" Water Quality Standards; Establishment of Numeric Criteria for Priority Toxic Pollutants; States' Compliances Federal Register, Volume: 57 , Issue: 246 , Page: 60848 ( 57 FR 60848) , Tuesday, December 22, 1992 Agency: Environmental Protection Agency( EPA) Document Type: Rules and Regulations Code of Federal Regulations ( CFR): 40 CFR Part 131 Numbers: No. WH FRL 4543 9 Dates: Effective: 19930205 Contact Information: David K. Sabock, or; R. Kent Ballentine, 202 260 1315 Action: Final rule Internal Data: ( FR Doc. 92 30611 Filed 12 21 92; 8: 45 am)

SUMMARY: This rule promulgates for 14 States, the chemical specific, numeric criteria for priority toxic pollutants necessary to bring all States into compliance with the requirements of section 303( c)( 2)( B) of the Clean Water Act ( CWA). States determined by EPA to fully comply with section 303( c)( 2)( B) requirements are not affected by this rule. Th rule addresses two situations. For a few States, EPA is promulgating a limited number of criteria which were previously identified as necessary in disapproval letters to such States, and which the State has failed to address. For other States, Federal criteria are necessary for all priority toxic pollutants for which EPA has issued section 304( a) water quality criteria guidance and that are not the subject of approved State criteria. When these standards take effect, they will be the legally enforceable standards in the named States for all purposes and programs under the Clean Water Act, including planning, monitoring, NPDES permitting, enforcement an compliance. EPA is also withdrawing today the human health criteria published in the 1980 Ambient Water Quality Criteria documents f r: Beryllium, Cadmium, Chromium, Lead, Methyl Chloride, Selenium, Silver, nd 1,1,1 Trichloroethane. A summary of the criteria recommendation and he notice of availability of each criteria document were published at 45 FR 79318, November 28, 1980.

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 131 ( WH FRL 4543 9)

Water Quality Standards; Establishment of Numeric Criteria for Priority Toxic Pollutants; States' Compliance AGENCY: Environmental Protection Agency.

ACTION: Final rule.

 SUMMARY: This rule promulgates for 14 States, the chemical specific, numeric criteria for priority toxic pollutants necessary to bring all States into compliance with the requirements of section 303( c)( 2)( B) of the Clean Water Act ( CWA). States determined by EPA to fully comply with section 303( c)( 2)( B) requirements are not affected by this rule.

The rule addresses two situations. For a few States, EPA is promulgating a limited number of criteria which were previously identified as necessary in disapproval letters to such States, and which the State has failed to address. For other States, Federal criteria are necessary for all priority toxic pollutants for which EPA has issued section 304( a) water quality criteria guidance and that are not the subject of approved State criteria.

When these standards take effect, they will be the legally enforceable standards in the named States for all purposes and programs under the Clean Water Act, including planning, monitoring, NPDES permitting, enforcement and compliance.

EPA is also withdrawing today the human health criteria published in the 1980 Ambient Water Quality Criteria documents for: Beryllium, Cadmium, Chromium, Lead, Methyl Chloride, Selenium, Silver, and 1,1,1 Trichloroethane. A summary of the criteria recommendation and the notice of availability of each criteria document were published at 45 FR 79318, November 28, 1980.

EFFECTIVE DATE: This rule shall be effective February 5, 1993.

ADDRESSES: The public may inspect the administrative record for this rulemaking, including documentation supporting the aquatic life and human health criteria, and all public comments received on the proposed rule at the Environmental Protection Agency, Standards and Applied Science Division, Office of Science and Technology, room 919 East Tower, Waterside Mall, 401 M Street, SW., Washington, DC 20460 ( Telephone: 202 260 1315) on weekdays during the Agency's normal business hours of 8 a. m. to 4: 30 p. m. A reasonable fee will be charged for photocopies. Inquiries can be made by calling 202 260 1315.

FOR FURTHER INFORMATION CONTACT: David K. Sabock or R. Kent Ballentine, Telephone 202 260 1315.

SUPPLEMENTARY INFORMATION:

This preamble is organized according to the following outline: A. Introduction and Overview 1. Introduction 2. Overview B. Statutory and Regulatory Background 1. Pre Water Quality Act Amendments of 1987 ( Pub. L. 100 4) 2. The Water Quality Act Amendments of 1987 ( Pub. L. 100 4) a. Description of the New Requirements b. EPA's Initial Implementing Actions for sections 303( c) and 304( l) 3. EPA's Program Guidance for section 303( c)( 2)( B) C. State Actions Pursuant to section 303( c)( 2)( B) D. Determining State Compliance with section 303( c)( 2)( B) 1. EPA's Review of State Water Quality Standards for Toxics 2. Determining Current Compliance Status E. Rationale and Approach For Developing the Final Rule 1. Legal Basis 2. Approach for Developing the Final Rule 3. Approach for States that Fully Comply Subsequent to Issuance of this Final Rule F. Derivation of Criteria 1. Section 304( a) Criteria Process 2. Aquatic Life Criteria 3. Criteria for Human Health 4. Section 304( a) Human Health Criteria Excluded 5. Cancer Risk Level 6. Applying EPA's Nationally Derived Criteria to State Waters 7. Application of Metals Criteria G. Description of the Final Rule and Changes from Proposal 1. Changes from Proposal 2. Scope 3. EPA Criteria for Priority Toxic Pollutants 4. Applicability H. ( Reserved) I. Response to Public Comments 1. Legal Authority 2. Science 3. Economics 4. Implementation 5. Timing and Process 6. State Issues J. Executive Order 12291 K. Regulatory Flexibility Act L. Paperwork Reduction Act A. Introduction and Overview 1. Introduction This section of the Preamble introduces the topics which are addressed subsequently and provides a brief overview of EPA's basis and rationale for promulgating Federal criteria for priority toxic pollutants. Section B of this Preamble presents a description of the evolution of the Federal Government's efforts to control toxic pollutants beginning with a discussion of the authorities in the Federal Water Pollution Control Act Amendments of 1972. Also described in some detail is the development of the water quality standards review and revision process which provides for establishing both narrative goals and enforceable numeric requirements for controlling toxic pollutants. This discussion includes the changes enacted in the 1987 Clean Water Act Amendments which are the basis for this rule. Section C summarizes State efforts since 1987 to comply with the requirements of section 303( c)( 2)( B). Section D describes EPA's procedure for determining whether a State has fully complied with section 303( c)( 2)( B). Section E sets out the rationale and approach for developing the final rule, including a discussion of EPA's legal basis. Section F describes the development of the criteria included in this rule. Section G summarizes the provisions of the final rule. ( Section H is reserved.) Section I contains the response to major public comments received on the proposal. Sections J, K, and L address the requirements of Executive Order 12291, the Regulatory Flexibility Act, and the Paperwork Reduction Act, respectively. Section M provides a list of subjects covered in this rule.

A public hearing on the proposed rule was held on December 19, 1991, in Washington, DC. A total of 26 non EPA people registered at the hearing. The public comment period closed on December 19, 1991. EPA received a total of 153 written comments on the proposed rule.

2. Overview This rule, which establishes Federal criteria for certain priority toxic pollutants in a number of States, is important for several environmental, programmatic and legal reasons.

First, control of toxic pollutants in surface waters is an important priority to achieve the Clean Water Act's goals and objectives. The most recent National Water Quality Inventory indicates that one third of monitored river miles, lake acres, and coastal waters have elevated levels of toxics. Forty seven States and Territories have reported elevated levels of toxic pollutants in fish tissues. States have issued a total of 586 fishing advisories and 135 bans, attributed mostly to industrial discharges and land disposal.

The absence of State water quality standards for toxic pollutants undermines State and EPA toxic control efforts to address these problems. Without clearly established water quality goals, the effectiveness of many of EPA's water programs is jeopardized. Permitting, enforcement, coastal water quality improvement, fish tissue quality protection, certain nonpoint source controls, drinking water quality protection, and ecological protection all depend to a significant extent on complete and adequate water quality standards. Numeric criteria for toxics are essential to the process of controlling toxics because they allow States and EPA to evaluate the adequacy of existing and potential control measures to protect aquatic ecosystems and human health. Formally adopted standards are the legal basis for including water quality based effluent limitations in NPDES permits to control toxic pollutant discharges. The critical importance of controlling toxic pollutants has been recognized by Congress and is reflected, in part, by the addition of section 303( c)( 2)( B) to the Act. Congressional impatience with the pace of State toxics control programs is well documented in the legislative history of the 1987 CWA amendments. In order to protect human health, aquatic ecosystems, and successfully implement toxics controls, EPA believes that all actions which are available to the Agency must be taken to ensure that all necessary numeric criteria for priority toxic pollutants are established in a timely manner.

Second, as States and EPA continue the transition from an era of primarily technology based controls to an era in which technology based controls are integrated with water quality based controls, it is important that EPA ensures timely compliance with CWA requirements. An active Federal role is essential to assist States in getting in place complete toxics criteria as part of their pollution control programs. While most States recognize the need for enforceable water quality standards for toxic pollutants, their recent adoption efforts have often been stymied by a variety of factors including limited resources, competing environmental priorities, and difficult scientific, policy and legal challenges. Most water quality criteria for toxic pollutants have been available since 1980. Section 303 of the CWA requires States to review, revise, and adopt updated water quality standards every three years as part of a continuing triennial review process. The water quality standards regulation has required State adoption of numeric criteria for toxic pollutants since 1983 ( see 40 CFR 131.11). Despite the availability of scientific guidance documents and clear statutory and regulatory requirements, a preliminary assessment of the water quality standards for all States in February of 1990 showed that only six States had established fully acceptable criteria for toxic pollutants. This rate of toxics criteria adoption is contrary to the CWA requirements and is a reflection of the difficulties faced by States. In such circumstances, it is EPA's responsibility to exercise its CWA authorities to move forward the toxic control program in concert with the statutory scheme.

EPA's action will also help restore equity among the States. The CWA is designed to ensure all waters are sufficiently clean to protect public health and the environment. The CWA allows some flexibility and differences among States in their adopted and approved water quality standards, but it was not designed to reward inaction and inability to meet statutory requirements.

Although most States have made important progress toward satisfying CWA requirements, some have still failed to fully comply with section 303( c)( 2)( B). The CWA authorizes EPA to promulgate standards where necessary to meet the requirements of the Act. Where States have not satisfied the CWA requirement to adopt water quality standards for toxic pollutants, which was reemphasized by Congress in 1987, it is imperative that EPA take action.

EPA's ability to oversee State standards setting activities and to correct deficiencies in State water quality standards is critical to the effective implementation of section 303( c)( 2)( B). This rule is a necessary and important component of EPA's implementation of section 303( c)( 2)( B) as well as EPA's overall efforts to control toxic pollutants in surface waters.

On February 26, 1992, EPA's Deputy Administrator issued " Guidance on Risk Characterization for Risk Managers and Risk Assessors" which addresses a problem that affects public perception regarding the reliability of EPA's scientific assessments and related regulatory decisions. The guidance noted that " when risk information is presented to the * * * public, the results have been boiled down to a point estimate of risk * * * which do not fully convey the range of information considered and used in developing the assessment." The guidance lays out principles and implementation procedures to address risk assessments in future EPA presentations, reports and decision packages. The guidance specifically notes, " However, we do not expect risk assessment documents that are close to completion to be rewritten." The proposal for this final rule was published in November, 1991, three months prior to the risk assessment guidance being issued. Since the Agency was striving to meet a mid February statutory deadline for final publication, when the risk guidance was issued the rulemaking package was essentially complete. The specifics of the aquatic life and human health guidelines are discussed in the preamble and in the response to public comments. The actual methodology and criteria documents describe in detail the risk assessment process involved in deriving a water quality criteria and the water quality standards contained in this rule and the resulting risk characterization. The water quality criteria methodology and individual criteria documents are part of the record for this rule. Therefore, while all the specifics of the new risk characterization guidance were not followed in this preamble, the spirit of the guidance is reflected.

Moreover, EPA has initiated a review and update of these criteria methodologies. These updates will be conducted in conformance with the risk characterization guidance and include public involvement and review.

