42266 823Z9300 40 CFH Parts 122,123,131, and 132 [FRL-468»-7) BIN 2040-AC08 PropoMd Water Quality Guidance for the Great Lakes System AGENCY: U.S. Environmental Protection Agency. • , ACTION: Proposed rule; availability of documents; correction. SUMMARY: The purpose of this document {g to announce the availability of two reports that EPA is considering as it develops the final Water Quality Guidance for the Great Lakes System; to request public comment on the possible application of the options set forth in these reports in the final Guidance; and to make corrections to the preamble and proposed rule text for the proposed Water Quality Guidance for the Great Lakes System, including missing text and changes that were inadvertently omitted during the editing of the Recycled/Recyclable- Printed with Vegetable Oil Based Inks on 100% Recycled Paper (50% Postconsumer) • Please recycle as newsprint ------- ------- Federal Register / Vol. 58, No. 151 / Monday, August 9, 1993 / Proposed Rules 42267 proposed rule. The proposed rule was published in the April 16,1993, Federal Register (58 FR 20802). with corrections published at 58 FR 21046. The two reports being made available for public comment are: "Revision of Methodology for Deriving National Ambient Water Quality Criteria for the Protection of Human Health: Report of Workshop and EPA's Preliminary Recommendations for Revision" ("Preliminary Recommendations"), and "Interim Report on Data and Methods for Assessment of 2.3.7,8- Tetrachlorodibenzo-p-dioxin Risks to Aquatic Life and Associated Wildlife" ("Interim Dioxin Report"). EPA wants to ensure that the public has an opportunity to comment on whether any of the options in the Preliminary Recommendations should be adopted in the final Great Lakes Water Quality Guidance methodologies for development of human health criteria and values, and for development of bioaccumulation factors. EPA also invites the public to comment on whether any of the data and methods in the Interim Dioxin Report-should be adopted in the final Great Lakes Guidance. DATES: Written comments should be submitted on or before September 13, 1993. Comments postmarked after this date may not be considered. ADDRESSES: Send written comments to Wendy Schumacher, Water Quality Branch (WQS-16J). U.S. EPA. Region V, 77 West Jackson Blvd.. Chicago, Illinois, 60604 (telephone: 312-886-0142). Commenters are requested to submit one original and 4 copies of their written comments. In addition, EPA encourages commenters to provide one copy of their comments in electronic format, preferably 5.25" or 3.5" diskettes compatible with WordPerfect for DOS. A copy of the reports identified in this document are available for inspection and copying at the U.S. EPA Region V Records Center, 77 W. Jackson Blvd.. Chicago, Illinois, by appointment only. Appointments may be made by calling Wendy Schumacher (telephone: 312- 886-0142). A reasonable fee will be charged for photocopies. The two reports are also available by mail upon request for a fee (see section I.C of Supplementary Information for more information). FOR FURTHER INFORMATION CONTACT: Kenneth A. Fenner, Water Quality Branch Chief. (WQS-16J). U.S. EPA Region V, 77 W. Jackson Blvd.. Chicago. Illinois, 60604 (telephone: 312-353- 2079). SUPPLEMENTARY INFORMATION: I. Availability of Documents and Request for Comments Section 304(a)(l) of the Clean Water Act (33 U.S.C 1314(a)(l)) requires EPA to publish and-periodically update ambient water quality criteria. These criteria are to reflect the latest scientific knowledge on the identifiable effects of pollutants on public health and welfare, aquatic life and recreation. Section 118(c)(2) of the Clean Water Act requires EPA to publish water quality guidance for the Great Lakes System which includes guidance on numerical limits on pollutants in ambient Great Lakes waters to protect human health, aquatic life and wildlife. The proposed Water Quality Guidance for the Great Lakes System was published on April 16.1993, in the Federal Register (58 FR 20802). Corrections to the proposed preamble and proposed rule text were published in the Federal Register on the same date (58 FR 21046). This Guidance, once finalized, will establish minimum water quality standards, antidegradation policies, and implementation procedures for waters within the Great Lakes System in the States of New York, Pennsylvania, Ohio, Indiana, Illinois, Minnesota, Wisconsin, and Michigan, including waters within the jurisdiction of Indian Tribes. A. Great Lakes Guidance Human Health Methodology In 1980, EPA published National guidelines for the development of protective criteria for contaminants that may adversely affect human health in ambient water. These guidelines can be found at 45 