[Federal Register: May 7, 1997 (Volume 62, Number 88)] [Proposed Rules] [Page 24887-24896] >From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr07my97-36] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 372 [OPPTS-400111; FRL-5590-1] RIN 2070-AC00 Addition of Dioxin and Dioxin-Like Compounds; Modification of Polychlorinated Biphenyls (PCBs) Listing; Toxic Chemical Release Reporting; Community Right-to-Know AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: In response to a petition filed under section 313(e)(1) of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), EPA is proposing to add a chemical category that includes dioxin and 27 dioxin-like compounds to the list of toxic chemicals subject to the reporting requirements under EPCRA section 313 and section 6607 of the Pollution Prevention Act of 1990 (PPA). EPA believes that dioxin and the dioxin-like compounds that are included in the petition, meet the criteria for addition to the list of toxic substances as established in EPCRA section 313(d)(2)(B). EPA is also proposing to modify the existing EPCRA section 313 listing for polychlorinated biphenyls (PCBs) in order to exclude those PCBs that are included in the proposed dioxin and dioxin-like compounds category. DATES: Written comments must be received by July 7, 1997. ADDRESSES: Written comments should be submitted in triplicate to: OPPT Docket Clerk, TSCA Document Receipt Office (7407), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Rm. G-099, Washington, DC 20460, Attention: Docket Control Number OPPTS-400109. Comments containing information claimed as confidential must be clearly marked as confidential business information (CBI). If CBI is claimed, three additional sanitized copies must also be submitted. Nonconfidential versions of comments on this proposed rule will be placed in the rulemaking record and will be available for public inspection. Comments should include the docket control number for this proposal, OPPTS-400111, and the name of the EPA contact for this proposal. Unit VII. of this preamble contains additional information on submitting comments containing information claimed as CBI. Comments and data may also be submitted electronically by sending electronic mail (e-mail) to: [email protected]. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in WordPerfect 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket control number OPPTS-400109. No CBI should be submitted through e-mail. Electronic comments on this proposed rule may be filed online at many Federal Depository Libraries. Additional information on electronic submissions can be found in Unit VII. of this preamble. FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Acting Petitions Coordinator, 202-260-3882, e-mail: [email protected], for specific information on this proposed rule, or for more information on EPCRA section 313, the Emergency Planning and Community Right-to-Know Hotline, Environmental Protection Agency, Mail Code 5101, 401 M St., SW., Washington, DC 20460, Toll free: 1-800-535-0202, in Virginia and Alaska: 703-412-9877 or Toll free TDD: 1-800-553-7672. SUPPLEMENTARY INFORMATION: I. Introduction A. Regulated Entities Entities potentially regulated by this action are those which manufacture, process, or otherwise use any of the 28 chemicals included in the proposed category and which are subject to the [[Page 24888]] reporting requirements of section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), 42 U.S.C. 11023 and section 6607 of the Pollution Prevention Act of 1990 (PPA), 42 U.S.C. 13106. However, based on what EPA knows about the sources of the chemicals in the proposed category, EPA believes that, under current reporting thresholds, it is highly unlikely that any entities will be required to report for the proposed chemical category. If thresholds are lowered in the future, then some of the potentially regulated categories and entities would include: ------------------------------------------------------------------------ Examples of regulated Category entities ------------------------------------------------------------------------ Industry Facilities that: incinerate hazardous waste, municipal solid waste, sewage sludge, or other wastes that contain chlorine; manufacture chlorinated organic compounds; operate metallurgical processes such as steel production, smelting operations, and scrap metal recovery furnaces; burn coal, wood, petroleum products, and used tires; treat or dispose of polychlorinated biphenyls. ------------------------------------------------------------------------ Federal Government Federal Agencies that are engaged in the combustion of wastes. ------------------------------------------------------------------------ This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your facility would be regulated by this action, you should carefully examine the applicability criteria in part 372 subpart B of Title 40 of the Code of Federal Regulations. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding ``FOR FURTHER INFORMATION CONTACT'' section. B. Statutory Authority This action is taken under section 313(d)(1) of EPCRA. EPCRA is also referred to as Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA) (Pub. L. 99-499). C. Background Section 313 of EPCRA requires certain facilities manufacturing, processing, or otherwise using listed toxic chemicals in amounts above reporting threshold levels, to report their environmental releases of such chemicals annually. Beginning with the 1991 reporting year, such facilities must also report pollution prevention and recycling data for such chemicals, pursuant to section 6607 of PPA. When enacted, section 313 established an initial list of toxic chemicals that was comprised of more than 300 chemicals and 20 chemical categories. Section 313(d) authorizes EPA to add chemicals to or delete chemicals from the list, and sets forth criteria for these actions. Under section 313(e)(1), any person may petition EPA to add chemicals to or delete chemicals from the list. EPA has added and deleted chemicals from the original statutory list. Pursuant to EPCRA section 313(e)(1), EPA must respond to petitions within 180 days either by initiating a rulemaking or by publishing an explanation of why the petition has been denied. EPA issued a statement of petition policy and guidance in the Federal Register of February 4, 1987 (52 FR 3479), to provide guidance regarding the recommended content and format for petitions. On May 23, 1991 (56 FR 23703), EPA issued a statement of policy and guidance regarding the recommended content of petitions to delete individual members of the section 313 metal compound categories. EPA has published a statement clarifying its interpretation of the section 313(d)(2) and (3) criteria for adding and deleting chemicals from the section 313 toxic chemical list (59 FR 61432; November 30, 1994) (FRL-4922-2). II. Description of Petition On August 28, 1996, EPA received a petition from Communities For A Better Environment