B. Statutory and Regulatory Background 1. Pre Water Quality Act Amendments of 1987 ( Pub. L. 100 4)

Section 303( c) of the 1972 Federal Water Pollution Control Act Amendments ( FWPCA) ( 33 U. S. C. 1313( c)) established the statutory basis for the current water quality standards program. It completed the transition from the previously established program of water quality standards for interstate waters to one requiring standards for all surface waters of the United States.

Although the major innovation of the 1972 FWPCA was technology based controls, Congress maintained the concept of water quality standards both as a mechanism to establish goals for the Nation's waters and as a regulatory requirement when standardized technology controls for point source discharges and/ or nonpoint source controls were inadequate. In recent years, these so called water quality based controls have received new emphasis by Congress and EPA in the continuing quest to enhance and maintain water quality to protect the public health and welfare.

Briefly stated, the key elements of section 303( c) are: ( a) A water quality standard is defined as the designated beneficial uses of a water segment and the water quality criteria necessary to support those uses; ( b) The minimum beneficial uses to be considered by States in establishing water quality standards are specified as public water supplies, propagation of fish and wildlife, recreation, agricultural uses, industrial uses and navigation; ( c) A requirement that State standards must protect public health or welfare, enhance the quality of water and serve the purposes of the Clean Water Act; ( d) A requirement that States must review their standards at least once each three year period using a process that includes public participation; ( e) The process for EPA review of State standards which may ultimately result in the promulgation of a superseding Federal rule in cases where a State's standards are not consistent with the applicable requirements of the CWA, or in situations where the Agency determines Federal standards are necessary to meet the requirements of the Act.

Another major innovation in the 1972 FWPCA was the establishment of the National Pollutant Discharge Elimination System ( NPDES) which requires point source discharges to obtain a permit before legally discharging to the waters of the United States. In addition to the permit limits established on the basis of technology ( e. g. effluent limitations guidelines), the Act requires discharges to meet instream water quality standards. ( See section 301( b)( 1)( C), 33 U. S. C. 1311( b)( 1)( C)).

The water quality standards serve a dual function under the Clean Water Act regulatory scheme. Standards establish narrative and numeric definitions and quantification of the Act's goals and policies ( see section 101, 33 U. S. C. 1251) which provide a basis for identifying impaired waters. Water quality standards also establish regulatory requirements which are translated into specific discharge requirements. In order to fulfill this critical function, adopted State criteria must contain sufficient parametric coverage to protect both human health and aquatic life.

In its initial efforts to control toxic pollutants, the FWPCA, pursuant to section 307, required EPA to designate a list of toxic pollutants and to establish toxic pollutant effluent standards based on a formal rulemaking record. Such rulemaking required formal hearings, including cross examination of witnesses. EPA struggled with this unwieldy process and ultimately promulgated effluent standards for six toxic pollutants, pollutant families or mixtures. ( See 40 CFR part 129.) Congress amended section 307 in the 1977 Clean Water Act Amendments by endorsing the Agency's alternative procedure of regulating toxic pollutants by use of effluent limitations guidelines, by amending the procedure for establishing toxic pollutant effluent standards to provide for more flexibility in the hearing process for establishing a record, and by directing the Agency to include sixty five specific pollutants or classes of pollutants on the toxic pollutant list. EPA published the required list on January 31, 1978 ( 43 FR 4109). This toxic pollutant list was the basis on which EPA's efforts on criteria development for toxics was focused.

During planning efforts to develop effluent limitations guidelines and water quality criteria, the list of sixty five toxic pollutants was judged too broad as some of the pollutants were, in fact, general families or classes of organic compounds consisting of many individual chemicals. EPA selected key chemicals of concern within the 65 families of pollutants and identified a more specific list of 129 priority toxic pollutants. Two volatile chemicals and one water unstable chemical were removed from the list ( see 46 FR 2266, January 8, 1981; 46 FR 10723, February 4, 1981) so that at present there are 126 priority toxic pollutants. This list is published as appendix A to 40 CFR part 423.

Another critical section of the 1972 FWPCA was section 304( a) ( 33 U. S. C. 1314( a)). Section 304( a)( 1) provides, in pertinent part, that EPA * * * shall develop and publish * * * criteria for water quality accurately reflecting the latest scientific knowledge ( A) on the kind and extent of all identifiable effects on health and welfare including, but not limited to, plankton, fish, shellfish, wildlife, plant life, shorelines, beaches, esthetics, and recreation which may be expected from the presence of pollutants in any body of water, * * * and ( C) on the effects of pollutants on biological community diversity, productivity, and stability, * * *

In order to avoid confusion, it must be recognized that the Clean Water Act uses the term " criteria" in two separate ways. In section 303( c), which is discussed above, the term is part of the definition of a water quality standard. That is, a water quality standard is comprised of designated uses and the criteria necessary to protect those uses. Thus, States are required to adopt regulations or statutes which contain legally achievable criteria. However, in section 304( a), the term criteria is used in a scientific sense and EPA develops recommendations which States consider in adopting regulatory criteria.

In response to this legislative mandate and an earlier similar statutory requirement, EPA and a predecessor agency have produced a series of scientific water quality criteria guidance documents. Early Federal efforts were Water Quality Criteria ( 1968 " Green Book") and Quality Criteria for Water ( 1976 " Red Book"). EPA also sponsored a contract effort with the National Academy of Science National Academy of Engineering which resulted in Water Quality Criteria, 1972 ( 1973 " Blue Book"). These early efforts were premised on the use of literature reviews and the collective scientific judgment of Agency and advisory panels. However, when faced with the list of 65 toxic pollutants and the need to develop criteria for human health as well as aquatic life, the Agency determined that new procedures were necessary. Continued reliance solely on existing scientific literature was deemed inadequate, since for many pollutants essential information was not available. EPA scientists developed formal methodologies for establishing scientifically defensible criteria. These were subjected to review by the Agency's Science Advisory Board of outside experts and the public. This effort culminated on November 28, 1980, when the Agency published criteria development guidelines for aquatic life and for human health, along with criteria for 64 toxic pollutants. ( See 45 FR 79318.) Since that initial publication, the aquatic life methodology was slightly amended ( 50 FR 30784, July 29, 1985) and additional criteria was proposed for public comment and finalized as Agency criteria guidance. EPA summarized the available criteria information in Quality Criteria for Water 1986 ( 1986 " Gold Book") which is updated from time to time. However, the individual criteria documents, as updated, are the official guidance documents. EPA's criteria documents provide a comprehensive toxicological evaluation of each chemical. For toxic pollutants, the documents tabulate the relevant acute and chronic toxicity information for aquatic life and derive the criteria maximum concentrations ( acute criteria) and criteria continuous concentrations ( chronic criteria) which the Agency recommends to protect aquatic life resources. For human health criteria, the document provides the appropriate reference doses, and if appropriate, the carcinogenic slope factors, and derives recommend criteria. The details of this process are described more fully in a later part of this Preamble.

Programmatically, EPA's initial efforts were aimed at converting a program focused on interstate waters into one addressing all interstate and intrastate surface waters of the United States. Guidance was aimed at the inclusion of traditional water quality parameters to protect aquatic life ( e. g., pH, temperature, dissolved oxygen and a narrative " free from toxicity" provision), recreation ( e. g., bacteriological criteria) and general aesthetics ( e. g., narrative " free from nuisance" provisions). EPA also required State adoption of an antidegradation policy to maintain existing high quality or ecologically unique waters as well as maintain improvements in water quality as they occur.

The initial water quality standards regulation was actually a part of EPA's water quality management regulations implementing section 303( e) ( 33 U. S. C. 1313( e)) of the Act. It was not comprehensive and did not address toxics or any other criteria specifically. Rather, it simply required States to adopt appropriate water quality criteria necessary to support designated uses. ( See 40 CFR 130.17 as promulgated in 40 FR 55334, November 28, 1975).

After several years of effort and faced with increasing public and Congressional concerns about toxic pollutants, EPA realized that proceeding under section 307 of the Act would not comprehensively address in a timely manner the control of toxics through either toxic pollutant effluent standards or effluent limitations guidelines because these controls are only applicable to specific types of discharges. EPA sought a broader, more generally applicable mechanism and decided to vigorously pursue the alternative approach of EPA issuance of scientific water quality criteria documents which States could use to adopt enforceable water quality standards. These in turn could be used as the basis for establishing State and EPA permit discharge limits pursuant to section 301( b)( 1)( C) which requires NPDES permits to contain * * * any more stringent limitation, including those necessary to meet water quality standards * * *, or required to implement any applicable water quality standard established pursuant to this Act.

Thus, the adoption by States of appropriate toxics criteria applicable to their surface waters, such as those recommended by EPA in its criteria documents, would be translated by regulatory agencies into point source permit limits. Through the use of water quality standards, all discharges of toxics are subject to permit limits and not just those discharged by particular industrial categories. In order to facilitate this process, the Agency amended the water quality standards regulation to explicitly address toxic criteria requirements in State standards. The culmination of this effort was the promulgation of the present water quality standards regulation on November 8, 1983 ( 40 CFR part 131, 48 FR 51400).

The current water quality standards regulation ( 40 CFR part 131) is much more comprehensive than its predecessor. The regulation addresses in detail both the beneficial use component and the criteria component of a water quality standard. Section 131.11 of the regulation requires States to review available information and,

* * * to identify specific water bodies where toxic pollutants may be adversely affecting water quality or the attainment of the designated water use or where the levels of toxic pollutants are at a level to warrant concern and must adopt criteria for such toxic pollutants applicable to the water body sufficient to protect the designated use. The regulation provided that either or both numeric and narrative criteria may be appropriately used in water quality standards.

EPA's water quality standards emphasis since the early 1980' s reflected the increasing importance placed on controlling toxic pollutants. States were strongly encouraged to adopt criteria in their standards for the priority toxic pollutants, especially where EPA had published criteria guidance under section 304( a) of the Act.

Under the statutory scheme, during the 3 year triennial review period following EPA's 1980 publication of water quality criteria for the protection of human health and aquatic life, States should have reviewed those criteria and adopted standards for many priority toxic pollutants. In fact, State response to EPA's criteria publication and toxics initiative was disappointing. A few States adopted large numbers of numeric toxics criteria, although primarily for the protection of aquatic life. Most other States adopted few or no water quality criteria for priority toxic pollutants. Some relied on a narrative " free from toxicity" criterion, and so called " action levels" for toxic pollutants or occasionally calculated site specific criteria. Few States addressed the protection of human health by adopting numeric human health criteria.

In support of the November, 1983, water quality standards rulemaking, EPA issued program guidance entitled, Water Quality Standards Handbook ( December 1983) simultaneously with the publication of the final rule. The foreword to that guidance noted EPA's two fold water quality based approach to controlling toxics: chemical specific numeric criteria and biological testing in whole effluent or ambient waters to comply with narrative " no toxics in toxic amounts" standards. More detailed programmatic guidance on the application of biological testing was provided in the Technical Support Document for Water Quality Based Toxics Control ( TSD) ( EPA 440/ 4 85 032, September 1985). This document provided the needed information to convert chemical specific and biologically based criteria into water quality standards for ambient receiving waters and permit limits for discharges to those waters. The TSD focused on the use of bioassay testing of effluent ( so called whole effluent testing or WET methods) to develop effluent limitations within discharge permits. Such effluent limits were designed to implement the " free from toxicity" narrative standards in State water quality standards. The TSD also focused on water quality standards. Procedures and policy were presented for appropriate design flows for EPA's section 304( a) acute and chronic criteria. In 1991, EPA revised and expanded the TSD. ( Technical Support Document for Water Quality based Toxics Control, EPA 505/ 2 90 001, March 1991.) A Notice of Availability was published in the Federal Register on April 4, 1991 ( 56 FR 13827). All references in this Preamble are to the revised TSD.

The Water Quality Standards Handbook and the TSD are examples of EPA's efforts and assistance that were intended to help, encourage and support the States in adopting appropriate water quality standards for the protection of their waters against the deleterious effects of toxic pollutants. In some States, more and more numeric criteria for toxics were being adopted as well as more aggressive use of the " free from toxics" narratives in setting protective NPDES permit limits. However, by the time of Congressional consideration and action on the CWA reauthorization, most States had adopted few, if any, water quality standards for priority toxic pollutants.

