24 ELR 10285 | Environmental Law Reporter | copyright © 1994 | All rights reserved

A Practitioner's Guide to the Toxic Substances Control Act: Part II

Carolyne R. Hathaway and David J. Hayes and William K. Rawson

Editors' Summary: In this second installment of a three-part Article, the authors continue a detailed examination of the TSCA statute and regulatory program. They begin the installment with a review of TSCA § 5(e) orders and consent orders and significant new use rules. They next discuss imposition of requirements to conduct health and environmental effects testing on chemical manufacturers and processors, summarizing TSCA § 4's statutory authority and EPA's regulatory program. They conclude this installment with a discussion of exemptions from test rules, cost reimbursement provisions, and judicial review.

Carolyne R. Hathaway is a senior environmental associate in the Washington, D.C., office of the national law firm of Latham & Watkins. David J. Hayes is a partner at Latham & Watkins and chairs the Environmental Department of the firm's Washington, D.C., office. He also chairs the Board of Directors of the Environmental Law Institute. William K. Rawson is an environmental partner in Latham & Watkins' Washington, D.C., office.

[24 ELR 10286]

VI. Regulation of Chemical Substances Under TSCA § 5(e) Consent Orders and Generic SNURS

A. Statutory Provisions

Under § 5(e) of the Toxic Substances Control Act (TSCA),¹ the U.S. Environmental Protection Agency (EPA) may issue a proposed order prohibiting or limiting the manufacture, processing, distribution in commerce, use, or disposal of a new chemical substance that may present an unreasonable risk to health or the environment.² To regulate a chemical under § 5(e), EPA must determine: (1) that the available information is insufficient to permit a reasoned evaluation of the substance's health and environmental effects; and (2) either that in the absence of such information, the manufacturing, processing, distribution, use, or disposal of the substance may present an unreasonable risk of injury to health or the environment, or that the substance will be produced in substantial quantities and may reasonably be expected to enter the environment in substantial quantities or result in significant or substantial human exposure.³

EPA must issue a proposed order under § 5(e) at least 45 days before the end of the premanufacture notice (PMN) review period.⁴ Unless the PMN submitter files objections to the proposed order within 30 days after receiving notice of the proposed order from EPA, the order will take effect upon the expiration of the notice review period.⁵ Objections must specify with particularity the provisions of the order deemed to be objectionable and the grounds for the objections.⁶

If the PMN submitter files objections to the proposed order, EPA must seek an injunction in United States District Court to enforce the order unless EPA determines, on the basis of the objections, that the findings required to support the § 5(e) order may not be made.⁷ Once EPA applies for an injunction, the district court will apply the identical statutory standard to determine whether an injunction is warranted.⁸

B. Consent Orders

In practice, EPA has issued relatively few "unilateral"⁹ orders under the approach set forth in § 5(e). If EPA contemplates taking action on a new chemical substance under § 5(e), the Agency typically will communicate its concerns to the PMN submitter and request that the submitter voluntarily suspend the PMN review period.¹⁰ Confronted with the possibility of regulation under § 5(e), the PMN submitter must decide whether to await the issuance of a proposed unilateral order and then file objections and oppose an injunction action in district court, withdraw the PMN,¹¹ or attempt to negotiate a consent order with the Agency. Under these circumstances, submitters generally have elected either to withdraw the PMNs or to negotiate consent orders.

Neither § 5(e) nor the regulations explicitly authorize negotiated consent orders. Section 5(e) consent orders nonetheless have been widely used because they permit flexibility in the development of the order and input from the PMN submitter regarding the terms of the order. They also avoid the cost of a court challenge and an adversarial relationship with EPA. As of September 30, 1989, 233 consent orders had been signed, and 435 PMNs were subject to such orders.¹²

To facilitate and streamline the negotiation of § 5(e) consent orders, EPA has developed standard "generic" consent orders to address risk- or exposure-based concerns relating to the human health effects or ecotoxicity of particular substances.¹³ The consent orders consist of two sections -- the preamble, which includes the following subsections:

I. Introduction

II. Summary of Terms of the Order

III. Contents of PMN

IV. EPA's Assessment of Risk

V. EPA's Conclusions of Law

VI. Information Required to Evaluate Health or Environment Effects

and the actual order, which includes:

I. Terms of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation of Information

II. Recordkeeping

III. Modification and Revocation of Consent Order

IV. Effect of Consent Order

The preamble to the consent order establishes EPA's basis for and conclusions supporting regulation of the chemical substance under § 5(e). The consent orders explicitly provide that agreement to the order does not constitute [24 ELR 10287] an admission of the facts or conclusions underlying EPA's determinations.¹⁴

The heart of the consent order is the subsection that sets forth the terms of manufacture, import, processing, distribution in commerce, use, and disposal pending submission and evaluation of information. These terms generally identify applicable testing requirements and limit the aggregate manufacturing or import volume of the substance while the testing is conducted.¹⁵ The testing must be completed and the final report and underlying data submitted to EPA at least 14 weeks before the manufacturer reaches the production limit.

Once the test reports are submitted, the standard consent orders contemplate three possible responses by EPA. If EPA determines that the data are "scientifically equivocal,"¹⁶ manufacture may continue beyond the production limit only if the other restrictions in the order are met.¹⁷ If EPA determines that the study results are "scientifically invalid,"¹⁸ manufacture may not continue beyond the aggregate production limit unless the company reconducts the study or submits a report refuting EPA's conclusion.¹⁹ Finally, if EPA determines that the data are valid but indicative of an unreasonable risk despite the terms of the order, then manufacture, import, processing, distribution, use, and disposal of the PMN substance must cease unless the company complies with additional requirements or restrictions specified by EPA or submits a report refuting EPA's conclusions.²⁰

The standard consent orders do not automatically revoke or modify the order in the event of valid, negative study results.²¹ The company may, however, petition the Agency to revoke or modify an order when the test data demonstrate that the substance presents no unreasonable risk and the controls specified in the order are unnecessary.²² The company must comply with the other terms of the consent order until notified in writing by EPA that the order has been revoked or modified.²³

EPA's generic consent orders include lists of the various terms, limitations, and restrictions that the Agency may select as appropriate for incorporation into a particular chemical-specific consent order. These terms or restrictions may require:

Protection in the Workplace, including the use of gloves, goggles, protective clothing, respirators, or other personal protective equipment;²⁴

Hazard Communication Programs, including labeling requirements, material data safety sheets, employee information and training, and precautionary statements;²⁵

Restrictions on Manufacture, Processing, Use, or Distribution, including limits on production volume, restriction to "enclosed" or "site-limited" production, processing, or use, restriction to a specified use (e.g., as an intermediate) or category of use (e.g., industrial, commercial, or consumer), and restriction on the form (e.g., solid, liquid, gas, or powder), in which the substance may be manufactured, processed, or used;²⁶

Disposal Restrictions, including requirements that disposal take place only by incineration, landfill, and/or deep-well injection;²⁷

Restrictions on Releases to Water, including the use of specified treatment technologies and volume or concentration limitations;²⁸ and

Recordkeeping Provisions, including the maintenance of records regarding production, processing, use, and disposal activities and documenting compliance with the terms of the consent order.²⁹

EPA generally has resisted negotiating changes to the overall structure and general provisions of the standard § 5(e) consent orders. The Agency has sought to restrict negotiation to issues such as the specific testing requirements and other limitations and restrictions on activities relating to the manufacture, processing, use, distribution, and disposal of the specific chemical at issue.

C. Overview of the Significant New Use Rules (SNURs)

TSCA § 5(e) consent orders are negotiated in the context of PMN submissions on new chemical substances for which EPA has determined that there is insufficient test data available and that in the absence of such information, may either present an unreasonable risk or result in substantial exposure. Thus, a § 5(e) consent order applies only to the first manufacturer submitting the PMN for the new chemical substance. Significant new use rules (SNURs) provide the mechanism by which EPA can apply the restrictions on manufacture, processing, use, and disposal that are included [24 ELR 10288] in § 5(e) consent orders to subsequent manufacturers and processors of the PMN substance.

EPA finalized "generic" or "expedited" SNUR regulations in 1989.³⁰ These regulations facilitate the broader promulgation of SNURs to restrict activities involving substances subject to § 5(e) consent orders, as well as to restrict activities other than those identified in a PMN that involve new chemical substances not regulated under a § 5(e) order. The SNUR regulations consist of five subparts to 40 C.F.R. Part 721:

[] Subpart A establishes definitions of the terms found in the other subparts. It also includes general provisions addressing application of the SNUR requirements, exemptions, and notice requirements. These general provisions are discussed in the section on PMN requirements in Part V of Part I of this Article.³¹

[] Subpart B establishes standard significant new use designations that EPA may apply to particular chemical substances for which a SNUR has been promulgated. These designations, which include workplace protection requirements, hazard communication programs, limitations on industrial, commercial, and consumer activities, disposal restrictions, and restrictions on releases to water, track those typically included in § 5(e) consent orders. A particular designation will apply to a SNUR substance only if it is expressly referenced as applying in the chemical-specific rules in Subpart E.³²

[] Subpart C establishes recordkeeping requirements which, like the specific use designations in Subpart B, EPA may apply to a particular SNUR substance by referencing the provision in the chemical-specific rules in Subpart E.³³

[] Subpart D establishes expedited procedures for creating significant new use requirements for chemical substances subject to § 5(e) consent orders. It also establishes criteria for designating as significant new uses activities, not described in a PMN, involving chemical substances that have completed PMN review but are not subject to an order under § 5(e).³⁴

[] Subpart E contains the SNURs that have been promulgated for specific chemical substances.³⁵ These substances also are flagged as SNUR substances on the TSCA Inventory.

D. Standard Significant New Use Designations

Standard significant new use designations, corresponding to terms commonly incorporated into § 5(e) consent orders, are included in 40 C.F.R. Part 721, Subpart B. These provisions apply to a specific chemical substance only when they are referenced in a SNUR in Subpart E of the SNUR regulations. These provisions can include:

Protection in the Workplace, including provisions for gloves, protective clothing, goggles or equivalent eye protection, and respirators.³⁶

Hazard Communications Programs, including written hazard communication programs, labeling, material safety data sheets, employee information and training, and hazard exposure and precautionary statements.³⁷

Limits on Industrial, Commercial, and Consumer Activities, including restriction to enclosed or site-limited use, manufacture, or processing; restrictions on the use or category of use (industrial, commercial, consumer); manufacture and import volume limitations; and restrictions on the use, manufacture, or processing of a particular form (powder, solid, liquid, or gas) of the substance.³⁸

Disposal Restrictions, including limiting disposal of the substance to incineration, landfill, and/or deepwell injection;³⁹ and

Restrictions on Releases to Water and Computation of Estimated Surface Water Concentrations, including direct limitations on releases to water, specified treatment technologies, and concentration limitations.⁴⁰

In addition to the above restrictions, generic recordkeeping requirements, which may similarly be incorporated into SNURs for specific chemical substances, are included in Subpart C. EPA provided additional clarification of these generic provisions and their relationship to the testing and other requirements found in § 5(e) orders in a letter to the Chemical Manufacturers Association dated March 15, 1990.⁴¹