to add dioxin and 27 dioxin-like compounds to the list of chemicals subject to the reporting requirements of EPCRA section 313 and PPA section 6607. The petitioner believes that because dioxin and dioxin-like compounds are highly toxic, persist and bioaccumulate in the environment, and may cause severe adverse health effects, they meet the listing criteria of EPCRA section 313(d)(2). The petitioner also requested that EPA lower the reporting thresholds for these chemicals because under current reporting thresholds no facilities would be required to file a report on these chemicals, and thus the public would not be able to obtain information on releases of these highly toxic and environmentally persistent chemicals. Although the petition to add these chemicals to the EPCRA section 313 list is subject to the 180-day statutory petition response deadline discussed in Unit I.C. of this preamble, the request to lower the reporting thresholds is not subject to this statutory deadline (see EPCRA section 313(f)(2)). III. Technical Review of the Petition The technical review of the petition to add dioxin and dioxin-like compounds to the EPCRA section 313 list of toxic chemicals included an analysis of the chemistry (Ref. 1), environmental fate (Ref. 2), and health effects (Ref. 3) data available for dioxin and the 27 dioxin- like compounds identified in the petition. A summary of the review of the available data is provided below and a more detailed discussion can be found in the EPA technical reports (Refs. 1, 2, and 3) and other cited references. A. Chemistry, Use and Sources The petitioner requested the addition of dioxin and dioxin-like compounds to the EPCRA section 313 list of toxic chemicals. Dioxin and dioxin-like compounds refers to a group of 28 environmentally stable compounds which includes 7 polychlorinated dibenzo-p-dioxins (CDDs), 10 polychlorinated dibenzofurans (CDFs), and 11 co-planar polychlorinated biphenyls (PCBs). The chemical structures and nomenclature for these compounds are discussed below. The structure of dibenzo-p-dioxin and the conventional numbering system for substituent positions are shown below: [GRAPHIC] [TIFF OMITTED] TP07MY97.005 Chlorine can be substituted at the 8 possible positions marked on the two benzene rings to give 75 different congeners of chlorinated dibenzo-p-dioxins. Only the seven CDDs, having chlorine substitution at the 2, 3, 7, and 8 positions, are thought to have dioxin-like toxicity (i.e, toxicity similar to 2,3,7,8-tetrachlorodibenzo-p-dioxin which is referred to simply as ``dioxin'' or 2,3,7,8-TCDD). The seven CDDs included in the petition contain four to eight chlorines. The chemical names for the seven CDDs are listed below with their corresponding Chemical Abstract Service Registry Numbers (CAS No.) in parenthesis: [[Page 24889]] 1,2,3,4,6,7,8-heptachlorodibenzo-p-dioxin, (35822-46-9) 1,2,3,4,7,8-hexachlorodibenzo-p-dioxin, (39227-28-6) 1,2,3,6,7,8-hexachlorodibenzo-p-dioxin, (57653-85-7) 1,2,3,7,8,9-hexachlorodibenzo-p-dioxin, (19408-74-3) 1,2,3,4,6,7,8,9-octachlorodibenzo-p-dioxin, (3268-87-9) 1,2,3,7,8-pentachlorodibenzo-p-dioxin, (40321-76-4) 2,3,7,8-tetrachlorodibenzo-p-dioxin, (1746-01-6) The structure of dibenzofuran and the conventional numbering system for substituent positions are shown below. [GRAPHIC] [TIFF OMITTED] TP07MY97.006 Chlorine can be substituted at the 8 possible positions marked on the 2 benzene rings to give 135 different congeners of chlorinated dibenzofurans. Only 10 CDFs, having chlorine substitution at the 2, 3, 7, and 8 positions, are thought to have dioxin-like toxicity. The 10 CDFs included in the petition have 4 to 8 chlorines. The chemical names for the 10 CDFs are listed below with their corresponding CAS Nos. in parenthesis: 1,2,3,4,6,7,8-heptachlorodibenzofuran, (67562-39-4) 1,2,3,4,7,8,9-heptachlorodibenzofuran, (55673-89-7) 1,2,3,4,7,8-hexachlorodibenzofuran, (70648-26-9) 1,2,3,6,7,8-hexachlorodibenzofuran, (57117-44-9) 1,2,3,7,8,9-hexachlorodibenzofuran, (72918-21-9) 2,3,4,6,7,8-hexachlorodibenzofuran, (60851-34-5) 1,2,3,4,6,7,8,9-octachlorodibenzofuran, (39001-02-0) 1,2,3,7,8-pentachlorodibenzofuran, (57117-41-6) 2,3,4,7,8-pentachlorodibenzofuran, (57117-31-4) 2,3,7,8-tetrachlorodibenzofuran, (51207-31-9) The structure of biphenyl and the conventional numbering system are shown below. [GRAPHIC] [TIFF OMITTED] TP07MY97.007 The 10 positions marked on the 2 benzene rings (i.e., 2', 3, 3', 4, 4', 5, 5', 6, and 6') can be chlorinated to give 209 different congeners of chlorinated biphenyls. Eleven PCBs believed to have dioxin-like toxicity are included in the petition. These 11 PCBs have 4 to 7 chlorine atoms, but contain no more than 1 chlorine at the 4 ortho positions (i.e., 2, 2', 6 or 6') and all have 2 chlorines at the para positions (i.e., 4 and 4') and at least 2 chlorines at the meta positions (i.e., 3, 3', 5, or 5'). All 11 are regarded as coplanar PCBs. Coplanar PCBs are those in which the two benzene rings can rotate into the same plane. The two benzene rings can rotate into the same plane since chlorine substitution in only one of the ortho positions does not block the rotation of the two benzene rings over the bond connecting positions 1 and 1'. The chemical names for the 11 PCBs included in the petition are listed below with their corresponding CAS Nos. in parenthesis: 2,3,3',4,4',5,5'-heptachlorobiphenyl, (39635-31-9) 2,3,3',4,4',5-hexachlorobiphenyl, (38380-08-4) 2,3,3',4,4',5'-hexachlorobiphenyl, (69782-90-7) 2,3',4,4',5,5'-hexachlorobiphenyl, (52663-72-6) 3,3',4,4',5,5'-hexachlorobiphenyl, (32774-16-6) 2,3,3',4,4'-pentachlorobiphenyl, (32598-14-4) 2,3,4,4',5-pentachlorobiphenyl, (74472-37-0) 2,3',4,4',5-pentachlorobiphenyl, (31508-00-6) 2',3,4,4',5-pentachlorobiphenyl, (65510-44-3) 3,3',4,4',5-pentachlorobiphenyl, (57465-28-8) 3,3',4,4'-tetrachlorobiphenyl, (32598-13-3) Except for laboratory scale preparation for chemical analysis and testing, CDDs and CDFs have never been produced intentionally for any commercial use; rather, they occur as trace contaminants in many chemical-industrial and thermal processes, and may be present in the chemical products and waste streams from such processes. PCBs, however, were commercially produced in large quantities and, as discussed below, were used in the U.S. mainly as nonflammable and heat resistant fluids for transformers and as dielectric media for capacitors. Except for small quantities of PCBs that are inadvertently generated during an excluded manufacturing process and exemptions that have been granted by EPA under section 6(e)(3) of the Toxic Substances Control Act (TSCA) for the manufacture of PCBs for research and development purposes, the manufacturing of PCBs was banned in the U.S. in 1979 and their use and disposal regulated. However, PCBs continue to be released to the environment through the use and disposal of products manufactured years ago. CDDs and CDFs are classified as chlorinated tricyclic aromatic hydrocarbons and they are structurally very similar