by Deems A. Buell, Marc B. Blaustein and Jeremiah R. Lynch (included as Attachment B to ACC's comments in response to the HAP proposed test rule, TSCA Docket No. OPPTS-42187A; FRL-4869-1).
13. 58 Fed. Reg. 28743 (emphasis added).
16. Id. at 81664.