Further, as stated previously, covered facilities are not required to report on toxic chemicals in mixtures and trade name products for which they have no concentration information, or for which such information is not readily available. Therefore, it is unlikely that facilities will have additional enforcement concerns. Several commenters argue that the need to be consistent with the OSHA HCS that EPA cited in the 1988 final rule continues to be relevant with regards to collecting information on very small quantities. EPA disagrees that the need to be consistent with OSHA to reduce burden is sufficient to justify retaining the de minimis exemption for PBT chemicals. EPA is not required to be consistent with the OSHA HCS. In 1988, EPA chose to be consistent with the OSHA HCS as part of its rationale for the exemption, because the Agency expected facilities to be familiar with these levels and thought that covered facilities might only have access to MSDSs for information on the content and percentage composition of toxic chemicals in mixtures. (See 53 FR 4509) However, EPA has never instructed facilities to stop looking if information concerning a toxic chemical is not on an MSDS. Rather, EPA has consistently instructed facilities to use their best readily available data in determining compliance with EPCRA section 313. As EPA explained earlier, given 10 years of experience with the program, the Agency believes that facilities may have other sources of information, in addition to MSDSs, available to them. Therefore, if a facility has better information regarding the concentration of a toxic chemical in a mixture, for example, that the chemical is above the de minimis level, the facility should be using that information to comply with EPCRA section 313. Further, EPA is consistent in some respects because under the OSHA HCS, if an employer has reason to believe that a permissible exposure limit for a component may be exceeded under the mixture's normal circumstances of use, the HCS also requires employers to list chemicals that are below the 1.0% and 0.1% thresholds. Therefore, OSHA adopted exceptions to the 1.0% and 0.1% limits under the HCS. Similarly, PBT chemicals are different from other toxic chemicals in that they may pose a more significant concern to the environment in much smaller quantities than other toxic chemicals. Furthermore, as explained in other responses in this unit, EPA believes the remainder of its rationale for the de minimis exemption is not applicable to PBT chemicals. For example, contrary to the commenter's statement, the small concentrations subject to the de minimis exemption are not necessarily small quantities and may contribute significantly to exceeding the lowered reporting thresholds. Some commenters argue that the Agency has not justified why the exemption will result in increased health risk to the public or the environment. One commenter specifically argues that given the extremely low levels of these PBT chemicals in coal, the risk to the general public from these releases, which they believe is the original purpose of the legislation, is not apparent. Another commenter asserts that EPA must demonstrate that the removal of the exemption for specific PBT chemicals will have a public health or environmental benefit. Yet another commenter argues that the concentration of toxic chemicals contained in mixtures is irrelevant to public health concerns when the compounds of concern remain chemically bound within benign compounds. EPA strongly disagrees with those commenters who indicated that EPA must consider risk to the general public when determining whether to eliminate the de minimis exemption. A primary purpose of the TRI program is to provide data on the releases (and other waste management activities) of listed toxic chemicals to communities so that they may use these data in conjunction with toxicity information for the chemical and site specific information to determine if releases present a potential risk. They can also use TRI data in other ways. For example, an individual can use TRI data as a factor 58729 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations in choosing a neighborhood in which to live. The purpose of TRI, however, is not to make a national determination of risk, nor did EPA consider risk in its original adoption of the de minimis exemption under EPCRA section 313. Moreover, as previously explained, EPA originally promulgated the de minimis exemption based on several considerations that are inapplicable to PBT chemicals. Where, as here, the rationale and factual bases underlying an exemption no longer exist with respect to a particular class, the Agency believes it cannot justify retaining the exemption for that class. Further, the Agency has received no information from any commenters that contradicts the Agency's factual and legal conclusions, or that would otherwise present a basis for retention of the de minimis exemption. EPA also disagrees with the comment that because there are very low levels of PBT chemicals (e. g., mercury) in coal that the risk to the general public is not apparent. EPA believes that the commenter misunderstands the concept of risk. Because a chemical is in a low concentration in coal does not in itself control the level of risk that can result when coal is combusted. For example, mercury compounds are found in very low concentrations in coal. When coal is combusted, mercury compounds are either converted into mercury chloride or reduced to elemental mercury. Some of the mercury/ mercury chloride is released to air and some remains in the bottom ash. The concentration of the mercury/ mercury chloride in the air wastestream will not be the same as the concentration originally present in the coal. Once the mercury/ mercury chloride is released, it will be carried varying distances before it is deposited. Mercury can be transported over large distances, while mercury chloride may be deposited relatively rapidly by wet and dry deposition processes. The amount of mercury in a community or ecosystem will depend upon sources both local and distant. Once mercury has been deposited, it will bioaccumulate in organisms and will also persist in the environment as a sink for exposure and bioaccumulation. The amount of mercury that a human, animal, or plant will be exposed to is related more closely to exposure pathways and the quantity that is present in an ecosystem rather than the concentration in the coal that is combusted. Thus, EPA believes that the commenter is incorrect. One commenter asserts that the elimination of the de minimis thresholds would not yield meaningful additional information. The commenter argues that the proposed rule vastly overstates the significance of TRI data and therefore incorrectly concludes that the de minimis thresholds would `` deprive communities of important information on PBT chemicals'' (at 64 FR 714). Instead, the commenter contends, TRI data only provide a snapshot view of releases from the chemical industry and the few other industry sectors subject to TRI reporting and that many potential release sources are not subject to TRI reporting. The commenter argues that these sources overwhelm the limited additional information that will be reported by eliminating the de minimis exemption. EPA disagrees that the proposed rule vastly overstates the significance of the TRI data. The public, all levels of government, and the regulated community have come to rely on TRI data in improving decision making, measuring pollution prevention, and understanding the environmental and health consequences of toxic chemical releases and other waste management activities. Although the Toxics Release Inventory does not contain a complete inventory of every release, EPA believes it does provide one of the most comprehensive and accessible sources of release and other waste management information available. EPA also disagrees with the commenter's assertion that the data base only contains information from the chemical industry and a few others. In fact, all 20 manufacturing industry groups as well as an additional 7 other industries including metal and coal mining facilities and hazardous waste management facilities are subject to EPCRA section 313. Further, with the addition of these 7 newly covered industries, EPA expects over 27,500 facilities to submit over 110,000 reports on more than 630 toxic chemicals to the TRI for the 1998 reporting year. Currently no other sources of information can provide releases and information on other waste management quantities and qualitative source reduction data with the scope, level of detail, and chemical coverage as data currently included in TRI. Further, as EPA has previously explained, PBT chemicals can remain in the environment for a significant amount of time and can bioaccumulate in animal tissues. Even relatively small releases of such chemicals have the potential to accumulate over time and cause significant adverse impacts on human health and the environment. Therefore, EPA believes it is particularly important to gather and disseminate to the public relevant information on even relatively small amounts of releases and other waste management of PBT chemicals. Under the 10,000 and 25,000 pound/ year reporting thresholds, a significant amount of the releases and other waste management activities involving PBT chemicals are not being captured and thus the public does not have the information needed to determine if these chemicals are present in their communities at levels that may pose a significant risk. Several commenters argue that the de minimis exemption already does not apply to the manufacture of a toxic chemical unless the toxic chemical is manufactured as an impurity or is imported. Therefore, any incidental manufacturing of a PBT chemical as a by product would not be eligible for the de minimis exemption and would be subject to reporting. Thus, they argue, the elimination of the exemption will provide little additional information and will not provide added value. The commenters are correct in stating that there are instances where PBT chemicals are manufactured as byproducts and would, therefore, not be affected by the elimination of the de minimis exemption. However, as EPA explained in the PBT proposal, there are also many instances where a PBT chemical may exist in a mixture or trade name product at a concentration below the 1% or 0.1% de minimis limit but where the processing or otherwise use of the PBT chemical in that mixture would otherwise contribute significantly to or in itself exceed the reporting thresholds (at 64 FR 714). For example, mercury can be found at very low concentrations in steel. A resmelting facility could process and release more than 100 pounds of mercury a year from its resmelting activities. However, although this total quantity is greater than the 10 pound proposed threshold for mercury, if the concentration of mercury in the steel is less than the de minimis limit, none of the mercury would be reportable if the de minimis level is retained for PBT chemicals. Releases and other waste management associated with these exempt activities would be absent from the TRI data base. Because even minimal releases of PBT chemicals may result in elevated concentrations in the environment or in an organism and can have the potential to cause an adverse effect, EPA believes that all releases of these chemicals are of concern and that such information is significant and of value to the public. a. Readily available data. Some commenters assert that the elimination of the de minimis exemption will conflict with the condition that reporters obtain data from readily 58730 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations available sources. They argue that because concentrations below 1% (and 0.1% for carcinogens) are not required on MSDSs, reporters will no longer be able to use MSDSs to screen for products containing PBT chemicals below these concentrations. They further contend that AP 42 guidance, Air CHIEF CD ROM, TANKS, CHEMDAT8 and WATER8 would provide additional assistance in estimating the amount of a PBT coincidentally manufactured in wastestreams or released; however, these tools will not help quantify the amount of chemical in materials which are distributed in commerce or used as feedstock. They assert that there are no other consistent sources of information on whether a product contains a PBT chemical below de minimis levels. They also assert that the elimination of the de minimis exemption will cause additional burden for the regulated community because covered facilities will struggle with how to comply in the absence of information. The Agency believes that since reporting first began in 1988, new sources of information have become available to covered facilities to use to determine concentrations of toxic chemicals in mixtures. In addition to the data bases and information sources cited by the commenter, EPA believes there are other sources of data that can and should be used in making threshold determinations and release and other waste management calculations for PBT chemicals. Examples of these sources of information include EPA guidance documents (e. g., EPCRA Section 313 Industry Guidance: Electricity Generating Facilities (EPA 745± B± 99± 003)) and trade association guidance documents (e. g., National Council of the Paper Industry for Air and Stream Improvement (NCASI) Technical Bulletins and NCASI's Handbook of Chemical Specific Information for SARA Title III Section 313 Form R Reporting). In addition, relevant information has become much more accessible to covered facilities over the past 10 years. For example, the United States Geological Survey's U. S. Coal Quality Database has been in existence since the mid 1970s, but only more recently has it been made available on the Internet. (http:// energy. er. usgs. gov/ products/ databases/ UScoal/ index. htm) EPA believes that these tools, in addition to the ones cited by the commenter, will help covered facilities quantify the amount of chemical in materials which are distributed in commerce or used as feedstock and will allow covered facilities to make reasonable calculations to comply with EPCRA section 313. Further, the Agency believes that it underestimated how much information covered facilities had available to them in 1988 regarding small concentrations of toxic chemicals in mixtures. Therefore, EPA believes that facilities have sufficient information to make threshold determinations and release and other waste management calculations for PBT chemicals below de minimis concentrations. However, as EPA explained above, if a covered facility has no information, including no reasonable estimates or other reasonably known information, on the concentration of the toxic chemical in the mixture, they need not consider the chemical in that mixture for threshold determinations and release and other waste management calculations (at 53 FR 4511). Therefore if the only source of information on a toxic chemical in a mixture is from an MSDS, and the MSDS does not indicate if the chemical is contained in the mixture, the facility is not required to consider the toxic chemical towards threshold determinations or release and other waste management calculations. Because some facilities covered under EPCRA section 313 have more extensive information available to them than they did in 1988, or EPA underestimated how much information they had available in 1988, and because these facilities are not required to report if they have no information on the concentration of the toxic chemical, the Agency believes that in these cases retention of the de minimis exemption would allow facilities to avoid reporting when information is available to them that would otherwise permit them to report. Some commenters assert that facilities will have to begin monitoring for trace quantities of chemicals in mixtures if the de minimis exemption is eliminated for PBT chemicals. One commenter argues that the only way facilities would be able to estimate the levels of dioxin in combustion products and wastewater treatment `` would be to undertake the costly burden of monitoring what comes off at a series of concentrations and temperatures. '' Another commenter asserts that if the de minimis level is eliminated, industry would be subject to increased enforcement action because exhaustive testing may be insufficient to detect the chemicals. EPA disagrees with the commenters because, as stated previously, EPCRA section 313( g)( 2) limits monitoring requirements under EPCRA section 313. Under this section, facilities are not required to perform any additional monitoring or analysis of production, process or use other than that already collected under other requirements. However, if a facility is required to monitor toxic chemicals under another statute, this data must be considered in determining thresholds and release and other waste management calculations under EPCRA section 313. EPCRA section 313( g)( 2) requires that facilities use readily available data, or in absence of such data, facilities are required to use reasonable estimates. If no monitoring data are available, the facility should use other readily available information in making threshold determinations and release and other waste management calculations. Further, if the facility believes that it has other, more representative data than its monitoring data, the facility should use that information instead. As to specifically