and have similar physical and chemical properties. CDDs and CDFs normally exist as complex mixtures of congeners. One of the congeners, 2,3,7,8-TCDD, has been extensively studied due to its high toxicity (Ref. 4). The 7 CDDs and 10 CDFs included in the petition are high melting solids. They have extremely low vapor pressures, are highly insoluble in water, are quite lipophilic, and tend to persist and bioaccumulate in the environment (see Unit III.B. of this preamble for a more complete discussion of environmental fate including persistence and bioaccumulation). They are classified as lipophilic since 2,3,7,8-TCDD is more soluble in many organic solvents, fats, and oils than in water, although the overall solubility of 2,3,7,8-TCDD in organic solvents is quite low. The water solubility of 2,3,7,8-TCDD is about 19 parts per trillion (ppt), while that of 2,3,7,8-tetrachlorodibenzofuran is about 420 ppt. Generally, water solubility decreases as the chlorine substitution increases. The CDDs and CDFs are stable toward heat, oxidation, acids, and alkalies. CDDs and CDFs can be photolyzed by sunlight or ultraviolet radiation (Refs. 5 and 6). The melting point, water solubility, vapor pressure, and log Kow of the 17 CDDs and CDFs included in the petition have all been measured or calculated (Ref. 1). PCBs differ structurally from CDDs and CDFs, yet some have similar physical and chemical properties. They are chemically stable, have low vapor pressure, have low water solubility (1 part per billion (ppb)), and they are very lipophilic. Due to their high thermal stability, low flammability, high heat capacity, and low electrical conductivity, PCBs, under the U.S. trade name Aroclor series, were highly favored as cooling liquids in electrical equipment from 1929 to 1979. The Aroclor series vary greatly in congener numbers and compositions. Although most of the individual congeners are solids, Aroclors, since they are complex mixtures, exist as oils, viscous liquids, or sticky resins (Ref. 7). PCBs are unchanged in the presence of oxygen and active metals at temperatures up to 170 deg.C (Ref. 7). Pyrolysis of technical grade PCBs produces CDFs (Ref. 8). In [[Page 24890]] the presence of a hydrogen donor, PCBs undergo photodechlorination when exposed to sunlight or ultraviolet radiation. With the exception of the vapor pressure for 1 PCB, EPA has identified measured or calculated melting points, vapor pressures, and log Kow s for each of the 11 PCBs (Ref. 1). From 1929 to 1977, PCBs were produced commercially in the U.S. in large quantities by catalytic partial chlorination of biphenyl under heated conditions to produce complex mixtures, each containing 60 to 90 different congeners and a specific percent of chlorine (Refs. 7 and 9). Because of their excellent thermal resistance and dielectric properties, PCBs were used mainly as insulators for transformers and as a dielectric medium for capacitors. PCBs were also used as plasticizers; ingredients in lacquers, printing inks, paints and varnishes, and adhesives; waterproofing compounds in various types of coatings; dye carriers for pressure-sensitive copying paper; lubricants or lubricant additives under extreme conditions; heat transfer fluids; fire resistant hydraulic fluids; and as vacuum pump fluids (Refs. 10 and 11). The production of PCBs peaked at 33,000 tons in 1970 (Ref. 7). Although PCBs are no longer produced in the U.S. (except as discussed earlier in this Unit) and other industrialized countries, PCBs continue to be released into the environment through the use and disposal of products containing or contaminated with PCBs, and by the reintroduction of PCBs into the air and water from previously contaminated soil and sediment. Disposal and use of PCBs and PCB- containing materials have been regulated by EPA under TSCA since 1978 (Ref. 12). Some uses of PCBs are allowed, but the uses are very restrictive (Ref. 13). CDDs and CDFs are not produced commercially and there are no known commercial uses. CDDs and CDFs are produced in small amounts in laboratories for use in chemical analysis, and they are generated in trace amounts as byproducts from various chemical and combustion processes (Refs. 14 and 15). CDDs and CDFs can be produced from aromatic or potentially aromatic forming compounds in the presence of a chlorine source. The formation is enhanced under alkali conditions at elevated temperatures or in the presence of air upon heating. Industrial products, most likely to be contaminated with CDDs and CDFs, are polychlorinated phenols, polychlorinated diphenyl ethers, and other polychlorinated aromatic compounds (Ref. 15). CDDs and CDFs share most of the same precursor compounds, but chlorinated biphenyls form only corresponding furans and chlorinated 2-hydroxy phenyl ethers form only dioxins. The largest identified source for CDDs and CDFs is the combustion of waste (municipal, medical, and hazardous) (Refs. 4, 14, 15, and 16). Other sources include pulp and paper mills (from chlorine bleaching processes); oil refineries (catalyst regeneration processes); manufacture of chlorinated organic chemicals (chlorinated phenols and other aromatics, chlorinated aliphatic solvents and monomers, herbicides, etc.); combustion and incineration of wastes; steel production and smelting operations; and energy generation (combustion of coal, wood, petroleum products, tires etc.). The dioxin-like compounds have been found in all environmental media (air, water, soil, sediments) and foods. B. Environmental Fate There is a good general understanding of the environmental fate and transport of CDDs, CDFs, and PCBs. CDDs and CDFs are primarily associated with particulate and organic matter in air, water, soil, and sediment, although vapor phase transport and deposition of lower chlorinated CDDs and CDFs does occur and is important to human exposure (Ref. 17). CDDs and CDFs with four or more chlorines are extremely stable in most environmental media and thus may be classified as persistent organic pollutants (POPs). CDDs and CDFs entering the atmosphere are removed by either photodegradation or wet/dry deposition (Refs. 18 and 19). For CDDs and CDFs sorbed to soil, burial in place or movement to water bodies by erosion of the soil are the predominant fate. CDDs and CDFs entering the aquatic environment primarily undergo sedimentation and burial. Resuspension of sediments can be an important route of exposure to fish and other aquatic organisms. Benthic sediments are believed to be the ultimate environmental sink (Ref. 20). Coplanar PCBs, like CDDs and CDFs, have very low water solubilities and tend to sorb strongly to organic matter in soils and sediments. However, they have somewhat higher vapor pressures than the CDDs and CDFs. Atmospheric transport and deposition are thought to be the principal mechanisms that account for the widespread environmental distribution of CDDs, CDFs, and PCBs (Ref. 21). Like CDDs and CDFs, PCBs are quite stable and may be classified as POPs. Soil erosion and sediment