Document 9xdZdqae1O2Kaq1NmOYBKXJR

ABD00291774 Tuesday February 16, 1988 Part II Environmental Protection Agency 40 CFR Part 372 Toxic Chemical Release Reporting; Community Rlght-to*know; Final Rule ABD00291775 4500 Federal Register / Vol. 53, No. 30 / Tuesday. February 16. 1988 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Pari 372 (OPTS-400002A; FRL 32M-2) Toxic Chemical Release Reporting; Community Right-to-know AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. summary: This rule contains the uniform toxic chemical release reporting form as required by section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986. Section 313 requires that owners and operators of certain facilities that manufacture, import, process, or otherwise use certain toxic chemicals report annually their releases of those chemicals to each environmental medium. This rule also requires certain suppliers of toxic chemicals to notify recipients of such chemicals in mixtures and trade name products. OATE: This rule is effective March 17. 1988. FOP FURTHER INFORMATION CONTACT: Sam K. Sdsnett. Deputy Project Coordinator (T^--779). Emergency Planning and Community Right-to-Know Hotline. Environmental Protection Agency, Room. WH 562A. 401 M Street. SW. (Washington. DC 20460. (800-5330202). In Washington, DC and Alaska. 202-179-2449). SUPPLEMENTARY INFORMATION: I. Authority The Agency is promulgating this rule pursuant to sections 313 and 328 of Title ill of (he Superfund Amendments and Renuthorizalicn Act of 1986. Pub. L 99499 (42 U.S.C. 11013 and 11028). Title HI is also ti*1 fIeI.d "The Emergency Planning and Community Right-To-Know Act of 1986." Section 313 of Title HI requires owners and operators of covered facilities to report annually their releases of listed toxic chemicals. Section 313 also specifies that EPA must publish a uniform toxic chemical release form. In addition, section 328 provides EPA with the authority to promulgate such regulations as may be necessary to carry out the purposes of Title HI. II. Background A- Regulatory History and Summary of Public Participation On October 17.1986. the President signed into law the Superfund Amendments and Reauthorization Act of 1986 (SARA). Pub. L. 99-499. The major function of this legislation is to amend and reauthorize provisions of the shipped and/or produced at 20 through Comprehensive Environmental 39 establishments versus non-20 through Response. Compensation, and Liability Act of 1980 (CERCLA). However. Title Hi of SARA is a free-standing statute (not part of CERCLA) that is titled "The Emergency Planning and Community Right-To-Know Act of 1986." In general. Title HI contains authorities relating to emergency planning, emergency notification, community right-to-know on chemicals, and a toxic chemical release inventory. The focus of this rule is the toxic chemical release inventory provision contained in section 313 of Title 111 of SARA. Section 313 requires owners and operators of certain facilities that manufacture, process, or otherwise use a listed chemical to report annually their releases of such chemicals to any environmental medium. The reports are to be sent to both EPA and the State in which the facility is located. The basic . purpose of this provision is to make available to the public information about releases of certain toxic chemicals that result from operations of certain facilities in their community. EPA issued a proposed rule, published m the Federal Register of June 4.1987 (52 FR 21132). The proposed rule contained the toxic chemical release inventory reporting form and interpretive requirements for reporting. The preamble of the proposed rule outlined the public participation activities that led up to the development of the proposal. After publication. EPA received over 100 written comments on the proposed rule, in addition. EPA held public meetings in Washington. DC. Chicago. U. and San Francisco. GA. Attendees at these meetings presented oral comments representative of wide range of interests including the affected industry, environmental and other public interest groups. State and local governments, and individual citizens. In addition. EPA has held other meetings with, and received other communications from, interested parties. 39 establishments in that facility. EPA has included a definition of "full- time employee" and guidance on determining SIC coverage. EPA has not included a small business exemption in this rule different from that provided by section 313. However, the Agency is allowing reporting in ranges for releases to an environmental medium and for off-site transfers of wastes that are below 1.000 pounds per year. EPA expects that small businesses will benefit most from this provision. The range reporting is for calendar years 1987,1988. and 1989 only. The thresholds are those provided by the statute: For manufacturing or processing as defined--75.000 pounds for 1987. 50.000 pounds for 1988. 25.000 pounds per year for 1989 and thereafter. For toxic chemicals otherwise used the threshold is 10.000 pounds per year for all years. Reports must be submitted annually oo or before July 1 for the preceding year's data. The chemicals subject to reporting initially are those chemicals as provided by section 313(c). with certain technical modifications. Additions or deletions of chemicals from the list may result from petitions or EPA's own review of the list. Any such changes will be by notice and comment rulemaking, and EPA will identify the reporting years which they apply. Mixtures and trade name products imported, processed, or used at a facility roust be evaluated for the presence of listed toxic chemicals. However. EPA has applied a de minimis concentration limitation of 1 percent (or 0.1 percent if the chemical is a carcinogen) consistent with the Occupational Safety and Health Administration (OSHA) Hazard Communications Standard (HCS) in 29 CFR 1910.1200. Toxic chemicals present io concentrations below the de minimis limit do not have to be factored into B. Overview of Final Rule Requirements threshold and release reporting The reporting requirements of this rule apply to owners and operators of covered facilities that manufacture, process, or otherwise use listed toxic chemicals. A covered facility is one that: Has 10 or more full-time employees. Is in SIC codes 20 through 39. Exceeds an applicable manufacture, process, or use threshold. EPA interprets "in SIC codes 20 through 39" to relate to the primary SIC code of the facility. If the facility is comprised of multiple establishments, facility coverage is based on a relative calculations. In relation to reporting on mixtures. EPA has developed a supplier requirement. Owners or operators of facilities in SIC codes 20 through 39 who supply mixtures or trade name products containing listed toxic chemicals must notify their customers about the presence and concentration of those chemicals in their products. However, the de minimis limit as described above also applies to this requirement. The supplier notification requirement takes effect with the first product shipment n comparison of the value of products 1989. ABD00291776 Federal Register / Vol. 53, No. 30 / Tuesday. February 16, 1988 / Rules and Regulations 4501 Certain definitions have been modifed. The definition of "article'' has been revised to more closely parallel the OSHA HCS article definition. In addition, article processing or use is exempt from threshold and release determinations under this rule. However, respondents must pay careful attention to the non-release criteria in this definition. The definition of "manufacture" retains the interpretation that coincidentally produced impurities and other byproducts must be accounted for. However, the consideration of an impurity is subject to the abovereferenced de minimis limitation. This de minimis limitation does not apply to the byproducts produced coincidentally as a result of manufacturing, processing, use. waste treatment, or disposal. EPA has attempted to clarify the differences between processing and use. Processing activities are basically those that incorporate a chemical into a product for distribution in commerce. Use activities are primarily nonincorporative activities. A new part of the rule is an exemptions section. The major function of this section is to outline activities that are not subject to certain requirements. In particular, this section exempts activities in laboratories from threshold and release determinations. There are a number of specific changes from the proposed rule in Form R. the Toxic Chemical Release Inventory Reporting Form. The fonn is more modular ui design in order to reduce the frequency of the same information having to be filled in for each chemicalspecific submission. Other specific changes are as follows: 1. The certification statement (Part L Section 2) has been modified. 