tracking PBT chemicals in wastewater, the commenter does not specify whether the toxic chemicals discussed in the comment are manufactured as byproducts are processed, or otherwise used. As discussed above, the de minimis exemption does not apply to toxic chemicals manufactured as byproducts Therefore, if PBT chemicals are coincidentally manufactured during on site wastewater treatment, covered facilities would be required to consider those PBT toxic chemicals for threshold determinations and release and other waste management calculations even if the de minimis exemption were retained for PBT chemicals. Similarly, PBT chemicals manufactured as a result of burning fuel would not be exempt even if the de minimis exemption were retained because manufactured byproducts are not eligible for this exemption. PBT chemicals in below de minimis concentrations in mixtures that are imported, processed, or otherwise used will be affected by the elimination of the de minimis exemption. Covered facilities will need to consider these quantities towards threshold determinations and release and other waste management calculations. These calculations would include the amounts contained in combustion by products and wastewater treatment units. Additional monitoring of these quantities, however, would not be required under EPCRA section 313. Finally, EPA has limited the dioxin listing with the qualifier `` manufacturing; and the processing or otherwise use of dioxin and dioxin like compounds if the dioxin and dioxin like compounds are present as contaminants in a chemical and if they were created 58731 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations during the manufacturing of that chemical. '' Therefore, not all processing or otherwise use activities of the dioxin and dioxin like compounds category must be considered towards a facility's threshold determinations. Some commenters assert that EPA should maintain the de minimis exemption for PBT chemicals present as impurities. They argue that information on PBT chemicals present as impurities is not readily available and that obtaining the relevant data, conducting the initial reviews to determine what information is available, and identifying data gaps would impose a huge burden on industry. They argue that even developing estimates with any accuracy entails a significant amount of time. In the instance of impurities, they assert that the absence of data and the difficulty in developing estimates will result in a heavy burden with little information of value being reported. These commenters believe that the elimination of the de minimis level is a requirement to provide new data when utilizing the de minimis exemption. EPA disagrees with these commenters. Although there are burdens associated with obtaining relevant data, determining available information and identifying data gaps, EPA disagrees that the elimination of the de minimis exemption for PBT chemicals present as impurities would vastly increase the extent of this required effort. From the comment, it is unclear why requiring facilities to identify and evaluate process streams containing small quantities of PBT chemicals as impurities is more burdensome than for larger quantities of these chemicals manufactured, processed, or otherwise used at a covered facility in excess of the activity thresholds. For example, a facility monitors for chemical A at a concentration of greater than 0.001% and monitors for chemical B at a concentration of greater than 1.5%. The monitoring is done for the same wastestream and the same frequency. There is no differential in effort or burden. Currently, the only difference is that facilities can ignore available data when utilizing the de minimis exemption. One commenter asserts that the de minimis exemption should be retained for PBT chemicals present at mining facilities. The commenter argues that the burden upon the mining industry is even greater in the context of the low thresholds proposed for PBT chemicals. Further, the commenter asserts that although EPCRA does not require covered facilities to conduct tests concerning the amount of listed chemicals processed, most reporters rely upon their knowledge of their manufacturing processes and raw materials to produce meaningful data for EPCRA section 313 reporting purposes. The commenter contends that this is not true of the mining industry. Due to the volume of materials moved in the extraction process and the heterogeneous nature of the materials mined, process knowledge often is inadequate to produce a meaningful picture of the minute levels of PBT chemicals that may be present in mining operations. The commenter asserts that inadequate process knowledge combined with the enormous expense of constantly testing the processed materials makes the elimination of the de minimis exemption for PBT chemicals unworkable as applied to mining operations. EPA disagrees with the commenter. As the commenter points out, under EPCRA section 313( g)( 2), facilities are not required to perform any additional monitoring or analysis of production, process, or use other than that already collected under other statutory or regulatory requirements. Therefore, there should be no added cost due to testing to comply with EPCRA section 313. However, EPA believes that in many cases mining facilities have the information needed to make reasonable estimates regarding small concentrations of PBT chemicals in the ores mined. In addition, as EPA explained in the 1988 final rule, if a covered facility has no information on the concentration of the toxic chemical in the mixture, including no reasonable estimates, the facility need not consider the chemical in that mixture for threshold determinations and release and other waste management calculations. If a mining facility does have information regarding the concentration of a toxic chemical in a mixture or trade name product, the facility must consider all non exempted sources of the chemical for threshold determinations. If an activity threshold is exceeded for the chemical, the facility must then calculate release and other waste management quantities. Covered mining facilities will need to identify and evaluate process streams when considering a PBT chemical in concentrations below the de minimis level just as they already do for toxic chemicals found in process streams in concentrations above the de minimis level. Therefore, given that covered facilities: (1) Are not required to perform additional monitoring; (2) are not required to consider concentrations of toxic chemicals for which they have no information; and (3) need only consider readily available data, EPA disagrees that identifying and evaluating mining activities involving mixtures containing less than 1.0% or 0.1% concentrations of PBT chemicals will be more burdensome than for larger quantities of these chemicals manufactured, processed, or otherwise used at a mining facility in excess of the activity thresholds. b. Alternate de minimis level. Several commenters argue that in lieu of eliminating the de minimis exemption for PBT chemicals, it would make more sense to change the level for the de minimis exemption for these chemicals. Some commenters argue that a more appropriate approach would be to compare the current thresholds and the current de minimis levels and use the same ratio to create a new de minimis level for the lowered PBT chemical thresholds. Therefore, they argue, the existing level is 1% for a threshold of 10,000 pounds, so an analogous reduction of the de minimis level would be 0.01% for the new proposed threshold of 100 pounds and 0.001% for the new proposed threshold of 10 pounds per year and 1 ppb for dioxins. One commenter argues that the current de minimis level of 0.1% for known or suspected carcinogens is not appropriate for dioxins. They suggest that EPA lower the de minimis exemption for dioxins proportionally to the lower reporting threshold EPA sets in the final rule. They assert that a reporting threshold for dioxins of 0.002 pound TEQ (not the threshold in the PBT proposal nor the one that EPA is finalizing today), is approximately seven orders of magnitude less than the current 10,000 pound threshold. Therefore, they argue, the 0.1% de minimis exemption should be lowered proportionally to 1 x 10 8 %. This translates to a concentration of 100 parts per trillion. EPA disagrees with these commenters. As explained previously, EPA adopted the de minimis exemption for several reasons including the desire to be consistent with information mandated by the OSHA HCS. This OSHA standard requires the listing of hazardous chemicals on MSDSs but allows chemical suppliers to omit from the MSDSs hazardous chemicals that are below certain concentrations: Specifically, levels of 0.1% for OSHA carcinogens and 1.0% for other hazardous chemicals. However, the rationale for the OSHA HCS de minimis exemption is not relevant to PBT chemicals and therefore, is insufficient by itself to support an alternative de minimis exemption for PBT chemicals. 58732 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations As explained in the 1983 final rule, OSHA chose the 1.0% concentration limit based on comments that this level seemed to be sufficiently protective of workers and was considered to be reasonable by a number of commenters (48 FR 53280, at 53290, November 25, 1983). OSHA was also persuaded by comments that in some instances the 1.0% cut off levels may not be protective enough with respect to certain health hazards and adopted the 0.1% level for carcinogens (at 48 FR 53292). Specifically, PBT chemicals are of concern because they persist and bioaccumulate in the environment. Persistence and bioaccumulation were not considered as a part of the OSHA rulemaking. In addition, as explained in other responses in this unit, EPA's original rationale for this exemption is inapplicable to PBT chemials, and the commenters have provided no alternate rationale to support an exemption based on extrapolating new de minimis levels from the proposed thresholds. Therefore, given the different intents between the OSHA HCS and EPCRA section 313, EPA does not believe that creating alternative de minimis levels for PBT chemicals based on a ratio between the lowered threshold and the OSHA HCS levels is appropriate. Several commenters support EPA's elimination of the de minimis exemption for PBT chemicals. They assert that retention of the de minimis exemption would undermine the changes to the reporting threshold and would allow an unnecessary loophole from reporting. They assert that the rule does not require any additional testing for impurities and that the only additional reporting would be for those facilities that use sufficient quantities of mixtures or trade name products containing PBT chemicals as impurities. One commenter asserts that one of the original reasons for the de minimis exemption levels, that it was based on OSHA HCS thresholds of 1.0% for hazardous chemicals in mixtures and 0.1% for carcinogens in mixtures, does not apply to raw materials that are not manufactured chemicals, such as crude oil, coal, and mining inputs. EPA agrees with these commenters and is eliminating the de minimis exemption for PBT chemicals addressed in today's rule. As discussed above, the reasons EPA indicated for originally adopting the de minimis exemption are not applicable to PBT chemicals. In addition, EPA has received no compelling arguments from commenters to extend the de minimis exemption to PBT chemicals. Because the purpose of today's rulemaking is different from past rulemakings in that it is intended to capture information on significantly smaller quantities of releases and other waste management associated with these chemicals, the de minimis exemption could significantly limit the amount of reporting on PBT chemicals. Therefore, given that: (1) Covered facilities have several sources of information available to them regarding the concentration of PBT chemicals in mixtures; (2) even minimal releases of persistent bioaccumulative chemicals may result in significant adverse effects and can reasonably be expected to significantly contribute to the proposed lower thresholds; and (3) the concentration levels chosen, in part, to be consistent with the OSHA HCS are inappropriately high for PBT chemicals, EPA believes that the reasons for the de minimis exemption that the Agency held for previous rulemakings do not apply to PBT chemicals. EPA is therefore eliminating the de minimis exemption for PBT chemicals. c. Supplier notification. Several commenters were confused by EPA's failure to modify the de minimis exemption for PBT chemicals under the supplier notification requirements. As explained in the PBT proposal, the Agency believes that covered facilities have sufficient information available to them on PBT chemicals. The requirement of additional information under the supplier notification requirements would result in redundancies. Commenters that correctly understood EPA's inaction on this topic support the retention of the de minimis exemption for purposes of Subpart C Supplier Notification Requirements under 40 CFR 372.45( d)( 1). EPA agrees with these commenters and has therefore taken no action on the supplier notification requirements for PBT chemicals. 2. Other exemptions. Although the Agency received several comments regarding the existing exemptions, EPA is not modifying any of these exemptions in this rule. Any changes to these exemptions would require additional rulemaking, and any comments submitted to EPA during this rulemaking will be considered as part of EPA's evaluation of these exemptions. 3. Use of alternate threshold and Form A. One issue that commenters raise relates to EPA's proposal to exclude all PBT chemicals from the alternate threshold of 1 million pounds for PBT chemicals. Several commenters argue that EPA should retain the alternate threshold of 1 million pounds for PBT chemicals. EPA disagrees. As stated in detail in the proposal, EPA believes that use of the existing alternate threshold and reportable quantity for Form A would be inconsistent with the intent of expanded PBT chemical reporting. The general information provided on the Form A, on the quantities of the chemical that the facility manages as waste is insufficient for conducting meaningful analyses on PBT chemicals. A commenter states that because PACs in fuel are destroyed during combustion, EPA should retain the alternate threshold or provide a new alternate threshold. First, the commenter did not provide any information to support the contention that PACs in fuel are destroyed during combustion. And, to the contrary, EPA believes that, even if some or all of the PACs in fuel are destroyed during combustion, additional PACs may be created during the combustion process. Consequently, absent any information to support the basis for such an option, or the need for an alternate threshold, EPA does not believe it would be appropriate at this time to provide a new alternate Form A threshold. Although EPA solicited comments on this issue in the proposal, at this time, the Agency believes that it is appropriate to collect and analyze several years worth of data at the lowered thresholds before EPA considers developing a new alternate threshold and reportable quantity appropriate for PBT chemicals. In addition, the commenter also appears to be raising a broader issue than just the destruction of PACs during combustion. The commenter implies that when a facility estimates its releases to be zero, the facility should be eligible to use the Form A. However, the commenter appears to misunderstand how to calculate the amounts required to determine eligibility for the Form A. Facilities may use the Form A provided that they do not exceed 500 pounds for the total annual reportable amount for a chemical, and that their amounts manufactured or processed or otherwise used do not exceed 1 million pounds. The annual reportable amount is equal to the combined total quantities released at the facility, treated at the facility, recovered at the facility as a result of recycle operations, combusted for the purpose of energy recovery at the facility, and amounts transferred from the facility to off site locations for the purpose of recycle, energy recovery, treatment, and/ or disposal. The commenter only appears to consider their releases as reportable amounts and does not appear to consider quantities generated from their other waste management activities as reportable amounts. This additional waste management information on PBT chemicals is very important to 58733 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations communities because it helps them understand the quantities of EPCRA section 313 chemicals that are being transported through their communities, the destination of these EPCRA section 313 chemicals, as well as the reported waste management activity at the receiving facility. In conclusion, EPA has not proposed to disregard this waste management information in calculating the annual reportable amount, therefore the commenter's approach is not consistent with current reporting under Form A or appropriate as an approach for reporting on PBT chemicals. The commenter also states that the alternate threshold should be retained in order to ensure that only meaningful amounts of substances are reported under EPCRA section 313. EPA disagrees that retention of the alternate threshold would ensure that only meaningful information is reported under EPCRA