FR 79347, dated November 28.1980. Using the 1980 National Guidelines, criteria may be developed based on lexicological endpoints (cancer and non-cancer adverse health effects), and organoleptic effects. The guidelines for derivation of criteria consider potential human exposure via consumption of water and ingestion of contaminated fish and shellfish. The proposed Great Lakes Water Quality Guidance includes proposed numeric criteria to protect human health for 20 pollutants and methodologies to derive cancer and non-cancer human health criteria and values for additional pollutants. It also includes a methodology for development of bioaccumulation factors to be used in developing human health and wildlife criteria. Although the objectives of the proposed Great Lakes Human Health Guidance are similar to those of the 1980 National Guidelines, the proposed Great Lakes Human Health Methodology differs from current National Guidance in several respects. For example, the Great Lakes Guidance uses bioaccumulation factors which account for uptake of pollutants directly from the waters of the Great Lakes System plus uptake of pollutants from the food chain rather than bioconcentration factors (which only account for uptake of pollutants directly from the water). Additionally, a fish consumption rate that is based on data from the Great Lakes area is used in the proposed Guidance. For additional details on the proposed methodology. including similarities and differences with the 1980 National Guidelines, readers are referred to the preamble discussion contained in the April 16, 1993, notice (58 FR 20863-20877). The April 16,1993. proposed Guidance indicated that EPA is currently in the process of reviewing and revising its 1980 National Guidelines. EPA believes that the National Guidelines should be evaluated from time to time to determine whether significant advances have occurred in the science which should be reflected in the National methodology guidelines. As a first step in the revision effort, EPA prepared an issues paper and held a workshop on September 13-16.1992, in Bethesda, Maryland to discuss the issues with a group of experts from EPA, other federal agencies, states, academia, industry, conservation groups and other interested parties. The workshop participants were divided into six working groups which discussed the following technical subjects: (1) cancer risk, (2) non-cancer risk, (3) exposure. (4) microbiology. (5) minimum data and (6) bioaccumulation. Each group provided a written summary of the information discussed by the group. The reports from the workshop and EPA's preliminary recommendations for revisions to the human health methodology were integrated into a report entitled, "Revision of Methodology for Deriving National Ambient Water Quality Criteria for the Protection of Human Health: Report of Workshop and EPA's Preliminary Recommendations for Revision" ("Preliminary Recommendations"), prepared by the Human Risk Assessment Branch, U.S. EPA Office of Water. January 8,1993. The Preliminary Recommendations report was submitted to EPA's Science Advisory Board (SAB) for review and comment during the SAB's February 9- 10.1993, meeting. The SAB meetings are open to the public and the public may submit comments on the issues. discussed at these meetings directly to ------- 42268 Federal Register / VoL 58. No. 151 / Monday. August 9. 1993 / Proposed Rules the SAB. EPA anticipates that the SAB will provide formal written comments on the Preliminary Recommendations in an SAB report expected this year. EPA will make the SAB report available to the public at that time. EPA will consider all public comments submitted to the SAB in response to the February 9-10,1993. SAB review meeting and any public comments on the final SAB report, when it becomes available, in the preparation of the final Great Lakes Guidance. EPA encourages the public to also send one original and 4 copies of their written comments to the SAB directly to Ms. Wendy Schumacher at the address specified at the beginning of today's notice. EPA is providing this notice of availability, and placing the Preliminary Recommendations in the administrative record for the proposed Great Lakes Water Quality Guidance, because EPA intends to consider all the recommendations concerning issues associated with the National guidelines revision, and discussed in the subject report, in the development of final Water Quality Guidance for human health protection in the Great Lakes System. EPA will also consider the SAB comments on the Preliminary Recommendations in finalizing the Great Lakes Guidance, and intends to issue a subsequent notice of availability when the SAB report is issued. The following are some examples of alternatives