E. Expedited SNUR Procedures

In July 1989, EPA promulgated regulations at 40 C.F.R. Part 721, Subpart B, establishing an expedited process for issuing SNURs on selected chemical substances.⁴² Prior to September 30, 1989, 16 chemical substances were subject to final SNURs.⁴³ In contrast, 435 PMNs were subject to § 5(e) consent orders.⁴⁴ In the absence of a corresponding SNUR, the restrictions embodied in the § 5(e) consent orders applied only to the original PMN submitters. The expedited [24 ELR 10289] SNUR procedures were promulgated to "simplify the preparations of individual SNURS for chemicals subject to Section 5(e) Orders and for other selected new chemicals that have completed premanufacture review," thereby extending the restrictions in the consent order to all future manufacturers and processors of the PMN substance.⁴⁵ Between January 1990 and July 1, 1991, following the promulgation of the expedited SNUR procedures, more than 200 final SNURs were promulgated.⁴⁶

Like the SNURs process generally, the expedited process for issuing SNURs may be applied either (1) to new chemical substances which, following the submission of a PMN, are regulated under § 5(e) orders;⁴⁷ or (2) to new chemical substances that have completed PMN review and for which EPA determines that activities, other than those described in the PMN, "may result in significant changes in human exposure or environmental release levels and/or that concern exists about the substance's health or environmental effects," but that are not subject to an order under § 5(e).⁴⁸

1. New Chemical Substances Subject to § 5(e) Consent Orders

EPA must issue a SNUR for each new chemical substance subject to a § 5(e) order, unless it specifically determines that no SNUR is required for the substance.⁴⁹ Thus, EPA probably will issue SNURs for most substances subject to § 5(e) orders. If, however, EPA believes that there are unlikely to be manufacturers or processors of the substance other than the PMN submitter or that for other reasons a SNUR is inappropriate, the Agency is required to publish a notice in the Federal Register explaining its reasons for not issuing a SNUR.⁵⁰

SNURs issued for substances subject to § 5(e) orders must "be based on and be consistent with" the final § 5(e) order.⁵¹ EPA also may designate as "significant new uses" other activities that are not included in the § 5(e) order. Such additional SNUR designations must be made pursuant to the procedures and criteria for PMN substances not subject to § 5(e) orders.⁵²

2. New Chemical Substances Not Subject to § 5(e) Consent Orders

The expedited SNUR procedures also may be used to regulate certain activities involving a PMN substance not subject to a § 5(e) order.⁵³ Such expedited SNURs may only regulate those activities that are not described in the PMN and that satisfy several "concern criteria" specified in the regulations.⁵⁴ Moreover, EPA has determined that certain significant new use designations, including specified cumulative manufacture or import limits in the absence of test results⁵⁵ and required use of personal protective equipment,⁵⁶ are not appropriate for expedited significant new use designations on PMN substances not subject to § 5(e) orders.⁵⁷

Expedited SNURs may be issued for PMN substances that satisfy the "concern criteria" set forth in the regulations.⁵⁸ These concern criteria generally track those used by EPA to determine whether regulation under § 5(e) is appropriate. Under these concern criteria, EPA may regulate substances for which the Agency makes one or more of the following findings:

the substance (or its metabolites) has been shown to be a carcinogen or possible carcinogen based on valid test data or its structure activity relationship (SAR) to a closely analogous carcinogen;

the substance has been shown, based on test data or SAR, to cause acutely toxic effects;

the substance (or its metabolites) may, based on test data or SAR, cause chronic effects, serious acute effects, or developmentally toxic effects; or

concern exists regarding the health or environmental effects of one or more of the substance's byproducts or impurities.⁵⁹

Activities may be regulated under an expedited SNUR if they are accompanied by changes in exposure or release levels that are significant in relation to these health or environmental concerns.⁶⁰

3. Procedures for Issuing Expedited SNURs

EPA may issue the expedited SNURs using three processes detailed in 40 C.F.R. Part 721, Subpart D:

Direct Final Rulemaking. EPA generally will use direct final rulemaking to issue SNURs unless the Agency determines that in a particular case, another approach is more appropriate. Under this approach, EPA will publish a final rule establishing a SNUR for a new chemical substance to take effect 60 days from the date of publication unless EPA receives, within 30 days, a notice of intent to submit adverse or critical comments on the rule. If a notice of intent to comment is received within 30 days, EPA will withdraw the direct final rule and publish a proposed SNUR with a 30-day comment period. If, following consideration of any comments that are submitted, EPA decides to impose significant new use restrictions and notice requirements, a final [24 ELR 10290] SNUR will be published, adding the substance to the list of SNUR substances in 40 C.F.R. Part 721, Subpart E.⁶¹

Immediately Effective Interim Final Rules. EPA may promulgate an expedited SNUR using immediately effective interim final rulemaking procedures where it believes that there may be a particularly high potential hazard associated with the uncontrolled use of the substance or a particularly high likelihood that someone may commence a significant new use activity prior to the time the final SNUR would take effect.⁶² EPA's reasons for using the interim final rulemaking procedure must be articulated in the interim final rule. Under this approach, EPA publishes an interim final rule to take effect on the date of publication. The notice provides a 30-day comment period, and ceases to be in effect 180 days after publication unless EPA issues a final SNUR responding to any comments received.⁶³

Notice and Comment Rulemaking. EPA will use notice and comment rulemaking where the Agency believes that there is likely to be significant public interest in commenting on the SNUR.⁶⁴ Under this approach, EPA publishes a proposed SNUR in the Federal Register and establishes a 30-day comment period. If, following consideration of the comments received, EPA decides to impose significant new use limitations and notice requirements, it publishes a final SNUR adding the substance to 40 C.F.R. Part 721, Subpart E.⁶⁵

4. Procedures for Revoking or Modifying a SNUR

EPA also may revoke or modify significant new use restrictions and notification requirements established pursuant to the expedited procedures.⁶⁶ Modifications may be made either on EPA's initiative or in response to the written request of an affected person⁶⁷ if EPA makes one of the following determinations:

Test data or other information obtained by EPA provide a reasonable basis for concluding that the significant new use activities will not present an unreasonable risk of injury to human health or the environment;

EPA has promulgated a rule under TSCA § 4 or § 6, or EPA or another agency has taken other action that eliminates the need for the SNUR;

EPA has received SNURs for the activities designated as significant new uses and concluded that additional SNURs for such activities are unnecessary;

EPA has received new information or reexamined existing test data and concluded that the substance does not meet the concern criteria or does not present an unreasonable risk of injury to human health or the environment; or

Test data to which the SNUR restrictions were tied have been developed and submitted to EPA.⁶⁸

VII. TSCA § 4: Test Rules

A. Overview

When Congress enacted TSCA in 1976, it anticipated that the statutory authority to require chemical manufacturers and processors to generate testing data would play a central role in administration of the new law.⁶⁹ As explained in the purposes section of TSCA, Congress stated that it is the policy of the United States that:

adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be the responsibility of those who manufacture and those who process such chemical substances and mixtures.⁷⁰

TSCA § 4 provides EPA with authority to implement this policy by imposing health and environmental effects testing requirements on chemical manufacturers and processors. Over the years, EPA has made significant progress in developing testing programs for existing chemicals under § 4. EPA has issued detailed regulations governing development of test rules, negotiation of enforceable testing consent agreements, and compliance with testing requirements under test rules and consent orders. The Agency also has developed regulations governing laboratory practices, test methodologies, and the sharing of test costs for § 4 rules. Several thousand chemicals have been screened for possible testing, and considerable testing has been completed or is underway on many chemicals. This chapter summarizes EPA's statutory authority to require testing under § 4, and provides an analysis of EPA regulations governing the conduct of such testing.

B. StatutoryAuthority to Require Testing

TSCA § 4 provides EPA with authority to require testing of any chemical substance or mixture for which EPA makes the following findings, specified in § 4(a):

(1) "there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted,"⁷¹

and

(2) "testing of such substance or mixture with respect to such effects is necessary to develop such data."⁷²

and either

[24 ELR 10291]

(3) "the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or that any combination of such activities, may present an unreasonable risk of injury to health or the environment" [a § 4(a)(1)(A) finding];⁷³

or

"a chemical substance or mixture is or will be produced in substantial quantities, and (I) it enters or may reasonably be anticipated to enter the environment in substantial quantities or (II) there is or may be significant or substantial human exposure to such substance or mixture" [a § 4(a)(1)(B) finding].⁷⁴

Additionally, in the case of mixtures, EPA must make an additional finding that the effects which the mixture's manufacture, distribution in commerce, processing, use, or disposal or any combination of such activities may have on health or the environment may not be reasonably and more efficiently determined or predicted by testing the chemical substances that comprise the mixture.⁷⁵

When the required findings have been made for a chemical substance or mixture, testing must be conducted. However, EPA may require testing only to develop data with respect to the health and environmental effects for which there is an insufficiency of data and experience, and only to the extent that the data are relevant to a determination that the manufacture, distribution in commerce, processing, use, or disposal of the test substance or mixture does or does not present an unreasonable risk of injury to health or the environment.⁷⁶

1. The "May Present an Unreasonable Risk" Finding

The term "unreasonable risk" is not defined in the statute. Nor does the statute specify the amount of evidence that is needed to support a finding that a chemical "may present" such an unreasonable risk. The legislative history also provides very little guidance on these points, although the House Report did state that regulatory "costs are not to be incurred unless they are offset by benefits of at least the same magnitude."⁷⁷

EPA explained its approach to § 4(a)(1)(A) findings in its earliest testing proposals.⁷⁸ The Agency has divided the statutory language into three parts: (1) may present a hazard; (2) may present a risk; and (3) may present an unreasonable risk.⁷⁹ The following summarizes the Agency's approach to each aspect of the finding:

[] May present a hazard. EPA identified several factors relevant to an evaluation of potential health hazards of a substance, including: physical and chemical properties; structural similarity to chemicals with known adverse effects; results from previous testing of the compound, even if equivocal or unreliable; and anecdotal and clinical reports of injury. EPA stated that a determination that a chemical may present a hazard would not be based on definitive scientific data, but of necessity would involve reasonable scientific assumptions, extrapolations, and interpolations.⁸⁰

[] May present a risk. EPA uses the term "risk" to include both hazard and exposure potential. Because toxicity is of little concern if there is no human exposure to the chemical, EPA explained that it would look at both toxicity and exposure in determining whether to test chemicals. EPA explained further that the more severe the potential hazard, the less exposure the Agency would consider necessary to conclude that there is a potentially serious risk. The Agency also indicated that it did not consider evidence of actual human exposure necessary to support a finding under § 4(a)(1)(A). Rather, EPA stated that it is sufficient to show that there is a reasonable likelihood that exposure may arise because of activities associated with the manufacturing, processing, distribution, use, or disposal of the chemical.⁸¹

[] May present an unreasonable risk. EPA stated that it would pursue the following policy for purposes of § 4(a)(1)(A) findings: "If there is substantial evidence that exposure to a chemical may lead to a serious health effect or increase in mortality and that people may be exposed to the chemical, EPA will presume that the activities in question (manufacturing, processing, using, transporting, disposing) 'may present an unreasonable risk' unless the rule is likely to result in a significant loss to society of the benefits of the substance. In the latter instances, if EPA's analysis shows that the costs of testing may cause manufacturers or processors to cease or severely restrict their commercial activities, EPA will weigh this potential adverse impact against the benefits of testing before presuming that the chemical may present an unreasonable risk."⁸²

Numerous test rules have been promulgated based on § 4(a)(1)(A) findings. The Agency has largely followed the approach described in its early testing proposals. On several occasions, a final test rule has been challenged by chemical manufacturers responsible for the required testing. In each case, industry argued that EPA had not demonstrated sufficient human exposure to support the testing requirements. In Shell Chemical Company v. U.S. Environmental Protection Agency,⁸³ the appellate court remanded the case to EPA for supplemental findings concerning changes in use of the test substance that had occurred following promulgation of the test rule. In Ausimont U.S.A. Inc. v. U.S. Environmental Protection Agency,⁸⁴ the testing requirements were upheld. Neither of these cases provided much guidance concerning what would be deemed sufficient evidence of human exposure to support a "may present an unreasonable risk finding" in future test rules.