section 313. The 500 pound waste eligibility could be interpreted by some data users, as a worst case, to mean that greater than 500 pounds of the chemical has been released into the environment (i. e., 500 pounds of production related waste as release and some quantity of catastrophic release). Other data users may assume that the facility had no catastrophic releases and all of the toxic chemical in waste was managed in a manner other than as a release, e. g., the toxic chemical in waste was recycled. For PBT chemicals where any release is a concern, an uncertainty level of 500 pounds may result in data that is virtually unusable. As a result, EPA does not agree with the commenter that the alternate threshold will ensure that only meaningful amounts of substances will be reported under EPCRA section 313. In addition, the commenter argues elimination of the alternate threshold for PBT chemicals will cause reporting burdens to increase while failing to provide for the collection of substantial additional release information. EPA's economic analysis used reporting costs for the Form R to estimate the costs to those facilities that would not be able to use the alternate threshold. The economic analysis also evaluated the benefits of the collection of additional release and other waste management of PBT chemicals (Ref. 67). The commenter does not dispute those estimates. As a result, EPA sees no compelling argument to revise its decision to exclude all PBT chemicals from the alternate threshold of 1 million pounds. A number of commenters argue that EPA should eliminate the alternate threshold of 1 million pounds for all PBT chemicals on the EPCRA section 313 list. One commenter asserts that in light of the relatively small quantities of concern for PBT chemicals, particularly those with no deliberate commercial manufacture, it makes little sense to retain the Form A. The commenter further states that it believes that a modified Form A would be inappropriate due to the concern over releases of these chemicals at low levels. Another commenter adds that the Form A is clearly inappropriate for chemicals that will now have thresholds significantly lower than the 500 pound waste generation level. The commenter further contends that it is not appropriate for EPA to set a new Form A threshold for PBT chemicals, given the need to collect more information on these substances. EPA agrees with the commenters that all PBT chemicals should be excluded from the alternate threshold of 1 million pounds. As stated in detail in the proposal, EPA believes that use of the existing alternate threshold and reportable quantity for Form A would be inconsistent with the intent of expanded PBT chemical reporting (at 64 FR 715± 716). The general information provided in the Form A on the quantities of the chemical that the facility manages as waste is insufficient for conducting meaningful analyses on PBT chemicals. EPA also agrees that a new alternate threshold for PBT chemicals would be inappropriate due to the concern over releases and other waste management of these chemicals at low levels. As stated in the proposal, even small quantities of persistent bioaccumulative chemicals may cause elevated concentrations in the environment and organisms that may cause significant adverse effects. Given the persistent and bioaccumulative nature of these chemicals and the need for the public to have information about smaller amounts of these PBT chemicals, EPA believes it would be inappropriate at this time to allow an option that would exclude significant information on some releases and other waste management of these chemicals. In response to EPA's proposal to exclude all PBT chemicals from the alternate threshold of 1 million pounds, one commenter argues that EPA should consider establishing a new alternate reporting threshold for these chemicals. The commenter states that, at a minimum, an alternate reporting threshold of 10 to 100 pounds would be consistent with the throughputreporting threshold proposed for all PBT chemicals except dioxins. The commenter further states that the SBA's analysis suggests significant reductions in burden associated with alternate reporting thresholds of 50 pounds for PBT chemicals. The commenter states that, based on an SBA study commissioned of petroleum bulk plants, which it estimates will be the largest group of reporters under this proposal, it finds that most of the reports avoided by this alternate threshold would reflect zero releases. EPA disagrees with the comment suggesting that a new alternate threshold be established for PBT chemicals. As stated in the proposal, even small quantities of persistent bioaccumulative chemicals may cause elevated concentrations in the environment and organisms that may cause significant adverse effects. Given the persistent and bioaccumulative nature of these chemicals and the need for the public to have information about smaller amounts of these PBT chemicals, EPA believes it would be inappropriate at this time to allow an option that would exclude significant information on some releases and other waste management of these chemicals. The general information provided in the Form A on the quantities of the chemical that the facility manages as waste is insufficient for conducting meaningful analyses on PBT chemicals. Therefore, EPA does not agree that a new alternate threshold for PBT chemicals should be established. The commenter also suggests that reporting burdens will increase while failing to provide for the collection of substantial additional release information. EPA's economic analysis used reporting costs for the Form R to estimate the costs to those facilities that would not be able to use the alternate threshold. The economic analysis also evaluated the benefits of the collection of additional release and other waste management of PBT chemicals (Ref. 67). The commenter does not dispute those estimates. As a result, EPA sees no compelling argument to revise its decision to exclude all PBT chemicals from the alternate threshold of 1 million pounds. 4. Data precision issuesÐ a. Use of significant digits, half pound and whole numbers. EPA proposed to require reporting of all releases and other waste management quantities of PBT chemicals (except dioxin) that are greater than 1 ¤10 of a pound, provided that the accuracy in the underlying data on which the estimate is based supports this level of precision. EPA further stated that releases and other waste management quantities would continue to be reported to two significant digits. In addition, EPA stated that for quantities of 10 pounds or greater, only 58734 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations whole numbers would be required to be reported. For the category of dioxin and dioxin like compounds, which have a proposed reporting threshold of 0.1 gram, EPA proposed that facilities report all releases and other waste management activities greater than 100 mg (i. e., 0.0001 gram). After reviewing all comments on this issue, EPA is providing the following guidance on the level of precision covered facilities should use to report their releases and other waste management quantities of PBT chemicals. Facilities should continue to report releases and other waste management amounts greater than 1 ¤10 of a pound (except dioxin), at a level of precision supported by the accuracy of the underlying data and the estimation techniques on which the estimate is based. This approach is consistent with the statutory reporting requirements when estimating reportable amounts. The statute requires facilities to, among other things, report ``[ t] he annual quantity of the toxic chemical entering each environmental medium. '' (42 U. S. C. 11023( g)( 1)( C)( iv)). To determine this `` annual quantity, '' the statute directs facilities to use readily available data (including monitoring data). When such data are not readily available, the statute directs facilities to use reasonable estimates. (42 U. S. C. 11023( g)( 2)). However, while the statute allows for some level of imprecision regarding reportable amounts, it does not create an exemption or exception that would allow facilities to report less precisely than provided for by their data or estimation techniques. Therefore, facilities should report PBT chemicals as precisely as their estimation techniques or readily available data allow. If a facility's release or other management calculations support reporting an amount that is more precise than two significant digits, then the facility should report that more precise amount. b. Use of range reporting. In the preamble to the proposed rule, EPA requested comments on its proposal to eliminate the use of range reporting in Form Rs for PBT chemicals. Commenters disagree with the proposal for a number of reasons outlined below. Commenters argue that applying different reporting conventions for PBT chemicals would complicate EPCRA section 313 reporting, cause compliance difficulty, and introduce data inconsistencies (i. e., ranges for some chemicals but not for others). Commenters also argue that eliminating the use of range reporting for PBT chemicals has the potential to mislead the public and divert attention from actual risks. EPA disagrees that the elimination of the use of range reporting for PBT chemicals will cause insurmountable obstacles to EPCRA section 313 reporting and cause compliance difficulties and data inconsistencies. There are already many different industries that report to EPA for 643 chemicals. EPA provides numerous guidance documents and training opportunities to reporting industries. With the finalization of the PBT rule, EPA will provide updated guidance documents, will prepare and provide, in those cases where it is appropriate, chemical specific guidance documents, and will continue to offer training in order to assist facilities in reporting under EPCRA section 313. EPA also believes that the Agency will be able to adequately explain to the public the different reporting requirements for PBT chemicals so that they are put in context of other TRI data. EPA currently does this for other types of chemicals on the EPCRA section 313 list such as metals and pesticides. Additionally, EPA believes that the elimination of range reporting is a critical part of this rulemaking, of which the ultimate intent is to provide useful information on PBT chemicals to assist communities in determining if PBT chemicals are present in their communities at levels that may pose an unacceptable risk. This information on PBT chemicals can also be used by government agencies and others to identify problems, set priorities, and take appropriate steps to reduce any potential risks to human health and the environment. Consequently, the information collected about these PBT chemicals will inform the public rather than mislead the public and will actually assist the public in determining the risk of PBT chemicals in their communities. Commenters also argue that reporting numerical values for PBT chemicals assumes a level of accuracy that generally does not exist in the measurement of releases. In addition, commenters state that estimating numerical values would require the use of material balances, which are difficult to apply and essentially inaccurate for chemicals used in low concentrations. Commenters contend that, especially where reports are estimates, ranges may in fact provide more information than point estimates. Commenters argue that, for these reasons, elimination of range reporting will result in inaccurate estimates. Commenters also state that eliminating the use of range reporting for PBT chemicals would give the false impression of precise data, where uncertainty inherently exists. As stated in the proposal, EPA believes that the use of ranges could misrepresent data accuracy because the low or the high end range numbers may not really be that close to the estimated value, even taking into account its inherent error (i. e., error in measurements and developing estimates) (at 64 FR 716). The user of the data must make a determination on whether to use the low end of the range, the mid point, or the upper end. For example, a release of 501 pounds could be misinterpreted as 999 pounds if reported as a range of 500± 999. This represents nearly a 100% error. This uncertainty severely limits the applicability of release information where the majority of releases, particularly for PBT chemicals, are expected to be within the amounts eligible for range reporting. The utility of these data would be severely limited given the uncertainty associated with data reported using ranges. Therefore, due to this uncertainty, EPA believes that facilities should report numerical values, not ranges, for PBT chemicals. In addition, EPA believes that the information available to the typical EPCRA section 313 reporter is generally greater and/ or more accessible than it was 10 years ago. Because of this improved information availability, EPA believes that many facilities will be able to accurately estimate releases and offsite transfers for further waste management of PBT chemicals in quantities of less than 1,000 pounds without the use of range codes. Although it may be true that some facilities will be better able to make those estimates than others, EPA does not believe this justifies not collecting the more specific and useful information from those facilities that can provide it. Further, the Form R and Instructions and annual TRI data release provide information on the methods used to generate information reported and characterize many of the limitations that may apply to the data. This aids the data user in understanding the overall nature of the information available under EPCRA section 313. Facilities are required, for each release or transfer amount, to indicate on the the principal method used to determine the amount of release reported. There are codes which allow the facility to indicate whether the estimate is based on monitoring data, mass balance calculations, published emission factors, or other approaches such as engineering calculations or best engineering judgment. By looking at the 58735 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations information provided through the use of these codes, users of the data can gain an understanding of the degree of accuracy or uncertainty in any particular number reported by a facility. Thus, EPA believes that false impressions will not be communicated to the data user about the accuracy of the information filed. Finally, EPCRA permits facilities to use reasonable estimates in the absence of readily available data to calculate reportable amounts. Compliance with EPCRA section 313 does not require that additional monitoring or sampling be done. Thus, the statute contemplates some level of imprecision in the data that may be filed, yet, by authorizing reporting based on reasonable estimates, affirms the community right to know purposes relative to information based on such reasonable estimates. Reporting releases of low volumes of PBT chemicals based on such reasonable estimates is no different than reporting on other toxic chemicals based on the same kind of information. The TRI data that has been reported since 1987 is a blend of estimates based on monitoring data, mass balance calculations, published emissions factors, and engineering calculations or engineering judgment. The commenters contend that eliminating the use of range reporting for PBT chemicals would be extremely burdensome to facilities. EPA explained in the proposal that the original intent of providing the range reporting option was primarily as a burden reducing measure focused on small businesses. In past expansion activities, EPA has tried to retain burden reducing options wherever feasible. However, EPA does not expect the elimination of range reporting to significantly affect the unit cost of reporting because many facilities that could use range reporting are not choosing to do so. An analysis of the 1997 data reported under EPCRA section 313 reveals that the number of instances in which a range code was used for reporting quantities in sections 5 and 6 of the Form R was 37,168. These 37,168 instances included 7,605,305 pounds of releases and transfers using the median of the range code reported. However, there were 66,842 instances in which range reporting could have been used (i. e., the amounts reported where below 1,000 pounds), but the reporting facility chose instead to report a number rather than a range. These 66,842 instances included 13,662,758 pounds of releases and transfers. Thus, in 64% of the instances where range reporting could have been used facilities reported a number instead. The fact that in a majority of the instances in which range reporting could have been used facilities opted to report specific numbers would appear to indicate that the elimination of range reporting for PBT chemicals is unlikely to impose any significant additional burden on facilities. Therefore, EPA does not expect the elimination of range reporting to have any significant effect on unit reporting costs. Commenters also argue that the elimination of the use of range reporting for PBT chemicals could result in an increase in the threat to confidential information and a possible increase in trade secret claims. Commenters maintain that Congress considered the need to protect trade secret information in the discussion of reporting chemical use and presence in ranges for EPCRA section 313:

The conference substitute provides for reporting categories of use and ranges of chemicals present because the exact use of an identified chemical at a facility or the exact amount present may disclose secret processes. In some circumstances, this information may need to be reported in terms of broad 43 categories of use or amount ranges. . . . (H. R. Report No. 99± 962, 298)

However, EPA believes that the conference report language cited by the commenter clearly refers only to the use of range reporting for the data element entitled `` maximum amount of the toxic chemical on site at any time during the calendar year. '' EPA is not precluding range reporting for maximum amounts on site. Contrary to the notion expressed by the commenter, Congress did not expressly direct EPA to allow range reporting for the reporting of releases and transfers off site for further waste management. Additionally, in the statute, Congress provided the only means and mechanism for facilities to protect confidential business information (CBI) through the statute's trade secret provisions. If the commenter believes that any report filed might reveal confidential information as to the identity of the chemical, the commenter may choose to file a CBI claim by following the procedures as outlined in 40 CFR part 350. In addition, the statute is clear that trade secret claims may only be made for the identity of the chemical. Therefore, EPA believes that Congress adequately provided procedures for the protection of CBI and that a possible increase in CBI claims does not outweigh the need for increased information on releases and other waste management of PBT chemicals. See, Legislative History at 5185. Commenters also argue that eliminating the use of range reporting for PBT chemicals will not result in the collection of substantial additional release information. EPA disagrees. The issue of range reporting is closely tied to the lowering of the reporting thresholds for PBT chemicals. As EPA noted in the proposal,