discussed in the January 8, 1993, Preliminary Recommendations to the SAB but not included in the April 16/1993, proposal. "" Data 1. The proposed Great Lakes Guidance would include two tiers of criteria/ values for the protection of human health which differ in minimum data requirements. For example, to develop a noncancer Tier I criterion, the miniTmim requirement is a no-observed-adverse- effect-level (NOAEL) from a well conducted subchronic mammalian study. The duration of the study must be at least 90 days in rodents, or 10 percent of the lifespan of other appropriate species. For a noncancer Tier n value, the minimum acceptable database is a NOAEL from a well conducted repeated dose mammalian study of at least 28 days. For both Tier I criteria and Tier n values all relevant data must be considered. The terms "criteria" and "values" are used to differentiate between protective ambient concentrations derived with optimum, as opposed to acceptable, data requirements. Both Tier I criteria and Tier n values will have regulatory effect under the proposed Great Lakes Guidance. [See 58 FR 20871-74.) One option discussed in the January 8,1993. Preliminary Recommendations involves a five-tier approach based on the quality and type of lexicological information. These tiers range from high confidence data (Tier I) to no available data (Tier V). Data requirements for Tier I chemicals include mechanistic, pharmacokinetic, and target organ toxidty data. TierH includes those chemicals with enough data to establish a reference dose (RED) for noncancer endpoints or a cancer potency factor. Readers are referred to the April 16, 1993 notice (58 FR 20872-73) for information on the minimum acceptable data base for an RfD or a cancer potency factor. Tier ffl includes: (1) Chemicals for which available data are not sufficient to meet the requirements for RfD development but consist of at least a well conducted 28-day repeated oral dose rodent bioassay resulting in a NOAEL. (2) chemicals which are Group C chemicals (see U.S. EPA's Guidelines for Carcinogenic Risk Assessment. published on September 24.1986 at 51 FR 33992) and for which insufficient data to calculate a cancer potency slope exists, and (3) chemicals which are Group C chemicals of low concern (e.g., chemicals of low potency or in which the mechanism of carcinogenicity does not appear directly related to humans due to species differences in toxicokinetics). Tier IV chemicals include those not meeting the 28-day minimum data requirement for Tier ffl, but available noncancer and cancer data (such as acute toxicity data, genetic toxicology, structure activity relationship data) indicates a potential health hazard. Tier W data are insufficient to develop a numeric criterion but may be used in interpreting narrative criteria. Tier V indicates no data availability. Under this alternative five-tier approach, Tiers I and n are equivalent to Tier I criteria in the proposed Great Lakes Guidance while Tier m is equivalent to Tier n values in the Guidance. This alternative scheme is a refinement of the proposed Great Lakes Guidance 2-tier approach. The extra tiers are added to better describe and categorize the quality of the data. EPA requests comment on the use of this alternative classification scheme of five tiers for the Great Lakes Guidance and, specifically, on how these different tiers could be used in regulatory decision-making (e.g.. in setting permit limits). For example, in those instances where insufficient data exist to develop numeric criteria or values, available information could nevertheless be used to interpret State narrative criteria. 2. Relative Source Contribution Under the proposed Great Lakes Guidance, EPA assumes an 80 percent relative source contribution (RSC) from surface water pathways (water and fish) for bioaccumulative contaminants of concern (BCCs). and 100 percent RSC for non-BCCs, in deriving noncancer criteria/values. A 100 percent RSC is . assumed for all chemicals in deriving cancer criteria/values. (See 58 FR 20870.) Several alternative options are described in the Preliminary Recommendations. One option is to use a subtraction approach to account for other sources of exposure (e.g., air. food) when there are sufficient data to quantitatively apportion them rather than using arbitrary default values. (In the case of no available data, a default assumption will still have to be made.) The contribution from these other sources could be subtracted from the Reference Dose (RfD) in deriving the criteria. One of the options includes the use of a 20 percent floor and an 80 percent ceiling for the RSC when adequate exposure data are available, and a 20 percent default value when adequate exposure data are lacking. There is no differentiation for bioaccumulative and non- bioaccumulative chemicals under any of the options in the report EPA requests specific comments on the possibility of incorporating one of the RSC options described in the January 8,1993, Preliminary Recommendations in the final Great Lakes Guidance. 