In Chemical Manufacturers Association [CMA] v. U.S. [24 ELR 10292] Environmental Protection Agency,⁸⁵ however, the question of the evidence necessary to support a "may present an unreasonable risk" finding was considered by the Court of Appeals for the District of Columbia Circuit, which upheld EPA's testing requirements for 2-ethylhexanoic acid (EHA).⁸⁶ CMA is significant because the court, in a lengthy opinion, squarely endorsed the Agency's contention that the mere potential for human exposure is sufficient to support a § 4(a)(1)(A) finding. The principal points in the court's ruling include:

To support a "may present" finding under § 4(a)(1)(A), EPA need not show that an unreasonable risk is more probable than not, but it must demonstrate that such a risk is "a more-than-theoretical probability";⁸⁷

In meeting this burden, § 4 requires EPA to make a showing of both toxicity and exposure;⁸⁸

EPA's "may present" finding does not require direct evidence of exposure. Rather, EPA may demonstrate such potential for exposure through circumstantial evidence regarding the conditions of the substance's manufacture and use, such as production volume, size of affected worker population, and opportunities for exposure during sampling, loading, and unloading operations;⁸⁹

EPA does not always need to show that exposure is of a recurrent nature. Evidence of isolated or one-time exposure will suffice, so long as rare exposure may create an "unreasonable risk" in light of the toxicity concerns identified by EPA;⁹⁰ and

Once EPA has shown "a more-than-theoretical probability" of exposure, the burden shifts to industry to rebut this showing by presenting evidence that exposure is no more than theoretical or speculative. If industry does not meet this burden, EPA need not augment the record with additional evidence of actual exposure.⁹¹

The ramifications of the D.C. Circuit's decision are complex. On the one hand, the court agreed with the industry contentions that the "unreasonable risk" finding under § 4 requires evidence of both toxicity and exposure and that the level of exposure must correlate with EPA's toxicity concerns. On the other hand, the decision eased the Agency's evidentiary burden of proving the requisite level of exposure to support a "may present" finding, while at the same time increasing the industry burden of rebuttal to a nearly impossible level. If the D.C. Circuit's decision is accepted in other federal circuits, EPA will have widespread flexibility to make § 4(a)(1)(A) findings.

2. The "Substantial Quantities or Substantial Human Exposure" Finding

In contrast to § 4(a)(1)(A), § 4(a)(1)(B) authorizes EPA to require testing based solely on a substance's production volume and potential for human or environmental exposure. EPA must find that "a chemical substance or mixture is or will be produced in substantial quantities, and (I) it enters or may reasonably be anticipated to enter the environment in substantial quantities or (II) there is or may be significant or substantial human exposure to such substance or mixture."⁹²

EPA first exercised its § 4(a)(1)(B) exposure-based testing authority in 1981. At that time, the Agency did not establish general criteria for so-called "B" findings, but instead indicated that:

[i]t is the Agency's view that establishment of strict numerical definitions of substantial production, substantial exposure or release, or significant exposure is neither feasible nor desirable at this stage of implementing Section 4 of TSCA. Rather, it is EPA's intention to make judgments on these factors on a case-by-case basis, at least until some additional experience is gained.⁹³

Throughout the 1980s, EPA used this case-by-case approach to justify several test rules based on "B" findings. Then, in 1988, CMA and various companies petitioned for judicial review of the final test rule for cumene.⁹⁴ This rule, which required extensive health and environmental effects studies, was supported by a finding under § 4(a)(1)(B) that substantial quantities of cumene entered the environment as a result of emissions from manufacturing and processing facilities,and that these emissions resulted in "substantial or significant" human exposure by residents of surrounding metropolitan areas.

In April 1990, the Court of Appeals for the Fifth Circuit remanded the cumene test rule to EPA with a directive to "articulate the standards or criteria on the basis of which it found the quantities of cumene entering the environment from the facilities in question to be 'substantial' and the human exposure potentially resulting to be 'substantial.'"⁹⁵ The court found that EPA had not "articulated any understandable basis" for its definition of "substantial exposure" under § 4(a)(1)(B).⁹⁶ The court elaborated as follows:

Here, we are unable to conclude from the final rule itself, or from the administrative record, or prior EPA decisions, on what basis or in light of what criteria the EPA concluded either that the quantities of cumene found to enter the environment from the facilities in question were "substantial" or that the human exposure potentially resulting therefrom was "substantial." As to the former, no standards [24 ELR 10293] or criteria whatever have been articulated, either for application generally or to this particular case.⁹⁷

Responding to the Fifth Circuit's decision, EPA published a proposed Statement of Policy ("the B Policy") on July 15, 1991, establishing standards and criteria for applying the exposure-based testing provisions of § 4(a)(1)(B).⁹⁸ Key elements of the proposed policy were as follows:

EPA proposed to make findings of "substantial production" under § 4(a)(1)(B) for substances produced in quantities of 1 million pounds or more per year.⁹⁹

EPA interpreted the term "substantial human exposure" under § 4(a)(1)(B) to mean "exposure to large numbers of people."¹⁰⁰ To apply this interpretation, EPA proposed to adopt numerical criteria for workers, consumers and the general population. Exposure to a chemical would be considered "substantial" if the potentially exposed population exceeded one of the following levels:

If these threshold criteria were met, EPA would presume the existence of "substantial human exposure" and require testing. No other indices of exposure would be considered.

EPA interpreted the term "significant human exposure" not in terms of the number of exposed people but in terms of the "nature of the exposure."¹⁰¹ Thus, EPA stated that even where the size of the potentially exposed population was below EPA's numerical thresholds, EPA would make a "B" finding where "the nature of the exposure is more direct than that which usually characterizes general population exposure, consumer exposure, or worker exposure."¹⁰²

EPA interpreted the phrase "enters the environment in substantial quantities" to mean "large release" of a chemical from plant equipment.¹⁰³ Applying this approach, EPA stated that it would make a "B" finding wherever a chemical had been released to the environment in quantities equal to at least 10 percent of total production or one million pounds per year, whichever was lower. In such situations, EPA would not consider other factors (such as the chemical's persistence in the environment or estimated environmental concentrations) that bore on the extent of human or environmental exposure.

Industry submitted written comments on the proposed "B" policy, raising several concerns regarding the legal and scientific basis for the proposed criteria. Industry argued that EPA's definition of "substantial human exposure" was unjustified because it focused totally on the number of potentially exposed persons and excluded consideration of other relevant factors. In determining whether human exposure is "substantial," industry urged EPA to consider all indicators of a substance's exposure potential, including its physical and biological properties, manner of use and release, exposure concentrations, and duration and frequency of exposure. In addition, industry argued that the Agency should not rely exclusively on the magnitude of environmental releases to determine whether a substance "enters the environment in substantial quantities." Instead, industry urged EPA to consider not simply the total poundage released, but also persistence in the environment, typical airborne concentrations beyond site boundaries, and the likely levels of human or environmental exposure.

EPA published its final "B" policy on May 14, 1993.¹⁰⁴ The final policy is identical in all respects to the proposed policy. EPA stated that it would apply the generic numerical criteria "for most substances considered for testing under TSCA section 4(a)(1)(B)."¹⁰⁵ However, the Agency also stated that it may consider "additional factors" on a case-by-case basis, and require testing in certain cases even if the numerical criteria of the "B" policy are not met.¹⁰⁶

3. Scope of Testing Requirements

Under § 4(b)(1), a test rule must include "standards" which prescribe key aspects of the test methodology that will be employed. Once EPA determines the test standards to be included in a test rule, TSCA requires consideration of the relative costs of the various test protocols and methodologies which may be required under the rule, and the availability of the facilities and personnel needed to perform the testing required under the rule. Subject to this limitation and the requirement that any testing be supported by the specific findings set forth in § 4(a), EPA is given broad authority to prescribe in each test rule such testing as may be necessary to evaluate the potential risks to human health and the environment from the manufacture, distribution in commerce, processing, use, or disposal of the chemical substances covered by the test rule.¹⁰⁷

EPA has developed testing guidelines for chemical fate, environmental effects, and health effects testing.¹⁰⁸ These guidelines include approximately 100 different tests in the areas of: physical and chemical properties; environmental transport processes; environmental transformation processes (biodegradation under various conditions, hydrolysis, and photolysis); aquatic toxicity; terrestrial toxicity (avian and plant toxicity tests); acute, subchronic, and chronic toxicity; oncogenicity; genetic toxicity; neurotoxicity; and metabolism.

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When promulgating a test rule or negotiating a testing consent agreement, the Agency typically will use these guidelines as the basis for developing specific test standards for the chemicals or mixtures to be tested. The Agency also may consider using other established testing guidelines, including testing guidelines developed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),¹⁰⁹ and testing guidelines developed by the Organization for Economic Cooperation and Development.¹¹⁰

The test methodologies that may be prescribed in test standards include serial or hierarchical tests, in vitro tests, whole animal tests, and epidemiologic studies, but in the case of epidemiologic studies of employees, EPA is required to consult with the National Institute for Occupational Safety and Health.¹¹¹

4. Persons Subject to Testing Requirements

Depending on the specific findings made to support a test rule, EPA may require manufacturers and/or processors to conduct the required testing themselves.¹¹² Regulations governing the implementation of test rules require the Agency to specify in each test rule whether manufacturers, processors, or both are subject to the testing requirements.¹¹³

Manufacturers generally are subject to testing requirements whenever the testing is being required to allow evaluation of risks that are primarily associated with manufacture of the chemical, associated with both manufacture and processing of the chemical, or associated with distribution in commerce, use, and/or disposal activities concerning the chemical.¹¹⁴

The Agency also has the authority to impose testing requirements on processors in the first two circumstances listed. However, the § 4 regulations provide that processors typically will be subject to testing requirements under these circumstances only if no manufacturer submits a notice of intent to conduct the required testing.¹¹⁵ Processors also will be subject to testing requirements if the testing is being required to allow evaluation of risks associated solely with processing of the chemical.¹¹⁶

Facilities that manufacture less than 500 kilograms (kg) (1,100 lbs.) of a test chemical annually, or that manufacture small quantities of the chemical solely for research and development, typically will not be required to conduct testing or submit data under a test rule.¹¹⁷ These facilities must comply with the requirements of a test rule only if directed to do so in a particular test rule, or if directed to do so in a separate Federal Register notice (when no other manufacturer has filed a notice of intent to conduct the required testing). If testing is being required to allow evaluation of risks associated primarily with manufacture of a chemical for research and development purposes, manufacturers of the chemical for these purposes will be subject to the testing requirements of the test rule.

C. Selection of Specific Chemicals for Testing

TSCA § 4(e) establishes a committee, known as the Interagency Testing Committee (ITC), to identify chemical substances and mixtures to which EPA should give priority consideration for promulgation of test rules.¹¹⁸ Additionally, the Agency on its own initiative actively reviews chemicals for possible testing needs. The following sections describe the role of the ITC's and EPA's chemical screening activities.