State practices of developing case by case effluent limits using procedures that were not standardized in State regulations made it difficult to ascertain whether such procedures were consistently applied. The use of approaches to control toxicity that did not rely on the statewide adoption of numeric criteria for the priority toxic pollutants generated frustration in Congress. Senator Robert T. Stafford, first chairman and then ranking minority member of the authorizing committee, noted during the Senate debate:

An important problem in this regard is that few States have numeric ambient criteria for toxic pollutants. The lack of ambient criteria ( for toxic pollutants) make it impossible to calculate additional discharge limitations for toxics * * *. It is vitally important that the water quality standards program operate in such a way that it supports the objectives of the Clean Water Act to restore and maintain the integrity of the Nation's Waters. ( bracketed material added). A Legislative History of the Water Quality Act of 1987 ( Pub. L. 100 4), Senate Print 100 144, USGPO, November 1988 at page 1324.

Other comments in the legislative history similarly note the Congressional perception that the States were failing to aggressively address toxics and that EPA was not using its oversight role to push the States to move more quickly and comprehensively. Thus Congress developed the water quality standards amendments to the Clean Water Act for reasons similar to those strongly stated during the Senate debate by a chief sponsor, Senator John H. Chafee,

A cornerstone of the bill's new toxic pollution control requirements is the so called beyond BAT program * * *. Adopting the beyond BAT provisions will assure that EPA continues to move forward rapidly on the program * * *. If we are going to repair the damage to those water bodies that have become highly degraded as a result of toxic substances, we are going to have to move forward expeditiously on this beyond BAT program. The Nation cannot tolerate endless delays and negotiations between EPA and States on this program. Both entities must move aggressively in taking the necessary steps to make this program work within the time frame established by this Bill * * *. Ibid, at page 1309.

This Congressional impatience with the pace of State and EPA progress and an appreciation that the lack of State standards for toxics undermined the effectiveness of the entire CWA based scheme, resulted in the 1987 adoption of stringent new water quality standard provisions in the Water Quality Act amendments.

2. The Water Quality Act Amendments of 1987 ( Pub. L. 100 4)

a. Description of the New Requirements The 1987 Amendments to the Clean Water Act added Section 303( c)( 2)( B) which provides:

Whenever a State reviews water quality standards pursuant to paragraph ( 1) of this subsection, or revises or adopts new standards pursuant to this paragraph, such State shall adopt criteria for all toxic pollutants listed pursuant to section 307( a)( 1) of this Act for which criteria have been published under section 304( a), the discharge or presence of which in the affected waters could reasonably be expected to interfere with those designated uses adopted by the State, as necessary to support such designated uses. Such criteria shall be specific numerical criteria for such toxic pollutants. Where such numerical criteria are not available, whenever a State reviews water quality standards pursuant to paragraph ( 1), or revises or adopts new standards pursuant to this paragraph, such State shall adopt criteria based on biological monitoring or assessment methods consistent with information published pursuant to section 304( a)( 8). Nothing in this section shall be construed to limit or delay the use of effluent limitations or other permit conditions based on or involving biological monitoring or assessment methods or previously adopted numerical criteria.

b. EPA's Initial Implementing Actions for Sections 303( c) and 304( l)

The addition of this new requirement to the existing water quality standards review and revision process of section 303( c) did not change the existing procedural or timing provisions. For example, section 303( c)( 1) still requires that States review their water quality standards at least once each 3 year period and transmit the results to EPA for review. EPA's oversight and promulgation authorities and statutory schedules in section 303( c)( 4) were likewise unchanged. Rather, the provision required the States to place heavy emphasis on adopting numeric chemical specific criteria for toxic pollutants ( i. e., rather than just narrative approaches) during the next triennial review cycle. As discussed in the previous section, Congress was frustrated that States were not using the numerous section 304( a) criteria that EPA had developed, and was continuing to develop, to assist States in controlling the discharge of priority toxic pollutants. Therefore, for the first time in the history of the Clean Water Act, Congress took the unusual action of explicitly mandating that States adopt numeric criteria for specific toxic pollutants.

In response to this new Congressional mandate, EPA redoubled its efforts to promote and assist State adoption of water quality standards for priority toxic pollutants. EPA's efforts included the development and issuance of guidance to the States on acceptable implementation procedures for several new sections of the Act, including sections 303( c)( 2)( B) and 304( l).

The 1987 CWA Amendments added to, or amended, other CWA Sections related to toxics control. Section 304( l) ( 33 U. S. C. 1314( l)) was an important corollary amendment because it required States to take actions to identify waters adversely affected by toxic pollutants, particularly those waters entirely or substantially impaired by point sources. Section 304( l) entitled " Individual Control Strategies for Toxic Pollutants," requires in part, that States identify and list waterbodies where the designated uses specified in the applicable water quality standards cannot reasonably be expected to be achieved because of point source discharge of toxic pollutants. For each segment so identified, the State is required to develop individual control strategies to reduce the discharge of toxics from point sources so that in conjunction with existing controls on point and nonpoint sources, water quality standards will be attained. To assist the States in identifying waters under section 304( l), EPA's guidance listed a number of potential sources of available data for States to review. States generally assembled data for a broad spectrum of pollutants, including the priority toxic pollutants, which could be useful in complying with sections 304( l) and 303( c)( 2)( B). In fact, between February 1988 and October 1988, EPA assembled pollutant candidate lists for section 304( l) which were then transmitted to each jurisdiction. Thus, each State had a preliminary list of pollutants that had been identified as present in, or discharged to, surface waters. Such lists were limited by the quantity and distribution of available effluent and ambient monitoring data for priority toxic pollutants. This listing exercise further emphasized the need for water quality standards for toxic pollutants. Lack of standards increased the difficulty of identifying impaired waters. On the positive side, the data gathered in support of the 304( l) activity proved helpful in identifying those pollutants most obviously in need of water quality standards.

EPA, in devising guidance for section 303( c)( 2)( B), attempted to provide States the maximum flexibility that complied with the express statutory language but also with the overriding congressional objective: Prompt adoption and implementation of numeric toxics criteria. EPA believed that flexibility was important so that each State could comply with section 303( c)( 2)( B) and to the extent possible, accommodate its existing water quality standards regulatory approach. The options EPA identified are described in the next Section of this Preamble. EPA's program guidance was issued in final form on December 12, 1988 but was not substantially different from earlier drafts available for review by the States. The availability of the guidance was published in a Federal Register Notice on January 5, 1989 ( 54 FR 346).

3. EPA's Program Guidance for Section 303( c)( 2)( B)

EPA's section 303( c)( 2)( B) program guidance identified three options that could be used by a State to meet the requirement that the State adopt toxic pollutant criteria "* * * the discharge or presence of which in the affected waters could reasonably be expected to interfere with those designated uses adopted by the State, as necessary to support such designated uses." Option 1. Adopt statewide numeric criteria in State Water Quality Standards for all section 307( a) toxic pollutants for which EPA has developed criteria guidance, regardless of whether the pollutants are known to be present.

This option is the most comprehensive approach to satisfy the statutory requirements because it would include all of the priority toxic pollutants for which EPA has prepared section 304( a) criteria guidance for either or both aquatic life protection and human health protection. In addition to a simple adoption of EPA's section 304( a) guidance as standards, a State must select a risk level for those toxic pollutants which are carcinogens ( i. e., that cause, or may cause cancer in humans).

Many States found this Option attractive because it ensured comprehensive coverage of the priority toxic pollutants with scientifically defensible criteria without the need to conduct a resource intensive evaluation of the particular segments and pollutants requiring criteria. This option would also not be more costly to dischargers than other options because permit limits would only be based on the regulation of the particular toxic pollutants in their discharges and not on the total listing in the water quality standards. Thus, actual permit limits should be the same under any of the options.

Option 2. Adopt chemical specific numeric criteria for priority toxic pollutants that are the subject of EPA section 304( a) criteria guidance, where the State determines based on available information that the pollutants are present or discharged and can reasonably be expected to interfere with designated uses.

This option results in the adoption of numeric water quality standards for some subset of those pollutants for which EPA has issued section 304( a) criteria guidance based on a review of current information. To satisfy this Option, the guidance recommended that States use the data gathered during the section 304( l) water quality assessments as a starting point to identify those water segments that need water quality standards for priority toxic pollutants. That data would be supplemented by a State and public review of other data sources to ensure sufficient breadth of coverage to meet the statutory objective. Among the data available to be reviewed were: ( 1) Ambient water monitoring information, including those for the water column, sediment, and aquatic life ( e. g., fish tissue data); ( 2) NPDES permit applications and permittee self monitoring reports; ( 3) effluent guideline development documents, many of which contain priority toxic pollutant scans; ( 4) pesticide and herbicide application information and other records of pesticide or herbicide inventories; ( 5) public water supply source monitoring data noting pollutants with maximum contaminant levels ( MCLs); and ( 6) any other relevant information on toxic pollutants collected by Federal, State, industry, agencies, academic groups, or scientific organizations. EPA also recommended that States selecting this option adopt a translator provision similar to that described in Option 3 but applicable to all chemicals causing toxicity, and not just priority toxic pollutants.

This Option 2 review resulted in a State proposing new or revised water quality standards and providing an opportunity for public review and comment on the pollutants, criteria, and water bodies included. Throughout this process, EPA's Regional Offices were available to assist States by providing additional guidance and technical assistance on applying EPA's recommended criteria to particular situations in the States." ******************************************************************************************************************* Here is the second one. ( 56 FR 58420). If you would like, I can talk you through the process of obtaining it yourself.

Amendments to the Water Quality Standards Regulation To Establish the Numeric Criteria for Priority Toxic Pollutants Necessary to Bring All States Into Compliance With Section 303( c)( 2)( B) Federal Register, Volume: 56 , Issue: 223 , Page: 58420 ( 56 FR 58420) , Tuesday, November 19, 1991 Agency: Environmental Protection Agency( EPA) Document Type: Proposed Rules Code of Federal Regulations ( CFR): 40 CFR Part 131 Numbers: WH FRL 4029 2 Dates: Comment by: 19911219; Hearing: 19911219 Contact Information: William R. Diamond, 202 260 1315,; or; David K. Sabock, 202 260 1315,; or; R. Kent Ballentine, 202 260 1315 Action: Proposed rule Internal Data: ( FR Doc. 91 27270 Filed 11 18 91; 8: 45 am)

SUMMARY: This proposed rulemaking would promulgate the chemical specific, numeric criteria for priority toxic pollutants necessary to bring all States into compliance with the requirements of section 303( c)( 2)( B) of the Clean Water Act ( CWA). States which have been determined by EPA to fully comply with section 303( c)( 2)( B) requirements would not be affected by today's proposed rulemaking. The proposed rulemaking addresses several situations. For a few States EPA would promulgate only a limited number of criteria because the Agency previously identified, in disapproval letters to such States, the specific priority toxic pollutants that require new or revised criteria. For these States, EPA would promulgate Federal criteria only for the priority toxic pollutants which require new or revised criteria. In the vast majority of States, EPA would promulgate, at a minimum, broadly applicable Federal criteria for all priority toxic pollutants for which EPA has issued section 304( a) water quality criteria guidance and that are not the subject of approved State criteria. For those priority toxic pollutants included in today's proposed rulemaking where the section 304( a) criteria recommendation is based on carcinogenicity, the proposed criteria are based on an incremental one in one million cancer risk level ( i. e., 10 6). The primary focus of this rule is the inclusion of the water quality criteria for pollutant( s) in State standards as necessary to support water quality based control programs. The Agency is accepting comment on the criteria proposed in today's rule. However, Congress has established a very ambitious schedule for the promulgation of the final criteria. The statutory deadline in section 303( c)( 4) clearly indicates that Congress intended the Agency to move very expeditiously when Federal action is warranted. The Agency believes that the limited time available for promulgation of the regulation can be used most efficiently and effectively by addressing those issues that have not already come before the Agency.

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 131 ( WH FRL 4029 2)

Amendments to the Water Quality Standards Regulation To Establish the Numeric Criteria for Priority Toxic Pollutants Necessary to Bring All States Into Compliance With Section 303( c)( 2)( B)

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

SUMMARY: This proposed rulemaking would promulgate the chemical specific, numeric criteria for priority toxic pollutants necessary to bring all States into compliance with the requirements of section 303( c)( 2)( B) of the Clean Water Act ( CWA). States which have been determined by EPA to fully comply with section 303( c)( 2)( B) requirements would not be affected by today's proposed rulemaking.