transport in water bodies and volatilization from soil and water with subsequent atmospheric transport and deposition are believed to be the dominant transport mechanisms, and account for the widespread environmental occurrence of PCBs (Ref. 22). Photodegradation of the more highly chlorinated congeners to less chlorinated products can be a significant transformation process for PCBs exposed to light (Ref. 23). There is now a substantial body of evidence indicating that microbial dehalogenation resulting in less chlorinated PCBs also occurs and may be a significant fate process under anaerobic conditions, principally in sediments (Refs. 22, 24, and 25). However, dehalogenation is a slow process that occurs over a time frame of years. CDDs, CDFs, and PCBs are very hydrophobic compounds, and this is reflected by their high estimated or measured octanol/water partition coefficients. Because of their high lipophilic nature, these compounds accumulate to a significant level in the fatty tissues of biota. This potential has been amply documented in both experimental and monitoring studies for many of the compounds. Measured bioconcentration factors (BCFs) for all the CDDs, CDFs, and PCBs included in the petition consistently exceed 1,000 (and may be much higher), indicating that they are all bioaccumulative (Refs. 26 and 27). CDDs, CDFs, and PCBs are found in measurable levels in human tissues across the general population. Typical levels for U.S. adults determined from literature data (Ref. 28) are 30 ppt toxic equivalents (TEQ) for CDDs and CDFs and 20 ppt TEQ for PCBs. TEQs are determined by summing the products of multiplying concentrations of individual dioxin-like compounds times the corresponding toxicity equivalence factor (TEF) for that compound (TEFs are discussed in Unit III.C. of this preamble). The principal route of human exposure is thought to be consumption of animal fats (e.g., beef, pork, poultry, milk, dairy products, and fish) (Ref. 29). For meat and dairy products, the mechanism by which these foods become contaminated is thought to be air deposition onto plants which are then eaten by livestock (Refs. 21 and 30). Fish absorb these compounds directly from water or contact with sediments (Ref. 27). C. Toxicity Evaluation EPA has done extensive risk and hazard assessments over the years for dioxin and dioxin-like compounds and is in the final stages of reassessment of these compounds based on up-to-date [[Page 24891]] data. The reassessment is looking at many things including the sources of these chemicals and potential exposures. While not yet final, nothing in the current reassessment indicates less than high hazard levels for these compounds. Therefore, the reassessment will not change the toxicity determination as it relates to the EPCRA section 313 listing criteria. An extensive data base exists showing that 2,3,7,8-TCDD is a potent toxicant in animals and has the potential to produce a wide spectrum of toxic effects in humans. There is sufficient evidence to conclude that 2,3,7,8-TCDD is carcinogenic in experimental animals (Refs. 4, 31, 32, and 33). Long-term studies in rats, mice, hamsters and Medaka (a small fish) using various routes of administration all produced positive results at dose levels well below the maximum tolerated dose (MTD), leading to the conclusion that 2,3,7,8-TCDD is a potent carcinogen. Depending on the species of the animal, the principal target organs are the liver, lung, thyroid gland, and nasal-oral cavities by oral administration. When administered topically, 2,3,7,8-TCDD induced skin tumors in mice. Available human data cannot clearly demonstrate whether a cause and effect relationship exists between 2,3,7,8-TCDD exposure and increased incidence of cancer. However, there are a number of epidemiological studies associating exposure to 2,3,7,8-TCDD with increased cancer mortality (Refs. 4 and 32). Based on the EPA weight-of-evidence classification criteria, there is sufficient evidence to conclude that 2,3,7,8-TCDD is a probable human carcinogen. It has been listed by the National Institute of Environmental Health Sciences/National Toxicology Program (NIEHS/NTP) as a substance which may reasonably be anticipated to be a human carcinogen (Ref. 31). Based on the 1985 slope factor (Ref. 4) 2,3,7,8-TCDD is the most potent chemical carcinogen that EPA has regulated. Similarly, there is sufficient evidence for the carcinogenicity of PCBs in experimental animals (Refs. 34 and 35). Based on the evidence from animal studies and inadequate/limited evidence for carcinogenicity to humans, PCBs are classified as group B2, probable human carcinogens by EPA (Ref. 36) and are listed as substances which may reasonably be anticipated to be human carcinogens in the NIEHS/NTP Annual Report on Carcinogens (Ref. 31). In addition to carcinogenic effects, 2,3,7,8-TCDD and PCBs have been shown to cause a variety of adverse effects in laboratory animals (Refs. 32, 33, and 35). Humans exposed to 2,3,7,8-TCDD or PCBs in a number of incidents have been reported to develop chloracne, liver disorders, porphyria, and neurological changes (Refs. 4, 33, and 35). In a number of animal species tested, including fish, birds, and mammals, 2,3,7,8-TCDD has been shown to induce various reproductive, fetotoxic and teratogenic responses. With a No Observed Effect Level (NOEL) of about 0.001 micrograms per kilogram (g/kg) in reproductive toxicity studies in rats, and a Minimum Effective Dose (MED) of about 0.1 g/kg/day in teratogenicity studies in rats and mice, 2,3,7,8-TCDD is one of the most, if not the most, potent reproductive/developmental toxicant known. Studies in various animal species have also demonstrated that the immune system is a target for toxicity of 2,3,7,8-TCDD. 2,3,7,8-TCDD has been shown to cause decreases in thymic and splenic weights, and alter serum immunoglobin levels in mice at oral doses as low as 0.01 ug/kg/week (Refs. 4 and 33). The 11 dioxin-like PCBs are believed to have toxicities similar to CDDs and CDFs. In addition, PCBs as a class display a variety of adverse human health effects. Reproductive dysfunction due to exposure to PCBs has been documented in a wide variety of animal species including the rat, mouse, rabbit, monkey, and mink. Irregular menstrual cycle, decreased mating performance, early abortion, as well as resorption are the most commonly observed effects. Teratogenic effects have been noted in mice, dogs, and chickens which showed various skeletal deformities. Data from animal studies suggest that the immune system is also a sensitive target for toxicity of PCBs. Thymic atrophy, cellular alterations in the spleen and lymph nodes accompanied by reduced antibody production have been observed in rats, rabbits, and monkeys exposed to PCBs by various routes (Refs. 8 and 35). There are more limited data for other dioxin-like compounds. However, many of these compounds, especially those with chlorine or bromine substitution at the 2,3,7,8-positions, are generally recognized