2. The facility identification section of the form (Part 1. Section 3) contains the name and telephone number of a public contact person for the facility. In the first reporting year, if this information is available, the facility must provide its latitude and longitude. In subsequent years, if this information is not readily available, the facility must develop it and provide it. 3. In the chemical identity section of the form (Part LUL Section 1) one change in the reporting requirements affects the generic chemical identity to be provided in cases where the specific chemical identity is claimed trade secret. The respondent is to develop its own generic chemical name rather than using a predefined generic name as EPA had proposed. The generic name it to be structurally descriptive of the chemical. Reporting may also be based on a genetically identified mixture or trade name product component. (See Part 111, Section 2 of the form.) This reporting would occur in cases where a user has information that a genericaUy identified component of a mixture or trade name product is a section 313 chemical that, by itself, exceeds a threshold but the user does not know the specific identity. 4. The release reporting section of the form (Part ILL Section 5) contains several modifications. As mentioned above, for calendar years 1987,1988. and 1989. facilities may take advantage of range reporting check boxes for releases of a toxic chemical to an environmental medium of less than 1.000 pounds per year. The releases to water portion of the form has been disaggregated by stream and respondents must indicate what percentage of the release was contributed by stormwater runoff if they have monitoring data. In addition, underground injection of wastes at a facility must be entered on a specific line in the release section. The proposed columns indicating section 304 releases or that a permit applies to releases have been deleted from the final form. 5. EPA has included the reporting of transfers of section 313 toxic chemicals in waste to off-site locations. However, these transfers are to be reported in a separate section of the form (Part 111. Section 6). 8. The waste treatment section of the form remains unchanged from the proposal except that EPA has provided for reporting sequential waste treatment. 7. The optional section on waste minimization has been retained but the narrative part of this section has been removed. A 3-year sunset provision will apply to this form section. 8. The form also contains a preformatted supplemental information sheet (Part IV)- ILL Issues Relating to Facility coverage A. Interpretation of SIC Code Coverage Standard Industrial Classification (SIC) code coverage is one of three criteria specified in section 313(b) for determining whether a facility is subject to reporting. The preamble of the proposed nile stated that "in SIC codes 20-39" meant that the primary SIC code for the facility is within the 20 through 39 designations. The proposed rule also included facilities that engage in one or more activities in SIC codes 20 through 39 even if the primary SIC code for the facility itself is not SIC 20 through 39. Many commenters argued against including "secondary" SIC activities. First, commenters stated that the definition of a facility ia the whole collection of buildings, not parts thereof. Second, they argued that SIC codes are used to define the primary purpose of an establishment, not all activities. Therefore, including facilities that engage in activities in SIC code 20 through 39 but for which the primary SIC code for the facility is outside SIC code 20 through 39 is in direct contradiction to the established assignment and usage of SIC codes. Third, commenters stated that it exceeded the intent of the legislation and stretched the capabilities of the industrial classification system. Finally, the commenters stated that any increase in SIC code coverage should be through discrete and more focused rulemakings, as prescribed m section 313(b)(1)(B) and (b)(2). with substantial sector-by-sector justification to warrant increased reporting on non manufacturing sectors. The SIC code system was developed to calssify establishments by type of economic activity. A SIC code applies to an establishment, which was defined as an economic unit, generally at a single physical location, where business is conducted or where services or industrial operations are performed. SIC codes are not directly applicable to facilities as defined in section 329(4) of Title III and this rule. A "facility" is defined as all buildings, equipment, structures, and other stationary items which are located on a single site or adjacant contiguous sites owned or operated by the same person. Therefore, a facility can be a much larger, more complex operation than an establishment. The definition of primary SIC code is generally considered to be the code related to the types of products distributed from an establishment that have the highest dollar value added. Based on the public comments received on the proposed rule, the Agency has revised its interpretation of "in SIC Codes 20 through 39." The revision is designed to remove the confusion and ambiguity in the proposed rule caused by linking the concepts of facility and primary SIC code. The final rule provides that a facility ia in SIC codes 20 through 39 based on the SIC codes for the one or more establishments that comprise the facility. EPA bas identified the following three possible scenarios relating establishments. SIC codes, and facilities: 1.The establishment is the same as the facility. Where an establishment is the same as a facility, given that the other eligibility criteria are met and the establishment's primary SIC code is in 20 through 39. the facility is covered for purposes of reporting. Because there is ABD00291777 4502 Federal Register / Vol. 53. No. 30 / Tuesday, February 16. 1986 / Rules and Regulations no distinction between the establishment and the facility, reporting of releases from the facility is straightforward. 2. The facility is comprised of two or more establishments. all of which have a primary SIC code of20 through 39. For multi-establishment facilities, when all of the establishments' primary SIC codes are in 20 through 39. given that the other eligibility criteria are met for the facility, the facility is covered for purposes of reporting. 3. The facility is comprised of two or more establishments, one or more of which have a primary SIC code of 20 through 39. For multi-establishment facilities when one or more of the establishments' primary SIC codes are in 20 through 39. the facility is covered for purposes of reporting if either of the following criteria apply for the reporting year a. The sum of the value of products shipped from and/or produced at all establishments with primary SIC codes in 20 through 39 is greater than 50 percent of the total value of products shipped from and/or produced at all establishments that comprise the facility. b. One establishment whose primary SIC code is in 20 through 39 has a value of products shipped and/or produced that is larger than that of any other establishment in the facility. Facilities may refer to data they submitted to the U.S. Department of Commerce. Bureau of the Census, for the Annual Census of Manufacturers (Form MA-1000) to calculate the relative values of products shipped and/or produced. Once a facility is covered in either of the above cases, all releases of listed toxic chemicals must be accounted for. even from individual establishments in the facility that fall outside of the 20 through 39 SIC codes. B. Reporting by Multi-Establishment Facilities Several commenters raised the concern that it will be difficult for facilities consisting of more than one establishment to submit a single report covering the entire facility. Commenters noted that individual establishments, owned by the same parent company, often have different management lines of authority within the company. In these cases, commenters noted, it would be difficult to combine information into one reporting form. As explained in A. of this unit the facility is the unit that is responsible for reporting. While EPA could continue to require a single submission for multiestablishment facilities. EPA has decided to require a compliance determination by the whole facility covering all its establishments, but to allow individual establishments or groups of establishments to report separately, provided all releases and waste treatment methods are accounted for. However, if individual establishments or groups of establishments report separately for one chemical they must continue to report separately for all other chemicals at the facility. Under this approach