The proposed rulemaking addresses several situations. For a few States EPA would promulgate only a limited number of criteria because the Agency previously identified, in disapproval letters to such States, the specific priority toxic pollutants that require new or revised criteria. For these States, EPA would promulgate Federal criteria only for the priority toxic pollutants which require new or revised criteria. In the vast majority of States, EPA would promulgate, at a minimum, broadly applicable Federal criteria for all priority toxic pollutants for which EPA has issued section 304( a) water quality criteria guidance and that are not the subject of approved State criteria.

For those priority toxic pollutants included in today's proposed rulemaking where the section 304( a) criteria recommendation is based on carcinogenicity, the proposed criteria are based on an incremental one in one million cancer risk level ( i. e., 10 6).

The primary focus of this rule is the inclusion of the water quality criteria for pollutant( s) in State standards as necessary to support water quality based control programs. The Agency is accepting comment on the criteria proposed in today's rule. However, Congress has established a very ambitious schedule for the promulgation of the final criteria. The statutory deadline in section 303( c)( 4) clearly indicates that Congress intended the Agency to move very expeditiously when Federal action is warranted. The Agency believes that the limited time available for promulgation of the regulation can be used most efficiently and effectively by addressing those issues that have not already come before the Agency.

DATES: All written comments received on or before December 19, 1991, will be considered in the preparation of any final rulemaking.

A public hearing will be held on December 19, 1991, in Washington, DC, beginning at 9 a. m. The hearing officer reserves the right to limit oral testimony to 10 minutes, if necessary.

ADDRESSES: Comments, in quadruplicate, on this proposed rule should be addressed to William R. Diamond, Director, Standards and Applied Science Division ( WH 585), Office of Science and Technology, 401 M Street, SW., Washington, DC 20460 ( Telephone: 202 260 1315). The public may inspect the administrative record for this rulemaking, including documentation supporting the aquatic life and human health criteria, and all comments received on this proposed rule at EPA's Public Information Reference Unit, EPA Library, room 2904, Waterside Mall, 401 M Street, SW., Washington, DC 20460 ( Telephone: 202 260 5926) on weekdays during the Agency's normal business hours of 8 a. m. to 4: 30 p. m. Each of EPA's ten Regional offices will also have copies for public inspection and copying of the administrative records for the States in that Region. These records will be available in the Water Management Divisions of each respective Regional office. A reasonable fee will be charged for photocopies.

The public hearing will be held in the EPA auditorium, 401 M Street, SW., Washington, DC.

FOR FURTHER INFORMATION CONTACT: David K. Sabock or R. Kent Ballentine, Telephone 202 260 1315. SUPPLEMENTARY INFORMATION: This preamble is organized according to the following outline: A. Introduction and Overview 1. Introduction 2. Overview B. Statutory and Regulatory Background 1. Pre Water Quality Act Amendments of 1987 ( P. L. 100 4) 2. The Water Quality Act Amendments of 1987 ( P. L. 100 4) a. Description of the New Requirements b. EPA's Initial Implementing Actions for Sections 303( c) and 304( l) 3. EPA's Program Guidance for Section 303( c)( 2)( B) 4. Revisions to the Water Quality Standards Regulation to Incorporate the Requirements of Section 303( c)( 2)( B) C. State Actions Pursuant to Section 303( c)( 2)( B) D. Determining State Compliance With Section 303( c)( 2)( B) 1. EPA's Review of State Water Quality Standards for Toxics 2. Determining Current Compliance Status E. Rationale and Approach for Developing Today's Proposed Rulemaking 1. Legal Basis 2. Approach for Developing Today's Proposed Rulemaking 3. Approach for States That Fully Comply Subsequent to Issuance of Today's Proposed Rulemaking F. Derivation of Proposed Criteria 1. Section 304( a) Criteria Process 2. Aquatic Life Criteria 3. Criteria for Human Health 4. Section 304( a) Human Health Criteria Excluded 5. Cancer Risk Level Proposed 6. Applying EPA's Nationally Derived Criteria to State Waters G. Description of the Proposed Rule 1. Scope 2. EPA Criteria for Priority Toxic Pollutants 3. Applicability H. Specific Issues for Public Comment I. Executive Order 12291 J. Regulatory Flexibility Act K. Paperwork Reduction Act A. Introduction and Overview 1. Introduction This section of the preamble introduces the topics which are addressed subsequently and provides a brief overview of EPA's basis and rationale for proposing to promulgate Federal criteria for priority toxic pollutants. Section B of this preamble presents a description of the evolution of the Federal Government's efforts to control toxic pollutants beginning with a discussion of the authorities in the Federal Water Pollution Control Act Amendments of 1972. Also described in some detail is the development of the water quality standards review and revision process which provides for establishing both narrative goals and enforceable numeric requirements for controlling toxic pollutants. This discussion includes the recent changes enacted in the 1987 Clean Water Act Amendments which are the basis for this proposed rulemaking. Section C summarizes State efforts since 1987 to comply with the requirements of Section 303( c)( 2)( B). Section D describes EPA's procedure for determining whether a State has fully complied with Section 303( c)( 2)( B). Section E sets out the rationale and approach for developing today's proposed rulemaking, including a discussion of EPA's legal basis. Section F describes the development of the criteria included in today's proposed rulemaking. Section G summarizes the provisions of the proposed rule and Section H highlights certain issues raised by the proposal for public comment. Sections I, J, and K address the requirements of Executive Order 12291, the Regulatory Flexibility Act, and the Paperwork Reduction Act, respectively. Section L provides a list of subjects covered in today's proposed rulemaking.

2. Overview Today's proposed rulemaking to establish Federal toxics criteria for States is important for a number of environmental, programmatic and legal reasons.

First, control of toxic pollutants in surface waters is an important priority to achieve the Clean Water Act's goals and objectives. The most recent National Water Quality Inventory indicates that one third of monitored river miles, lake acres, and coastal waters have elevated levels of toxics. Forty seven States and Territories have reported elevated levels of toxic pollutants in fish tissues. States have issued a total of 586 fishing advisories and 135 bans, attributed mostly to industrial discharges and land disposal.

The absence of State water quality standards for toxic pollutants undermines EPA's overall toxic control efforts to address these problems. Without clearly established water quality goals, the effectiveness of many of EPA's water programs is jeopardized. Permitting, enforcement, coastal water quality improvement, fish tissue quality protection, certain nonpoint source controls, drinking water quality protection, and ecological protection all depend to a significant extent on complete and adequate water quality standards. Numeric criteria for toxics are essential to the process of controlling toxics because they allow States and EPA to evaluate the adequacy of existing and potential control measures to protect aquatic ecosystems and human health. Formally adopted standards form the legal basis for including water quality based effluent limitations in NPDES permits to control toxic pollutant discharges. The critical importance of controlling toxic pollutants has been recognized by Congress and is reflected, in part, by the addition of section 303( c)( 2)( B) to the Act. Congressional impatience with the pace of State toxics control programs is well documented in the legislative history of the 1987 CWA amendments. In order to protect human health, aquatic ecosystems, and successfully implement toxics controls, EPA believes that all actions which are available to the Agency must be taken to ensure that all necessary numeric criteria for priority toxic pollutants are established in a timely manner.

Second, as States and EPA continue the transition from an era of primarily technology based controls to an era in which technology based controls are integrated with water quality based controls, it is important that EPA ensures timely compliance with CWA requirements. An active Federal role is essential to assist States in getting in place complete toxics criteria as part of their pollution control programs. While most States recognize the need for enforceable water quality standards for toxic pollutants, their recent adoption efforts have often been stymied by a variety of factors including limited resources, competing environmental priorities, and difficult scientific, policy and legal challenges. Although many water quality criteria for toxic pollutants have been available since 1980 and the water quality standards regulation has required State adoption of numeric criteria for toxic pollutants since 1983 ( see 40 CFR 131.11), a preliminary assessment of the water quality standards for all States in February of 1990 showed that only six States had established fully acceptable criteria for toxic pollutants. This rate of toxics criteria adoption is contrary to the CWA requirements and is a reflection of the difficulties faced by States. EPA should exercise its CWA authorities to assist States in such circumstances.

EPA's proposed action will also help restore equity among the States. The CWA is designed to ensure all waters are sufficiently clean to protect public health and the environment. The CWA allows some flexibility and differences among States in their adopted and approved water quality standards, but it was not designed to reward inaction and inability to meet statutory requirements.

Although most States have made some progress toward satisfying CWA requirements, many appear to have failed to fully comply with section 303( c)( 2)( B). The CWA assigns EPA the legal responsibility to promulgate standards where necessary to meet the requirements of the Act. Where States have not satisfied the CWA requirement to adopt water quality standards for toxic pollutants, which was re emphasized by Congress in 1987, it is imperative that EPA take action.

EPA's ability to oversee State standards setting activities and to correct deficiencies in State water quality standards is critical to the effective implementation of section 303( c)( 2)( B). This proposed rulemaking is a necessary and important component of EPA's implementation of section 303( c)( 2)( B) as well as EPA's overall efforts to control toxic pollutants in surface waters.

B. Statutory and Regulatory Background 1. Pre Water Quality Act Amendments of 1987 ( Pub. L. 100 4)

Section 303( c) of the 1972 Federal Water Pollution Control Act Amendments ( FWPCA) ( 33 U. S. C. 1313( c)) established the statutory basis for the current water quality standards program. It completed the transition from the previously established program of water quality standards for interstate waters to one requiring standards for all surface waters of the United States. Although the major innovation of the 1972 FWPCA was technology based controls, Congress maintained the concept of water quality standards both as a mechanism to establish goals for the Nation's waters and as a regulatory requirement when standardized technology controls for point source discharges and/ or nonpoint source controls were inadequate. In recent years these so called water quality based controls have received new emphasis by Congress and EPA in the continuing quest to enhance and maintain water quality to protect the public health and welfare.

Briefly stated, the key elements of section 303( c) are: ( a) A water quality standard is defined as the designated beneficial uses of a water segment and the water quality criteria necessary to support those uses; ( b) The minimum beneficial uses to be considered by States in establishing water quality standards are specified as public water supplies, propagation of fish and wildlife, recreation, agricultural uses, industrial uses and navigation; ( c) A requirement that State standards must protect public health or welfare, enhance the quality of water and serve the purposes of the Clean Water Act; ( d) A requirement that States must review their standards at least once each three year period using a process that includes public participation; ( e) The process for EPA review of State standards which may ultimately result in the promulgation of a superseding Federal rule in cases where a State's standards are not consistent with the applicable requirements of the CWA, or in situations where the Agency determines Federal standards are necessary to meet the requirements of the Act.

Another major innovation in the 1972 FWPCA was the establishment of the National Pollutant Discharge Elimination System ( NPDES) which requires point source dischargers to obtain a permit before legally discharging to the waters of the United States. In addition to the permit limits established on the basis of technology ( e. g. effluent limitations guidelines), the Act requires dischargers to meet instream water quality standards. ( See section 301( b)( 1)( C), 33 U. S. C. 1311( b)( 1)( C)).

Thus water quality standards serve a dual function under the Clean Water Act regulatory scheme. Standards establish narrative and numeric definitions and quantification of the Act's goals and policies ( see section 101, 33 U. S. C. 1251) which provide a basis for identifying impaired waters. Water quality standards also establish regulatory requirements which are translated into specific discharge requirements. In order to fulfill this critical function, adopted State criteria must contain sufficient parametric coverage to protect both human health and aquatic life.

In its initial efforts to control toxic pollutants, the FWPCA, pursuant to section 307, required EPA to designate a list of toxic pollutants and to establish toxic pollutant effluent standards based on a formal rulemaking record. Such rulemaking required formal hearings, including cross examination of witnesses. EPA struggled with this unwieldy process and ultimately promulgated effluent standards for six toxic pollutants, pollutant families or mixtures. ( See 40 CFR part 129.) Congress amended section 307 in the 1977 Clean Water Act Amendments by endorsing the Agency's alternative procedure of regulating toxic pollutants by use of effluent limitation guidelines, by amending the procedure for establishing toxic pollutant effluent standards to provide for more flexibility in the hearing process for establishing a record, and by directing the Agency to include sixty five specific pollutants or classes of pollutants on the toxic pollutant list. EPA published the required list on January 31, 1978 ( 43 FR 4109). This toxic pollutant list was the basis on which EPA's efforts on criteria development for toxics was focused.