to exhibit toxicity and carcinogenicity similar to 2,3,7,8-TCDD. Indeed, carcinogenesis bioassays of a mixture of 1,2,3,6,7,8- and 1,2,3,7,8,9-hexachlorodibenzo-p-dioxin have shown that these compounds are carcinogenic, inducing liver tumors in both sexes of rats and mice (Ref. 37). Presently, there is considerable evidence showing that the initial event involved in carcinogenesis and toxicity of dioxin and dioxin-like compounds is their stereospecific interaction with a cytosolic receptor (Ah receptor) (Ref. 38). Because of their common mechanism of action, Toxicity Equivalence Factors (TEFs) have been established for dioxin- like compounds. TEFs represent order of magnitude estimates of the relative potency of dioxin-like compounds compared to 2,3,7,8-TCDD, and have been considered by EPA and the international scientific community to be a valid and scientifically sound approach for assessing the likely health hazard of dioxin-like compounds (Ref. 39). Structure- activity relationship analysis of halogenated dibenzo-p-dioxin, dibenzofuran, and related compounds indicates that the degree of toxicity of these dioxin-like compounds is dependent on the number and positions of chlorine substitutions; all the lateral positions (2, 3, 7, and 8) must be chlorinated to achieve the greatest degree of toxicity. Examination of all the dioxin and dioxin-like compounds (7 CDDs and 10 CDFs) specified in the petition revealed that they all contain chlorine at the 2, 3, 7, and 8 positions. The range of the TEFs for CDDs and CDFs is between 0.5 and 0.001, indicating that they are estimated to be about half to three orders of magnitude less toxic than 2,3,7,8-TCDD. The PCBs included in this proposal also have proposed TEF values which range from 0.1 to 0.00001 (Ref. 40). Nonetheless, all of these dioxin-like compounds are potent carcinogens and highly toxic compounds given the level of toxicity of 2,3,7,8-TCDD (Refs. 32, 33, and 35). Therefore, based on the available toxicity data, it is concluded that the 7 CDDs, 10 CDFs, and 11 PCBs specified in this petition are highly toxic and are reasonably anticipated to cause serious adverse health effects, including cancer, in humans. IV. Technical Summary EPA's technical review revealed that dioxin and dioxin-like compounds are known to cause chloracne, immunotoxicity, reproductive/ developmental effects, and cancer in experimental animals, and that it is reasonable to anticipate that these chemicals will also cause cancer and other serious adverse chronic health effects in humans. The review also shows that dioxin and dioxin-like compounds are chemically stable compounds that persist and bioaccumulate in the environment. V. Petition Response and Rationale EPA is proposing to grant the petition to add dioxin and dioxin- like compounds to the EPCRA section 313 [[Page 24892]] list of toxic chemicals. However, as discussed in Unit V.C. of this preamble, EPA is not proposing to lower reporting thresholds for these compounds at this time. A. Proposed Addition of a Chemical Category EPA is proposing to add a delimited chemical category entitled ``Dioxin and Dioxin-like Compounds'' to the EPCRA section 313 list of toxic chemicals. This delimited category will include the 28 individual chemicals identified by name and CAS number under Unit III.A. of this preamble. The technical review of dioxin and dioxin-like compounds indicates that these chemicals are highly toxic and persist and bioaccumulate in the environment. EPA believes that the toxicity data for these chemicals clearly indicate that these chemicals are known to cause or can reasonably be anticipated to cause cancer and other serious chronic health effects in humans. Therefore, EPA believes that dioxin and dioxin-like compounds meet the EPCRA section 313(d)(2)(B) criteria for listing. In addition, because dioxin and dioxin-like compounds can reasonably be anticipated to cause high chronic toxicity and cancer, EPA does not believe that an exposure assessment is necessary to conclude that these compounds meet the toxicity criterion of EPCRA section 313(d)(2)(B). For a discussion of the use of exposure in EPCRA section 313 listing/delisting decisions, see 59 FR 61432, November 30, 1994. As EPA has explained in the past (59 FR 61432, November 30, 1994), the Agency believes that EPCRA allows a chemical category to be added to the list, where EPA identifies the toxic effect of concern for at least one member of the category and then shows why that effect can reasonably be expected to be caused by all other members of the category. Here, individual toxicity data do not exist for each member of the proposed category; however, as discussed in Unit III.C. of this preamble, there is sufficient information to conclude that all of these chemicals are highly toxic based on structural and physical/chemical property similarities to those members of the category for which data are available. For purposes of EPCRA section 313, threshold determinations for chemical categories must be based on the total of all chemicals in the category (see 40 CFR 372.25(d)). For example, a facility that manufactures three members of a chemical category would count the total amount of all three chemicals manufactured towards the manufacturing threshold for that category. When filing reports for chemical categories, the releases are determined in the same manner as the thresholds. One report is filed for the category and all releases are reported on one Form R (the form for filing reports under EPCRA section 313 and PPA section 6607). B. Modification of Current Listing for PCBs The current EPCRA section 313 list of toxic chemicals includes a listing for polychlorinated biphenyls (PCBs) under the CAS No. 1336-36- 3. This is a broad listing that includes all chlorinated 1,1'- biphenyls, not just the ones that are proposed to be included in the dioxin and dioxin-like compounds category. The non-dioxin-like PCBs are also toxic and EPA is not proposing to remove them from the EPCRA section 313 list. However, EPA is proposing to modify the current PCBs listing to exclude those PCBs that are listed as part of the new category in order to avoid having some PCBs reportable under two listings, which might lead to double reporting. EPA is proposing to modify the current PCB listing to read ``polychlorinated biphenyls (PCBs) (excluding those PCBs listed under the dioxin and dioxin-like compounds category).'' C. Deferral of Lower Reporting Thresholds The petitioner also requested that EPA lower the reporting thresholds for dioxin and dioxin-like compounds. This request is not subject to the statutory 180-day petition response deadline in EPCRA section 313(e)(1) and EPA intends to address this request as part of the Agency's ongoing project to assess the utility and impacts of lowering reporting thresholds for EPCRA section 313 listed toxic chemicals that persist and bioaccumulate in the environment. EPA has initiated this project in response to concerns that chemicals that persist and