the entire facility must determine compliance as a single unit. Thus the Agency ensures ao reporting will be missed because certain individual establishments do not meet thresholds for employees or chemical activities. For example, a facility is comprised of two establishments, with combined employment totaling 60 full time workers. Establishment A uses 5.000 pounds of benzene and establishment B uses 8.000 pounds of benzene. The facility as a whole exceeds 10 full-time employees and combined use by both establishments exceeds the 10.000 pound threshold for the use of benzene at the facility. Therefore this facility must report for benzene. It baa two options. It can file a report that represents the combined data associated with all activities with benzene at both establishments. Alternatively, both establishments can file separate reports accounting for their individual releases and other related data. If both establishments file separate reports, then they must submit separate reports for all chemicals subject to reporting. However, if. for example, a toxic chemical is used at one establishment but is not present at ail at the other establishment only the establishment that uses the chemical must report for that chemical. The form provides a way for users of the data to know whether all or only part of a facility is included in a specific report. Check boxes correspond to (1) the entire covered facility or (2) one or more establishments within a covered, multi-establishment facility. A second issue regarding multiestablishment facilities relates to the requirement that the owner or operator of a facility must report. EPA proposed that if no report was Hied, both the owner and operator (if different) would be liable. Commenters requested clarification on the liabilities and obligations of an owner of leased property, where the owner's interest is solely one of real estate. These commenters believe that such an owner should not have obligations to report because it is not in a position which would allow it to determine compliance or report the required information. The owner would not be able to submit a report without the cooperation of the operator. EPA recognizes these difficulties. The final rule exempts certain owners of leased property from reporting requirements. These exemptions apply only to those owners of property who have no business interest in the property other than real estate. Owners who are part of the same business organization as the operators would not be exempt, nor would owners of businesses that contract out the operations of a particular site. In these cases, the owner has a business interest beyond that of the real estate and has the ability to exert some control over the operator. A commenter identified an additional problem that occurs when the establishments in a multi-establishment facility are operated by different persons which have no common corporate relationship, such as in an industrial park. EPA identified two possible scenarios. In the first scenario, the owner of the facility operates an establishment in the facility but leases a portion of the facility to another person who operates another establishment. The owner and this other operator do not have any business relationship other than landlord and tenant Also, the owner does not know what chemicals are manufactured, processed, or used in that operator's establishment. In the second scenario, the owner of the facility, having only a real estate interest in the facility, does not operate any establishment in the facility and leases all of the facility to two or more persons who operate establishments in the facility. Under the exemption discussion above, the owner would not be subject to reporting. However, in both scenarios, the operators would be subject to reporting, but they have no common corporate or business interest and do not know what chemicals are manufactured, processed, or used in each other's establishments. In neither of these situations is one person in a position to know all of the information necessary to make a determination whether the facility as a whole is a covered facility and whether a toxic chemical is manufactured, processed, or used at the facility in excess of an applicable threshold. Accordingly, EPA has decided that, in such a situation, each operator should treat the establishments it operates as a facility for purposes of reporting. These operators must make the determinations under the rule for SIC code coverage, number of full-time employees, and whether a toxic chemical is ABD00291778 Federal Register / Vol. 53. No. 30 / Tuesday, February 16. 1988 / Rules and Regulations 4503 manufactured, processed, or otherwise used in excess of an applicable threshold, but only for those establishments they operate. Appropriate provisions have been added to the rule. form, and instructions to provide for this approach. To ensure that related companies do not avoid reporting for multi-establishment facilities. EPA has limited use of this approach to operators of separate establishments in the same facility who do not have any common corporate or business interest, i.e. they are not engaged in partnerships, joint ventures, ownership of a controlling interest in one by the other, or ownership of a controlling interest in both by a third person. Another situation may arise where a person owns a parcel of land on which it operates one or more establishments and also leases land immediately adjacent to it on which that same person operators one or more additional establishments. Section 329(4) of Title 111 defines "facility'' to include "a single site or * * * contiguous or adjacent sites * * * which are owned or operated by the same person * * Thus in this situation the 'facility'* would be the total site including the land owned by the person and the adjacent land leased by the person. To make the SIC code determinations and reporting threshold determinations, the person is required to consider the activities at all the establishments he or she operates on the total site. Having made the determinations that the total facility is a covered facility and that an applicable reporting threshold has been met. the person may submit separate reports for the establishments as described above. C. Auxiliary Facilities--Laboratory Activity Exemption Commenters requested that EPA clarify whether auxiliary operations which have primary SIC codes within 20 through 39 (manufacturing) are covered for purposes of section 313 reporting. Auxiliary establishments are defined under the SIC code system as operations which primarily support other establishments. Common types of auxiliary operations are research and development laboratories, warehouses, storage facilities, and waste treatment facilities. The SIC code system assigns these facilities SIC codes according to the establishment they service: thus, auxiliary establishments tied to manufacturing establishments are given a manufacturing SIC code. Commenters argued that the statute did not contemplate including establishments that do not engage in manufacturing. They stated further that EPA has the discretion to modify the facility coverage criteria to correct such anomalies. 1. Auxiliary facilities must make a compliance determination. EPA has determined that the most consistent way to treat a stand-alone auxiliary establishment (i.e. one that is not a part of a larger facility) is to require that it make a compliance determination. If such an establishment is classified in SIC codes 20 through 39 because it supports a manufacturing activity, it must review its chemical activities and the level of such activities to determine if it must report. It is possible that an establishment such as a warehouse standing alone will not be subject to reporting. If no manufacture (including importation), processing (including repackaging), or use of covered toxic chemicals occurs, the facility is not subject. Similarly, persons who own or operate auxiliary establishments that are within the defined boundaries of a larger multi-establishment facility must review the manufacture, processing, or use activities involving listed toxic chemicals at all the establishments in the facility. Such auxiliary establishments must be factored into the "value of shipments and/or production** calculation to the extent it is applicable, and must be counted toward the employee threshold. The activity of manufacturing, processing, or using a toxic chemical in the auxiliary establishment counts toward the chemical thresholds for the facility. 