During planning efforts to develop effluent limitation guidelines and water quality criteria, the list of sixty five toxic pollutants was judged too broad as some of the pollutants were, in fact, general families or classes of organic compounds consisting of many individual chemicals. EPA selected key chemicals of concern within the 65 families of pollutants and identified a more specific list of 129 priority toxic pollutants. Three volatile chemicals were removed from the list ( see 46 FR 2266, January 8, 1981; 46 FR 10723, February 4, 1981) so that at present there are 126 priority toxic pollutants. This list is published as Appendix A to 40 CFR part 423. Another critical section of the 1972 FWPCA was section 304( a) ( 33 U. S. C. 1314( a)). Section 304( a)( 1) provides, in pertinent part, that EPA * * * shall develop and publish * * * criteria for water quality accurately reflecting the latest scientific knowledge ( A) on the kind and extent of all identifiable effects on health and welfare including, but not limited to, plankton, fish, shellfish, wildlife, plant life, shorelines, beaches, esthetics, and recreation which may be expected from the presence of pollutants in any body of water, * * * and ( C) on the effects of pollutants on biological community diversity, productivity, and stability, * * *

In order to avoid confusion, it must be recognized that the Clean Water Act uses the term " criteria" in two separate ways. In section 303( c), which is discussed above, the term is part of the definition of a water quality standard. That is, a water quality standard is comprised of designated uses and the criteria necessary to protect those uses. Thus, States are required to adopt regulations or statutes which contain legally achievable criteria. However, in section 304( a), the term criteria is used in a scientific sense and EPA develops recommendations which States consider in adopting regulatory criteria.

In response to this legislative mandate and an earlier similar statutory requirement, EPA and a predecessor agency have produced a series of water quality criteria documents. Early Federal efforts were Water Quality Criteria ( 1968 " Green Book") and Quality Criteria for Water ( 1976 " Red Book"). EPA also sponsored a contract effort with the National Academy of Science National Academy of Engineering which resulted in Water Quality Criteria, 1972 ( 1973 " Blue Book"). These early efforts were premised on the use of literature reviews and the collective scientific judgment of Agency and advisory panels. However, when faced with the list of 65 toxic pollutants and the need to develop criteria for human health as well as aquatic life, the Agency determined that new procedures were necessary. Continued reliance solely on existing scientific literature was now inadequate, since for many pollutants essential information was not available. EPA scientists developed formal methodologies for establishing scientifically defensible criteria. These were subjected to review by the Agency's Science Advisory Board and the public. This effort culminated on November 28, 1980, when the Agency published criteria development guidelines for aquatic life and for human health, along with criteria for 64 toxic pollutants. ( See 45 FR 79318.) Since that initial publication, the aquatic life methodology was slightly amended ( 50 FR 30784, July 29, 1985) and additional criteria were proposed for public comment and finalized as Agency criteria guidance. EPA summarized the available criteria information in Quality Criteria for Water 1986 ( 1986 " Gold Book") which is updated from time to time. However, the individual criteria documents, as updated, are the official guidance documents.

EPA's criteria documents provide a comprehensive toxicological evaluation of each chemical. For toxic pollutants, the documents tabulate the relevant acute and chronic toxicity information for aquatic life and derive the criteria maximum concentrations ( acute criteria) and criteria continuous concentrations ( chronic criteria) which the Agency recommends to protect aquatic life resources. For human health criteria, the document provides the appropriate reference doses, and if appropriate the carcinogenic slope factors, and derives recommended criteria. The details of this process are described more fully in a following part of this preamble.

Programmatically, EPA's initial efforts were aimed at converting a program focused on interstate waters into one addressing all interstate and intrastate surface waters of the United States. Guidance was aimed at the inclusion of traditional water quality parameters to protect aquatic life ( e. g., pH, temperature, dissolved oxygen and a narrative " free from toxicity" provision), recreation ( e. g., bacteriological criteria) and general aesthetics ( e. g., narrative " free from nuisance" provisions). EPA also required State adoption of an antidegradation policy to maintain existing high quality or ecologically unique waters as well as maintain improvements in water quality as they occur.

The initial water quality standards regulation was actually a part of EPA's water quality management regulations implementing section 303( e) ( 33 U. S. C. 1313( e)) of the Act. It was not comprehensive and did not address toxics or any other criteria specifically. Rather, it simply required States to adopt appropriate water quality criteria necessary to support designated uses. ( See 40 CFR 130.17 as promulgated in 40 FR 55334, November 28, 1975).

After several years of effort and faced with increasing public and Congressional concerns about toxic pollutants, EPA realized that proceeding under section 307 of the Act would not comprehensively address in a timely manner the control of toxics through either toxic pollutant effluent standards or effluent limitations guidelines because these controls are only applicable to specific types of discharges. EPA sought a broader, more generally applicable mechanism and decided to vigorously pursue the alternative approach of EPA issuance of scientific water quality criteria documents which States could use to adopt enforceable water quality standards. These in turn could be used as the basis for establishing State and EPA permit discharge limits pursuant to section 301( b)( 1)( C) which requires NPDES permits to contain * * * any more stringent limitation, including those necessary to meet water quality standards * * *, or required to implement any applicable water quality standard established pursuant to this Act.

Thus, the adoption by States of appropriate toxics criteria applicable to their surface waters, such as those recommended by EPA in its criteria documents, would be translated by regulatory agencies into point source permit limits. Through the use of water quality standards, all discharges of toxics are subject to permit limits and not just those discharged by particular industrial categories. In order to facilitate this process, the Agency amended the water quality standards regulation to explicitly address toxic criteria requirements in State standards. The culmination of this effort was the promulgation of the present water quality standards regulation on November 8, 1983 ( 40 CFR part 131, 48 FR 51400).

The current water quality standards regulation ( 40 CFR part 131) is much more comprehensive than its predecessor. The regulation addresses in detail both the beneficial use component and the criteria component of a water quality standard. Section 131.11 of the regulation requires States to review available information and,

* * * to identify specific water bodies where toxic pollutants may be adversely affecting water quality or the attainment of the designated water use or where the levels of toxic pollutants are at a level to warrant concern and must adopt criteria for such toxic pollutants applicable to the water body sufficient to protect the designated use.

The regulation provided that either or both numeric and narrative criteria may be appropriately used in water quality standards.

EPA's water quality standards emphasis since the early 1980' s reflected the increasing importance placed on controlling toxic pollutants. States were strongly encouraged to adopt criteria in their standards for the priority toxic pollutants, especially where EPA had published criteria guidance under Section 304( a) of the Act.

Under the statutory scheme, during the 3 year triennial review period following EPA's 1980 publication of water quality criteria for the protection of human health and aquatic life, States should have reviewed those criteria and adopted standards for many priority toxic pollutants. In fact, State response to EPA's criteria publication and toxics initiative was disappointing. A few States adopted large numbers of numeric toxics criteria, although primarily for the protection of aquatic life. Most other States adopted few or no water quality criteria for priority toxic pollutants. Some relied on a narrative " free from toxicity" criterion, and so called " action levels" for toxic pollutants or occasionally calculated site specific criteria. Few States addressed the protection of human health by adopting numeric human health criteria. In support of the November, 1983, water quality standards rulemaking, EPA issued program guidance entitled, Water Quality Standards Handbook ( December 1983) simultaneously with the publication of the final rule. The foreword to that guidance noted EPA's two fold water quality based approach to controlling toxics: chemical specific numeric criteria and biological testing in whole effluents or ambient waters to comply with narrative " no toxics in toxic amounts" standards. More detailed programmatic guidance on the application of biological testing was provided in the Technical Support Document for Water Quality Based Toxics Control ( TSD) ( EPA 440/ 4 85 032, September 1985). This document provided the needed information to convert chemical specific and biologically based criteria into water quality standards for ambient receiving waters and permit limits for discharges to those waters. The TSD focused on the use of bioassay testing of effluents ( so called whole effluent testing or WET methods) to develop effluent limitations within discharge permits. Such effluent limits were designed to implement the " free from toxicity" narrative standards in State water quality standards. The TSD also focused on water quality standards. Procedures and policy were presented for appropriate design flows for EPA's section 304( a) acute and chronic criteria. EPA revised the TSD. ( Technical Support Document for Water Quality based Toxics Control, EPA 505/ 2 90 001, March 1991.) A Notice of Availability was published in the Federal Register on April 4, 1991 ( 56 FR 13827). All references in this Preamble are to the revised TSD.

The Water Quality Standards Handbook and the TSD are examples of EPA's efforts and assistance that were intended to help, encourage and support the States in adopting appropriate water quality standards for the protection of their waters against the deleterious effects of toxic pollutants. In some States, more and more numeric criteria for toxics were being included as well as more aggressive use of the " free from toxics" narratives in setting protective NPDES permit limits. However, by the time of Congressional consideration and action on the CWA reauthorization, most States had adopted few, if any, water quality standards for priority toxic pollutants.

State practices of developing case by case effluent limits using procedures that were not standardized in State regulations made it difficult to ascertain whether such procedures were consistently applied. The use of approaches to control toxicity that did not rely on the statewide adoption of numeric criteria for the priority toxic pollutants generated frustration in Congress. Senator Robert Stafford, first chairman and then ranking minority member of the authorizing committee, noted during the Senate debate:

An important problem in this regard is that few States have numeric ambient criteria for toxic pollutants. The lack of ambient criteria ( for toxic pollutants) make it impossible to calculate additional discharge limitations for toxics * * * It is vitally important that the water quality standards program operate in such a way that it supports the objectives of the Clean Water Act to restore and maintain the integrity of the Nation's Waters. ( bracketed material added). A Legislative History of the Water Quality Act of 1987 ( Pub. L. 100 4), Senate Print 100 144, USGPO, November 1988 at page 1324.

Other comments in the legislative history similarly note the Congressional perception that the States were failing to aggressively address toxics and that EPA was not using its oversight role to push the States to move more quickly and comprehensively. Thus Congress developed the water quality standards amendments to the Clean Water Act for reasons similar to those strongly stated during the Senate debate by a chief sponsor, Senator John Chaffee,

A cornerstone of the bill's new toxic pollution control requirements is the so called beyond BAT program. * * * Adopting the beyond BAT provisions will assure that EPA continues to move forward rapidly on the program. * * * If we are going to repair the damage to those water bodies that have become highly degraded as a result of toxic substances, we are going to have to move forward expeditiously on this beyond BAT program. The Nation cannot tolerate endless delays and negotiations between EPA and States on this program. Both entities must move aggressively in taking the necessary steps to make this program work within the time frame established by this Bill * * * Ibid, at page 1309. This Congressional impatience with the pace of State and EPA progress and an appreciation that the lack of State standards for toxics undermined the effectiveness of the entire CWA based scheme, resulted in the 1987 adoption of stringent new water quality standard provisions in the Water Quality Act amendments.

2. The Water Quality Act Amendments of 1987 ( Pub. L. 100 4)

a. Description of the New Requirements The 1987 Amendments to the Clean Water Act added section 303( c)( 2)( B) which provides: Whenever a State reviews water quality standards pursuant to paragraph ( 1) of this subsection, or revises or adopts new standards pursuant to this paragraph, such State shall adopt criteria for all toxic pollutants listed pursuant to section 307( a)( 1) of this Act for which criteria have been published under section 304( a), the discharge or presence of which in the affected waters could reasonably be expected to interfere with those designated uses adopted by the State, as necessary to support such designated uses. Such criteria shall be specific numerical criteria for such toxic pollutants. Where such numerical criteria are not available, whenever a State reviews water quality standards pursuant to paragraph ( 1), or revises or adopts new standards pursuant to this paragraph, such State shall adopt criteria based on biological monitoring or assessment methods consistent with information published pursuant to section 304( a)( 8). Nothing in this section shall be construed to limit or delay the use of effluent limitations or other permit conditions based on or involving biological monitoring or assessment methods or previously adopted numerical criteria.

b. EPA's Initial Implementing Actions for Sections 303( c) and 304( l)

This new requirement to the existing water quality standards review and revision process of section 303( c) did not change the existing procedural or timing provisions. For example, section 303( c)( 1) still requires that States review their water quality standards at least once each 3 year period and transmit the results to EPA for review. EPA's oversight and promulgation authorities and statutory schedules in section 303( c)( 4) were likewise unchanged. Rather, the provision required the States to place heavy emphasis on adopting numeric chemical specific criteria for toxic pollutants ( i. e., rather than just narrative approaches) during the next triennial review cycle. As discussed in the previous section, Congress was frustrated that States were not using the numerous section 304( a) criteria that EPA had developed, and was continuing to develop, to assist States in controlling the discharge of priority toxic pollutants. Congress therefore took an usual action; for the first time in the history of the Clean Water Act, it explicitly mandated that States adopt numeric criteria for specific toxic pollutants.