bioaccumulate in the environment can have a cumulative effect and therefore it is important for the public to be able to track even low releases of such chemicals. The current reporting thresholds of 25,000 pounds for manufacturing or processing and 10,000 pounds for otherwise use are high enough that many biologically significant releases of persistent bioaccumulative chemicals are usually not reported. EPA believes that rather than proposing lower reporting thresholds for dioxin and dioxin-like compounds at this time, this issue should be considered within the context of lower reporting thresholds for all EPCRA section 313 listed toxic chemicals that persist and bioaccumulate in the environment. Taking this approach will provide adequate time for EPA to evaluate and address issues pertaining to the use of lower reporting thresholds for these chemicals. Therefore, EPA is not proposing to lower the reporting thresholds for the dioxin and dioxin- like compounds category proposed as part of today's petition response. However, EPA is requesting comment on the issue of lower reporting thresholds for these compounds. D. Schedule for Final Rule Based on what EPA knows about the sources of the chemicals in the proposed dioxin and dioxin-like compounds category, EPA believes that, under current reporting thresholds, it is highly unlikely that any reports would be filed for the category if it were added to the EPCRA section 313 list. EPA believes that delaying final action to add this category to the EPCRA section 313 list will not result in a loss of significant information. Therefore, if after consideration of comments received on this proposed rule, EPA decides to finalize the addition of the category, EPA will postpone that action until a rule lowering the reporting thresholds for the category is ready to be finalized. EPA intends to address the issue of lower reporting thresholds for the dioxin and dioxin-like compounds category within the next year. VI. Request for Public Comment EPA requests general comments on this proposal to add the delimited dioxin and dioxin-like compounds category to the list of toxic chemicals subject to the reporting requirements under EPCRA section 313 and PPA section 6607. Further, EPA requests comment on the issue of lowering the EPCRA section 313 reporting thresholds for the proposed dioxin and dioxin-like compounds category. Comments should be submitted to the address listed under the ADDRESSES unit at the front of this document. All comments must be received by July 7, 1997. VII. Rulemaking Record A record, that includes the references in Unit VIII. of this preamble, has been established for this rulemaking under docket control number OPPTS-400111 (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from noon to 4 p.m., Monday through Friday, excluding legal holidays. The public [[Page 24893]] record is located in the TSCA Nonconfidential Information Center, Rm. NE-B607, 401 M St., SW., Washington, DC 20460. Electronic comments can be sent directly to EPA at: [email protected] Electronic comments must be submitted as an ASCII file avoiding the use of any special characters and any form of encryption. The official record for this rulemaking, as well as the public version, as described above will be kept in paper form. Accordingly, EPA will transfer all comments received electronically into printed, paper form as they are received and will place the paper copies in the official rulemaking record which will also include all comments submitted in writing. The official rulemaking record is the paper record maintained at the address in ``ADDRESSES'' at the beginning of this document. VIII. References 1. USEPA, OPPT. Tou, Jenny; ``Chemistry Report for EPCRA 313 Petition for the Addition of Dioxin-Like Compounds.'' (December 9, 1996). 2. USEPA, OPPT. Boethling, Robert S.; ``Environmental Fate and Bioaccumulation Potential of Dioxin-Like Compounds.'' (January 14, 1997). 3. USEPA, OPPT. Memorandum from Dr. David Lai, Toxicologist, Health and Environmental Review Division. Subject: Health Effects Review of the Petition to Add Dioxin and Dioxin-Like Compounds to the TRI List. (October 21, 1996). 4. USEPA, OHEA. Health Assessment Document for Polychlorinated Dibenzo-p-dioxins. Prepared by the Office of Health and Environmental Assessment, U.S. Environmental Protection Agency, Washington, DC, (1985): EPA/600/8-84/014F. 5. Buser, H. R., ``Rapid Photolytic Decomposition of Brominated and Brominated/Chlorinated Dibenzodioxins and Dibenzofurans.'' Chemosphere v. 17(5), (1988), pp. 889-903. 6. USEPA, OTS. Exposure Assessment for Polychlorinated Biphenyls (PCBs), Polychlorinated Dibenzofurans (PCDFs), and Polychlorinated Dibenzodioxins (PCDDs) Released During Transformer Fires. Prepared by the Exposure Evaluation Division, Office of Toxic Substances, U.S. Environmental Protection Agency, Washington, DC and Versar Inc. EPA Contract No. 68-02-3986, Task No. 48. (June 1985): EPA 560/1985.4 7. International Programme on Chemical Safety (IPCS). 1993. Environmental Health Criteria 140, Polychlorinated Biphenyls and Terphenyls (Second Edition), World Health Organization, Geneva. 8. ATSDR. 1993. Toxicological Profile for Selected PCBs (Aroclor - 1260, -1254, -1248, -1242, -1232, -1221, and -1016). U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA, Report No. ATSDR/ TP-92/16. 9. Frame, G.M. et al., ``Comprehensive, Quantitative, Congener- Specific Analysis of Eight Aroclors and Complete PCB Congener Assignments on DB-1 Capillary GC Columns.'' Chemosphere v. 33(4), (1996), pp. 603-623. 10. Hatton, R.E., ``Chlorinated Biphenyls and Related Compounds.'' In: Kirk-Othmer, Encyclopedia of Chemical Technology, Vol. 5, 3rd Edition, John Wiley Sons, New York, NY (1979), pp. 844-848. 11. Beck, U, ``Chlorinated Biphenyls.'' In: Ullmanns Encyclopedia of Industrial Chemistry, 5th Edition, Vol. A6, VCH Publishers, New York (1986), Chapter 8, section 8.3, pp. 347-350. 12. ATSDR. 1995. Toxicological Profile for Polychlorinated Biphenyls (Draft). U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry (ATSDR), Atlanta, GA, Report No. ATSDR/TP-93/04. 13. USEPA. 1996. Code of Federal Regulations. 40 CFR 761.30. 14. Fiedler, H., ``Sources of PCDD/PCDF and Impact on the Environment.'' Chemosphere v. 32(1), (1996), pp. 55-64. 15. International Programme on Chemical Safety (IPCS). 1989. Environmental Health Criteria 88, Polychlorinated Dibenzo-paradioxins and Dibenzofurans, World Health Organization, Geneva. 16. Canadian Environmental Protection Act. 1990. Priority Substances List Assessment Report No. 1: Polychlorinated Dibenzodioxins and Polychlorinated Dibenzofurans. 17. Welsch-Paulsch, K., McLachlan, M., Umlauf, G. ``Determination of the Principal Pathways of Polychlorinated Dibenzo-p-dioxins and Dibenzofurans to Lolium Multiflorum (Welsh Ray Grass).'' Envion. Sci. Technol. v. 29, (1995), pp. 189-194. 18. Choudhry, G.C. and Hutzinger, O. ``Photochemical Formation and Degradation of PCDDs and PCDFs.'' Residue Reviews, v. 84, (1982), pp. 112-161. 