2. Exemption of laboratory activities. Commenters stated that it would be burdensome to require laboratories to determine whether they must comply because of the potentially large number of mixtures and chemicals on-site in small volumes and the relatively rapid turnover of such chemicals and mixtures in the laboratory setting. EPA agrees with comments that manufacturing, processing, or use of chemicals in a laboratory under the supervision of a technically qualified individual should be exempt from the provisions of this rule. This exemption is consistent with the exemption provided in rules implementing sections 311 and 312 of Title HI. and the OSHA HCS. The exemption does not apply to specialty chemical production or pilot plant scale operations. The Agency believes that this exemption provides a consistent and necessary reduction in the reporting burden. For example a stand-alone laboratory is classified in SIC codes 20 through 39 because it is an auxiliary facility supporting a manufacturing operation of a company. This laboratory is. in essence, exempt from the threshold determination and reporting requirements of this rule. Also a covered facility will not have to review chemical manufacture, processing, or use in a laboratory within that facility, provided such operation is not conducting specialty chemical production or pilot plant scale activities. If a toxic chemical is removed from such a laboratory for further processing or use in the facility, the facility must factor such amounts into threshold determinations and release reporting. The Agency does retain certain concerns about releases of toxic chemicals from laboratories. Therefore. EPA will review laboratories as part of its overall review of the types of facilities that should be covered by amendments to this rule. D. The Rule Contains no Modification of Facility Coverage EPA has discretionary authority to modify the coverage of facilities under section 313(b)(1)(B). The report of the congressional conference committee for Title (!I states that any such modifications are limited "* * * to adding SIC codes for facilities which, like facilities within the manufacturing sectors SIC codes 20 through 39. manufacture, process or use toxic chemicals in a manner such that reporting by these facilities is relevant to the purposes of this section." (H.R. Rep. No. 962.99th Cong.. 2nd sess. 292hereafter referred to as the conference report.) The conference report further states that section 313(b)(1)(B) is given to provide EPA with the authority to adjust coverage but that "it does not provide EPA the authority to change the overall scope of the reporting program for Toxic Chemical Release Forms." Id. at 293. The Agency proposed that facilities within SIC codes 20 through 39 be required to report. Comments from trade associations, private companies. Stale agencies, public interest groups and academia requested that EPA use its authority under section 313(b)(1)(B) to include other facilities. These commenters noted that other kinds of facilities beyond those in the manufacturing sector can have significant releases of toxic chemicals. They contend that if the current scope of reporting is not expanded, the public will not realize that manufacturing releases constitute only a part of the total releases of these chemicals into the environment. Most commenters provided specific examples of facilities that they would like to see added. They include: ABD00291779 4504 Federal Register / Vol. 53. No. 30 / Tuesday. February 16. 1988 / Rules and Regulations Commercial waste treatment facilities, transportation sites, federal facilities, municipal waste treatment facilities and publicly owned treatment works, disposal sites, petroleum and chemical bulk stations and terminals, tank farms, electrical services, petroleum wholesalers, farm suppliers, paint and varnish suppliers, and industrial launderers. Commenters suggested that SIC codes should not be a primary determinant of coverage and that EPA should consider the intent of the law to provide citizens information about releases from all important sources of emissions. Modification of facility coverage could also involve deletions of certain industries from the currently covered SIC codes. In deleting SIC codes the Agency will consider to what extent certain manufacturing operations produce or use toxic chemicals in a manner more similar to operations outside the manufacturing sector. The conference report includes an example of such an operation for facilities within SIC code 2875 that mix or blend fertilizer products for sale at the retail level. It is also possible that certain manufacturing operations, for example those that conduct simple article assembly, may not produce, import, process, use. or release significant amounts of covered toxic chemicals. If by the inherent nature of their activities such facilities are unlikely to otherwise be subject to reporting, then it would serve no purpose to continue to include them in the SIC code designations. The Agency is choosing not to modify the facility coverage of the rule at this time. The issues raised in the comments are important ones for EPA to consider in exercising its authority to modify coverage. Such issues should be dealt with through full notice and comment rulemaking. The Agency must carefully evaluate additional types of facilities that may be manufacturing, processing, or using listed toxic chemicals as well as facilities in SIC codes 20 through 38 that do not handle such chemicals. EPA is planning to initiate an evaluation of facility coverage in 1988. As part of this analysis. EPA will examine the predominant activities in SIC codes 20 through 39. The results of this evaluation and any recommended additions or deletions to the scope of covered facilities will be published as a proposed amendment to this rule. As part of this analysis EPA will also look at the concept of value of products shipped and/or produced from designated SIC code establishments. Another potentially more equitable approach of determining multi* establishment facility coverage is by production is included in the definition using "value added" instead of the value of manufacture under section 313. For of products shipped and/or produced. purposes of the rule however. EPA has The value-added approach may create distinguished between toxic chemicals less distortion and duplication when which are impurities that remain with comparing the contribution by another chemical that is processed, individual establishments for purposes distributed, or used, from toxic of the overall facility coverage chemicals that are byproducts either determination. However, value-added sent to disposal or processed, information may be less available and distributed, or used in their own right. more burdensome to determine than EPA also considers that it would be value of shipments and/or production. reasonable to apply a de minimis EPA will review the first few years of concentration limitation to toxic reported data and will attempt to chemicals that are impurities in another evaluate how the value of shipments chemical or mixture. In essence, the de and/or products approach affects minimis cut-off adopted for mixtures overall facility coverage. (see Unit VI.) would apply to the IV. Definitional Issues presence of impurities created as a result of making that mixture, or a A. Definition of Manufacture component of the mixture. Because the 1. Coincidentalproduction of toxic chemicals. EPA proposed to interpret "manufacture" to include coincidental production of a listed toxic chemical as a byproduct or impurity during the manufacture, processing, use. or disposal of any other chemical substance or mixture. Congress adopted the definition of "manufacture" used in regulations under the Toxic Substances Control Act (TSCA) where such an approach is used. The proposed rule's approach wa9 intended to cover those situations in which a listed toxic chemical is created (intentionally or unintentionally) and then passed on in commerce or disposed of. but never otherwise accounted for. Commenters objected to this interpretation of the manufacture covered toxic chemical as an impurity ends up in a product, most producers of the product will frequently know whether the chemical is present in concentrations that exceed the de minimis level, and. thu9 may be listed on the Material Safety Data Sheet (MSDS) for that product under the OSHA HCS. This final rule does not adopt a de minimis concentration limitation in connection with the production of a byproduct. EPA believes that the facility should be able to quantify the annual aggregate pounds of production of a byproduct which is not an impurity because the substance is separated from the production stream and used. sold, or disposed of. unlike an impurity which remains in the product. definition on grounds that it exceeded the statutory authority of Title III. They also stated that having to make such determinations would require expensive, detailed monitoring that most facilities do not do and would not