1. Role of the Interagency Testing Committee (ITC)

By statute, the ITC must consist of eight members, including one member appointed by each of the following: EPA, the Department of Labor, the Council on Environmental Quality, the National Institute for Occupational Safety and Health, the National Institute of Environmental Health Sciences, the National Cancer Institute, the National Science Foundation, and the Department of Commerce.¹¹⁹

Except for the EPA appointment, appointments must be made from among the officers and employees of each entity,¹²⁰ and no individual may serve on the ITC for more than four years in the aggregate.¹²¹ To guard against possible conflicts of interest, no member of the ITC may accept employment or compensation from any person subject to any requirement under TSCA, including any rule or order issued under § 4, for a period of at least 12 months after termination of service on the committee.¹²² Additionally, while serving on the committee, members may not own any stocks or bonds or have any pecuniary interest of substantial value in any person engaged in the manufacture, processing, or distribution in commerce of any chemical substance or mixture subject to any requirement of TSCA or any rule or order issued thereunder.¹²³

Several liaison organizations also participate in ITC deliberations. These organizations include the Agency for Toxic Substances and Disease Registry, the Consumer Product Safety Commission, the Department of Agriculture, the Department of Defense, the Department of Interior, the Department of Transportation, the Food and Drug Administration, the National Library of Medicine, the National Toxicology Program, and the International Trade Commission.¹²⁴

When making chemical testing recommendations, the ITC is directed to consider all relevant factors, including:

* the production volume;

* the quantities released to the environment;

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* the number of workers who are exposed and the duration of such exposure;

* the extent to which other persons are exposed to the substance or mixture;

* the extent to which the chemical is closely related to a chemical that is known to present an unreasonable risk of injury to health or the environment;

* the existence of data concerning the effects of the chemical on health or the environment;

* the extent to which testing of the chemical may result in the development of data upon which the effects of the chemical on health or the environment can reasonably be determined or predicted; and

* the reasonably foreseeable availability of facilities and personnel for performing testing on the chemical.¹²⁵

The ITC is directed to present its recommendations to EPA in the form of a list of chemical substances and mixtures set forth in the order in which the ITC determines EPA should take action under § 4. In establishing the list, the ITC must give priority attention to those chemicals and mixtures that are suspected of causing or contributing to cancer, gene mutations, or birth defects.¹²⁶

The ITC also is directed to "designate" chemical substances and mixtures on the list with respect to which the committee determines EPA should initiate a § 4(a) rulemaking proceeding. The total number of chemical substances and mixtures on the list that are designated may not exceed 50. EPA must respond to any such designation within 12 months by initiating a rulemaking proceeding under § 4(a), or by publishing in the Federal Register the Agency's reasons for not initiating such a proceeding.¹²⁷

The ITC was required to send its initial list and designations to EPA no later than September 30, 1977. The ITC must send revised lists to EPA every six months. EPA is obligated to publish each ITC report in the Federal Register, and to provide interested parties with an opportunity to submit written comments.¹²⁸

Since 1985, the ITC's practice has been to divide recommended chemicals into three categories: chemicals designated for priority consideration within 12 months; chemicals recommended with notice of intent to designate; and chemicals recommended without notice of intent to designate.¹²⁹

Though not expressly contemplated by § 4(e), the second category -- chemicals recommended with notice of intent to designate -- is a useful device for facilitating EPA review of priority chemicals identified by the ITC. Use of this category allows the ITC to identify chemicals and mixtures for priority testing consideration without subjecting EPA to the 12-month statutory deadline for taking action. As explained below, EPA has developed special procedures for responding to ITC recommendations with notice of intent to designate. The ITC's procedures and criteria for screening chemicals are described further in the ITC's Thirty-First Report.¹³⁰

2. Other Methods for Selection of Chemicals

In addition to receiving testing recommendations from the ITC, EPA also has an active program to identify the chemical testing needs of federal agencies. This program is centered in the Existing Chemicals Program of the Office of Pollution Prevention and Toxics (OPPT). Since about 1991, EPA has been using a Master Testing List (MTL) to set its chemical testing agenda.¹³¹

The current MTL contains 165 chemicals and nine chemical categories. Many of these chemicals have been recommended for testing by EPA program offices other than OPPT, including the Office of Air and Radiation and the Office of Water, and also by federal agencies outside EPA, including the Agency for Toxic Substances and Disease Registry and the Consumer Product Safety Commission. Additionally, 159 of the chemicals currently on the MTL are being tested under the Screening Information Data Set program, an international voluntary testing program under the auspices of the Organization of Economic Cooperation and Development.

OPPT previously has promulgated test rules under TSCA § 4 to fill data needs identified by other EPA program offices. For example, in 1988, EPA required chemical fate, hydrolysis, and health effects testing of 23 chemicals identified by the Office of Solid Waste.¹³² Additional information concerning OPPT's efforts to identify priority chemical testing needs is presented in the MTL.

D. Negotiation of Testing Consent Agreements

TSCA § 4 expressly contemplates that testing shall be required "by rule," and that test rules shall be promulgated pursuant to rulemaking proceedings conducted in a manner consistent with the requirements of § 553 of the Administrative Procedure Act.¹³³ EPA has determined, however, that it has implied authority to enter into enforceable testing consent agreements where such agreements provide procedural safeguards equivalent to those that apply where testing is conducted by rule.¹³⁴

Based on this authority, the Agency has indicated that it prefers to use enforceable consent agreements to accomplish testing where a consensus exists among EPA, affected manufacturers and/or processors, and interested members of the public concerning the need for and scope of testing.¹³⁵ The Agency has promulgated detailed procedures for conducting negotiations and developing testing consent agreements under § 4.¹³⁶ These procedures are described below; the Agency's use of voluntary testing programs during the early years of TSCA implementation is described first.

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1. Early Use of Voluntary Testing Programs

When EPA began to implement § 4 testing programs, it had difficulty meeting the statutory 12-month deadline for responding to ITC designations of chemicals for priority testing under § 4(e), and several such deadlines were missed. The Natural Resources Defense Council (NRDC) initiated a legal action to compel EPA to meet the statutory deadlines, resulting in a court order imposing a schedule for responding to several ITC reports.¹³⁷

EPA attempted to comply with the court order by negotiating voluntary testing agreements with chemical manufacturers. This approach offered the Agency greater flexibility in negotiating testing programs, and required fewer agency resources and less time to complete. However, this approach did not comport with the statutory requirement that testing requirements be developed pursuant to formal rulemaking proceedings. Thus, the "Negotiated Testing Program" prompted a second legal challenge by NRDC, and the use of voluntary testing agreements was declared unlawful.¹³⁸

Following the second court ruling, EPA, NRDC, and the Chemical Manufacturers Association worked together to develop regulations that would permit testing to be conducted under legally enforceable consent agreements. These regulations are described below.

2. Procedures for Negotiating Testing Consent Agreements

Following receipt of an ITC report in which chemicals are recommended for testing with notice of intent to designate, the regulations call upon EPA to use the following procedures for completing a preliminary evaluation of testing needs:

When EPA reaches a preliminary conclusion that testing is necessary, the Agency will explore whether a consent agreement can be negotiated. EPA has stated that it will use the following procedures for negotiating, formulating, and accepting consent agreements:

* In the initial Federal Register notice announcing the ITC's testing recommendations, the Agency will explain its procedures and timetable for negotiating consent agreements, and invite interested persons to identify themselves.

* Persons who respond to EPA's notice before the Agency's course-setting meeting will be deemed "interested parties" for purposes of the negotiations.

* Following the course-setting meeting announcing EPA's preliminary testing determinations, the Agency will meet with manufacturers, processors, and other interested parties for the purpose of attempting to negotiate a consent agreement.

* All negotiation meetings will be open to members of the public, and minutes of each meeting will be prepared by EPA.

* EPA will circulate meeting minutes, testing proposals, and other relevant materials to all interested parties.

* EPA will terminate negotiations after 10 weeks and proceed with rulemaking unless negotiations are likely to result in a draft consent agreement within four additional weeks. By the end of this four-week period, EPA either will have prepared a draft consent agreement reflecting the apparent consensus of the parties, or will terminate negotiations and proceed with rulemaking.

* In cases in which EPA prepares a draft consent agreement, it will be circulated to all interested parties, and a period of four weeks will be provided for submitting comments or written objections.

* If necessary, EPA will hold a public meeting to discuss comments on the draft consent agreement and to determine whether revisions in the agreement are appropriate.

* Where a consensus exists concerning the contents of a draft consent agreement, it will be circulated to EPA management and interested parties for final approval and signature.

* Upon final approval of a consent agreement, EPA will publish a Federal Register notice that summarizes the agreement, describes the ITC recommendations for the test substance, outlines the chemical's use and exposure characteristics, and explains the background, objectives, and rationale of the testing to be conducted.¹⁴⁰

The deadlines stated in the regulations for various steps in the information gathering and negotiation processes represent "target dates" that EPA tries to meet. In practice, the gathering of information and negotiation of consent agreements frequently takes much longer than EPA's schedule would indicate.

[24 ELR 10297]

The regulations do not specify detailed procedures or schedules for gathering information and negotiating testing consent agreements with respect to chemicals recommended by the ITC without notice of an intent to designate, or with respect to chemicals identified for testing consideration by OPPT. However, if EPA wishes to initiate negotiations concerning such chemicals, it typically publishes a Federal Register notice that describes the Agency's tentative evaluation of testing needs, announces a date for a public course-setting meeting, and invites interested persons to identify themselves and participate.¹⁴¹ Any negotiations the Agency conducts will conform to the procedures outlined above.¹⁴² To the extent feasible, the negotiations also will follow the preliminary evaluation schedule set forth in 40 C.F.R. Part 790, Appendix A, and described above.¹⁴³

3. Criteria for Determining Whether a Consensus Exists

EPA will not enter into a consent agreement in either of the following circumstances: (1) EPA and the affected manufacturers and/or processors cannot reach a consensus on the testing requirements or other provisions to be included in the consent agreement; or (2) the draft consent agreement is considered inadequate by other interested parties who have submitted timely written objections.¹⁴⁴

EPA may reject objections raised by other interested parties if the objections: (1) are not made in good faith; (2) are untimely; (3) do not involve the adequacy of the proposed testing program or other features of the agreement that may affect EPA's ability to fulfill the goals and purposes of TSCA; or (4) are not accompanied by a specific explanation of the grounds on which the draft consent agreement is considered objectionable.¹⁴⁵

The unwillingness of some manufacturers or processors to sign a consent agreement will not necessarily establish a lack of consensus. If EPA determines that the manufacturers or processors who are prepared to sign the agreement are capable of accomplishing the testing to be required, and that the consent agreement will achieve the purposes of the Act in all other respects, the Agency will go forward with testing under a consent agreement.¹⁴⁶

4. Terms of Testing Consent Agreements

To ensure that testing consent agreements provide procedural safeguards equivalent to those that apply to test rules, EPA has prescribed a list of provisions that must be included in each consent agreement.¹⁴⁷ These mandatory provisions include:

* a requirement that testing will be conducted in accordance with the EPA good laboratory practice regulations;¹⁴⁸

* schedules with reasonable deadlines for submitting interim progress and/or final reports to EPA;

* a requirement that the principal sponsor will submit a study plan to EPA in accordance with 40 C.F.R. § 790.62;

* a statement that the results of testing conducted pursuant to the consent agreement will be announced to the public in accordance with the procedures specified in § 4(d) of TSCA, and that the disclosure of data generated by such testing will be governed by § 14(b) of TSCA;

* a requirement that the manufacturers and/or processors signing the consent agreement will comply with the export notification requirements of § 12(b)(1) of TSCA … and a statement that any other person who exports or intends to export the test substance or mixture also is subject to the export notification requirements;

* a requirement that, in the event EPA promulgates a SNUR applicable to the test chemical under § 5(a)(2), the consent agreement will have the status of a test rule for purposes of § 5(b)(1)(A) and manufacturers and/or processors signing the agreement will comply with the data submission requirements imposed by that provision;

* a statement that each manufacturer and/or processor signing the agreement agrees that violation of its requirements will constitute a "prohibited act" under § 15(1) of TSCA and will trigger all provisions of TSCA applicable to a violation of § 15; and

* a statement that EPA may conduct laboratory inspections and/or study audits of the testing being conducted pursuant to the consent agreement in accordance with the authority and procedures contained in TSCA § 11.¹⁴⁹

5. Publication of Testing Consent Agreements

When EPA enters into a testing consent agreement, a notice is published in the Federal Register summarizing the testing requirements and supporting rationale.¹⁵⁰ Additionally, all consent agreements are codified at 40 C.F.R. Part 799, Subpart C. As of July 1, 1992, EPA had entered into enforceable consent orders requiring testing for 34 substances.¹⁵¹

E. Development of Test Rules

In cases in which EPA determines that consensus cannot be reached among EPA itself, affected manufacturers and processors, and other interested parties concerning the testing requirements or other provisions of a draft consent agreement, and it believes that the findings required by § 4(a) for a test rule can be made, the Agency will initiate [24 ELR 10298] rulemaking proceedings to promulgate a test rule.¹⁵² In some cases, EPA may proceed directly to a rulemaking without first exploring the possibility of negotiating a consent order. In particular, the Agency frequently will use immediate rulemaking proceedings for chemicals designated by the ITC, because the 12-month statutory deadline for responding to such designations does not leave much time to develop a testing proposal if consent order negotiations are unsuccessful.