19. Koester, C.J. and Hites, R.A. ``Wet and Dry Deposition of CDD/ Fs.'' Envion. Sci. Technol., v. 26, (1992), pp. 1375-1382. 20. Fletcher, C.L. and McKay, W.A. ``PCDDs and PCDFs in the Aquatic Environment - a Literature Review.'' Chemosphere, v. 26, (1993), pp. 1041-1069. 21. Lorber, M. et al., ``Development and Validation of Airto-Beef Food Chain, Model for Dioxin-Like Compounds.'' Sci. Total Envion. v. 156, (1994), pp. 39-65. 22. USEPA, OTS. Leifer, A. et al., ``Environmental Transport and Transformation of Polychlorinated Biphenyls.'' Office of Toxic Substances, U.S. Environmental Protection Agency, Washington, DC, (December 1983): EPA-560/5-83-025. 23. Lepine, R., Milot, S., Vincent, N. ``Formation of Toxic PCB Congeners and PCB-Solvent Adducts in a Sunlight Irradiated Cyclohexane Solution of Aroclor 1254.'' Bulletin of Environmental Contamination and Toxicology v. 48, (1992), pp. 152-156. 24. Abramowitz, D. ``Aerobic and Anaerobic Biodegradation of PCBs.'' Critical Reviews in Biotechnologies v. 10(3), (1990), pp. 241- 251. 25. Brown, J.F. and Wagner, R.E. ``PCB Movement, Dechlorination and Detoxication in the Acushnet Estuary.'' Environ. Toxicol. Chem. v. 9, (1990), pp. 1215-1233. 26. USEPA, ORD. Interim Report on Data and Methods for Assessment of 2,3,7,8-Tetra Chlorodibenzo-p-dioxin Risks to Aquatic Life and Associated Wildlife. Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC, (1993): EPA/600/R-93/ 055. 27. USEPA, OW. Great Lakes Water Quality Initiative Technical Support Document for the Procedure to Determine Bioaccumulation Factors. Office of Water, U.S. Environmental Protection Agency, Washington, DC, (March 1995): EPA-820-B-95005. 28. USEPA, OTS. Chlorinated Dioxins and Furans in the General U.S. Population: NHATS FY87 Results. Office of Toxic Substances, U.S. Environmental Protection Agency, Washington, DC, (December 1991): EPA- 560/5-91-003. 29. Travis, C.C. and Hattemer-Frey, H.A. ``Human Exposure to Dioxin.'' Sci. Total Environ. v. 104, (1991), pp. 97-127. 30. Fries, G.F. and Paustenbach, D.J. ``Evaluation of Potential Transmission of 2,3,7,8-Tetrachlorodibenzo-p-dioxin-Contaminated Incinerator Emmissions to Humans Via Foods.'' Journal of Toxicological and Environmental Health v. 29, (1990), pp. 143. 31. NIEHS. 1994. Seventh Annual Report on Carcinogens. U.S. Department of Health and Human Services, Public [[Page 24894]] Health Service, National Institute of Environmental Health Sciences, Research Triangle Park, NC. 32. USEPA. Interim Procedures for Estimating Risks Associated with Exposures to Mixtures of Chlorinated Dibenzo-p-dioxins and Dibenzofurans (CDDs and CDFs) and 1989 Update. Risk Assessment Forum, U.S. Environmental Protection Agency, Washington, DC, (1989): EPA/625/ 3-89/016. 33. Woo, Y.-t., Lai, D.Y., Arcos, J.C. and Argus, M.F.; ``Halogenated Phenoxy Acids, Aromatic Ethers, Dibenzofurans, and Dibenzo-p-dioxins.'' In: Chemical Induction of Cancer, Academic Press, New York, Vol. IIIB, (1985), pp. 237-274. 34. IARC 1987. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Suppl. 7. ``Polychlorinated Biphenyls,'' International Agency for Research on Cancer, Lyon, France, (1987), pp. 322-326. 35. Lai, D.Y.; ``Halogenated Benzenes, Naphthalenes, Biphenyls and Terphenyls in the Environment: Their Carcinogenic, Mutagenic and Teratogenic Potential and Toxic Effects.'' J. Environ. Sci. Health v. C2(2), (1984), pp. 135-184. 36. IRIS. 1996. U.S. Environmental Protection Agency's Integrated Risk Information System file pertaining to polychlorinated biphenyls. 37. NTP, 1980. ``Bioassay of a mixture of 1,2,3,6,7,8- Hexachlorodibenzo-p-dioxin and 1,2,3,7,8,9-Hexachlorodibenzo-p-dioxin (Gavage) for Possible Carcinogenicity,'' National Toxicology Program, Research Triangle Park, North Carolina. NTP80-12, NIH Publ. No. 80- 1754, 1980. 38. Poland, A. and Knutson, J.C.; ``2,3,7,8-Tetrachlorodibenzo-p- dioxin and Related Halogenated Aromatic Hydrocarbons: Examination of the Mechanism of Toxicity.'' Ann. Rev. Pharmacol. Toxicol. v. 22, (1982), p. 517. 39. Safe, S.; ``Polychlorinated Biphenyls, Dibenzo-p-dioxin and Dibenzofurans and Related Compounds: Environmental and Mechanistic Considerations Which Support the Development of Toxic Equivalency Factors.'' CRC Crit. Rev. Toxicol. v. 21, (1990), pp. 51-88. 40. Ahlborg, U.G. et al., ``Toxic Equivalency Factors for Dioxin- Like PCBs: Report on a WHO-ECEH and IPCS Consultation December 1993.'' Chemosphere v. 28, (1994), pp. 1049-1067. IX. Regulatory Assessment Requirements A. Executive Order 12866 Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is subject to review by the Office of Management and Budget (OMB). Pursuant to the terms of this Executive Order, this action was submitted to OMB for review, and any comments or changes made in response to OMB suggestions or recommendations have been documented in the public record. B. Regulatory Flexibility Act Pursuant to section 605(b) of the Regulatory Flexibility Act 5 U.S.C. 601 et seq., the Agency hereby certifies that this proposed action does not have a significant adverse economic impact on a substantial number of small entities. Based on what EPA currently knows about the sources of the chemicals in the proposed category, EPA believes that, under the current EPCRA section 313 reporting thresholds, it appears unlikely that any reports would be filed for the proposed category. Nevertheless, it is possible that 1 or more of the 13 facilities that currently report under the existing PCBs listing might process enough of the specific PCB members of the proposed category to exceed current reporting thresholds. Since, as discussed elsewhere in this proposed rule, the chemicals in the proposed category clearly meet the listing criteria of EPCRA section 313(d)(2), EPA is proposing to add them even though current projected reports are few. EPA estimates that the cost of reporting for any facility that exceeds reporting thresholds would be $3,023 and the cost to EPA of processing and reporting any filed report would be $77. EPA believes that under current reporting thresholds the proposed rule would not have a significant impact on facilities, including small entities. C. Paperwork Reduction Act This proposed rule does not contain any new information collection requirements that require additional approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. Currently, facilities subject to the reporting requirements under EPCRA 313 and PPA 6607 may either use the EPA Toxic Chemical Release Inventory Form R (EPA Form #9350-1), or the EPA Toxic Chemical Release Inventory Form A (EPA Form #9350-2). The Form R must be completed if a facility manufactures, processes, or otherwise uses any listed chemical above threshold quantities and meets certain other criteria. For the Form A, EPA established an alternate threshold for those facilities with low annual reportable amounts of a listed toxic chemical. A facility that meets the appropriate reporting thresholds, but estimates that the total annual reportable