In response to this new Congressional mandate, EPA redoubled its efforts to promote and assist State adoption of water quality standards for priority toxic pollutants. EPA's efforts included the development and issuance of guidance to the States on acceptable implementation procedures for several new sections of the Act, including Sections 303( c)( 2)( B) and 304( l).

The 1987 CWA Amendments added to, or amended, other CWA sections related to toxics control. Section 304( l) ( 33 U. S. C. 1314( l)) was an important corollary amendment because it required States to take actions to identify waters adversely affected by toxic pollutants, particularly those waters entirely or substantially impaired by point sources. Section 304( l) entitled " Individual Control Strategies for Toxic Pollutants," requires in part, that States identify and list waterbodies where the designated uses specified in the applicable water quality standards cannot reasonably be expected to be achieved because of point source discharge of toxic pollutants. For each segment so identified, the State is required to develop individual control strategies to reduce the discharge of toxics from point sources so that in conjunction with existing controls on point and nonpoint sources, water quality standards will be attained. To assist the States in identifying waters under section 304( l), EPA's guidance listed a number of potential sources of available data for States to review. States generally assembled data for a broad spectrum of pollutants, including the priority toxic pollutants, which could be useful in complying with sections 304( l) and 303( c)( 2)( B). In fact, between February 1988 and October 1988, EPA assembled pollutant candidate lists for section 304( l) which were then transmitted to each jurisdiction. Thus, each State had a preliminary list of pollutants that had been identified as present in, or discharged to, surface waters. Such lists were limited by the quantity and distribution of available effluent and ambient monitoring data for priority toxic pollutants. This listing exercise further emphasized the need for water quality standards for toxic pollutants. Lack of standards increased the difficulty of identifying impaired waters. On the positive side, the data gathered in support of the 304( l) activity proved helpful in identifying those pollutants most obviously in need of water quality standards.

EPA, in devising guidance for section 303( c)( 2)( B), attempted to provide the maximum flexibility in its options that not only complied with the express statutory language but also with the ultimate congressional objective: Prompt adoption of numeric toxics criteria. EPA believed that flexibility was important so that each State could comply with section 303( c)( 2)( B), accommodate its existing water quality standards regulatory approach, and not violate the resource constraints specific to the State. These options are described in the next Section of this preamble. EPA's program guidance was issued in final form on December 12, 1988 but was not substantially different from earlier drafts available for review by the States. The availability of the guidance was published in a Federal Register notice on January 5, 1989 ( 54 FR 346).

3. EPA's Program Guidance for Section 303( c)( 2)( B)

EPA's section 303( c)( 2)( B) program guidance identified three options that could be used by a State to meet the requirement that the State adopt toxic pollutant criteria "* * * the discharge or presence of which in the affected waters could reasonably be expected to interfere with those designated uses adopted by the State, as necessary to support such designated uses." Option 1. Adopt statewide numeric criteria in State Water Quality Standards for all section 307( a) toxic pollutants for which EPA has developed criteria guidance, regardless of whether the pollutants are known to be present.

This option is the most comprehensive approach to satisfy the statutory requirements because it would include all of the priority toxic pollutants for which EPA has prepared section 304( a) criteria guidance for either or both aquatic life protection and human health protection. In addition to a simple adoption of EPA's section 304( a) guidance as standards, a State must select a risk level for those toxic pollutants which EPA believes are carcinogens ( i. e., that cause, or may cause cancer in humans). EPA also recommended that States should supplement this comprehensive approach with a water quality standard variance and/ or a site specific criteria methodology to provide the opportunity for flexibility in applying criteria.

Many States found this option attractive because it ensured comprehensive coverage of the priority toxic pollutants with scientifically defensible criteria without the need to conduct a resource intensive evaluation of the particular segments and pollutants requiring criteria or future prevalence of priority toxic pollutants in their waters. It was also determined this option would not be more costly to dischargers than the other options because permit limits would only be based on the regulation of the particular toxic pollutants in their discharges and not on the total listing in the water quality standards. Thus, actual permit limits should be the same under any of the options.

Option 2. Adopt chemical specific numeric criteria for priority toxic pollutants that are the subject of EPA section 304( a) criteria guidance, where the State determines based on available information that the pollutants are present or discharged and can reasonably be expected to interfere with designated uses.

This option results in the adoption of numeric water quality standards for some subset of those pollutants for which EPA has issued section 304( a) criteria guidance based on a review of current information. To satisfy this option, the guidance recommended that States use the data gathered during the section 304( l) water quality assessments as a starting point to identify those water segments that need water quality standards for priority toxic pollutants. That data would be supplemented by a State and public review of other data sources to ensure sufficient breadth of coverage to meet the statutory objective. Among the available data to be reviewed were: ( 1) Ambient water monitoring data, including those for the water column, sediment, and aquatic life ( e. g., fish tissue data); ( 2) NPDES permit applications and permittee self monitoring reports; ( 3) effluent guideline development documents, many of which contain priority toxic pollutant scans; ( 4) pesticide and herbicide application information and other records of pesticide or herbicide inventories; ( 5) public water supply source monitoring data noting pollutants with maximum contaminant levels ( MCLs); and ( 6) any other relevant information on toxic pollutants collected by Federal, State, industry, agencies, academic groups, or scientific organizations. EPA also recommended that States adopt a translator provision similar to that described in Option 3 but applicable to all chemicals causing toxicity, and not just priority toxic pollutants.

This Option 2 review resulted in a State proposing new or revised water quality standards and providing an opportunity for public review and comment on the pollutants, criteria, and water bodies included. Throughout this process, EPA's Regional Offices were available to assist States by providing additional guidance and technical assistance on applying EPA's recommended criteria to particular situations in the States.

Option 3. Adopt a procedure to be applied to a narrative water quality standard provision prohibiting toxicity in receiving waters. Such procedures would be used by the State in calculating derived numeric criteria which must be used for all purposes under section 303( c) of the CWA. At a minimum, such criteria need to be developed for section 307( a) toxic pollutants, as necessary to support designated uses, where these pollutants are discharged or present in the affected waters and could reasonably be expected to interfere with designated uses.

The combination of a narrative standard ( e. g., " free from toxics in toxic amounts") and an approved translator mechanism as part of a State's water quality standards satisfies the requirements of section 303( c)( 2)( B). As noted above, such a procedure is also a valuable supplement to either option 1 or 2. There are several regulatory and scientific requirements EPA's guidance specifies are essential to ensure acceptable scientific quality and full involvement of the public and EPA in this approach. Briefly stated these are: ** The procedure ( i. e., narrative criterion and translator) must be used to calculate numeric water quality criteria; ** The State must demonstrate to EPA that the procedure results in numeric criteria that are sufficiently protective to meet the goals of the Act; ** The State must provide for full opportunity for public participation during the adoption of the procedure; ** The procedure must be formally adopted as a State rule and be mandatory in application; and ** The procedure must be submitted for review and approval by EPA as part of the State's water quality standards regulation.

Several States currently apply translators that have been approved by EPA. The scientific elements of a translator are similar to EPA's 304( a) criteria methodologies when applied on a site specific basis. For example, aquatic criteria are developed using a sufficient number and diversity of aquatic species representative of the biological assemblage of a particular water body. Human health criteria focus on determining appropriate exposure conditions ( e. g. amount of aquatic life consumed per person per day) rather than underlying pollutant toxicity. The results of the procedures are scientifically defensible criteria that are protective for the site's particular conditions. EPA review of translator procedures includes an evaluation of the scientific merit of the procedure using the Section 304( a) methodolgy as a guide.

Ideally, States adopting option 3 translator procedures should prepare a preliminary list of criteria and specify the waters the criteria apply to at the time of adoption. Although under option 3 the State retains flexibility to derive new criteria without revising the adopted standards, establishing this preliminary list of derived criteria at the time of the triennial review will assist the public in determining the scope of the adopted standards, and help ensure that the State ultimately complies with the requirement to establish criteria for all pollutants that can " reasonably be expected" to interfere with uses. EPA believes that States selecting solely option 3 should prepare an analysis similar to that required of option 2 States at the time of the triennial review.

EPA's December 1988 guidance also addressed the timing issue for State compliance with section 303( c)( 2)( B). The statutory directive was clear: All State standards triennial reviews initiated after passage of the Act must include a consideration of numeric toxic criteria.

The structure of section 303( c) is to require States to review their water quality standards at least once each three year period. Section 303( c)( 2)( B) instructs States to include reviews for toxics criteria whenever they initiate a triennial review. EPA initially looked at February 4, 1990, the 3 year anniversary of the 1987 CWA amendments, as a convenient point to index State compliance. The April 1990 Federal Register notice used this index point for the preliminary assessment. However, some States were very nearly completing their State administrative processes for ongoing reviews when the 1987 amendments were enacted and could not legally amend those proceedings to address additional toxics criteria. Therefore, in the interest of fairness, and to provide such States a full 3 year review period, EPA's FY 1990 Agency Operating Guidance provided that " By the end of the FY 88 90 triennium, States should have completed adoption of numeric criteria to meet the section 303( c)( 2)( B) requirements." ( p. 48.) The FY 88 90 triennium ended on September 30, 1990.

Clean Water Act section 303( c) does not provide penalties for States that do not complete timely water quality standards reviews. In no previous case has the EPA Administrator found that State failure to complete a review within three years jeopardized the public health or welfare to such an extent that promulgation of Federal standards pursuant to section 303( c)( 4)( B) was justified. The pre 1987 CWA never mandated State adoption of priority toxic pollutants or other specific criteria. EPA relied on its water quality standards regulation ( 40 CFR 131.11) and its criteria and program guidance to the States on appropriate parametric coverage in State water quality standards, including toxic pollutants. However, because of Congressional concern exhibited in the legislative history for the 1987 Clean Water Act amendments regarding undue delays by States and EPA, and because States have been explicitly required to adopt numeric criteria for appropriate priority toxic pollutants since 1963, the Agency in this proposed rulemaking is proceeding pursuant to section 303( c)( 4)( B) and 40 CFR 131.22( b).

4. Revisions to the Water Quality Standards Regulation to Incorporate the Requirements of Section 303( c)( 2)( B)

In a rulemaking separate from today's proposal, EPA intends to propose amendments to the Water Quality Standards Regulation to incorporate the requirements of section 303( c)( 2)( B). EPA views the effects of that intended rulemaking to be prospective only. EPA's expected regulatory change would provide principally more consistency among the States in their approaches to adopting appropriate toxic and other criteria in future triennial reviews.

The current requirements for water quality criteria in State water quality standards are addressed in 40 CFR 131.11. EPA's intended rulemaking will propose amendments to this section and incorporate the three options described in its December 12, 1988 guidance. Of special concern are the specific requirements for the translator provision described as option 3.

The current regulation at 40 CFR part 131 in conjunction with the statutory language provides a clear and unambiguous basis and process for today's proposed Federal promulgation.

C. State Actions Pursuant to Section 303( c)( 2)( B) There has been substantial progress by many States in the adoption, and EPA approval, of water quality standards for toxic pollutants. For example, for freshwater aquatic life uses, the average number of priority toxic pollutants with criteria adopted has tripled from ten per State in 1986 to thirty per State on February 4, 1990. In addition, the number of States with at least some aquatic life criteria adopted has increased from thirty three in April 1986 to forty five as of February 4, 1990.

Furthermore, virtually all States have at least proposed new toxics criteria for priority toxic pollutants since section 303( c)( 2)( B) was added to the CWA in February of 1987. Unfortunately, not all such State proposals address, in a comprehensive manner, the requirements of section 303( c)( 2)( B). For example, some States have proposed to adopt criteria to protect aquatic life, but not human health; other States have proposed human health criteria which do not address major human exposure pathways. In addition, in some cases final adoption of proposed State toxics criteria which would be approvable by EPA has been substantially delayed due to controversial and difficult issues associated with the toxics criteria adoption process. For purposes of today's proposed rulemaking, it is EPA's judgment that only 35 States completed actions which fully satisfy the requirements of section 303( c)( 2)( B).