Test rules issued under § 4(a) must be promulgated in a manner consistent with § 553 of the Administrative Procedure Act, subject to the following additional requirements: (1) EPA must give interested persons an opportunity for oral presentation of data and arguments, in addition to an opportunity to make written submissions; (2) a transcript shall be made of any oral presentation; and (3) EPA must make and publish with the final rule the specific findings required by § 4(a).¹⁵³

EPA has promulgated regulations governing the development of test rules.¹⁵⁴ These regulations provide for single-phase and two-phase rulemaking procedures. The latter procedures are appropriate when the Agency proposes testing for which suitable study protocols or testing guidelines are not already available. In practice, EPA rarely uses the two-phase rulemaking procedures. Both sets of procedures are described below.

1. Single-Phase Test Rule Development

Under single-phase test rule development, EPA will promulgate a test rule through a notice-and-comment rulemaking procedure that specifies the following:

identification of the chemical for which testing is required;

the health or environmental effects for which testing is being required;

which test substance(s) must be tested;

standards for the development of test data;

the EPA good laboratory practice requirements for the required testing;

a schedule for submission of interim reports and/or final reports to EPA;

who must submit either letters of intent to conduct testing or exemption applications; and

what types of data EPA will examine in determining equivalence if more than one test substance is to be tested.¹⁵⁵

In most cases, EPA will initiate rulemaking proceedings by publishing a proposed test rule in the Federal Register. However, the Agency has stated that when the ITC's testing recommendations raise "unusually complex and novel issues," the Agency may publish an advance notice of proposed rulemaking (ANPR).¹⁵⁶ For ITC-designated chemicals, publication of an ANPR will satisfy the Agency's obligation to initiate rulemaking proceedings within 12 months of receipt of the ITC designation.¹⁵⁷

2. Two-Phase Test Rule Development

Under two-phase test rule development, EPA first promulgates a Phase I test rule. This test rule will include all the provisions described above for single-phase test rules, except that instead of prescribing specific test standards, the Phase I test rule only identifies guidelines for the development of test data.¹⁵⁸ Specific test standards and schedules are developed in a second phase of rulemaking, through the submission of proposed study plans by test sponsors.¹⁵⁹ Once test standards and schedules for all required tests have been developed and incorporated in approved study plans, a Phase II test rule is promulgated.

3. Publication of Test Rules

All final test rules are published in the Federal Register and are accompanied by a detailed preamble that explains the Agency's rationale for its testing decisions and responds to public comment. Additionally, all final test rules are codified in 40 C.F.R. Part 799, Subpart B (specific chemical test rules) or Subpart D (multichemical test rules). As of July 1, 1992, the Agency had promulgated 29 specific chemical test rules (in some cases requiring testing of more than one chemical), and one multichemical test rule requiring testing of 23 substances.¹⁶⁰

F. Complying With Test Rules and Consent Agreements

Because testing consent agreements contain provisions intended to ensure that the agreements provide procedural safeguards equivalent to those that apply to test rules,¹⁶¹ testing under consent agreements is conducted in much the same way as it is under § 4 test rules. Notable exceptions are that under a consent agreement, test sponsors are not required to submit letters of intent to test or applications for exemptions -- instead, signing the consent agreement constitutes the binding commitment of each test sponsor --and test sponsors are not entitled to receive compensation from manufacturers or processors of the test chemicals who do not participate in the testing. The following sections summarize the principal obligations of test sponsors conducting testing under consent orders and test rules.

1. Submission of Letter of Intent to Conduct Testing

Within 30 days after the effective date of a test rule, each person subject to the rule and required to comply with the testing requirements must, for each test required, submit to EPA either a letter of intent to conduct the testing or an [24 ELR 10299] application for an exemption.¹⁶² Each letter of intent to conduct testing must include:

identification of the test rule;

name, address, and telephone number of the firm(s) that will be sponsoring the tests;

name, address, and telephone number of the appropriate individual to contact for further information;

for sponsors participating in a testing consortium, a list of all members of the consortium, the signature of an authorized representative of each member, and a designation of who is to serve as principal sponsor;

a list of the testing requirements for which the sponsor(s) intends to conduct tests; and

if EPA is requiring testing of more than one representative substance, which test substance the sponsor(s) intends to use in each of the tests.¹⁶³

2. Procedure Where No Letter of Intent to Conduct Testing Is Submitted

EPA has promulgated procedures to address situations in which no person subject to a test rule submits a letter of intent within the required time period. The procedures vary depending on whether the test rule applies to manufacturers, processors, or both.¹⁶⁴

a. Procedure Where Only Manufacturers Are Subject to the Test Rule

If testing is being required solely to evaluate the risks associated with manufacturing activities, and no manufacturer submits a letter of intent to conduct testing within 30 days after the effective date of the test rule, EPA will notify all manufacturers of this fact and give them an opportunity to take corrective action.¹⁶⁵ The notice will be provided by certified mail or publication in the Federal Register, will specify the tests for which no letter of intent has been submitted, and will be sent or directed to all manufacturers, including facilities that manufacture the test chemical in small quantities (less than 500 kg per year) or solely for research and development.¹⁶⁶ If no manufacturer submits a letter of intent to conduct testing within 30 days after receipt of the certified letter or publication of the Federal Register notice, all manufacturers subject to the rule will be deemed to be in violation of the test rule.¹⁶⁷

b. Procedure Where Both Manufacturers and Processors Are Subject to the Test Rule

If testing is being required to evaluate risks associated with manufacturing and processing activities or with distribution in commerce, use, or disposal of the test substance, and the test rule states that manufacturers and processors are responsible for testing, and no manufacturer subject to the rule submits a letter of intent to conduct testing within 30 days after the effective date of the test rule, then EPA will publish a notice in the Federal Register specifying the tests for which no letter of intent has been submitted.¹⁶⁸ Within 30 days after publication of the Federal Register notice, each facility that manufactures the test substance in small quantities (less than 500 kg per year) or solely for research and development purposes, and each facility that processes the subject chemical, must submit either a letter of intent to conduct testing or an application for an exemption.¹⁶⁹ If no manufacturer or processor of the test chemical submits a letter of intent to conduct one or more of the required tests within 30 days, EPA will notify all manufacturers and processors of this fact by certified letter or Federal Register notice and give them 30 days to take corrective action.¹⁷⁰ If no manufacturer or processor responds within 30 days by submitting a letter of intent to conduct the required tests, all manufacturers and processors subject to the rule will be deemed to be in violation of the test rule.¹⁷¹

c. Procedure Where Only Processors Are Subject to the Test Rule

If testing is being required solely to allow evaluation of risks associated with processing activities, and no processor submits a letter of intent to conduct one or more of the required tests within 30 days after the effective date of the test rule, then EPA will notify all processors of this fact by certified mail or publication of a Federal Register notice specifying the tests for which no letter of intent has been submitted.¹⁷² If no processor submits a letter of intent to conduct the required tests within 30 days after receipt of the certified letter or publication of the Federal Register notice, all processors subject to the rule will be deemed to be in violation of the test rule.¹⁷³

3. Submission of Study Plans

Test sponsors acting under a single-phase test rule or a testing consent agreement must submit a study plan for each test prior to the initiation of the test, unless directed by a particular test rule or consent agreement to submit study plans at a specific time.¹⁷⁴ In the case of a two-phase test rule, the study plans must be submitted within 90 days after the effective date of the Phase I rule.¹⁷⁵

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Study plans must be prepared in accordance with EPA good laboratory practice requirements,¹⁷⁶ and must contain the following information:

* identity of the test rule or consent agreement;

* the specific test requirements to be covered by the study plan;

* the names and addresses of the test sponsors;

* the names, addresses, and telephone numbers of the responsible administrative officials and project managers in the principal sponsor's organization;

* the name, address, and telephone number of the appropriate individual to contact for oral and written communications with EPA;

* the names and addresses of the testing facilities and the names, addresses, and telephone numbers of the testing facilities' administrative officials and project managers responsible for the testing;

* brief summaries of the training and experience of each professional involved in the study;

* identity of and data on the chemical substances being tested;

* a detailed study protocol for each test; and

* the test schedule and dates for submission of interim and final reports.¹⁷⁷

EPA will review each study plan to determine whether it includes all required information.¹⁷⁸ The submitter will be given 15 days to remedy any deficiencies.¹⁷⁹ EPA will not review the detailed study protocol to determine if it meets all the mandatory requirements of the test standard specified in the test rule, but places this burden on the submitter.¹⁸⁰

In the case of a two-phase test rule, if EPA determines that the proposed study plan is complete, the Agency will publish a proposed Phase II test rule in the Federal Register and solicit public comment.¹⁸¹ After considering any written or oral comments on the proposed study plan, the Agency will adopt the test protocol portion of the study plan, as proposed or as modified in response to agency review and public comments, as the test standard for the required testing in a final Phase II test rule.¹⁸² The Agency also will adopt the proposed or a modified test schedule as the schedule for the required testing.¹⁸³

4. Submission of Interim and Final Reports

Whether testing is conducted under a test rule or a consent agreement, test sponsors will be required to submit interim progress reports as well as final study reports. Interim progress reports typically must be submitted every six months, starting six months after the effective date of the test rule or consent agreement.¹⁸⁴ Each test will be assigned its own deadline for the submission of a final study report, based on what the Agency believes is a reasonable amount of time to conduct the test and prepare a final report.