Since PBT chemicals can remain in the environment for a significant amount of time and can bioaccumulate in animal tissues, even relatively small releases of such chemicals from individual facilities have the potential to accumulate over time to higher levels and cause significant adverse impacts on human health and the environment.

EPA also noted in the proposal that,

Under current reporting thresholds, a significant amount of the releases and other waste management activities involving PBT chemicals are not being captured and thus the public does not have the information needed to determine if PBT chemicals are present in their communities and at levels that may pose a significant risk.

Therefore, by the lowering of reporting thresholds, EPA will receive important information on the quantities of PBT chemicals being released or otherwise managed as waste. Given the lowering of the reporting thresholds, continued use of ranges could misrepresent data accuracy because the low or the high end range numbers may not really be that close to the estimated value, even taking into account any inherent error (i. e., errors in measurements and developing estimates). The user of the data must make a determination on whether to use the low end of the range, the mid point, or the upper end. For example, a release of 501 pounds could be misinterpreted as 999 pounds if reported as a range of 500± 999. This represents a nearly 100% error. This uncertainty severely limits the applicability of release information where the majority of releases, particularly for PBT chemicals, are expected to be within the amounts eligible for range reporting. Given that the large uncertainty would be part of these data and would severely limit their utility, EPA has concluded that facilities must report numerical values, not ranges, for PBT chemicals. In addition to the above comments, several commenters recommend the use of multiple ranges rather than total elimination of ranges just for PBT chemicals. One commenter generally agrees with EPA's position that reporting ranges `` B'' (11 to 499 pounds) and `` C'' (500 to 999 pounds), as they currently exist, may be too broad to provide meaningful information for PBT chemicals. Because the proposal does not impose any new obligation to measure or test beyond what is currently required, however, the commenter believes it is still 58736 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations appropriate to retain the `` A'' reporting range of 1 to 10 pounds for PBT chemicals. The commenter contends that the use of a specific number conveys a sense of precision that may not actually exist. The commenter argues that the retention of the `` A'' reporting range in its current form, coupled with the new reporting range of `` greater than zero, but less than 1 pound, '' will provide meaningful and valuable information to the public on PBT chemical transfers or releases. Another commenter agrees with the purpose underlying the EPA's proposal to prohibit the use of range reporting for PBT chemicals and believes the ranges authorized under the current rules are too broad to be useful for PBT chemicals. However, the commenter believes that EPA should recognize that reporting in ranges is often necessary because uncertainty makes the selection of a single number arbitrary. Another commenter argues that EPA should retain range reporting for PBT chemicals, even if the ranges are lower than those allowed for non PBT chemicals. The commenter further contends that they believe that range reporting helps to correct some of the error introduced to EPCRA section 313 reporting through the use of estimates. EPA disagrees that the Agency should retain the `` A'' reporting range of 1 to 10 pounds for PBT chemicals or that the Agency should retain some form of range reporting for PBT chemicals. As stated in the proposal, EPA believes that the use of ranges could misrepresent data accuracy because the low or the high end range numbers may not really be that close to the estimated value, even taking into account its inherent error (i. e., error in measurements and developing estimates). The user of the data must make a determination on whether to use the low end of the range, the mid point, or the upper end. For example, a release of 501 pounds could be misinterpreted as 999 pounds if reported as a range of 500± 999. This represents a nearly 100% error. Even with a lower range such as 1 to 10 pounds, the uncertainty associated with range reporting could severely limit the applicability of release information for PBT chemicals. Numerical values are particularly important since PBT chemicals can remain in the environment for a significant amount of time and can bioaccumulate in animal tissues. This means that even relatively small releases of such chemicals from individual facilities have the potential to accumulate over time to higher levels and cause adverse impacts on the environment and organisms. The utility of these data would be limited given the uncertainty associated with data reported using ranges. Therefore, due to this uncertainty, EPA is requiring that facilities report numerical values, not ranges, for PBT chemicals. In addition, EPA believes that the information available to the typical EPCRA section 313 reporter is generally greater and more accessible than it was 10 years ago. Because of this improved information availability, EPA believes that facilities will be able to accurately estimate releases and off site transfers for further waste management of PBT chemicals in quantities of less than 1,000 pounds without the use of range codes. Although it may be true that some facilities will be better able to make those estimates than others, EPA does not believe this justifies not collecting the more specific and useful information from those facilities that can provide it. Further, in the Form R, facilities are required, for each release or transfer amount, to indicate the principal method used to determine the amount of release reported. There are codes which allow the facility to indicate whether the estimate is based on monitoring data, mass balance calculations, published emission factors, or other approaches such as engineering calculations or best engineering judgment. By looking at the information provided through the use of these codes, users of the data can gain an understanding of the degree of accuracy or uncertainty in any particular number reported by a facility. Thus, EPA does not believe that false impressions will be communicated to the data user about the accuracy of the information filed. Finally, as noted earlier EPCRA permits facilities to use reasonable estimates in the absence of readily available data to calculate reportable amounts. EPCRA does not require that additional monitoring or sampling be done in order to report. Thus, the statute contemplates some level of imprecision in the data that may be filed, yet, by authorizing reporting based on reasonable estimates, affirms the community right to know purposes relative to information based on such reasonable estimates. A number of commenters agreed with EPA's proposal that range reporting be eliminated for all PBT chemicals on the EPCRA section 313 list. The commenters agreed with EPA's belief that the use of ranges could misrepresent data accuracy and significantly impact the usefulness of the data. J. Other Issues 1. Placing reported data into context. Several commenters make the same general comment that EPCRA section 313 does not capture all sources of PBT chemical releases and therefore will not provide a complete or accurate picture of the releases of these chemicals. Commenters criticize the proposal for not putting the PBT releases from EPCRA section 313 covered facilities into context, in terms of either risk or the amount of PBT releases expected from non covered facilities or sources. EPA disagrees with the implication by several commenters that simply because EPCRA section 313 may not capture all the sources of releases of PBT chemicals EPA should not attempt to capture more information from the facilities that do report under EPCRA section 313. This comment has been voiced in every major rulemaking under EPCRA section 313 but, as EPA has stated in the past, this is not an argument that EPA believes should restrict any efforts to collect additional data under EPCRA section 313. The mere fact that for some chemicals significant release sources are not captured does not in any way diminish the importance of the information that can be provided by those facilities that are required to report under EPCRA section 313. There is currently no one single reporting requirement that captures all of the releases of PBT chemicals and makes that information available to the public. For those chemicals that do have large release sources not captured under EPCRA section 313, EPA will use all available data to aid its actions and those of other international and national organizations and the public in efforts to address concerns on PBT chemicals. For example, all data will be considered to aid EPA's PBT strategy or other EPA PBT related programs; EPA will not rely solely on the data collected under EPCRA section 313. In addition, if there are significant sources of PBT chemicals that are not reported under EPCRA section 313, EPA will attempt to let the public know that some sources are not captured. In fact, in the most recent TRI data release documents, EPA has been providing information to the pubic on other sources of releases for certain EPCRA section 313 chemicals. In addition, EPA will continue to improve and augment public information materials so that users of the data will have information available to put in context the releases and other waste management of PBT chemicals by industries reporting under EPCRA section 313 versus those industries that do not report under EPCRA section 313. 58737 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations In fact, rather than an argument against lowering the reporting thresholds for PBT chemicals, EPA believes that the argument the commenters are making is one that supports expanding the types of facilities that should be required to report under EPCRA section 313 and not an argument that supports denying the public the right to know about PBT chemical releases from EPCRA section 313 covered facilities. Some commenters stated that since EPA did not use exposure or risk considerations, the data on PBT chemical releases will be misleading to the public by indicating risks where none exist. EPCRA section 313 is not a risk based reporting system, and, as discussed in Unit VI. F., EPA believes that a risk based approach to EPCRA section 313 reporting is at odds with the overriding policy of EPCRA section 313, which is to get information about the use, disposition, and management of toxic chemicals into the public domain, enabling the users of this information to evaluate the information and draw their own conclusions about risk. The intent of EPCRA section 313 is to move the determination of which risks are acceptable from EPA to the communities in which the releases occur. This basic, local empowerment is a cornerstone of the right to know program. In addition, EPA will continue to improve its annual public data release as well as its outreach and education efforts to assist users in understanding the data. Consequently, EPA disagrees with the commenters that the information reported on releases and other waste management of PBT chemicals will be misleading to the public. Another commenter states that the quantities of PBT chemicals reported in the TRI will be far smaller than the quantities of other chemicals which pose far less significant health risks. The commenter is concerned that the small quantities could lead members of the public to overlook the data on PBT chemicals. Therefore, the commenter argues that EPA should present PBT data in a way that draws the public's attention to it. The commenter states that it sees a danger that without sufficient education and guidance, the public may either overestimate or underestimate the health risks from PBT chemicals. The commenter believes that EPA should make a commitment to ensuring that the public is given the necessary education and guidance. EPA understands that the quantities of PBT chemicals may be reported in smaller quantities than other chemicals under EPCRA section 313 and that these quantities have the potential to be overlooked. EPA is also sensitive to the issue that data on PBT chemicals must be presented clearly to assist data users in understanding how the information on PBT chemicals is different from that reported on other chemicals under EPCRA section 313. EPA will continue to improve its annual public data release as well as its outreach and education efforts to assist users in understanding the data. Despite the concerns voiced by the commenters, EPA still believes that it is important to collect and disseminate this information so that communities can use the information with other site specific factors to determine if releases into their communities result in risks that the community determines warrant further action given other factors, such as economic and environmental conditions, or particularly vulnerable human or ecological populations. Another commenter expresses concern that release numbers for PBT chemical will not be comparable to those for other chemicals with higher reporting thresholds or to releases of the PBT chemical in previous years. The commenter adds that the lower thresholds may mislead the public into thinking that releases are rising or that a new chemical has been introduced at a facility. EPA understands the commenter's concern but does not believe this is a justification for not collecting additional information about PBT chemicals. EPA believes that it will be able to adequately explain to the public the different reporting requirements for PBT chemicals so that they are put in context of other TRI data. EPA will make clear which PBT chemicals were reportable prior to the finalization of this rule and what the reporting threshold was for these chemicals. Finally, EPA will continue to improve its annual public data release as well as its outreach and education efforts to assist users in understanding the data. 2. Manufacture only qualifier for chemicals other than dioxin. Many commenters request that EPA add a `` manufacture only'' qualifier to all PBT chemicals, not just the dioxin and dioxin like compounds category. The commenters assert that the addition of the manufacture only qualifier to all PBT chemicals would greatly reduce the burden of the rule. Some commenters suggest that at a minimum the manufacture only qualifier should apply to polychlorinated biphenyls (PCBs), since EPA's rationale for applying the qualifier to dioxin and dioxin like compounds is equally applicable to PCBs. One commenter contends that EPA's statement that the manufacture qualifier is appropriate for chemicals that are `` ubiquitous in the environment'' because otherwise many facilities would be required to report simply due to background levels in raw materials applies to PCBs as well. Some commenters suggest that unintentionally manufactured byproducts such as hexachlorobenzene and octachlorostyrene should also have the manufacture only qualifier. Some commenters argue that the burden of the rule could be significantly reduced if EPA focused the reporting effort on the manufacturing sector, which should help concentrate EPA's pollution prevention efforts on the sector most likely to be able to make reductions. Some commenters contend that the primary source for PBT chemicals within the EPCRA section 313 reporting sectors is from manufacturing, and these are the sources that should be focused on for tracking PBT chemicals. Some commenters assert that EPA has acknowledged that many chemicals identified as persistent and bioaccumulative are not imported, processed, or otherwise used, but are manufactured as by products (at 64 FR 715). Some commenters assert that they agree that manufacturing is the primary source for environmental loading of PBT chemicals from EPCRA section 313 facilities, and thus the effort for reporting should be concentrated on the sources where PBT chemicals are generated and data can be gathered. Some commenters argue that concentration on the manufacturing of PBT chemicals provides an efficient focus for meaningful pollution prevention efforts. Some commenters assert that they are concerned that data from importing, processing, or otherwise use of PBT chemicals will be inaccurate and misleading since processors and users may not have the resources to conduct the analyses required to provide accurate estimates. One commenter contends that the fear of enforcement might motivate those importing, processing, or otherwise using PBT chemicals to report `` some amount'' and that such information is likely to be inaccurate, and will not accurately reflect the true level of concern. Some commenters assert that instead of requiring reports from the many sources where effective emissions reductions may not be possible, that the addition of a manufacture only activity qualifier for all PBT chemicals will provide the public with the most accurate information on PBT chemical emissions and the best opportunity to monitor EPCRA section 313 related 58738 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations environmental loading of these chemicals. EPA believes that in order to obtain any reporting on dioxin and dioxin like compounds a very low threshold is required, which is several orders of magnitude lower than the thresholds for other PBT chemicals. At such a low reporting threshold it is estimated that thousands of reports could potentially be filed by facilities, mainly food processing facilities, due to the amount of dioxins in the raw materials they process. The dioxins found in the meat and dairy products that food processors handle have been previously released, circulated in the environment, and bioaccumulated in animals, thus these are not additional loadings to the environment but loadings that have already occurred and cycled through the environment due to the persistence and bioaccumulative properties of these compounds. The unique combination of very low thresholds, the number of food processors that would be required to file, and the fact that they would be filing because of the bioaccumulation of previously released material led EPA to propose to add only dioxin and dioxinlike compounds that are manufactured. EPA is finalizing the addition of dioxin with a revised qualifier in response to the unique set of conditions that apply to the reporting of dioxin and dioxinlike compounds. EPA proposed and is finalizing the addition of dioxin with a qualifier to reduce reporting burden on facilities, mainly in the food processing industry, that results from the unique combination of circumstances related to the reporting for these chemicals and to focus on those activities that add to the loading of dioxins in the environment rather than on activities dealing with previously released and bioaccumulated chemicals. EPA did not conclude and does not believe that the manufacturing activity is the only important source of PBT chemical releases to the environment and believes that other activities such as processing or use can result in significant releases of PBT chemicals, including chemicals released to the environment for the first time. As discussed in Unit VI. G., EPA has modified the dioxin qualifier to reflect this. The unique combination of circumstances that exists for dioxin and dioxin like compounds does not exists for any of the other PBT chemicals being added by this rule. EPA did not conclude that the manufacture qualifier is generally appropriate for other chemicals that are being added and that are `` ubiquitous in the environment. '' The full statement in the proposal was `` These dioxin and dioxin like compounds are ubiquitous in the environment and thus under the very low reporting thresholds necessary to get reports from any sources (see discussion in Unit VII. A. 2.), facilities that process raw materials would be required to report simply because the raw material contains background levels of these chemicals'' (at 64 FR 710). Clearly EPA made this statement in the context of the `` very low reporting thresholds necessary to get reports [for the dioxin and dioxin like compounds category] from any sources. '' This statement is consistent with the unique combination of circumstances that exists for dioxin and dioxin like compounds and was not intended to apply to all PBT chemicals. Neither did EPA conclude that the manufacturing activity is the activity for which facilities would be most likely to be able to make reductions or that EPA's pollution prevention efforts should focus solely on the manufacturing of PBT chemicals. Commenters provided no basis for such a conclusion and EPA believes that processors and users of PBT chemicals also have the opportunity to make effective emissions reductions by using less of a PBT chemical, by not using materials that contain PBT chemicals as contaminants, etc. In addition, the purposes of reporting under EPCRA section 313 are not limited to the collection of information from sources where effective reductions in release and other waste management quantities are possible. Data collected under EPCRA section 313 can serve a variety of information purposes that do not depend on how easy it is for the source to achieve reduction in releases and other waste management. The commenter statement that EPA has acknowledged that many chemicals identified as persistent and bioaccumulative are not imported, processed, or otherwise used, but are manufactured as by products, is incorrect. The actual statement was: ``[ m] any of the chemicals identified as persistent and bioaccumulative in today's action are not imported, processed, or otherwise used but are manufactured as by products'' (at 64 FR 715). As the words `` today's action'' clearly demonstrate, this statement was not a broad statement about all PBT chemicals but simply an acknowledgment that many of the PBT chemicals in the proposed rule were byproducts In addition, this statement was made in the context of the discussion on the de minimis exemption about how removing the exemption for PBT chemicals would affect the chemicals in the proposed rule; it was not a statement made in connection with the discussion on the manufacture only qualifier. EPA also did not state that manufacturing is the primary source for environmental loading of PBT chemicals from facilities covered under EPCRA section 313. The discussion on the loading of chemicals in the environment from manufacturing was in relation to the reporting of dioxin which, as discussed above, presents a unique combination of circumstances that EPA considered to determine how to focus its listing decision and does not apply to all PBT chemicals. EPA disagrees with the statements that data from facilities that import, process, or otherwise use PBT chemicals will be inaccurate and misleading or that such facilities will report some quantity out of fear of enforcement and that such information is likely to be inaccurate, and will not accurately reflect the true level of concern. EPA believes that facilities that import, process, or otherwise use PBT chemicals will be just as able to report as facilities that manufacture PBT chemicals. It is no more difficult to do calculations regarding small numbers than it is to do calculations on larger numbers, so if a facility that imports, processes, or otherwise uses PBT chemicals has information that allows them to make a reasonable estimation of quantities then they should be just as able to report as any manufacturing facility would be able to report on small quantities manufactured as by products. If facilities that import, process, or otherwise use PBT chemicals do not have data available that allows them to make a reasonable estimation of quantities then they are not required to report. As for fear of enforcement, EPA can take enforcement actions both for under reporting and over reporting so facilities should not report an amount of a PBT chemical in order to avoid an enforcement action. EPA does not believe that the unique combination of circumstances that exists for dioxin and dioxin like compounds exists for any of the other PBT chemicals being added by this rule nor does EPA believe that reduced burden or any of the other reasons suggested by the commenters provide a sufficient reason to focus on manufacturing activity only for the other PBT chemicals in this rule. Therefore, EPA does not believe that it is appropriate to add a manufacture only qualifier to any of the other PBT chemicals in this rule. 3. Waste management issues. Some commenters contend that because activities such as recycling, approved 58739 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations waste disposal, and treatment are incorporated into reported volumes, the EPCRA section 313 reported releases will be substantial overestimates of the actual quantities released to the ambient environment. They further argue that although this information may be useful to source reduction efforts, merging of reporting requirements under section 313 of EPCRA and section 6607 of PPA has resulted in information which is misleading to the public's desire to know the actual exposures that are occurring. Another commenter asserts that by requiring electricity generating facilities to report transfers off site for treatment and disposal of PCBs from transformers, EPA has established a disincentive to properly dispose of PCB transformers and remove them from use because most PCB wastes transferred to off site facilities are destroyed in regulated units which destroy at least 99.9999% of the PCBs. They are concerned that because the casual reader may conclude additional releases of PCBs to the environment have occurred, companies would have a disincentive to voluntarily remove PCBs. The commenters are incorrect in stating that EPCRA section 313 release quantities include recycling and treatment amounts. Under EPCRA section 313, if a chemical activity threshold is met for the chemical, covered facilities are required to report the quantity of the toxic chemical entering each environmental medium; this includes `` releases. '' The definition of release pursuant to EPCRA section 329( 8) means:

any spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, or disposing into the environment (including the abandonment or discarding of barrels, containers, and other closed receptacles) of any hazardous chemical, extremely hazardous substance, or toxic chemical.

There is no language in this definition, any other provision of EPCRA, or in the regulations promulgated pursuant to EPCRA section 313, that limit this definition to ambient releases to the environment which may result in public exposure. In fact the definition specifically includes disposing of toxic chemicals as well as the abandonment of closed receptacles. In addition, neither the statute nor the regulations limit this definition to on site releases. Therefore, the statutory definition of release under EPCRA section 313 is significantly broader than the commenter seems to believe. In addition to release reporting, under section 6607( b)( 1) of the PPA, if a covered facility meets the reporting thresholds under EPCRA section 313, the facility is required to report the `` quantity of the chemical entering any wastestream (or otherwise released to the environment). . . .'' This quantity includes amounts of the toxic chemical released, treated, and recycled. However, this quantity does not include: [t] he amount of any toxic chemical released into the environment which resulted from a catastrophic event, remedial action, or other one time event, and is not associated with production processes during the reporting year. (PPA 6607 (b)( 7)) (emphasis added) Therefore, the quantity of the toxic chemical entering the wastestream as collected under section 6607( b)( 1) of the PPA, is the amount of the toxic chemical in production related waste. Covered facilities currently report the amount of the toxic chemical in production related waste as quantities of the toxic chemical released, treated, combusted for energy recovery and recycled. These quantities are collected as separate data elements in section 8 of the Form R. Further, facilities report the ultimate disposition of toxic chemicals in waste such that these quantities (i. e., amounts released, treated, combusted for energy recovery, and recycled) are mutually exclusive. Collectively, then, these quantities are the amount entering the waste stream or the quantity of the toxic chemical in production related waste. For example, a covered facility transfers 1,000,000 pounds of PCBs to an incinerator for treatment. The covered facility knows that 999,999 pounds are destroyed in the incinerator and the remaining 1 pound is disposed in a landfill. The facility reports 999,999 pounds as transferred off site for treatment and 1 pound as transferred off site for disposal. These two quantities are reported as separate data elements on the Form R. The quantity reported as disposed off site is considered released because, as explained previously, disposal is a type of release. The entire quantity (1,000,000 pounds) is the amount of production related waste. Once collected, EPA presents the TRI data to the public in a number of formats. In its annual data release documents, EPA highlights different aspects of the quantities of toxic chemicals released and otherwise managed as waste. For example, EPA presents total on site releases and, as subsets, presents the quantities released to air, surface water, underground injection and on site land releases. (See 1997 Toxics Release Inventory (EPA 745± R± 99± 003) Figure 2 3 `` TRI On site Releases'') EPA also presents the quantity of total releases in the public data release. As discussed earlier, under EPCRA section 313, release quantities are not limited to quantities released to the ambient environment. Therefore, total releases, as presented in the public data release include both on and off site releases as well as a variety of disposal methods. For example, in Table 2 20A of the 1997 public data release, EPA presents TRI on site and off site releases by chemical and type of release (e. g., air emissions, underground injection, etc.) (1997 Toxics Release Inventory; EPA 745± R± 99± 003). In addition to TRI release data, EPA presents production related waste quantities in the public data release. Because production related waste includes releases, EPA includes release quantities with other waste management quantities. However, in this document, the Agency generally distinguishes quantities of the toxic chemical released from other types of waste management. EPA does not count the quantities of toxic chemicals treated, combusted for energy recovery or recycled as quantities released. (See, for example, 1997 Toxics Release Inventory (EPA 745 R 99 003) Table 2 20A `` TRI On site and Off site Releases, by Chemical, 1997'' and Table 2 20B `` TRI Chemicals in Waste, by Chemical, 1997'') Further, EPA does not believe that the TRI program provides a disincentive for the proper and safe handling of PCBs in transformers managed as waste. As explained earlier, covered facilities are required under EPCRA section 313 and section 6607 of the PPA to report quantities of toxic chemicals released or otherwise managed as waste if they meet a chemical activity threshold. Quantities of toxic chemicals sent offsite for treatment are described as such. These transfers are not included as releases. In addition, EPA disagrees that quantities of PCBs sent off site for treatment will be misunderstood by the public because these quantities are accurately represented in the TRI data base and in the public data release as a separate type of waste management. Another commenter asserts that the proposed rule will not encourage waste minimization because facilities will not be able to modify process designs to accomodate such minimization simply on the basis of data generated from guidance documents or reasonable estimates. The commenter asserts that although industry has made substantial minimization gains, the technology is not available to treat or remove chemicals of concern from manufactured products or waste (prior to generation) at such low 58740 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations concentrations and that any future improvements will be enormously expensive due to the low concentrations that would likely be involved. EPA disagrees with the commenter. In the preamble to the proposed rule, EPA did not assert that covered facilities will begin performing waste minimization activities as a direct result of this rulemaking. Rather, the Agency stated that the PBT chemical rulemaking will provide data on PBT chemicals to EPA, industry, and the public. For example, several EPA offices have ongoing projects and programs that deal with issues concerning PBT chemicals. EPA has established the PBT planning group which is a coordinating body consisting of representatives from various program offices throughout EPA that are dealing with PBT chemicals. This group has developed a strategy to reduce pollution from PBT chemicals through the application of regulatory and nonregulatory authorities, with a strong emphasis on pollution prevention. The availability of that data, in turn, can allow all parties to identify and track releases of PBT chemicals and monitor the progress of the programs designed to reduce the amount of PBT chemicals entering the environment. The data will also allow EPA and others to design prevention strategies that are focused and effective. In addition, EPA disagrees with the commenter's last assertion concerning the available technology and its costs. Although there are some processes that might not, at present, be amenable to source reduction in terms of PBT chemicals, some processes may be. For example, it may be possible to stringently control fuel composition, flow times, temperature, and other conditions in order to substantially reduce or even eliminate the incidental manufacture of dioxins during combustion processes. Therefore, EPA continues to believe that in some cases, opportunities for pollution prevention will present themselves resulting from information reported under EPCRA section 313 and section 6607 of the PPA. 4. Modulated reporting thresholds. The majority of commenters contend that modulating thresholds for reporting so that lower reporting thresholds are used every other year (with current thresholds used in alternate years) would introduce confusion for the regulated community and data users and would not significantly reduce burden. Further it could discourage facilities from establishing common standard procedures for data collection. Modulation will also result in data gaps, undermining data consistency and tracking. Many commenters believe that annual reporting is a fundamental attribute of TRI. EPA agrees that modulating the reporting thresholds would introduce confusion for both the regulated community and data users. For data users, EPA believes that modulating the reporting thresholds would limit the usefulness of the TRI data because there would be poor data consistency and poorer data quality. For the regulated community, EPA believes that the burden reduction would not be significant and would possibly be offset by the confusion that would be introduced by different thresholds in alternate years.