3. Development of Short-Tenn Advisory Levels Under the Great Lakes Guidance, all. criteria and values are developed based on an assumption of long-term v exposures to humans. A 70-year exposure is assumed, and fish and water consumption rates reflect long-term exposures. An alternative is discussed in the report to the SAB. The workshop report and EPA's preliminary recommendations include the concept of developing one-day Healtii Advisory Doses (HADs) which could be used to develop criteria to protect the public such as pregnant women) from large short-term doses of contaminants from consumption of fish containing pollutant residues. This concept was developed with the belief that people may consume large amounts of fish during a given meal and that reproduction/developmental effects (or other short-term acute effects) may not ------- Federal Register / Vol. 58, No. 151 / Monday, August 9, 1993 / Proposed Rules 42269 adequately be accounted for with a lifetime criterion using a long-term exposure assumptions. Criteria based on short-term exposures would supplement criteria based on long-term exposures. EPA requests specific comment on this issue with regard to the need for development of human health criteria based on short-term exposures. B. Interim Dioxin Report EPA released a peer-reviewed interim report on dioxin ecological effects on April 23,1993. This report is entitled, "Interim Report on Data and Methods for the Assessment of 2,3,7,8- Tetrachlorodibenzo-p-dioxin Risks to Aquatic Organisms and Associated Wildlife", prepared by the Office of Research and Development, U.S. EPA, March 1993 (EPA Report Number EPA/ 600/R-93/055). The report compiles and evaluates toxicity, exposure and bioaccumuhUion data from the current scientific literature for aquatic life and associated wildlife regarding dioxin. The report addresses issues related to risk characterization to illustrate the use of current information in ecological risk assessments. EPA is placing this document hi the administrative record for the Great Lakes Guidance because the proposed Great Lakes Guidance includes both human health and wildlife criteria for dioxin. The Interim Dioxin Report contains relevant information for the derivation of a wildlife criterion for dioxin. In addition, the Interim Dioxin Report summarizes available effects and exposure data for assessment of dioxin risks to aquatic life and provides information on how to derive dioxin bioaccumulation factors (BAFs). BAFs are used in deriving both human health and wildlife criteria. Under the BAF methodology in the Interim Report, the dioxin BAF varies with the particulate organic carbon (POC] content of the ambient water. The Interim Report shows BAFs and environmental concentrations associated with risks to aquatic life and wildlife based on Lake Ontario data (POC of 0.2 mgTL). Available information suggests that POC levels vary considerably among the waters of the Great Lakes system. For example. POC levels range from less than 0.05 mg/L in Lake Superior to levels from 2 mg/L to 20 mg/L (during heavy rain periods) in the Fox River, a tributary of Lake Michigan As the POC level increases, the effect concentration increases due to greater binding by organic matter. EPA did not propose an aquatic life- based criterion for dioxin in the April 16.1993. proposed Great Lakes Guidance because research efforts in this area are still on-going and the available data are not sufficient to derive a Tier I aquatic life criterion. The Interim Dioxin Report has data that may be used to calculate a Tier H aquatic life value for dioxin. EPA requests specific public comments on: (1) The applicability of the information contained in the Interim Dioxin Report to a wildlife criterion for dioxin in the Great Lakes System. (2) whether the information provided on aquatic life effects in the Interim Dioxin Report should be used in the final Great Lakes Guidance to calculate an interim numerical limit for dioxin to protect aquatic life (i.e.. a Tier II value), and (3) whether the methodology in the report should be used to develop BAFs that vary in the Great Lakes basin with POC levels in the ambient water or whether a single BAF should be used for consistency among the Great Lakes States. C. Document Availability The two reports that are referenced in this document are available for inspection and photocopying in the administrative record for this - rulemaking at the address listed at the beginning of this preamble. A reasonable fee will be charged for photocopies. The report, "Revision of Methodology for Deriving National Ambient Water Quality Criteria for the Protection of Human Health: Report of Workshop and EPA's Preliminary Recommendations for Revision" is available for a fee upon written request or telephone call to the National Technical Information Center (NT1S). U.S. Department of Commerce. 