amount of the chemical does not exceed 500 pounds per year, can take advantage of an alternate manufacture, process, or otherwise use threshold of 1 million pounds per year for that chemical, provided that certain conditions are met, and submit the Form A instead of the Form R. In addition, respondents may designate the specific chemical identity of a substance as a trade secret pursuant to EPCRA section 322 (42 U.S.C. 11042; 40 CFR part 350). OMB has approved the reporting and recordkeeping requirements related to Form R, supplier notification, and petitions under OMB Control #2070-0093 (EPA ICR #1363); those related to Form A under OMB Control #2070-0143 (EPA ICR #1704); and those related to trade secret designations under OMB Control #2050-0078 (EPA ICR #1428). As provided in 5 CFR 1320.5(b) and 1320.6(a), an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9, 48 CFR Chapter 15, and displayed on the information collection instruments (e.g., forms, instructions, etc.). For Form R, EPA estimates the industry reporting and recordkeeping burden for collecting this information to average 74 hours per report in the first year, at an estimated cost of $4,587 per Form R. In subsequent years, the burden is estimated to average 52.1 hours per report, at an estimated cost of $3,023 per Form R. For Form A, EPA estimates the burden to average 49.4 hours per report in the first year, at an estimated cost of $3,101 per Form A. In subsequent years, the burden is estimated to average 34.6 hours per report, at an estimated cost of $2,160 per Form A. These estimates include the time needed to become familiar with the requirement (first year only); review instructions; search existing data sources; gather and maintain the data needed; complete and review the collection of information; and transmit or otherwise disclose the information. The actual burden to any specific facility may be different from this estimate depending on the complexity of the facility's operations and the profile of the releases at the facility. Upon promulgation of a final [[Page 24895]] rule, the Agency may determine that the existing burden estimates in both ICRs need to be amended in order to account for an increase in burden associated with the final action. If so, the Agency will submit an information collection worksheet (ICW) to OMB, requesting that the total burden in each ICR be amended, as appropriate. The Agency would appreciate any comments or information that could be used to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Please submit your comments within 60 days as specified at the beginning of this proposal. Copies of the existing ICRs may be obtained from Sandy Farmer, OPPE Regulatory Information Division, Environmental Protection Agency (2137), 401 M St., SW., Washington, DC 20460, by calling (202) 260-2740, or electronically by sending an e- mail message to ``[email protected].'' D. Unfunded Mandates Reform Act and Executive Order 12875 This action does not impose any enforceable duty, or contain any ``unfunded mandates'' as described in Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4), or require prior consultation as specified by section 204 of the UMRA and Executive Order 12875 (58 FR 58093, October 28, 1993). E. Executive Order 12898 Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations,'' the Agency has determined that there are no environmental justice related issues with regard to this action since this action would add a reporting requirement for all covered facilities including those that may be located near minority or low-income populations. List of Subjects in 40 CFR Part 372 Environmental protection, Community right-to-know, Reporting and recordkeeping requirements, Toxic chemicals. Dated: April 28, 1997. Lynn R. Goldman, Assistant Administrator for Prevention, Pesticides and Toxic Substances. Therefore, it is proposed that 40 CFR part 372 be amended as follows: 1. The authority citation for part 372 would continue to read as follows: Authority: 42 U.S.C. 11013 and 11028. 2. Section 372.65 is amended by revising the entry for polychlorinated biphenyls under paragraph (a), revising the CAS number entry for 1336-36-3 under paragraph (b), and by adding alphabetically one category to paragraph (c) to read as follows: Sec. 372.65 Chemicals and chemical categories to which the part applies. * * * * * (a) * * * ------------------------------------------------------------------------ Chemical CAS No. Effective date ------------------------------------------------------------------------ * * * * * Polychlorinated biphenyls (PCBs) 1336-36-3 1/1/87 (excluding those PCBs listed under the dioxin and dioxin- like compounds category). * * * * * ------------------------------------------------------------------------ * * * * * (b) * * * ------------------------------------------------------------------------ CAS No. Chemical name Effective date ------------------------------------------------------------------------ * * * * * 1336-36-3 Polychlorinated 1/1/87 biphenyls (PCBs) (excluding those PCBs listed under the dioxin and dioxin-like compounds category). * * * * * ------------------------------------------------------------------------ * * * * * (c) * * * ------------------------------------------------------------------------ Category name Effective date ------------------------------------------------------------------------ * * * * * Dioxin and Dioxin-Like Compounds: (This 1/98 category includes only those chemicals listed below) 39635-31-9 2,3,3,4,4,5,5- Heptachlorobiphenyl 67562-39-4 1,2,3,4,6,7,8- Heptachlorodibenzofuran 55673-89-7 1,2,3,4,7,8,9- Heptachlorodibenzofuran 38380-08-4 2,3,3,4,4,5- Hexachlorobiphenyl 69782-90-7 2,3,3,4,4,5- Hexachlorobiphenyl 52663-72-6 2,3,4,4,5,5- Hexachlorobiphenyl 32774-16-6 3,3,4,4,5,5- Hexachlorobiphenyl 70648-26-9 1,2,3,4,7,8- Hexachlorodibenzofuran 57117-44-9 1,2,3,6,7,8- Hexachlorodibenzofuran 72918-21-9 1,2,3,7,8,9- Hexachlorodibenzofuran 60851-34-5 2,3,4,6,7,8- Hexachlorodibenzofuran 39227-28-6 1,2,3,4,7,8- Hexachlorodibenzo-p-dioxin 57653-85-7 1,2,3,6,7,8- Hexachlorodibenzo-p-dioxin 19408-74-3 1,2,3,7,8,9- Hexachlorodibenzo-p-dioxin 35822-46-9 1,2,3,4,6,7,8- Heptachlorodibenzo-p-dioxin 39001-02-0 1,2,3,4,6,7,8,9- Octachlorodibenzofuran 03268-87-9 1,2,3,4,6,7,8,9- Octachlorodibenzo-p-dioxin 32598-14-4 2,3,3,4,4- Pentachlorobiphenyl 74472-37-0 2,3,4,4,5- Pentachlorobiphenyl 31508-00-6 2,3,4,4,5- Pentachlorobiphenyl 65510-44-3 2,3,4,4,5- Pentachlorobiphenyl 57465-28-8 3,3,4,4,5- Pentachlorobiphenyl 57117-41-6 1,2,3,7,8- Pentachlorodibenzofuran 57117-31-4 2,3,4,7,8- Pentachlorodibenzofuran 40321-76-4 1,2,3,7,8- Pentachlorodibenzo-p-dioxin 32598-13-3 3,3,4,4- Tetrachlorobiphenyl 51207-31-9 2,3,7,8- Tetrachlorodibenzofuran 01746-01-6 2,3,7,8- Tetrachlorodibenzo-p-dioxin [[Page 24896]] * * * * * ------------------------------------------------------------------------ [FR Doc. 97-11899 Filed 5-6-97; 8:45 am] BILLING CODE 6560-50-F
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