VII. What Were the Results of EPA's Economic Analysis? EPA has prepared an economic analysis of the impact of this action, which is contained in a document entitled Economic Analysis of the Final Rule to Modify Reporting of Persistent Bioaccumulative Toxic Chemicals under EPCRA Section 313 (Ref. 67). This document is available in the public docket for this rulemaking. The analysis assesses the costs, benefits, and associated impacts of the rule, including potential effects on small entities. The major findings of the analysis are briefly summarized here.

A. What is the Need for the Rule? Federal regulations exist, in part, to address significant market failures. Markets fail to achieve socially efficient outcomes when differences exist between market values and social values. Two causes of market failure are externalities and information asymmetries. In the case of negative externalities, the actions of one economic entity impose costs on parties that are `` external'' to any market transaction. For example, a facility may release toxic chemicals without accounting for the consequences to other parties, such as the surrounding community, and the prices of that facility's goods or services thus will fail to reflect those costs. The market may also fail to efficiently allocate resources in cases where consumers lack information. For example, where information is insufficient regarding toxic releases, individuals' choices regarding where to live and work may not be the same as if they had more complete information. Since firms ordinarily have little or no incentive to provide information on their releases and other waste management activities involving toxic chemicals, the market fails to allocate society's resources in the most efficient manner. This rule is intended to address the market failures arising from private choices about PBT chemicals that have societal costs, and the market failures created by the limited information available to the public about the release and other waste management activities involving PBT chemicals. Through the collection and distribution of facilityspecific data on toxic chemicals, TRI overcomes firms' lack of incentive to provide certain information, and thereby serves to inform the public of releases and other waste management of PBT chemicals. This information enables individuals to make choices that enhance their overall well being. Choices made by a more informed public, including consumers, corporate lenders, and communities, may lead firms to internalize into their business decisions at least some of the costs to society relating to their releases and other waste management activities involving PBT chemicals. In addition, by helping to identify areas of concern, set priorities and monitor trends, TRI data can also be used to make more informed decisions regarding the design of more efficient regulations and voluntary programs, which also moves society towards an optimal allocation of resources. If EPA were not to take this action adding certain PBT chemicals to EPCRA section 313 and lowering reporting thresholds, the market failure (and the associated social costs) resulting from the limited information on the release and other waste management of PBT chemicals would continue. EPA believes that today's action will improve the scope of multi media data on the release and other waste management of PBT chemicals. This, in turn, will provide information to the public, empower communities to play a meaningful role in environmental decision making, and improve the quality of environmental decisionmaking by government officials. In addition, this action will serve to generate information that reporting facilities themselves may find useful in such areas as highlighting opportunities to reduce chemical use or release or other waste management and thereby lower costs of production and/ or waste management. EPA believes that these are sound rationales for adding chemicals to the EPCRA section 313 list of toxic chemicals and lowering reporting thresholds for PBT chemicals.

B. What Are the Costs Associated With This Rule? This action will result in the expenditure of resources that, in the absence of the regulation, could be used 58741 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations for other purposes. The cost of the rule is the value of these resources in their best alternative use. Most of the costs of the rule result from requirements on industry. Approximately 11,300 facilities are expected to submit approximately 20,000 additional Form R reports annually. The estimated composition of this reporting, by chemical, is shown in Table 4.

Table 4.Ð Summary of Chemical Reporting as Estimated for Proposed and Final Rules Chemical or Chemical Category Estimated Number of Reports (Annual)

Proposed Rule Final Rule Alkyl lead (tetraethyl lead and tetramethyl lead) 134 N/ A Benzo( g, h, i) perylene 353 909 Dioxin and dioxin like compounds category 1,863 1,475 Hexachlorobenzene 778 778 Mercury; mercury compounds category 5,230 5,346 Octachlorostyrene 230 230 Pentachlorobenzene 707 707 Pesticides (aldrin, chlordane, heptachlor, isodrin, methoxychlor, pendimethalin, toxaphene, trifluralin) 264 264 Polycyclic aromatic compounds (PACs) category 4,699 7,166 Polychlorinated biphenyls (PCBs) 2,267 2,310 Tetrabromobisphenol A 150 150 Vanadium; vanadium compounds category 654 655 Total 17,329 19,990 Table 5 displays the industry costs for this action based on the estimated number of facilities affected and the estimated number of additional reports. Aggregate industry costs in the first year for the rule are estimated to be $145 million; in subsequent years they are estimated to be $80 million per year. Industry costs are lower after the first year because facilities will be familiar with the reporting requirements, and many will be able to update or modify information from the previous year's report. EPA is expected to expend $2.0 million in the first year, and $1.6 million in subsequent years as a result of the rule.

Table 5.Ð Summary of Reporting and Associated Costs as Estimated for Proposed and Final Rules Proposed Rule Final Rule Number of new facilities 2,600 3,114 Total number of facilities 9,515 11,257 Number of Form Rs submitted 17,329 19,990 First year industry costs $126 million $145 million Subsequent year industry costs $70 million $80 million EPA costs $1.4 million $1.6 million The estimated cost of the final rule differs from the estimated cost of the proposed rule as shown in Table 5. There are six major reasons for this change. First, EPA received new data during the comment period on the concentrations of PACs and benzo( g, h, i) perylene in distillate fuel oil. Since approximately 18,000 manufacturing facilities subject to EPCRA 313 reporting use distillate fuel oil, this change had a significant positive effect on the estimated number of reports for PACs and benzo( g, h, i) perylene as shown in Table 4. Second, the methodology for estimating reporting from facilities in SIC 5171 (Bulk Petroleum Stations and Terminals) was revised to account for the mix of products containing PBT chemicals that are processed at these facilities. This revision also had a positive effect on the estimated number of reports. Third, because facility level dioxin emission factors for coal and oilburning manufacturing facilities have not been developed, the estimated number of reporting facilities was reduced. Fourth, the reporting qualifier for dioxin was changed from 58742 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations `` manufacture only'' to `` manufacturing; and the processing or otherwise use of dioxin and dioxin like compounds if the dioxin and dioxin like compounds are present as contaminants in a chemical and if they were created during the manufacturing of that chemical'' in the final rule. This resulted in additional expected reporting from facilities that process or otherwise use chemicals with dioxin impurities. Fifth, the Agency is not lowering EPCRA section 313 reporting thresholds for alkyl leads as part of this rulemaking. Therefore, no additional EPCRA section 313 reporting on alkyl leads is expected at this time. Sixth, the threshold for the PACs category was changed from 10 pounds in the proposed rule to 100 pounds in the final rule.