5285 Port Royal Road, Springfield, VA 22161. The toll free number is 800-553- 6847 and the local number is 703-487- 4650. Alternatively, copies may be obtained for a fee upon written request or telephone call to the Educational Resources Information Center/ Clearinghouse for Science. Mathematics. and Environmental Education (ERIC/ CSMEE), 1200 Chambers Road, room 310. Columbus. Ohio 43212 (phone number: 614-292- 6717). When ordering, please include the NTIS accession number. PB 93-213494. price code AO6. or the ERIC/CSMEE accession number, 687-D, $12.25. The report, "Interim Report on Data and Methods for Assessment of 2,3,7,8- Tetrachlorodibenzo-p-dioxin Risks to Aquatic Life and Associated Wildlife," is available upon written request or telephone call to the Center for Environmental Research Information, EPA Office of Research and Development, 26 West Martin Luther King Drive. Cincinnati, Ohio 45268 (phone number: 513-569-7562). n. Corrections This notice provides corrections to several paragraphs in the preamble and the proposed rule text for the proposed Water Quality Guidance for the Great Lakes System which appeared on the April 16,1993, Federal Register (58 FR 20802). The corrections provide missing text and changes that were inadvertently omitted during editing of the proposed rule and are in addition to corrections 1 through 7 published with the proposed rule in a separate section of the April 16.1993, Federal Register (58 FR 21046). Correction 8 The last sentence of the second paragraph of the DATES section of the notice should read, "The hearing officer reserves the right to limit oral testimony to 10 minutes or less, if necessary." (58 FR 20802) The words "or less" were omitted ihrough editing error. Correction 9 Two addresses in the ADDRESSES section contained typographical errors. Under Minnesota, the address should read. "Minnesota Pollution Control Agency, Library, 520 Lafayette, St. Paul. Minnesota (612-296-7719)." Under New York, the entry for NYSDEC, Region 8. should read. "NYSDEC, Region 8,6274 East Avon-Lima Road, Avon. New York, 14414 (716-226- 2466)." (58 FR 20802) Correction 10 The third sentence of the second paragraph of section I.A.4.a of the preamble should read, "An effluent limit of one mg/L of phosphorus was imposed on all major (greater than 1 million gallons per day) municipal sewage treatment facilities in the Great Lakes basin." (58 FR 20807) The. revision corrects an error in the units of the effluent limit. Correction 11 The references in sections I.A.4.b (58 FR 20809) and I.H (58 FR 20832) to a study by Ballschmitter et al., 1989, are deleted. Correction 12 The following reference should be added to the list in section LH of the preamble (58 FR 20832): Eisenreich, S.J. and W.M.J. Strachan. 1992. Estimating atmospheric deposition of toxic substances to the Great Lakes: an update, from workshop, Canada Center for Inland Waters, Burlington, Ontario, January ------- 42270 Federal Register / Vol. 58. No. 151 / Monday, August 9, 1993 / Proposed Rules 31—February 2,1992, sponsored by Great Lakes Protection Fund and Environment Canada. June 1992. Correction 13 The last sentence of section n.C of the preamble should read as follows: "For example, the EPA guidance document Technical Support Document for Water Quality-based Toxics Control' (March 1991) remains fully applicable as guidance within the Great Lakes System for topics that have not been addressed by the proposed Guidance, and fully applicable as guidance for all topics for waters outside the Great Lakes System." (58 FR 20835) The second word "guidance" replaces the word "evidence," which was a typographical error. Correction 14 The second sentence of the second paragraph of section n.D.3 of the preamble should read, "The approach may therefore result in permit limits which may later be found to be more stringent than those derived from new toxicity data." (58 FR 20837). The words "more stringent" replace the word . "nonresistant," which was a typographical error. Correction 15 The ninth paragraph of section n.G of the preamble should read as follows: "The third way that Table 6 affects the initial focus of this Guidance is in determining when States, Tribes, and/or permittees must generate data necessary to calculate Tier II values used in developing water quality-based effluent limits. Procedure 