5. Modification of Test Standards and Test Schedules

In cases in which a test sponsor wishes to modify a test schedule or a mandatory testing requirement (a "shall statement") in a test standard, the test sponsor must submit an application to the Office of Compliance Monitoring.¹⁸⁵ The application must include an appropriate explanation and rationale for the requested modification. Where a test sponsor has requested that EPA provide guidance or clarify a nonmandatory testing requirement (a "should statement") in a test standard, the test sponsor must submit its request to the TSCA Document Processing Center, with a copy of the cover memorandum sent to the Office of Compliance Monitoring.¹⁸⁶

If EPA determines that the requested modification of a test standard or schedule would "significantly alter the scope of the test or significantly change the schedule for completing the test," EPA will provide an opportunity for public comment.¹⁸⁷ A requested modification of a test standard or schedule will be deemed to alter the scope of the test or significantly change the schedule for completing the test if the modification would: change the test species; change the route of administration of the test chemical; change the period of time during which the test species is exposed to the test chemical; or extend the final reporting deadline more than 12 months from the date specified in the final rule.¹⁸⁸

EPA will approve a requested modification without first seeking public comment if an immediate modification to the test standard is necessary to preserve the accuracy or validity of an ongoing test.¹⁸⁹ EPA also may modify a testing requirement in a test standard if EPA determines that achievement of the requirement is not technically feasible.¹⁹⁰ Additionally, EPA may approve a test schedule extension exceeding 12 months without first seeking public comment if the Agency determines that the delay is not the fault of the test sponsor and is the result of unforeseen circumstances, such as a lack of laboratory availability or the unexpected failure of a long-term test.¹⁹¹

An application for a test schedule modification should be submitted at least 60 days before the reporting deadline [24 ELR 10301] in question.¹⁹² EPA normally will not approve any request for an extension submitted less than 30 days before the reporting deadline.¹⁹³ Test sponsors are directed to submit requests for test standard modifications as soon as they determine that the test cannot be successfully completed according to the test standard specified in the rule.¹⁹⁴

The regulations governing requests for modifications to testing consent agreements are similar to the provisions governing requests for modifications to test rules.¹⁹⁵ However, the regulations governing testing consent agreements include additional provisions to address situations in which manufacturers, processors, or other interested parties request modifications to the scope of testing to be performed under the consent agreement.¹⁹⁶

After reviewing such a request, if EPA determines that new issues have been raised that may warrant reconsideration of the scope of testing, it will publish a notice in the Federal Register and invite public comment.¹⁹⁷ Based on the comments received, the Agency may reopen negotiations, following the procedures specified in 40 C.F.R. § 790.22(b). The scope of testing will be modified only if a consensus can be reached among EPA, affected manufacturers and processors, and other interested parties.¹⁹⁸ If a consensus cannot be reached and EPA believes that testing beyond what is contained in the consent order should be required, it may initiate a rulemaking proceeding.¹⁹⁹ The testing requirements in the consent agreement will remain in effect during the rulemaking proceeding, except to the extent EPA determines that consent order testing may be unnecessary in light of the testing requirements that may be imposed by test rule.²⁰⁰

6. Submission of Information to EPA

The procedures governing testing consent agreements and test rules include requirements pertaining to the submission of information. Most of these requirements are found at 40 C.F.R. § 790.5 (general requirements) and § 790.7 (provisions pertaining to submission of confidential information). Additional requirements are included in specific provisions governing various aspects of compliance with the test rules and consent orders. Test sponsors should review applicable regulations carefully before making any submissions to EPA under a test rule or consent order.

Any information claimed as confidential will be treated in accordance with the procedures in TSCA § 14 and the applicable regulations.²⁰¹ A claim of confidentiality must be made at the time the information is submitted, and may be asserted by circling or otherwise marking the information claimed as confidential and designating it with the words "confidential business information," "trade secret," or other appropriate phrase indicating its confidential character.²⁰² A claim of confidentiality for study plan information must be substantiated by answering specific questions set forth in the regulations.²⁰³

7. Good Laboratory Practice (GLP) Standards

EPA has promulgated good laboratory practice (GLP) standards at 40 C.F.R. Part 792 "to ensure the quality and integrity of data submitted pursuant to testing consent agreements and test rules issued under section 4."²⁰⁴ Any person who submits to EPA a test required by a testing consent agreement or test rule issued under § 4 must certify that the study was conducted in accordance with GLP standards, or describe all differences between the practices used in the study and those required by GLP standards.²⁰⁵

GLP standards include specific requirements for test sponsors and testing facilities in each of the following areas: organization and personnel (Subpart B); physical plant and equipment (Subparts C and D); standard operating procedures for testing facilities (Subpart E); characterization and handling of test substances (Subpart F); protocol for and conduct of a study (Subpart G); and recordkeeping and preparation of reports (Subpart H). EPA has authority to inspect testing facilities and audit test data to determine if studies have been conducted in compliance with the GLP standards.²⁰⁶ Such GLP audits are conducted by EPA on a routine basis. If a testing facility refuses to permit a GLP audit, data developed by the facility will not be considered "reliable for purposes of showing that a chemical substance or mixture does not present a risk of injury to health or the environment."²⁰⁷

Failure to comply with GLP standards can lead to serious consequences for test sponsors. A test sponsor may be found in violation of § 15 of TSCA if: (1) the test was not conducted in accordance with GLP standards; (2) data or information submitted to EPA are false or misleading, contain significant omissions, or otherwise do not fulfill the requirements of GLP standards; or (3) entry to conduct an audit of test data or testing facilities is denied.²⁰⁸ Violations of GLP standards can lead to civil or criminal penalties under § 16 of TSCA, legal action in United States District Court under § 17 of TSCA, or criminal prosecution under 18 U.S.C. § 2 or 18 U.S.C. § 1001.²⁰⁹

As is the case when a testing facility refuses to permit a GLP inspection, EPA may, at its discretion, decide not to consider any study that was not conducted in accordance with GLP standards reliable for purposes of showing that a chemical does not present a risk of injury to health or the environment.²¹⁰ EPA may rely upon such studies, however, for purposes of showing adverse effects.²¹¹ Additionally, if test data submitted under a [24 ELR 10302] test rule or consent order are not developed in accordance with GLP standards, EPA may determine that the test sponsor has not fulfilled its obligations under § 4 and may require that the testing be repeated.²¹²

G. Exemptions From Test Rules and Cost Reimbursement Provisions

TSCA § 4(c) provides that any person required by a test rule to conduct tests and submit data may apply to EPA for an exemption from the rule.²¹³ Persons who are granted an exemption will be obligated to provide "fair and equitable" reimbursement to other persons who bear the costs of conducting the tests and submitting the data.²¹⁴ EPA has promulgated detailed regulations governing applications for exemptions from test rules and cost reimbursement.²¹⁵ A summary of these rules is set forth below.

1. Exemptions From Test Rules

Any manufacturer or processor subject to a test rule may submit an application for an exemption from performing any or all of the tests required under the test rule.²¹⁶ In most cases, only manufacturers are required to submit a notice of intent to test or to seek an exemption. Processors, facilities that annually manufacture less than 500 kg (1,100 lbs.) of a test substance, and facilities that manufacture small quantities solely for research and development are required to file notices of intent to test or applications for exemptions only if they are specifically directed to do so in a particular test rule or a Federal Register notice issued pursuant to 40 C.F.R. § 790.48(b)(2).²¹⁷

Exemption applications must be filed within 30 days after the effective date of the test rule or, if being submitted in compliance with a Federal Register notice published under 40 C.F.R. § 790.48(b)(2), within 30 days after publication of that notice.²¹⁸ A person who begins manufacturing or processing activities after the effective date of the test rule must submit an exemption application before such manufacturing or processing activities are begun.²¹⁹

An exemption application must contain the following information:

the identity of the test rule, the chemical identity, and the CAS number of the test substance on which the application is based;

the specific testing requirement from which an exemption is sought and the basis for the exemption request;

name, address, and telephone number of the applicant;

name, address, and telephone number of an appropriate individual to contact for further information;

and

if it is required in the test rule to establish equivalence: (1) the chemical identity of the test substance on which the application is based; and (2) the equivalence data specified in 40 C.F.R. § 790.85.²²⁰

If a test rule requires the testing of two or more test substances that are forms of the same chemical, the exemption application must include detailed information concerning the chemical identity of the substance manufactured or processed by the applicant.²²¹ The exact type of identifying data required will be specified in the test rule, but could include boiling point, melting point, chemical analysis (including identification and amount of impurities), additives, spectral data, and other physical or chemical information that may be relevant in determining whether the applicant's substance is equivalent to the specific test substance.²²²

Submission of equivalence data is not required when a test rule requires testing of a single representative substance. Under these circumstances, EPA will consider all forms of the chemical subject to the test rule to be equivalent.²²³

Each applicant for an exemption also must submit the following sworn statement with his or her application:

I understand that if this application is granted before the reimbursement period described in section 4(c)(3)(B) of TSCA expires, I must pay fair and equitable reimbursement to the person or persons who incurred or shared in the costs of complying with the requirement to submit data and upon whose data the granting of my application was based.²²⁴

EPA will conditionally approve an exemption application if: (1) the chemical substance or mixture with respect to which the application was submitted is equivalent to a test substance or mixture for which the required data have been submitted to EPA or are being developed under a § 4 test rule; and (2) submission of the required test data concerning that chemical substance or mixture would be duplicative of data that have been submitted or are being developed under a test rule.²²⁵

EPA may deny an exemption application if it determines that the application fails to meet either of these requirements for approval, or if the test sponsors have failed to perform any of their obligations under the test rule.²²⁶ EPA will notify the applicant of the denial by certified mail or Federal Register notice,²²⁷ after which the applicant will have 30 days to file an appeal.²²⁸ The Agency is required to notify the applicant of its final decision within 60 days after receipt of the appeal, or within 60 days after completion of any hearing.²²⁹ The filing of an appeal from the denial of an exemption does not act to stay the applicant's legal obligations under a test rule.²³⁰

[24 ELR 10303]

All approvals for exemption applications are conditional, in that they are expressly contingent upon the test sponsors' successful completion of testing according to specifications in the test rule.²³¹ EPA may terminate a conditional exemption if: (1) the test sponsors have not initiated testing by the deadlines established in the test rule; (2) data required by the test rule have not been generated in accordance with the test standards or submitted on time; or (3) testing has not been conducted in accordance with GLP requirements.²³² If EPA decides that one of the criteria for termination of a conditional exemption has been met, it will notify exemption holders by certified mail or Federal Register notice of the Agency's intent to terminate the conditional exemptions.²³³ Exemption holders will have 30days to submit information to rebut the Agency's preliminary decision, or to submit a letter of intent to conduct the required tests; the exemption holders also may request a hearing.²³⁴ Exemption holders will be notified by certified mail or Federal Register notice of the Agency's final decision.²³⁵

2. Cost Reimbursement

The Agency has promulgated detailed procedures and criteria for determining fair and equitable amounts of reimbursement for testing costs incurred under § 4(a).²³⁶ These provisions take effect only when private efforts to agree upon fair terms for reimbursement have failed and one or more of the parties requests EPA's assistance.²³⁷

Procedures for the conduct of hearings to resolve cost reimbursement disputes are set forth in 40 C.F.R. Part 791, Subpart B. A reimbursement proceeding may be initiated by filing a request for a hearing with a regional office of the American Arbitration Association and mailing a copy of the request to EPA and each person from whom reimbursement is sought.²³⁸ The hearing procedures include representation by legal counsel (if desired) at a hearing and presentation of sworn testimony with opportunity for cross-examination by opposing parties.²³⁹ The award shall be made promptly by the hearing officer and, unless otherwise agreed by the parties, no later than 30 days from the date of closing the hearing.²⁴⁰

Criteria to be used by the hearing officer to determine a fair and equitable amount of reimbursement are set forth in 40 C.F.R. Part 791, Subpart C. The regulations establish a presumption in favor of allocating testing costs based on production volume.²⁴¹ The hearing officer has discretion to modify the formula, or to use some other basis for allocation, if necessary. Additional factors that may be taken into account include, but are not limited to, the relative amounts of exposure attributable to each manufacturer and the effect of the reimbursement share on its competitive position.²⁴²

All costs reasonable and necessary to comply with a test rule are eligible for reimbursement, including: (1) direct and indirect costs of planning, conducting, analyzing and submitting the test results to EPA; (2) a reasonable profit, and a reasonable rate of interest and depreciation on the tester's initial capital investment; and (3) the cost of repeating tests where failure was demonstrably due to some cause other than negligence of the tester.²⁴³