be The major problem with applying a de minimis exemption to a toxic chemical produced as a result of use or disposal of another chemical is the difficulty of determining where and how to make a precentage determination. For example, required to do under section 313. Other commenters stated that, if such a determination were required, a de there may be various points in a treatment process at which a percentage determination could be taken. Also, minimis cut-off should apply, consistent with OSHA HCS requirements, to reduce the burden on the facility. EPA believes that the definition of those doing a better job of treatment could be unfairly penalized because such treatment may concentrate the chemical in waste prior to disposal. manufacture in section 313 includes the coincidental production of toxic Therefore, the conscientious facility may exceed the de minimis concentration of chemicals. Section 313(b)(1)(C) states the toxic chemical in a waste whereas that "(t)he term 'manufacture' means to another facility having much more dilute produce, prepare, import, or compound a waste would not be subject to reporting. toxic chemical." There is no limitation in Therefore. EPA believes that the this definition that would exclude manufacture of a toxic chemical coincidental to the production, estimation of a total annual mass quantity for such coincidental production during use or disposal is a processing/use. or disposal of another fair approach. chemical, nor is there any indication in In any case. EPA wishes to emphasize the legislative history of Title 111 that that the determination of such Congress intended to exclude toxic coincidental production should be based chemicals produced coincidentally. on the facility's existing production Accordingly, EPA believes that such records, monitoring, or analytical data. ABD00291780 Federal Register / Vol. 53, No. 30 / Tuesday, February 16. 1988 / Rulas and Relations 4505 and reasonable judgment on the part of (he facility's management. No further monitoring or analysis of production, process, use, or dispoul streams is required, consistent with section 313. 2. Import of toxic chemicals. Section 313(b)(1)(c) defines "manufacture'* to include import. Thus the owner or operator of a facility that manufactures or imports a toxic chemical is potentially subject to the reporting and supplier notification provisions of the final rule. If a toxic chemical is both manufactured and imported at a facility, the total amount manufactured and imported is aggregated for purposes of determining whether the reporting threshold for manufacturing has been met. Thus it is important for a facility to determine whether it is importing a toxic chemical, either in relatively pure form or as part of a mixture. The U.S. Customs Service defines an importer as a person who imports a chemical into the customs territory of the United States and includes the person primarily liable for the payment of any duties on the merchandise or an authorized agent acting on that person's behalf, the consignee, the importer of record, the actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20, and the transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with Subpart C of 19 CFR Part 144. Section 313 refers to a facility which manufactured (including imported) a toxic chemical. Section 313 does not define "import" or explain when a facility is considered to have imported a chemical. Given the broad Customs definition of who is an importer, several persons may be "importers" for any given shipment of a toxic chemical brought into the customs territory of the U.S. For example, a facility may conduct the entire import transaction using its own personnel in which case it would be the only importer. In other cases, facilities m3y act through import brokers or others who do the paperwork and pay the duties but provide for direct shipment of the chemical to the facility. EPA determined that for a given imported shipment of a toxic chemical, only one facility should be considered to have imported the shipment. Otherwise, there could be double counting of each shipment. Thus for purposes of the final rule. EPA has defined "import" to mean to cause a chemical to be imported into the customs territory of the U.S. For purposes of the definition of "import" EPA has defined "to cause" in a way which designates the person who in effect controls the importing of the chemical. Le. the person who intends manufacturer relationship as that it be imported and controls the "manufacturers" subject to the identity of the chemical and the amount requirements. However, for purposes of to be imported, not those who are merely involved in the transaction. Accordingly, through this definition, a facility which completes the entire import transaction for toxic chemical using its own personnel would be considered to have imported the chemical. Further, a facility that ordered the import of a toxic chemical through an import broker, specifying the identity, amount, and that it is to be imported, also would be considered to have imported the chemical. However, if a facility ordered a toxic chemical from a chemical supplier in the U.S., who in turn decided to import the chemical to fill the order or filled the order from a previously imported stock of the chemical, the chemical supplier's facility would be considered to have imported the toxic chemical. The facility which section 313 reporting. EPA interprets the definition of manufacture to apply only to a facility that actually produces a toxic chemical. Thus, in a toll manufacturer situation, the facility actually producing a toxic chemical would be subject to reporting, tf it produced more than the threshold for manufacturing. The other company's facility would be subject to the reporting for that chemical only if it also actually manufactured the chemical in excess of the manufacturing threshold, or if it processed or otherwise used the chemical in excess of an applicable threshold. EPA believes this interpretation is consistent with congressional intent to capture releases associated with manufacturing activities. ordered the chemical would not be considered to have imported the chemical because it did not control the amount to be imported or specify that it was to be imported. In most cases, determining whether a B. Clarifications Regarding Process and Otherwise Use: Exemption of Certain Uses EPA included the statutory definition of "process" in the proposed rule and facility caused the import of a toxic proposed a definition of "otherwise chemical will not be critical because a use." The statute does not specifically facility in SIC codes 20 through 39 which define "use" or "otherwise use" yet receives such a toxic chemical from an there are different reporting thresholds import shipment is also likely to process associated with manufacturing and or otherwise use the chemical. Since the processing activities versus the thresholds for manufacturing and "o'herwise using" of a listed toxic processing are the same and the use chemical. Therefore, the basic purpose threshold is lower than the of including a definition of "otherwise manufacturing threshold. EPA does not use" was to distinguish for the potential believe that defining "import" in this respondent what activities would be way will result in any facility escaping subject to the different thresholds. The the reporting requirements of the final proposed "otherwise use" definition was rule. In addition. EPA does not believe broad in scope, basically encompassing that facilities will evade supplier all uses of a chemical at a facility not notification requirements under this covered by the definitions of the terms approach. 3. Toil Manufacturers of Toxic Chemicals. EPA recognizes that it is a practice in the chemical industry for one company to contract with another company to produce a chemical exclusively for It. This may be done to use available production facilites, to take advantage of cheaper production techniques, or to avoid building additional plant capacity. The company initiating the activity typically retains control over the identity of the chemical, the amount to be produced, and the production technology. The company actually producing the chemical in these situations is often referred to ae a "toll manufacturer." Under TSCA, which authorizes EPA to apply certain requirements to persons who manufacture chemical substances and mixtures, EPA has sometimes treated both companies in a toll "manufacture" or "process." The preamble of the proposed rule contained one example of processing versus use of a chemical, and the proposed instructions for the form gave examples of manufacturing, processing, and use activities. Commenters from industry took issue with the proposed definition of otherwise use and requested further clarification of the differences between processing and use activities. Still other commenters recommended that certain uses be exempted from the final rule reporting requirements. 