The difficulties faced by States in adopting criteria for priority toxic pollutants are exemplified by recent State efforts to adopt criteria for the priority toxic pollutant 2,3,7,8 TCDD ( dioxin). As is generally true of State section 303( c)( 2)( B) efforts, State efforts to adopt numeric human health dioxin criteria have been slow and controversial, but in many respects impressive. For example, since 1987, a total of 34 States have adopted numeric human health criteria for dioxin which have been approved by EPA. In total, 38 States have adopted numeric human health criteria for dioxin. Twenty five of these 38 States adopted criteria during calendar year 1991, showing that the pace of State actions to adopt dioxin criteria has accelerated substantially.

The progress which has been made by States in adopting dioxin criteria is particularly impressive in light of the substantial attention and controversy which has been focused on such actions. EPA, States, dischargers, environmental groups, and the public at large have been involved in discussions concerning the ambient level of protection that is protective of public health. In some States, the struggle to select an appropriate dioxin criterion has been the major impediment to successful completion of section 303( c)( 2)( B) actions.

At issue are scientific questions specific to dioxin, such as determining the carcinogenic potency of the pollutant and the extent to which the pollutant tends to accumulate in fish tissues. Other issues are generic to EPA'S human health criteria, such as determining the rate at which humans consume fish and other forms of aquatic life, and the necessity of setting ambient criteria at levels which may not be detected by state of the art laboratories. Most of these issues relate, directly or indirectly, to concerns expressed by dischargers regarding the cost of complying with water quality based effluent limits for dioxin which, although variable from State to State, generally are based on State numeric water quality criteria that allow only minute quantities of dioxin per liter of water. For example, twelve States have adopted EPA's recommended ambient water column concentration of 0.013 picograms per liter.

Currently, a total of eleven States have proposed, or are expected to propose, numeric human health based criteria for dioxin. These States could face the same issues, obstacles, and resource requirements that the 38 States which previously adopted criteria have faced.

In summary, States have devoted substantial resources, and have made substantial progress, in adopting new or revised numeric criteria for priority pollutants. In so doing they have addressed a number of significant and difficult issues. These issues and the attendant controversy has accounted, at least in part, for the fact that 22 jurisdictions still have not adopted numeric toxics criteria that fully comply with section 303( c)( 2)( B). For a more detailed State specific outline of actions taken in response to section 303( c)( 2)( B), refer to part III of appendix 1, which itemizes State actions to adopt toxics criteria for States approved by EPA as being in full compliance as well as States which EPA has not approved as being in full compliance with section 303( c)( 2)( B). D. Determining State Compliance With Section 303( c)( 2)( B)

1. EPA's Review of State Water Quality Standards for Toxics The EPA Administrator has delegated the responsibility and authority for review and approval or disapproval of all State water quality standards actions to the 10 EPA Regional Administrators ( see 40 CFR 131.21). State section 303( c)( 2)( B) actions are thus submitted to the appropriate EPA Regional Administrator for review and approval. This de centralized EPA system for State water quality standards review and approval is guided by EPA Headquarter's Office of Water, which issues national policies and guidance to the States and Regions such as the annual Office of Water Operating Guidance and various technical operating guidance manuals.

For purposes of evaluating State compliance with CWA section 303( c)( 2)( B), EPA relied on the language of section 303( c)( 2)( B), the existing water quality standards regulation, and section 303( c)( 2)( B) national guidance to provide the basis for EPA review. In some cases, individual Regions also used Regional policies and procedures in reviewing State section 303( c)( 2)( B) actions. The flexibility provided by the national guidance, coupled with subtle differences in Regional policies and procedures, contributed to some differences in the approaches taken by States to satisfy section 303( c)( 2)( B) requirements.

As discussed previously, EPA's final guidance on compliance with section 303( c)( 2)( B) was developed to provide States with the necessary flexibility to allow State standards revisions that would complement the State's existing water quality standards program, fully comply with section 303( c)( 2)( B), and not violate State specific resource constraints. As guidance, it did not contain clearly defined limits on the range of acceptable approaches, but rather described EPA's recommendations on approaches States could use to satisfy the statutory requirements. Some innovative State approaches were expected as well as differences in terms of criteria coverage, stringency and application procedures.

Although the guidance provided for State flexibility, it was also consistent with existing water quality standards regulation requirements at 40 CFR 131.11 that explicitly require State criteria to be sufficient to protect designated uses. Such water quality criteria also must be based on sound scientific rationale and support the most sensitive use designated for a water body.

The most complicated EPA compliance determinations involve States that select EPA Options 2 or 3. Since most States use EPA's Section 304( a) criteria guidance, where States select Option 1, EPA normally is able to focus Agency efforts on verifying that all available EPA criteria are included, appropriate cancer risk levels are selected, and that sufficient application procedures are in place ( e. g. laboratory analytical methods, mixing zones, flow condition, etc.).

However, for States using EPA's Option 2 or 3, substantially more EPA evaluation and judgment is required because the Agency must evaluate which priority pollutants and, in some cases, segments or designated uses, require numeric criteria. Under these options, the State must adopt or derive numeric criteria for priority toxic pollutants for which EPA has section 304( a) criteria, "* * * the discharge or presence of which in the affected waters could reasonably be expected to interfere with those designated uses adopted by the State * * *" The necessary justification and the ultimate coverage and acceptability of a State's actions vary State to State because of differences in the adequacy of available monitoring information, local water bodies use designations, the effluent and nonpoint source controls in place, and different approaches to the scientific basis for criteria.

In submitting criteria for the protection of human health, States are not limited to a 1 in 1 million risk level ( 10 6). EPA generally regulates pollutants treated as carcinogens in the range of 10 6 to 10 4 for average exposed individuals. If a State selects a criterion that represents an upper bound risk level less protective than 1 in 100,000 ( i. e., 10 5), however, the State will need to have substantial support in the record for this level. This support should focus on two distinct issues. First, the record must include documentation that the decision maker considered the public interest of the State in selecting the risk level, including documentation of public participation in the decision making process as required by the water quality standards regulation at 40 CFR 131.20( b). Second, the record must include an analysis showing that the risk level selected, when combined with other risk assessment variables, is a balanced and reasonable estimate of actual risk posed, based on the best and most representative information available. The importance of the estimated actual risk increases as the degree of conservatism in the selected risk level diminishes. EPA will carefully evaluate all assumptions used by a State if the State chooses to alter any one of the standard EPA assumption values.

Where States select Option 3, EPA reviews must also include an evaluation of the scientific defensibility of the translator procedure. EPA must also verify that a requirement to apply the translator whenever toxics may reasonably be expected to interfere with designated uses ( e. g., where such toxics exist or are discharged) is included in the State's water quality standards. Satisfactory application procedures must also be developed by States selecting Option 3.

In general, each EPA Region made compliance decisions based on whatever information was available to the State at the time of the triennial review. For some States, information on the presence and discharge of priority toxic pollutants is extremely limited. Nevertheless, during the period of February 1988 to October 1990, to supplement State efforts, EPA assembled the available information and provided each State with various pollutant candidate lists in support of the section 304( l) and section 303( c)( 2)( B) activities. These were based in part on computerized searches of existing Agency data bases.

Beginning in 1988, EPA provided States with candidate lists of priority toxic pollutants and water bodies in support of CWA section 304( l) implementation. These lists were developed because States were required to evaluate existing and readily available water related data in order to comply with section 304( l). 40 CFR 130.10( d). A similar " strawman" analysis of priority pollutants potentially requiring adoption of numeric criteria under section 303( c)( 2)( B) was furnished to most States in September or October of 1990 for their use in on going and subsequent triennial reviews. The primary differences between the " strawman" analysis and the section 304( l) candidate lists were that the " strawman" analysis: ( 1) Organized the results by chemical rather than by water body, ( 2) included data for certain STORET monitoring stations that were not used in constructing the candidate lists, ( 3) included data from the Toxics Release Inventory database, and ( 4) did not include a number of data sources used in preparing the candidate lists ( e. g., those, such as fish kill information, that did not provide chemical specific information).

In its 1988 section 303( c)( 2)( B) guidance, EPA urged States, at a minimum, to use the information gathered in support of section 304( l) requirements as a starting point for identifying which priority toxic pollutants require adoption of numeric criteria. EPA also encouraged States to consider the presence or potential construction of facilities that manufacture or use priority toxic pollutants as a strong indication of the need for toxics criteria. Similarly, EPA indicated to States that the presence of priority pollutants in ambient waters ( including those in sediments or in aquatic life tissue) or in discharges from point or nonpoint sources also be considered as an indication that toxics criteria should be adopted. A limited amount of data on the effluent characteristics of NPDES discharges was readily available to States. States were also expected to take into account newer information as it became available, such as information in annual reports from the Toxic Chemical Release Inventory requirements of the Emergency Planning and Community Right To Know Act of 1986. ( Title III, Pub. L. 99 499.) In summary, EPA and the States had access to a variety of information gathered in support of section 304( l), section 303( c)( 2)( B), and section 305( b) activities. For some States, as noted above, such information for priority toxic pollutants is extremely limited. In the final analysis, the Regional Administrator made a judgment on a duly submitted State standards triennial review based on the State's record and the Region's independent knowledge of the facts and circumstances surrounding the State's actions. These actions, taken in consultation with the Office of Water, determined which State actions were sufficiently consistent with the coverage contemplated in the statute to justify approval. These approval actions include allowable variations among State water quality standards. EPA approval indicates that, based on the record, the State water quality standards met the requirements of the Act.

2. Determining Current Compliance Status The following summarizes the process generally followed by the Agency in assessing compliance with section 303( c)( 2)( B). As with other aspects of this rule, EPA invites comments on the compliance determination process.

A State was determined to be in full compliance with the requirements of section 303( c)( 2)( B) if, a. The State had submitted a water quality standards package for EPA review since enactment of the 1987 Clean Water Act amendments or was determined to be already in compliance, and, b. The adopted State water quality standards are effective under State law and consistent with the CWA and EPA's implementing regulations ( EPA's December 1988 guidance described three Options, any one, or a combination of which EPA suggested States could adopt for compliance with the CWA and EPA regulations), and c. EPA has issued a formal approval determination to the State.

States meeting these criteria are not included in this proposed rulemaking. States which adopted standards following Option 1 generally have been found to satisfy section 303( c)( 2)( B). An exception exists for selected States which attempted to follow Option 1 by adopting all EPA section 304( a) criteria by reference. EPA has withheld approval for a few States which have adopted such references into their standards because the adopted standards did not specify application factors necessary to implement the criteria ( e. g., a risk level for carcinogens). Other States have achieved full compliance following options 1, 2, 3, or some combination of these options.

As of the date of signature of today's proposal, the Agency has determined that 35 States and Territories are in full compliance with the requirements of section 303( c)( 2)( B). Compliance status for all States and Territories is set forth in Table 1.

Table 1. Preliminary Assessment of State Compliance with CWA Section 303( c)( 2)( B) Is State in compliance with section State 303( c)( 2)( B)? Alabama Yes. Alaska No. Arizona No. Arkansas No. California No. Colorado No. Connecticut No. Delaware Yes. Florida No. Georgia Yes. Hawaii No. Idaho No. Illinois Yes. Indiana Yes. Iowa Yes. Kansas No. Kentucky Yes. Louisiana No. Maine Yes. Maryland Yes. Massachusetts Yes. Michigan No. Minnesota Yes. Mississippi Yes. Missouri Yes. Montana Yes. Nebraska Yes. Nevada No. New Hampshire No. New Jersey No. New Mexico Yes. New York Yes. North Carolina Yes. North Dakota Yes. Ohio Yes. Oklahoma Yes. Oregon Yes. Pennsylvania Yes. Rhode Island No. South Carolina Yes. South Dakota Yes. Tennessee Yes. Texas Yes. Utah Yes. Vermont No. Virginia No. Washington No. West Virginia Yes. Wisconsin Yes. Wyoming Yes. American Samoa Yes. Commonwealth of the Northern Marianas Islands No. District of Columbia No. Guam Yes. Puerto Rico No. Tr. Territories Yes. Virgin Islands Yes.