Processors generally will be deemed to have fulfilled their testing and reimbursement responsibilities indirectly, through higher prices passed on by the manufacturers.²⁴⁴ Processors will have a responsibility to provide reimbursement to those paying for the testing under three circumstances:

when a test rule or subsequent Federal Register notice pertaining to a test rule expressly obligates processors as well as manufacturers to assume direct testing and data reimbursement responsibilities;

when one or more manufacturers demonstrate to the hearing officer that it is necessary to include processors in order to provide fair and equitable reimbursement in a specific case; or

when one or more processors voluntarily agree to reimburse manufacturers for a portion of test costs, in which case only those processors who volunteer will incur the obligation.²⁴⁵

The regulations do not establish any preferred basis for allocating testing costs among processors and manufacturers. They provide only that when processors as well as manufacturers are required to provide reimbursement, the hearing officer will decide in each case how the reimbursement should be allocated among the participating parties.²⁴⁶ When a test rule is applicable solely to processors, the hearing officer is directed to apportion testing costs based on the amount of the test chemical purchased or processed.²⁴⁷

The hearing officer's proposed order shall become final unless one of the parties requests agency review within 30 days.²⁴⁸ The final order shall be considered final agency action for purposes of judicial review.²⁴⁹ Failure to pay amounts awarded under Subpart 791 within the time allotted in the final order shall constitute a violation of TSCA § 15, for which penalties may be assessed.²⁵⁰

[24 ELR 10304]

H. Judicial Review

Any person may file a petition under TSCA § 19(a)(1)(A) for judicial review of a § 4 test rule.²⁵¹ There is no requirement that the petitioner be subject to or adversely affected by the test rule, nor must the petitioner have participated in the rulemaking proceedings. The petition may be filed with the United States Court of Appeals for the District of Columbia Circuit or for the circuit in which the petitioner resides or has its principal place of business.²⁵² The final rule will be upheld if it is supported by substantial evidence in the rulemaking record taken as a whole.²⁵³

1. 15 U.S.C. §§ 2601-2629, ELR STAT. TSCA §§ 2-30.

2. Id. § 2604(e), ELR STAT. TSCA § 5(e).

3. Id. § 2604(e)(1)(A), ELR STAT. TSCA § 5(e)(1)(A).

4. Id. § 2604(e)(1)(B), ELR STAT. TSCA § 5(e)(1)(B).

5. Id. § 2604(e)(1)(C), ELR STAT. TSCA § 5(e)(1)(C).

6. Id.

7. Id. § 2604(e)(2)(A), ELR STAT. TSCA § 5(e)(2)(A).

8. Id. § 2604(e)(2)(B), ELR STAT. TSCA § 5(e)(2)(B).

9. EPA distinguishes § 5(e) consent orders, "issued by EPA with the agreement of the submitter," from § 5(e) unilateral orders "issued by EPA without the agreement of the submitter." See U.S. EPA, ACCOMPLISHMENTS AND GOALS IN REDUCING TOXIC CHEMICAL RISK, FY 1989 REPORT TO CONGRESS ON THE TOXIC SUBSTANCES CONTROL ACT 113 (Dec. 1990) [hereinafter FY 1989 REPORT TO CONGRESS ON TSCA].

10. See 40 C.F.R. § 720.75(b) (1993). If the submitter does not agree voluntarily to suspend the PMN review period, EPA may, pursuant to its authority under § 5(c) and the regulations at 40 C.F.R. § 720.75(c), extend the notice review period for up to 90 days.

11. A PMN may be withdrawn by the submitter at any time during the PMN review period. See id. § 720.75(e). As of September 30, 1989, 330 PMNs had been withdrawn in the face of possible regulation under TSCA § 5(e) or (f). See FY 1989 REPORT TO CONGRESS ON TSCA, supra note 9, at 112.

12. FY 1989 REPORT TO CONGRESS ON TSCA, supra note 9, at 112-13.

13. See, e.g., U.S. EPA, GENERIC CONSENT ORDER -- RISK-BASED HEALTH (undated).

14. E.g., id. at 38.

15. E.g., id. at 1-34.

16. EPA has defined the term "scientifically equivocal data" as:

Data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of the potential risk of injury to human health or the environment of the PMN substance.

Id. Attachment A at 3.

17. Id. at 4.

18. EPA has defined the term "scientifically invalid" as:

Any significant departure from the EPA-approved protocol or the Good Laboratory Practice Standards at 40 C.F.R. Part 792 without prior or subsequent Agency approval that prevents a reasoned evaluation of the health or environmental effects of the PMN substance.

Id. Attachment A at 3.

19. Id. at 4-5.

20. Id. at 7-8.

21. The term "valid, negative results" is not defined in the GENERIC CONSENT ORDER, but is used here to mean the results of those studies that EPA does not determine to be "equivocal," "invalid," or indicative of an "unreasonable risk."

22. Id. at 37.

23. Id. at 8.

24. See id. at 8-13.

25. See id. at 14-25.

26. See id. at 25-31.

27. See id. at 31-32.

28. See id. at 33-34.

29. See id. at 34-36.

30. See Significant New Use Rules, General Provisions for New Chemical Follow-Up, 54 Fed. Reg. 31298 (1989).

31. 40 C.F.R. §§ 721.1-.47 (1993). These provisions were amended in 1988. See Significant New Use Rules, Amendments to General Provisions, 53 Fed. Reg. 28354 (July 27, 1988). See Carolyne R. Hathaway, David J. Hayes, and William K. Rawson, A Practitioner's Guide to the Toxic Substances Control Act: Part I, 24 ELR 10207 (May 1994).

32. See 40 C.F.R. §§ 721.50-.91 (1993).

33. See id. §§ 721.100-.125.

34. See id. §§ 721.160-.185.

35. See id. §§ 721.224-.2585. The format for Subpart E was established in 1988. See Significant New Use Rule, Technical Amendment, 53 Fed. Reg. 2845 (Feb. 2, 1988).

36. 40 C.F.R. § 721.63 (1993).

37. Id. § 721.72.

38. Id. § 721.80.

39. Id. § 721.85.

40. Id. §§ 721.90-.91.

41. Letter from John W. Melone, Director, Chemical Control Division, U.S. EPA, to Geraldine Cox, Vice President-Technical Director, Chemical Manufacturers Association (Mar. 15, 1990).

42. Significant New Use Rules, General Provisions for New Chemical Follow-Up, 54 Fed. Reg. 31298 (July 27, 1989).

43. See FY 1989 REPORT TO CONGRESS ON TSCA, supra note 9, at 112.

44. See id. at 112-13. This number includes 106 PMNs for synthetic fuels.

45. Id. at 37-38.

46. See 40 C.F.R. pt. 721, subpt. E (1993).

47. Id. § 721.160.

48. Id. § 721.170.

49. Id. § 721.160(a).

50. Id. § 721.160(a)(2).

51. Id. § 721.160(b).

52. Id.

53. Id. § 721.170.

54. Id. § 721.170(b)-(c).

55. See id. § 721.80(p)-(u).

56. See id. § 721.63.

57. See 54 Fed. Reg. at 31304; see also 40 C.F.R. § 721.170(c)(1) (1993). EPA has, however, proposed modifications to the expedited SNUR regulations that would eliminate this restriction and permit the Agency to use the expedited SNUR process to designate any of the provisions in 40 C.F.R. Part 721, Subpart B, as significant new uses. See Proposed Amendment to Expedited Process for Issuing Significant New Use Rules, Proposed Rule, 58 Fed. Reg. 7676 (Feb. 8, 1993).

58. 40 C.F.R. § 721.170(b) (1993).

59. Id. § 721.170(b)(1)-(5).

60. Id. § 721.170(c)(2)(ii).

61. See id. §§ 721.160(c)(3), 721.170(d)(4)(i).

62. 54 Fed. Reg. at 31305.

63. 40 C.F.R. §§ 721.160(c)(5), 721.170(d)(4)(iii) (1993).

64. 54 Fed.Reg. at 31305.

65. 40 C.F.R. §§ 721.160(c)(4), 721.170(d)(4)(ii)(1993).

66. Id. § 721.185.

67. See id. § 721.185(b).

68. Id. § 721.185(a)(1)-(6).

69. See H.R. REP. NO. 1679, 94th Cong., 2d Sess. 55-56 (1976), reprinted in 1976 U.S.C.C.A.N. 4539, 4540.

70. 15 U.S.C. § 2601(b), ELR STAT. TSCA § 2(b).

71. Id. § 2603(a)(1)(A)(ii), (B)(ii), ELR STAT. TSCA § 4(a)(1)(A)(ii), (B)(ii).

72. Id. § 2603(a)(1)(A)(iii), (B)(iii), ELR STAT. TSCA § 4(a)(1)(A)(iii), (B)(iii).

73. Id. § 2603(a)(1)(A)(i), ELR STAT. TSCA § 4(a)(1)(A)(i).

74. Id. § 2603(a)(1)(B)(i), ELR STAT. TSCA § 4(a)(1)(B)(i).

75. Id. § 2603(a)(2), ELR STAT. TSCA § 4(a)(2).

76. Id.

77. See H.R. REP. NO. 1341, 94th Cong., 2d Sess. 13 (1976), reprinted in 1976 U.S.C.C.A.N. 4491, 4503.

78. See Dichloromethane, Nitrobenzene, and 1,1,1-Trichloroethane, Proposed Test Rule, 46 Fed. Reg. 30300 (June 5, 1981); Chloromethane and Chlorinated Benzenes Proposed Test Rule, Amendments to Proposed Health Effects Standards, 45 Fed. Reg. 48524 (July 18, 1980).

79. See 45 Fed. Reg. at 48528.

80. Id.

81. Id.

82. Id. at 48529.

83. Shell Chemical Co. v. U.S. Environmental Protection Agency, 826 F.2d 295, 17 ELR 21146 (5th Cir. 1987).

84. Ausimont U.S.A. Inc. v. U.S. Environmental Protection Agency, 838 F.2d 93, 18 ELR 20456 (3d Cir. 1988).

85. Chemical Mfrs. Ass'n v. U.S. Environmental Protection Agency, 859 F.2d 977, 19 ELR 20001 (D.C. Cir. 1988).

86. EHA is a colorless liquid with a low vapor pressure. EHA is manufactured in enclosed processes and used exclusively as a chemical intermediate or reactant in the production of metal soaps and other products. EHA is totally consumed in the manufacture of these products, and as a result there are no consumer or industrial products offered for sale that contain EHA. The Agency's concerns pertained primarily to the potential for dermal (skin) exposure in the workplace during sampling, loading, and unloading operations. 859 F.2d at 980-81, 19 ELR at 20002.

87. Id. at 984-88, 19 ELR at 20003-07.

88. Id. at 988, 19 ELR at 20006-07.

89. Id. at 988-91, 19 ELR at 20007.

90. Id. at 989-90, 19 ELR at 20007-08.

91. Id. at 988-89, 19 ELR at 20008-09.

92. 15 U.S.C. § 2603(a)(1)(B), ELR STAT. TSCA § 4(a)(1)(B).

93. See 46 Fed. Reg. at 30300, 30302, supra note 78.

94. Cumene, Final Test Standards and Reporting Requirements, 53 Fed. Reg. 28195 (July 27, 1988); 40 C.F.R. § 799.1285 (1993).

95. Chemical Mfrs. Ass'n v. U.S. Environmental Protection Agency, 899 F.2d 344, 360, 20 ELR 20837, 20845 (5th Cir. 1990).