1.Clarification of the terms "process " and "otherwise use". In the public meetings, workshops, and in a preliminary question and answer document on section 313 issues. EPA has made the following basic distinction between processing and use activities. ABD00291781 4306 Federal Register / Vol. 53. No. 30 / Tuesday. February 16. 1988 / Rules and Regulations a. Processing is an incorporative activity. The process definition focuses on the incorporation of a chemical into a product that is distributed in commerce. This incorporation can involve reactions that convert the chemical, actions that change the form or physical state of the chemical, the blending or mixing of the chemical with other chemicals, the inclusion of the chemical in an article, or the repackaging of the chemical. Whatever the activity, a listed toxic chemical is processed if (after its manufacture) it is ultimately made part of some material or product distributed in commerce. Examples of the processing of chemicals include chemicals used as raw materials or intermediates in the manufacture of other chemicals, the formulation of mixtures or other products where the incorporation of the chemical imparts some desired property to the product (e g., a pigment, surfactant, or solvent), the preparation of a chemical for distribution in commerce in a desirable form, state, and/or quantity (i.e. repackaging), and incorporating the chemical into an article for industrial, trade, or consumer use. b. Otherwise use is a nonincorporative activity. EPA is interpreting otherwise using a covered toxic chemical to be activities that support, promote, or contribute to the facility's activities, where the chemical does not intentionally become part of a product distributed in commerce. Examples would be a chemical processing aid such as a catalyst, solvent, or reaction terminator. These chemicals may be integral parts of a reaction but do not become part of a product. Other examples would be manufacturing aids such as lubricants, refrigerants, or metalworking fluids, or chemicals used for other purposes at the facility such as cleaners, degreasers, or fuels. 2. Comments relating to EPA's interpretive distinction between process and use. One commenter disagreed with EPA's interpretation that a non* incorporative use of a solvent in chemical processing should be classified as otherwise using it. This commenter stated that the solvent can be integral to a reaction and that the solvent can be in the same equipment as other processed chemicals, with the same low probability of release. Another commenter stated that a catalyst should not be classified as a processing aid (i.c. otherwise used) because it participates in a reaction. EPA disagrees with these comments on the grounds that it is necessary and appropriate to distinguish processing from otherwise using based on the thrust cf the process definition (4) Use of products containing toxic (i.e.. whether the toxic chemical in chemicals for the purpose of maintaining question becomes part of some product motor vehicles operated by the facility, distributed m commerce). (5) Use of toxic chemicals present in Another commenter raised the process water and non-contact cooling example of a paint that is applied during the manufacture of automobiles. Certain toxic chemical components of the paint mixture would become part of the automobile and other toxic chemicals water as drawn from the environment or from municipal sources, or toxic chemicals present in air used either as compressed air or as part of combustion. (6) Use of articles. such as the solvents would evaporate as intended. Is the mixture processed, used, or both? EPA's interpretation is that the activity of each relevant component of the mixture would have to be evaluated. The solvents wfould be "used." Therefore, they would be subject to the 10.000 pound threshold. The other components of the mixture such as the pigments, would be "processed" because they are incorporated into the article. Therefore, those mixture components would be subject to reporting based on the process threshold. 3. Exemptions of certain uses. Several commenters stated that the proposed definition of otherwise use was too broad. They stated that without some limitations or exemptions the presence at the facility of a listed chemical in any form would have to be factored into threshold calculations. One example given was copper in copper pipes that are part of the facility. This can be interpreted as an ancillary use of copper. They claimed that such a situation would be unreasonable, would place an unnecessary reporting burden on many facilities, and would result in many meaningless reports. One commenter suggested that the otherwise use definition be modified to include the concept of "active" uses at the facility. Based on a review of the comments and questions received. EPA has determined that it is appropriate to place some limitations on the definition of "otherwise use." EPA has developed (8 372.38 of the rule) a listing of certain exempt uses of toxic chemicals as follows: (1) Use as a structural component of the facility. C. Full-Time Employee One commenter requested that EPA define what it means to have 10 or more full-time employees for compliance with section 313 reporting. The Bureau of the Census defines a full-time employee as a person working 35 hours or more per week, persons who worked 1 to 34 hours for non-economic reasons and usually work full-time, and persons with a job but not at work who usually work fulhtime. The Bureau of Labor Statistics has a very similar definition. Their definition does not include contract employees. The above two definitions are used in surveys conducted as of a particular week, not for an entire year. EPA considered two factors in the development of the employee threshold determination. First, the definition should reasonably apply to the annual basis of the reporting. Many facilities may have large seasonal variations in employment, and the standard must apply to those situations in an equitable manner. Second, facilities with large numbers of contract employees should not escape reporting because of different employment arrangements. EPA considered options for determining whether a facility meets the employee threshold as follows. First, full-time employee determinations could be made based on the highest number of full-time employees during any week of the calendar year. This method would ensure that facilities with highly variable employment patterns would be covered for reporting if they met the other requirements (SIC codes and chemical thresholds). Second, full-time employee counts could be determined by the number of employees as of a (2) Use of products for routine particular date during the year. Such an janitorial or facility grounds option would limit the burden of maintenance. Examples include use of checking through employment records, janitorial cleaning supplies, fertilizers, but is arbitrary with respect to the and pesticides similar in type or choice of a date. Third, the concentration to consumer products. determination could be based on the (3) Personal uses by employees or other persons at the facility of foods, concept of full time equivalents. A generally accepted level of annual full drugs, cosmetics, or other personal items time hours worked is 2.000 hours. The containing toxic chemicals, including number of payroll hours for the year supplies of such products within the would be divided by 2.000 to determine facility such as in a facility operated the equivalent number of full-time cafeteria, store, or infirmary. employees. Fourth, full-time employee ABD00291782 Federal Register / Vol. 53, No. 30 / Tuesday. February IQ. 1988 / Rules and Regulations 4307 counts could be determined by an average of tbe quarterly maximum number of full-time employees for the calendar year. This option would he the most burdensome to calculate. EPA decided to define full-time employee on the basis of a full-time equivalent calculation. Total annual hours worked by alt employees, including contract employees, at thn locility is divided by 2.000. In this way. a facility is able to make an easy determination of whether it equals or exceeds a 10 employee equivalent level by determining if the total hours worked at the facility equals or exceeds 20.000 hours. EPA believes that this approach provides a fair and consistent measure of employment. D. Definition ofArticle and Article Exemption These issues deal with the definition of article and whether articles should be explicitly exempt for the purposes of threshold determinations and release calculations. 