5.D of the proposed Implementation Procedures in appendix F requires that permitting authorities generate, or have permittees generate, the data necessary to calculate Tier n values for pollutants in Table 6 for which there is no Tier I criterion or Tier n value if the permitting authority determines based on a specified screening approach that a discharge causes, has the reasonable potential to cause or contributes to an excursion above a State water quality standard." (58 FR 20844) The word "permittee" replaces the word "permitter," which was a typographical error, in two places. Correction 16 The first sentence of the second to the last paragraph of section n.G of the preamble should read, "EPA invites comment on the proposed BAF level of 100C ojid any alternative BAF levels for use in defining BCCs." (58 FR 20845). The word "defining" replaces the word "defending," which was a typographical error. Correction 17 The fifth paragraph of section n.H of the preamble should read as follows: "If a Great Lakes State or Tribe fails to submit criteria, methodologies, policies, and procedures tp EPA for review, proposed § 132.5(c) provides that the requirements of this part will apply to discharges within the State or Federal Indian Reservation upon EPA's publication of a final rule in the Federal Register indicating the effective date of the part 132 requirements in the •identified jurisdictions. EPA does not intend to provide at that time an opportunity for another round of public comment on the criteria, methodologies, policies, and procedures presented in the proposed Guidance. EPA believes that under these circumstances, today's public comment period will provide adequate notice and opportunity for comment on all issues related to the criteria, methodologies, policies, and procedures. Accordingly, EPA will issue a final rule identifying the criteria, methodologies, policies, and procedures that apply in the appropriate jurisdictions." (58 FR 20846) Tho words "a final rule" replace "the final Guidance," to correct an editing error, in two places. Correction 18 The first sentence of the twelfth paragraph of section n.H of the preamble should read as follows: "Proposed § 132.5 of the proposed Guidance would provide that requirements of this part will become effective within a State or Federal Indian Reservation if the State or Tribe fails to make the necessary submission, or if one or more parts of the submission cannot be approved by EPA and the State or Tribe fails to correct the deficiency upon notice by EPA. following EPA's publication of a final rule in the Federal Register identifying the elements of the part 132 requirements that apply in the jurisdiction and their effective date in the jurisdiction." (58 FR 20846) As in correction 17, the words "a final rule" replace "the final Guidance," to correct an editing error. Correction 19 The ambient water quality criteria for aquatic life for pentachlorophenol and phenol should be corrected in Tables ni-1 and m-2 of the preamble (58 FR 20853) and Tables 1 and 2 of proposed part 132 (58 FR 21014). The correct values were used, however, in the support document, "Great Lakes Water Quality Initiative Criteria Documents for the Protection of Aquatic Life in Ambient Water." The corrected values are: for Pentachlorophenol, chronic criterion (CCC). 4.1 ug/L; for Phenol, acute criterion (CMC), 3600 ug/L; for Phenol, chronic criterion (CCC)r 110 ug/ L. Correction 20 The headings "Percentile" and "Sample Size" for Table ffl-3 of the preamble were transposed by typographical error. (58 FR 20856) "Percentile" should appear over the left column, and "Sample Size" should appear over the 7 sub-columns on the it. Correction 21 In Table DC-1 of the preamble, the entries for Major direct dischargers— Municipal should read 348.9 and 353.5 for Scenarios 3 and 4 respectively. (58 FR 20987) The initial "3"s were omitted through typographical error. The totals for Scenarios 3 and 4 were also in error for the same reason. They should read 473.9 and 505.5 for Scenarios 3 and 4 respectively. Please note that these errors occur only in the table. EPA used the correct figures in its analysis of the costs of implementing the Guidance, and in the preamble text discussing the analysis. The figures are also stated correctly in the support document, "Assessment of Compliance Costs Resulting from Implementation of the Proposed Great Lakes Water Quality Guidance." Correction 22 The telephone number for the National Technical Information Service in the second paragraph of section Xin of the preamble should be 800-553- 6847. (58 FR 21002) Dated: July 30.1993. Martha G. Prothro, Acting Assistant Administrator. [FR Doc. 93-18974 Filed 8-6-93; 8:45 am] BILUNQ CODE !««» JO P ------- |