C. What Are the Benefits of This Rule? In enacting EPCRA and PPA, Congress recognized the significant benefits of providing the public with information on toxic chemical releases and other waste management practices. EPCRA section 313 has empowered the Federal government, State governments, industry, environmental groups, and the general public to fully participate in an informed dialogue about the environmental impacts of toxic chemicals in the United States. EPCRA section 313's publicly available data base provides quantitative information on toxic chemical releases and other waste management practices. Since the TRI program's inception in 1987, the public, government, and the regulated community have had the ability to understand the magnitude of chemical releases in the United States, and to assess the need to reduce the uses, releases and other waste management of toxic chemicals. TRI enables all interested parties to establish credible baselines, to set realistic goals for environmental progress over time, and to measure progress in meeting these goals over time. The TRI program is a neutral yardstick by which progress can be measured by all stakeholders. The information reported under EPCRA section 313 increases knowledge of the amount of toxic chemicals released and waste management practices, and thus aids in the evaluation of the potential pathways of exposure, improves scientific understanding of the health and environmental risks of toxic chemicals; allows the public to make informed decisions on where to work and live; enhances the ability of corporate leaders and purchasers to more accurately gauge a facility's potential environmental liabilities; provides reporting facilities with information that can be used to save money as well as reduce emissions; and assists Federal, State, and local authorities in making better decisions on acceptable levels of toxic chemicals in the environment. There are two types of benefits associated with EPCRA section 313 reporting, those resulting from the actions required by the rule (such as reporting and recordkeeping), and those derived from follow on activities that are not required by the rule. Benefits of activities required by the rule include the value of improved knowledge about the release and waste management of toxic chemicals, which leads to improvements in understanding, awareness, and decision making. It is expected that this rule will generate such benefits by providing readily accessible information that otherwise would not be available to the public. The rule will benefit ongoing research efforts to understand the risks posed by PBT chemicals and to evaluate policy strategies that address the risks. The second type of benefits derive from changes in behavior that may result from the information reported under EPCRA section 313. These changes in behavior, including reductions in releases of and changes in the waste management practices for toxic chemicals may yield health and environmental benefits. These changes in behavior come at some cost, and the net benefits of the follow on activities are the difference between the benefits of decreased chemical releases and transfers and the costs of the actions needed to achieve the decreases. Because the state of knowledge about the economics of information is not highly developed, EPA has not attempted to quantify the benefits of adding chemicals to EPCRA section 313 or changing reporting thresholds. Furthermore, because of the inherent uncertainty in the subsequent chain of events, EPA has also not attempted to predict the changes in behavior that result from the information, or the resultant net benefits (i. e., the difference between benefits and costs). EPA does not believe that there are adequate methodologies to make reasonable monetary estimates of either the benefits of the activities required by the rule, or the follow on activities. The economic analysis of the rule, however, does provide illustrative examples of how the rule will improve the availability of information on PBT chemicals (Ref. 67). A number of commenters asserted that information on the magnitude of PBT chemical releases that would be reported as a result of this rule is required for EPA and commenters to evaluate the benefit of EPA's proposed alternatives. EPA disagrees with these commenters for the following reasons. Existing data do not support estimates of releases to multiple environmental media from the full range of facilities that may be affected by the rule because most of the data required for the analysis would only be available after the rule is in place. For most PBT chemicals and industry sectors, up todate multi media release and other waste management estimates for affected facilities do not exist. Even where release estimates are available for an industry sector, most are derived from national activity levels rather than from facility level information. To the extent that release estimates are available, they tend to cover only a single medium such as air. EPA does not believe that there is sufficient information to make reasonable predictions of the multi media releases and other waste management information that will be reported as a result of EPCRA section 313 rulemakings. Some commenters note that EPA has estimated releases of certain PBT chemicals in recent reports such as the Mercury Study Report to Congress (Ref. 65) and the Inventory of Source of Dioxin in the United States (Ref. 73). In fact, EPA reported the results of these reports in its economic analysis for this proposal. These studies do not provide community or facility level release estimates. The estimates in these studies are derived using a `` top down'' methodology in which emission factors are applied to activity levels for entire industries. While having an estimate of multi media PBT releases for a specific industry sector is a first step, other information would also be required to estimate the releases that would be reported as a result of each proposed alternative. Assuming that multi media release estimates were available for an entire industry sector, these releases would still have to be divided among individual facilities according to some currently unknown distribution. In addition, there is the complication that EPCRA section 313 reporting thresholds are based on chemical throughput (manufacture, process, or use) rather than chemical release. The relationship between a chemical throughput that triggers the submission of a report, and the releases reported will vary in some currently unknown manner among industries, as well as among facilities within an industry. Therefore, EPA does not believe that there is sufficient information to make reliable release estimates for this rule, when considering all the affected chemicals and industries. The 58743 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations uncertainties in the estimated values that go into such a calculation make predictions of facility level reporting extremely imprecise. Historical attempts to estimate the releases expected to be reported under EPCRA section 313 would have been imprecise to the point of being misleading, particularly in respect to estimates of releases per report or per facility (which some commenters have suggested that EPA should make). Further information on the feasibility of ex ante release estimates is available in the Response to Comments document (Ref. 69). Aside from the general issue of uncertainty in the estimates of aggregate releases, predictions of releases per facility or per report (or dollars of reporting cost per pound of releases reported) are likely to be misleading due to the biases built into the estimates. The predicted number of reports (and thus costs) is generally an overestimate, since EPA's economic analyses use conservative estimates to avoid underestimating true costs. On the other hand, predictions of releases will tend to underestimate emissions, because while there may be information available on releases of some chemicals from some sectors, such estimates will not include other sources where releases are not identified until more detailed data (such as TRI data) are collected. Combining the two sets of estimates compounds the problem. Since estimated pounds of releases are underestimated and reports are overestimated, pounds per report would be biased significantly downward. Likewise, estimates of dollars of reporting cost per pound of releases (which varies as the inverse of pounds per report) would be biased significantly upward. EPA notes that there were various reports and studies about air emissions of toxic chemicals prior to EPCRA section 313, but the collection of facility level data provided significant new information on releases as well as other waste management. EPA cannot predict, at this stage, the quantity of releases and other waste management that will be reported as the result of this action any more accurately than it could have predicted when it proposed the original EPCRA section 313 rule. Aside from the issue of whether EPA can predict releases and other waste management quantities prior to TRI reporting, EPA notes that pounds of releases (even if known) are not a reasonable proxy for the benefits of the information being provided. This is because the benefits of an informational regulation are not a linear function of the magnitude of the information being reported. EPA disagrees with the implicit assumption by commenters that the benefits of information from different facilities is strictly and systematically related to the quantity reported as being released. Calculations such as the commenters have suggested presume that the benefit to the public of knowing about a release of 20,000 pounds is twice as large as the benefit of knowing about a release of 10,000 pounds; and that the benefit of knowing about a 40,000 pound release is twice the benefit of knowing about a 20,000 pound release and four times the benefit of knowing about a 10,000 pound release. EPA does not believe this characterization to be accurate. One of the central purposes of TRI data is to inform the public about releases and other waste management of EPCRA section 313 listed toxic chemicals in their community so that the public can form its own conclusions about risks. The amount of releases and waste management quantities that a community may find relevant or useful will vary depending on numerous factors specific to that community, such as the toxicity of the various chemicals, potential exposure to these toxic chemicals, and the number of other facilities in the area that release EPCRA section 313 listed toxic chemicals. Section 313( h) of EPCRA states that the data are `` to inform persons about releases of toxic chemicals to the environment; to assist governmental agencies, researchers, and other persons in the conduct of research and data gathering; to aid in the development of appropriate regulations, guidelines, and standards; and for other similar purposes'' (See Unit VI. E. for a more detailed discussion on the purposes of EPCRA section 313). Pounds of releases reported does not measure how the data perform these functions, and thus is not a measure of benefits. Finally, EPA notes that commenters on this rule did not provide information on approaches or methodologies for estimating releases and/ or throughput, or on estimating releases from throughput data, for the spectrum of industries, chemicals, and facilities covered by the rule. Instead, some commenters submitted data from EPA studies (that EPA had already reviewed in the context of this rule and used as references for the economic analysis of the proposed rule) for very narrow slices of the regulated universe (for example, estimated mercury releases from electric utilities or estimated dioxin releases from the vinyl industry). EPA considered these data and determined that they are not sufficient to predict the releases and/ or throughput that will be reported as a result of this rule. Other commenters simply stated that EPA should consider releases without referencing any data. None of the commenters suggested new methodologies or approaches, or provided information from any sources that EPA had not already reviewed and considered. As a result, EPA continues to conclude that while there are data available to estimate national releases for some chemicals for some sectors, comprehensive, reliable data for all sectors and chemicals are unavailable, resulting in an incomplete data set. Furthermore, as stated previously, the quantity of releases reported are not a measure of the benefits of the rule. EPA does not believe that inaccurate or incomplete estimates of releases would aid the decision making process for the rule. Therefore, EPA has not estimated the releases that would be reported as a result of the rule.

D. What are the Potential Impacts on Small Entities? In accordance with the Regulatory Flexibility Act (RFA) and the Agency's longstanding policy of always considering whether there may be a potential for adverse impacts on small entities, the Agency has evaluated the potential impacts of this rule on small entities. The Agency's analysis of potentially adverse economic impacts is included in the Economic Analysis for this rule (Ref. 67). The following is a brief overview of EPA's findings. 1. Overall methodology. This rule may affect both small businesses and small governments. For the purpose of its analysis for the rule, EPA defined a small business using the small business size standards established by the Small Business Administration (SBA) at 13 CFR part 121. EPA defined small governments using the RFA definition of jurisdictions with a population of less than 50,000. No small organizations are expected to be affected by the rule. Only those small entities that are expected to submit at least one report are considered to be affected for the purpose of the small entity analysis, although EPA recognizes that other small entities will conduct compliance determinations under lower thresholds. The number of affected entities will be smaller than the number of affected facilities, because many entities operate more than one facility. Impacts were calculated for both the first year of reporting and subsequent years. First year costs are typically higher than continuing costs because firms must familiarize themselves with the requirements. Once firms have become familiar with how the reporting 58744 Federal Register / Vol. 64, No. 209 / Friday, October 29, 1999 / Rules and Regulations requirements apply to their operations, costs fall. EPA believes that subsequent year impacts present the best measure to judge the impact on small entities because these continuing costs are more representative of the costs firms face to comply with the rule. EPA analyzed the potential cost impact of the rule on small businesses and governments for the manufacturing sector and in each of the recently added industry sectors separately in order to obtain the most accurate assessment for each. EPA then aggregated the analyses for the purpose of determining whether it could certify that the rule will not, if promulgated, have a `` significant economic impact on a substantial number of small entities. '' RFA section 605( b) provides an exemption from the requirement to prepare a regulatory flexibility analysis for a rule where an agency makes and supports the certification statement quoted above. EPA believes that the statutory test for certifying a rule and the statutory consequences of not certifying a rule all indicate that certification determinations may be based on an aggregated analysis of the rule's impact on all of the small entities subject to it. 2. Small businesses. EPA used annual compliance costs as a percentage of annual company sales to assess the potential impacts on small businesses of this rule. EPA believes that this is a good measure of a firm's ability to afford the costs attributable to a regulatory requirement, because comparing compliance costs to revenues provides a reasonable indication of the magnitude of the regulatory burden relative to a commonly available measure of a company's business volume. Where regulatory costs represent a small fraction of a typical firm's revenue (for example, less than 1%, but not greater than 3%), EPA believes that the financial impacts of the regulation may be considered not significant. As discussed above, EPA also believes that it is appropriate to apply this measure to subsequent year impacts. Based on its estimates of additional reporting as a result of the rule, the Agency estimates that approximately 6,300 businesses will be affected by the rule, and that approximately 4,400 of these businesses are classified as small based on the applicable SBA size standards. For the first reporting year, EPA estimates that approximately 17 small businesses may bear compliance costs between 1% and 3% of revenues, and that no small businesses will bear costs greater than 3%. In subsequent years, EPA estimates that approximately 5 small businesses may bear compliance costs between 1% and 3% of revenues, and that no small businesses will bear costs greater than 3%. As stated above, EPA believes that subsequent year impacts are the appropriate measure of small business impacts. 3. Small governments. To assess the potential impacts on small governments, EPA used annual compliance costs as a percentage of annual government revenues to measure potential impacts. Similar to the methodology for small businesses, this measure was used because EPA believes it provides a reasonable indication of the magnitude of the regulatory burden relative to a government's ability to pay for the costs, and is based on readily available data. EPA estimates that 39 municipalities operate 49 publicly owned electric utility facilities. Of these facilities, 44 are expected to file additional reports as a result of this action. Of these affected facilities, 15 are operated by 15 small governments (i. e., those with populations under 50,000). It is estimated that none of these small governments will bear annual costs greater than 1% of annual government revenues. 4. All small entities. As discussed above, approximately 5 small businesses are expected to bear annual costs between 1% and 3% of annual revenues after the first year of reporting. None of the affected small governments are estimated to bear annual costs greater than 1% of annual revenues. No small organizations are expected to be affected by the rule. Thus, the total number of small entities with impacts above 1% of revenues does not change when the results are aggregated for all small entities (i. e., small businesses, small governments, and small organizations).