1. Modification of the article definition. The definition of article that appeared in the proposed rule is the same definition used in regulations under TSCA. One commenter asserted that the definition of article that appears in the OSHA HCS should be substituted for the proposed article definition. The commenter contended that the OSHA article definition is more appropriate for section 313 because the language in the Utter part of the OSHA definition relates to the potential for release and exposure during normal end use. Also, it would be consistent with provisions of the Title 111 sections 311 and 312 rule (52 FR 38344). The instructions for the sections 311 and 312 reporting forms incorporate exemption language from the OSHA HCS. part of which is the exemption of articles. The article definition in the proposed rule read as follows: "Article'' meant a manufactured item which is formed to a specific shape or design during manufacture, which has end use f'jnrttonis) dependent in whole or in part upon its shape or design during end use. and h us either no change in chemical composition during if9 end use or only those changes of composition which have no commercial purpose separate from that of the article, or result mixtures or articles, except that fluids and particles are not considered article* r^gurdless of shape or design..The article definition in the OSHA HCS reads as follows: "Article" means a manufactured item: (i) Which is formed to a specific shape or design during manufacture: (ii) which has end use funnion(s) dependent in whole or in part upon its shape or design during end use: and |ui| winch does not release, or otherwise result in exposure to a hazardous chemical under normal conditions of use. The first part of each definition are identical. The latter parts of the definitions differ significantly. The commenter pointed out that the OSHA I ICS definition will function more appropriately because it will keep certain exposure-causing items from being considered articles whereas the proposed definition would not. The commenter also asserts that the exception at the end of the proposed definition for fluids and particles is unnecessary. In its review of this issue EPA considered several options, including retaining the article definition as proposed, retaining the proposed definition but clarifying the wording of the latter part, and adapting the OSHA I ICS article definition for use in this rule. EPA has determined that it agrees with the commenter and has adopted the OSHA HCS article definition with some modifications because it is more appropriate for section 313 purposes than the TSCA definition. The TSCA article definition is worded primarily to distinguish "chemical substances" and "mixtures" from those manufactured items that contain chemical substances and mixtures. The OSHA HCS definition was adapted from the TSCA regulatory definition, for the purpose of exempting certain items from the MSDS preparation requirements: the supposition being that the item's normal end use would not release or cause exposure to a "hazardous chemical" in the article. The revised article definition in the final rule reads as follows: "Article" means a manufactured item: (i) Which is formed to a specific shape or design during manufacture; (ii) which has end use functions dependent in whole or in pert upon its shape or design during end use: end (iii) which does not release a toxic chemical under normal conditions of processing or use uf that item at the facility. EPA wishes to emphasize that under this definition an item will not qualify as an article if there are releases of toxic chemicals from the normal use or processing of that item. When attempting to apply this definition to an item used or processed at a facility, the facility should keep this release factor in mind. For example, under normal conditions the milling of metals (e.g. copper) can generate fume or dust containing listed toxic chemicals. Thus, the metal or plastic item being processed would not qualify as an article in that manufacturing setting. However, if the only "release" from processing an item is the disposal of solid scrap (e.g.. pieces of cloth or sections of pipe that are recognizable as having the same form as the item) then EPA considers that the processed item still qualifies as an article. Toxic chemicals in an item that qualifies as an article are not subject to reporting even if the facility disposes of the article after use. For example, the facility uses a battery that contains lead. Lead is not released from the battery during normal use at the facility. When the facility disposes of the battery, it does not have to factor the amount of lead in that article into a threshold or release calculation. 2. Articles exemption. The proposed rule covered the processing and use of toxic chemicals and mixtures containing such toxic chemicals. EPA included a proposed definition of article but. as certain commenters pointed out. did not specifically exclude the use or processing of articles. Commenters encouraged EPA to specifically exempt the use and processing of articles from the threshold determination and release reporting requirements of the rule. According to these comments, the normal end uses of such articles by definition do not result in the release of toxic chemcials contained within such articles. Therefore, such an exemption will reduce the burden on industry significantly because fewer materials will have to be evaluated for threshold and release determinations. The purpose of including an article definition in the rule was for the expressed purpose of exempting such articles. The final rule contains a new exemption section {$ 372.38). This section exempts articles containing covered toxic chemicals as defined under section D above from threshold and release determinations. EPA cautions facilities to evaluate carefully norma) processing and use of an item to determine if release of a toxic chemical occurs (i.e.. if indeed the item qualifies under the definition as an article). V. Threshold Issues A. Comments Requesting Modification of Thresholds The thresholds for reporting that were presented in the proposed rule are the thresholds mandated by section 313. The threshold for manufacturing or processing a toxic chemical is 75.000 pounds for 1987. 50.000 pounds for 1388. and 25.000 pounds for 1989 and thereafter. The threshold for otherwise using a toxic chemical is 10.000 pounds for any year. EPA has the authority to modify these thresholds provided that such modification obtains reporting of a substantial majority of total releases of each toxic chemical for all facilities subject to reporting. ABD00291783 4508 Federal Regis ' / Vol. 53, No. 30 / Tuesday, February 16. 1988 / Rules and Regulations A wide range of commer: vas received regarding potentis modifications to the thresh^ds. Commenters from environmental and public interest groups asserted that thresholds shoud be lowered to increase release reporting. One commenter stated that a 10.000 pound threshold, over 3 years should be used rather than a graduated threshold. Commenters representing the industry asserted that thresholds could be raised without affecting data quality or reporting requirements. Other related comments stated that thresholds should be modified to include only larger facilities and that the ''user" threshold should be raised to the same level as thresholds for the manufacturing or processing of a toxic substance. Additionally, one company commented that the determination of a need to modify thresholds should be based on the first few years' reporting levels. Comments from a professional society and a State government indicated that the proposed thresholds are valid and should not be raised. Additional comments presented alternatives to the type of thresholds presented in the proposal. Two commenters indicated that toxic effects could be used to determine threshold adjustments. One commenter recommended a different series of thresholds based on standard container sizes to make threshold determinations easier. Another commenter proposed that the statutory employee size limitation of 10 or fewer employees be removed rather than reducing threshold, amounts for reporting purposes. One commenter proposed an emissionsbased approach to exclude small releases of toxic chemicals, regardless of the quantity manufactured, processed, or used. The final rule contains the statutory thresholds present in the proposed rule. EPA does not believe that it has received in the comments sufficient data to support any overall modification of the sta tutory thresholds. In addition. EPA did not propose any such change. EPA agrees with comments to the effect that the first few years' data should be evaluated to determine whether modifications of the threshold would meet the statutory test of obtaining reporting on a substantial majority of the releases (i.e.. pounds released per year) of each chemical from subject facilities. EPA may consider changing the reporting thresholds based on several years of data collection. Revising the threshold amount can be based on specific chemicals, classes of chemicals, or categories of facilities. EPA may consider a number of factors for threshold modification including exposure factors such as population density, the distance of population from covered facilities, and the types of releases. Threshold modifications could also take into account the relative potency of the chemical or class of chemicals and the effects of concern. Another type of threshold modification the Agency will investigate relates to the type of facility, either generally by size or by type of industry. B. Threshold Determination Issues Several issues arose as a result of comment on EPA's proposed approaches to determining whether a facility has exceeded a threshold. 