Section III of appendix 1 provides a State by State summary of how compliance was achieved for the EPA approved States, and what has been, and yet needs to be, accomplished in States included in this proposed rule.

E. Rationale and Approach for Developing Today's Proposed Rulemaking The addition of section 303( c)( 2)( B) to the Clean Water Act was an unequivocal signal to the States that Congress wanted toxics criteria in the State's water quality standards. The legislative history notes that the " beyond BAT" program ( i. e., controls necessary to comply with water quality standards that are more stringent than technology based controls) was the cornerstone to the Act's toxic pollution control requirements.

The major innovation of the 1972 Clean Water Act Amendments was the concept of effluent limitation guidelines which were to be incorporated into NPDES permits. In many cases, this strategy has succeeded in halting the decline in the quality of the Nation's waters and, often, has provided improvements. However, the effluent limitation guidelines for industrial discharges and the similar technology based secondary treatment requirements for municipal discharges are not capable, by themselves, of ensuring that the fishable swimmable goals of the Clean Water Act will be met. The basic mechanism to accomplish this in the Act is water quality standards. States are required to periodically review and revise these standards to achieve the goals of the Act. In the 1987 CWA amendments, Congress focused on addressing toxics in several sections of the Act, but special attention was placed on the section 303 water quality standards program requirements. Congress intended that the adoption of numeric criteria for toxics would result in direct improvements in water quality by forcing, where necessary, effluent limits more stringent than those resulting from technology based effluent limitations guidelines.

As the legislative history demonstrates, Congress was dissatisfied with the piecemeal, slow progress being made by States in setting standards for toxics. Congress reacted by legislating new requirements and deadlines directing the States to establish toxics criteria for pollutants addressed in EPA Section 304( a) criteria guidance, especially for those priority toxic pollutants that could reasonably be expected to interfere with designated uses. In today's action, EPA is exercising its authority under section 303( c)( 4) to propose criteria where States have failed to act in a timely manner.

For those States not in compliance with section 303( c)( 2)( B) four and one half years after enactment, EPA now begins the process that will culminate in the promulgation of appropriate toxics criteria and the determination of the necessary parametric coverage and stringency of such criteria. While the previous section of this preamble explains EPA's approach to evaluating the adequacy of State actions in response to section 303( c)( 2)( B), this section explains EPA's legal basis for issuing today's proposed rulemaking, discusses EPA's general approach for developing the proposed State specific requirements in Sec. 131.36( d).

In addition to the Congressional directive and the legal basis for this proposed action, there are a number of environmental and programmatic reasons why further delay in establishing water quality standards for toxic pollutants is no longer acceptable.

Prompt control of toxic pollutants in surface waters is critical to the success of a number of Clean Water Act programs and objectives, including permitting, enforcement, fish tissue quality protection, coastal water quality improvement, sediment contamination control, certain nonpoint source controls, pollution prevention planning, and ecological protection. The decade long delay in State adoption of water quality standards for toxic pollutants has had a ripple effect throughout EPA's water programs. Without clearly established water quality goals, the effectiveness of many water programs is jeopardized.

Failure to take prompt action at this juncture would also undermine the continued viability of the current statutory scheme to establish standards. Continued delay subverts the entire concept of the triennial review cycle which is to combine current scientific information with the results of previous environmental control programs to direct continuing progress in enhancing water quality.

Finally, another reason to proceed expeditiously is to bring closure to this long term effort and allow State attention and resources to be directed towards important, new national program initiatives. Until standards for toxic pollutants are in place, neither EPA nor the States can fully focus on the emerging, ecologically based water quality activities such as wetlands criteria, biological criteria and sediment criteria.

1. Legal Basis Clean Water Act section 303( c) specifies that adoption of water quality standards is primarily the responsibility of the States. However, section 303( c) also describes a role for EPA of overseeing State actions to ensure compliance with CWA requirements. If the Agency's review of the State's standards finds flaws or omissions, then the Act authorizes EPA to initiate promulgation to correct the deficiencies ( see section 303( c)( 4)). The water quality standards promulgation authority has been used by EPA to issue final rules on nine separate occasions. These actions have addressed both insufficiently protective State criteria and/ or designated uses and failure to adopt needed criteria. Thus, today's action is not unique, although it would affect more States and pollutants than previous actions taken by the Agency.

The Clean Water Act in section 303( c)( 4) provides two bases for promulgation of Federal water quality standards. The first basis in paragraph ( A) applies when a State submits new or revised standards that EPA determines are not consistent with the applicable requirements of the Act. If, after EPA's disapproval, the State does not promptly amend its rules so as to be consistent with the Act, EPA must promulgate appropriate Federal water quality standards for that State. The second basis for EPA's action is paragraph ( B), which provides that EPA shall promptly initiate promulgation "* * * in any case where the Administrator determines that a revised or new standard is necessary to meet the requirements of this Act." EPA is relying on both section 303( c)( 4)( A) and section 303( c)( 4)( B) as the legal basis for this proposed rulemaking.

Section 303( c)( 4)( A) supports today's action for several States. These States have submitted criteria for some number of priority toxic pollutants and EPA has disapproved the State's adopted standards. The basis for EPA's disapproval generally has been the lack of sufficient criteria or particular criteria that were insufficiently stringent. In these cases, EPA has, by letter to the State, noted the deficiencies and specified the need for corrective action. ( See section III of appendix 1 for a summary description of each State's section 303( c)( 2)( B) history.) Not having received an appropriate correction within the statutory time frame, EPA is today proposing the needed criteria. The action in today's proposal pursuant to section 303( c)( 4)( A) may differ from those taken pursuant to section 303( c)( 4)( B) by being limited to criteria for specific priority toxic pollutants, particular geographic areas, or particular designated uses.

Section 303( c)( 4)( B) is the basis for EPA's proposed requirements for most States. For these States, the Administrator proposes criteria that would bring the States into compliance with the requirements of the CWA. In these cases, EPA is proposing, at a minimum, criteria for all priority toxic pollutants not addressed by approved State criteria. EPA is also proposing criteria for priority toxic pollutants where any previously approved State criteria do not reflect current science contained in revised criteria documents and other guidance sufficient to fully protect all designated uses or human exposure pathways, or where such previously approved State criteria are not applicable to all appropriate designated uses. EPA's action pursuant to section 304( c)( 4)( B) may include several situations.

In some cases, the State has failed to adopt and submit for approval any criteria for those priority toxic pollutants for which EPA has published criteria. This includes those States that have not submitted triennial reviews. In other cases, the State has adopted and EPA has approved criteria for either aquatic life or human health, but not both. In yet a third situation, States have submitted some criteria but not all necessary criteria. Lastly, one State has submitted criteria that do not apply to all appropriate geographic sections of the waters of the State. ( See section III of appendix 1.) The use of section 303( c)( 4)( B) requires a determination by the Administrator "* * * that a revised or new standard is necessary to meet the requirements of * * *" the Act. The Administrator's determination could be supported in different ways.

One approach would be for EPA to undertake a time consuming effort to research and marshall data to demonstrate the need for promulgation for each criteria for each stream segment or waterbody in each State. This would include evidence for each section 307( a) priority toxic pollutant for which EPA has section 304( a) criteria and that there is a " discharge or presence" which could reasonably " be expected to interfere with" the designated use. This approach would not only impose an enormous administrative burden, but would be contrary to the statutory scheme and the compelling Congressional directive for swift action reflected in the 1987 addition of section 303( c)( 2)( B) to the Act.

An approach that is more reasonable and consistent with Congressional intent focuses on the State's failure to complete the timely review and adoption of the necessary standards required by section 303( c)( 2)( B) despite information that priority toxic pollutants may interfere with designated uses of the State's waters. This approach is consistent with the fact that in enacting section 303( c)( 2)( B) Congress expressed its determination of the necessity for prompt adoption and implementation of water quality standards for toxic pollutants. Therefore, a State's failure to meet this fundamental 303( c)( 2)( B) requirement of adopting appropriate standards constitutes a failure " to meet the requirements of the Act." That failure to act can be a basis for the Administrator's determination under section 303( c)( 4)( B) that new or revised criteria are necessary to ensure designated uses are adequately protected. Here, this determination is buttressed by the existence of evidence of the discharge or presence of priority toxic pollutants in a State's waters for which the State has not adopted numeric water quality criteria. The Agency has compiled an impressive volume of information in the record for this rulemaking ( See appendix 1) on the discharge or presence of toxic pollutants in State waters. This data supports the Administrators's proposed determination pursuant to section 303( c)( 4)( B).

The Agency's choice to base the proposed determination on the second approach is supported by both the elicit language of the statutory provision and by the legislative history. Congress added subsection 303( c)( 2)( B) to section 303 with full knowledge of the existing requirements in section 303( c)( 1) for triennial water quality standards review and submission to EPA and in section 303( c)( 4)( B) for EPA promulgation. There was a clear expectation that these provisions be used in concert to overcome the programmatic delay that many legislators criticized and achieve the Congressional objective of the rapid availability of enforceable water quality standards for toxic pollutants. As quoted earlier, chief Senate sponsors, including Senators Stafford, Chafee and others, wanted the provision to eliminate State and EPA delays and force aggressive action.

In normal circumstances, it might be argued that to exercise section 303( c)( 4)( B) the Administrator might have the burden of marshalling conclusive evidence of " necessity" for Federally promulgated water quality standards. However, in adopting section 303( c)( 2)( B), Congress made clear that the " normal" procedure had become inadequate. The specificity and deadline in section 303( c)( 2)( B) were layered on top of a statutory scheme already designed to achieve the adoption of toxic water quality standards. Congressional action to adopt an essentially redundant provision was driven by their impatience with the lack of State progress. The new provision was essentially a Congressional " determination" of the necessity for new or revised comprehensive toxic water quality standards by States. In deference to the principle of State primacy, Congress, by linking section 303( c)( 2)( B) to the section 303( c)( 1) three year review period, gave States a last chance to correct this deficiency on their own. However, this Congressional indulgence does not alter the fact that section 303( c)( 2)( B) changed the nature of the CWA State/ EPA water quality standard relationship. The new provision and its legislative background indicate that the Administrator's determination to invoke his section 303( c)( 4)( B) authority in this circumstance can be met by a generic finding of inaction on the part of a State and without the need to develop data for individual stream segments. Otherwise, the Agency would face the heavy data gathering burden of justifying the need for each Federal criterion, the process could stretch for years and never be realized. To interpret the combination of subsections ( c)( 2)( B) and ( c)( 4) as an effective bar to prompt achievement of statutory objectives would be a perverse conclusion and render section 303( c)( 2)( B) essentially meaningless.

A second strong argument against requiring EPA to shoulder a heavy burden to exercise section 303( c)( 4)( B) authority is that it would invert the traditional statutory scheme of EPA as national overseer and States as the entity with the greatest local expertise. The CWA provides States the flexibility to tailor water quality standards to local conditions and needs based upon their wealth of first hand experience, knowledge and data. However, this allowance for flexibility is based on an assumption of reasoned and timely State action, not an abdication of State responsibility by failure to act. EPA does not possess the local expertise or resources necessary to successfully tailor State water quality standards. Therefore, the fact that the CWA allows States flexibility in standards development does not impose an inappropriate burden on EPA in the exercise of its oversight promulgation responsibilities. A broad Federal promulgation based on a showing of State inaction coupled with basic information on the discharge and presence of toxic pollutants meets the statutory objective of having criteria in place that are protective of public health and the environment. Without local expertise to help accurately narrow this list of pollutants and segments requiring criteria, there is no assurance of comparable protection. Nothing in the overall statutory water quality standards scheme anticipates EPA would develop this expertise in lieu of the States. EPA's lack of familiarity with local conditions argues strongly for a simple " determination" test to trigger section 303( c)( 4)( B) promulgations. It also supports the concept of an across the board rulemaking for all priority toxic pollutants with section 304( a) criteria.

A final major reason supporting a simple determination to trigger 303( c)( 4)( B) action is that comprehensive Federal promulgation imposes no undue or inappropriate burden on States or dischargers. It merely puts in place standards for toxic pollutants that are utilized in implementing Clean Water Act programs. Under this rulemaking, a State still retains the ability to adopt alternative water quality standards simply by completing its standards adoption process. Upon EPA approval of those standards, EPA would take actions to withdraw the Federally promulgated criteria.