96. Id. at 357, 20 ELR at 20843.

97. Id. at 359-60, 20 ELR at 20845.

98. TSCA Section 4(a)(1)(B) Proposed Statement of Policy, 56 Fed. Reg. 32294 (July 15, 1991).

99. Id. at 32296.

100. Id. at 32297.

101. Id.

102. Id.

103. Id. at 32296.

104. TSCA Section 4(a)(1)(B) Final Statement of Policy, Criteria for Evaluating Substantial Production, Substantial Release, and Substantial or Significant Human Exposure, 58 Fed. Reg. 28736 (May 14, 1993).

105. Id. at 28746. This does not mean that all chemicals that meet the "B" policy criteria will be considered for testing. EPA stated that "the 'B' policy is not intended to be, nor will it be used as an automatic trigger to testing." Id. at 28738. Selection of chemicals for testing is discussed in greater detail at Section C, below.

106. Id. at 28745-46.

107. See 15 U.S.C. § 2603(b)(2)(A), ELR STAT. TSCA § 4(b)(2)(A).

108. See 40 C.F.R. pts. 796-98 (1993).

109. 7 U.S.C. §§ 136-136y, ELR STAT. FIFRA §§ 2-2y.

110. See 40 C.F.R. § 790.60(b) (1993).

111. 15 U.S.C. § 2603(b)(2), ELR STAT. TSCA § 4(b)(2).

112. See 15 U.S.C. § 2603(b)(3), ELR STAT. TSCA § 4(b)(3).

113. See 40 C.F.R. § 790.42 (1993).

114. Id. § 790.42(a)(1).

115. Id. § 790.42(a)(2).

116. Id. § 790.42(a)(3).

117. See id. § 790.42(a)(4)-(5).

118. 15 U.S.C. § 2603(e), ELR STAT. TSCA § 4(e).

119. Id. § 2603(e)(2)(A), ELR STAT. TSCA § 4(e)(2)(A).

120. In addition, the Department of Labor appointee must be engaged in activities under the Occupational Safety and Health Act. Id.

121. 15 U.S.C. § 2603(e)(2)(B)(ii), ELR STAT. TSCA § 4(e)(2)(B)(ii).

122. Id. § 2603(e)(2)(C)(i), ELR STAT. TSCA § 4(e)(2)(C)(i).

123. Id. § 2603(e)(2)(C)(ii), ELR STAT. TSCA § 4(e)(2)(C)(ii).

124. See Thirty-First Report of the TSCA Interagency Testing Committee to the Administrator, 58 Fed. Reg. 26898 (May 5, 1993).

125. 15 U.S.C. § 2603(e)(1)(A), ELR STAT. TSCA § 4(e)(1)(A).

126. See id. § 2603(e)(1)(A), ELR STAT. TSCA § 4(e)(1)(A).

127. See id. § 2603(e)(1)(B), ELR STAT. TSCA § 4(e)(1)(B).

128. Id.

129. See 40 C.F.R. § 790.20 (1993).

130. See 58 Fed. Reg. at 26898, supra note 124.

131. See 56 Fed. Reg. 42055 (Aug. 26, 1991).

132. Office of Solid Waste Chemicals, Final Test Rule, 53 Fed. Reg. 22300, 22324 (1988); see 40 C.F.R. § 799.5055 (1993).

133. See 15 U.S.C. § 2603(a), (b)(5), ELR STAT. TSCA § 4(a), (b)(5).

134. See 40 C.F.R. § 790.1(b) (1993).

135. Id. § 790.1(c).

136. See id. pt. 790, subpt. B.

137. See Natural Resources Defense Council v. Costle, No. 79 Civ. 2411, 10 ELR 20274 (S.D.N.Y. 1980).

138. See Natural Resources Defense Council v. U.S. Environmental Protection Agency, 595 F. Supp. 1255, 14 ELR 20819 (S.D.N.Y. 1984).

139. 40 C.F.R. § 790.22(a) (1993); id. pt. 790, subpt. E, app. A (Schedule for Developing Consent Agreements and Test Rules).

140. Id. § 790.22(b)(1)-(10) (1993).

141. Id. § 790.28(b).

142. Id.

143. Id.

144. Id. § 790.24(a).

145. Id. § 790.24(b).

146. Id. § 790.24(c). Note that manufacturers and processors who perform the required testing will not be entitled to obtain reimbursement from manufacturers and processors who do not participate; the data reimbursement provisions of § 4(c), discussed below, do not apply to consent order testing. Most consent orders include a provision whereby test sponsors expressly acknowledge that the data reimbursement provisions do not apply. See U.S. EPA, Testing Order for 4-Vinyl-cyclohexene (4-VCH) (No. OPTS-42116) (announced at 56 Fed. Reg. 47912 (Sept. 23, 1991)) [hereinafter 4-VCH Consent Order].

147. See 40 C.F.R. § 790.60 (1993).

148. See id. pt. 792.

149. Id. § 790.60.

150. Id. § 790.22(b)(10).

151. See id. §§ 799.5000, 799.5025.

152. See id. §§ 790.1(c), 790.26(a).

153. 15 U.S.C. § 2603(b)(5), ELR STAT. TSCA § 4(b)(5).

154. See 40 C.F.R. § 790.40 (1993).

155. Id. § 790.40(b)(1)(i)-(viii).

156. Id. § 790.26(c).

157. See NRDC v. EPA, 595 F. Supp. at 1255, 14 ELR at 20819.

158. 40 C.F.R. § 790.40(b)(2) (1993).

159. Id. § 790.40(b)(3). Submission and review of study plans in two-phase rulemaking proceedings are described in Section F below.

160. See id. pt. 799, subpts. B, D.

161. See id. §§ 790.1(b), 790.60.

162. See id. § 790.45(a). Procedures governing exemption applications are addressed in Section G below.

163. Id. § 790.45(c).

164. Id. § 790.48.

165. Id. § 790.48(a).

166. Id. § 790.48(a)(2).

167. Id. § 790.48(a)(3).

168. Id. § 790.48(b)(2).

169. Id. § 790.48(b)(3).

170. Id. § 790.48(b)(4).

171. Id. § 790.48(b)(5).

172. Id. § 790.48(c)(2).

173. Id. § 790.48(c)(3).

174. Id. § 790.50(a)(1). The regulations governing consent agreements provide that study plans must be submitted 45 days prior to initiation of testing. See id. § 790.62(a). This also was the requirement for test rules prior to an amendment of the regulations on May 7, 1990. Testing Consent Agreements and Test Rules, 55 Fed. Reg. 18881 (May 7, 1990). The modification of this requirement for test rules but not for consent agreements appears to have been an oversight. EPA now provides in each testing consent agreement that study plans may be submitted at any time prior to initiation of each test. See 4-VCH Consent Order, supra note 146, Section V.

175. 40 C.F.R. § 790.50(a)(2) (1993).

176. See id. pt. 792. These requirements are discussed in detail below.

177. Id. §§ 790.50(c), 790.62(b).

178. Id. §§ 790.50(d)(1), 790.62(c)(1).

179. Id. §§ 790.50(d)(2), 790.62(c)(2).

180. See id. § 790.62(c)(1). The cited provision, which pertains to testing under consent agreements, states: "It is the responsibility of the test sponsor to review the study protocols to determine if they comply with all the mandatory testing conditions and requirements in the test standards." EPA also applies the same policy to test rules, although the quoted language does not appear at 40 C.F.R. § 790.50(d)(1), the corresponding provision pertaining to EPA review of study plans submitted under test rules.

181. Id. § 790.52(a).

182. Id. § 790.52(c).

183. Id.

184. See, e.g., id. § 799.2325(c)(1)(ii)(B) (final test rule for isopropanol); 4-VCH Consent Order, supra note 146, at Section III.C.

185. Id. § 790.55(a).

186. Id. § 790.5(b).

187. Id. § 790.55(b)(3).

188. Id. § 790.55(b)(4).

189. Id. § 790.55(b)(3).

190. Id.

191. Id.

192. Id. § 790.55(d)(1).

193. Id. § 790.55(d)(2).

194. Id. § 790.55(d)(5).

195. See id. § 790.68(b)-(c).

196. See id. § 790.68(a)(1).

197. Id.

198. Id. § 790.68(a)(2).

199. Id.

200. Id.

201. 15 U.S.C. § 2613, ELR STAT. TSCA § 14; 40 C.F.R. § 790.7(a) (1993).

202. 40 C.F.R. § 790.7(a)-(b) (1993).

203. See 40 C.F.R. § 790.7(c) (1993).

204. See id. § 792.1(a).

205. Id. § 792.12.

206. Id. § 792.15(a).

207. Id. § 792.15(b).

208. Id. § 792.17(a).

209. 18 U.S.C. §§ 2 and 1001 provide for criminal penalties for persons who make false statements or otherwise attempt to defraud the federal government or aid and abet such a scheme to defraud.

210. 40 C.F.R. § 792.17(b)(1993).

211. Id.

212. Id. § 792.17(c).

213. 15 U.S.C. § 2603(c), ELR STAT. TSCA § 4(c).

214. Id. § 2603(c)(4)(A), ELR STAT. TSCA § 4(c)(4)(A).

215. 40 C.F.R. pt. 790, subpt. E (1993); id. pt. 791.

216. Id. § 790.80(a)(1).

217. See id. § 790.80(a)(2).

218. Id. § 790.80(b)(1).

219. Id. § 790.80(b)(2).

220. Id. § 790.82(a)-(e).

221. See id. § 790.85.

222. See id. § 790.85(a).

223. Id. § 790.82(e)(2).

224. Id. § 790.99.

225. Id. § 790.87(a).

226. Id. § 790.88(a).

227. Id. § 790.88(b).

228. Id. § 790.90(a).

229. Id. § 790.90(c)-(e).

230. Id. § 790.90(f).

231. Id. § 790.87(c).

232. Id. § 790.93(a).

233. Id. § 790.93(b).

234. Id. § 790.93(c)-(d).

235. Id. § 790.93(e).

236. Id. § 791.1.

237. Id. § 791.2(b).

238. Id. § 791.20(a).

239. See id. § 791.30.

240. Id. § 791.37.

241. Id. § 791.40. For the purpose of determining fair reimbursement shares, production volume is measured over a period that begins one calendar year before publication of the final test rule in the Federal Register and continues up to the latest data available. Id. § 791.48(a). The relevant production volume includes amounts of the test chemical imported in bulk form and mixtures, and the total domestic production of the chemical including production as a byproduct. Id. § 791.48(b). The production volume calculation will not include: (a) impurities, unless the test rule specifically includes them; (b) amounts of the test chemical manufactured for export, unless covered by an "unreasonable risk" finding under TSCA § 12(a)(2); or (c) chemicals excluded from the jurisdiction of TSCA by § 3(2)(B). See id. § 791.48(b)-(d).

242. Id. § 791.40.

243. Id. § 791.50.

244. Id. § 791.45(a).

245. Id.

246. Id. § 791.45(c).

247. Id.

248. Id. § 791.60(a).

249. 15 U.S.C. § 2603(c)(3)(A), ELR STAT. TSCA § 4(c)(3)(A); 40 C.F.R. § 791.60(c) (1993).

250. 40 C.F.R. § 791.105 (1993).

251. See 15 U.S.C. § 2618(a)(1)(A), ELR STAT. TSCA § 19(a)(1)(A).

252. Id.

253. 15 U.S.C. § 2618(c)(1)(B)(i), ELR STAT. TSCA § 19(c)(1)(B)(i).

24 ELR 10285 | Environmental Law Reporter | copyright © 1994 | All rights reserved