1. Recycle and reuse. EPA proposed that a threshold determination in connection with on-site recycle and reuse activities be calculated by determining the amount of the toxic chemical in the recycle/reuse operation at the beginning of the year and add to that any quantity of the chemical brought on site. Commenters reacted to this proposal with the following: a. The threshold should be based on the amount of the chemical "acted upon." This would include the operating capacity of the recycle activity plus only the amount added during the year, not the total quantity brought on site. b. The amount calculated for the purpose of threshold determinations should only be the quantity added to or actually consumed by the recycle operations. c. EPA should clarify that the threshold amount recycled should not count a pound of chemical more than once as it cycles through the activity. After a review of the comments. EPA has determined that the threshold determinations should be based on the amount of the material added to a recyde/reuse system during the reporting year. TTiis would fairly depict the amount of a chemical "consumed" during a year in connection with this particular use. During start-up of such a recycle/reuse operation or in the event that the contents of the whole recycle system had to be replaced, this total system quantity would have to be factored into the facility's threshold determination for that chemical. EPA believes that this approach is consistent with the objectives of encouraging recycle/reuse activities. 2. Amount brought on site versus amount processed or used. The previous issue points toward a more general problem of distinguishing whether the threshold must be calculated based on the amount of a chemical brought on site during the year or the amount actually processed or used. One commenter cited a situation in which a facility may have a running inventory of over 10.000 pounds of toluene but actually uses only 9.000 pounds during the year. Provided that this is the only use of toluene, the commenters contended that the threshold for use has not been met. EPA agrees with this comment. The final rule provides that the threshold for processing and use is based upon the total amount actually used or processed at the facility, not the total amount brought to the facility during the year. This would not apply, however, in cases where importation contributes to a calculation of whether the facility exceeds a "manufacture" threshold. The act of importing the chemical to the facility is within the definition of manufacture. Therefore, any quantity brought on site due to importation has to be counted along with any amount of the same chemical produced at that facility. However when a facility does exceed a threshold, any emissions from amounts of the chemical in the running inventory (i.e. storage) would have to be factored into the emissions calculations. 3. Exceeding any threshold captures the facility for all releases of that chemical. A commenter objected to the interpretation that if a facility exceeds any threshold for a listed chemical, it must report all emissions of that chemical from the facility. The commenter claims that reporting should be limited to the activity that triggers the threshold to be consistent with Congressional intent because Congress set such thresholds to limit the burden on industry and provide the public with useful and manageable information. EPA disagrees with this comment. Congress indicated that section 313 should cover releases from the facility to all environmental media. The thresholds are provided as the means for determining facility coverage, not as a factor in determining which emissions from the facility must be reported. VI. Mixtures and Trade Name Products The proposed rule indicated that mixtures and trade name products that a facility imports, processes, or uses would be evaluated and any covered toxic chemicals in those products would be factored into threshold determinations and release reporting. However, EPA recognizes that facilities may not always have full information regarding mixture components. EPA provided detailed guidance in the preamble of the proposed rule for making a reasonable determination of what is "known to be present at the facility" with respect to determining the ABD00291784 Federal Register / Vol. 53. No. X / Tuesday. February 16. 1988 / Rules end Regulations 4509 presence and composition of covered toxic chemicals is nixbest ai the facility. The proposed instructions for the form also ostltaed a method for factoring mixtures into the threshold determinations, la addition, the proposal presented EPA's belief that suppliers of mixtures and trade name prodads hare a responsibility to provide their customers with iaformatioo seffccienl for them to comply with the requirements of section 313. EPA requested comment on several options for a supplier notification requirement in connection with, or in lieu of. a user determination requirement EPA received a -wide range of comment on the mixture issue. A. De Minimis Concentration Limit A predominant ana of comment was the request for some type of de minimis concentration limitation for listed toxic chemicals m mixtures. Commenters argued that many mixtures or trade name products may contain "trace* quantities of section 313 chemicals. They asserted that it would.be both unreasonable and extremely burdensome for processors and users of such products to have to account for these quantities in developing threshold determinations. In addition, commenters asserted that it would be equally as burdensome for suppliers of these products to have to determine and disclose small percentages of section 313 chemicals in their products beyond that currently required under the OSHA HCS. Most commenters suggested that EPA adopt a de minimis concentration limitation consistent with the OSHA HCS requirement. The HCS provides that a supplier does not have to list a "hazardous chemical" component in a mixture if that chemical comprises lees Mian 1 percent of the mixture or 0.1 percent where the chemical is a carcinogen (as defined m the HCS). Other commenters suggested de minimis levels ranging from 2 percent to 10 percent. Other related ooocept* would exempt from consideration solutions containing greater than 75 percent arater r would estabtishd^iiuaimfsrdeaae standards. Based on the comments received. EPA has determined that it la reasonable and appropriate to adopt a deminimis concentratioa limitation for toxic chemicals in mixtures under section 313. EPA believes that it ts necessary to provide a de minimis limitation to help reduce the information development burden both on the pari of the oaer and the supplier of such products. For the final rule EPA has adopted a de aimmit limitation of 1 percent, oral percent in the case of an OSHA HCS defined carcinogen. EPA believes that the de minimis level chosen is appropriate for two reasons. First, it is omsisteai with existing OSHA HCS requiremen's for development afMSDS information and with other requirements under sections 311 and 312 of Title 1IL Suppliers of products are familiar with these levels and. at least for the first two yearn of reporting, users of these mixtures are only likely to be able to rely on the product MSDS for information abont the content and percentage composition of covered toxic chemicals in these products. Seoond. EPA does not expect that the processing and use of mixtures containing less than the de minimis concentration would, in most instances, contribute significantly to the threshold determinations or releases of listed toxic chemicals from any givei facihty. Therefore, any listed toxic chemical that is present ia a mixture below these de minimis concentrations does not have to be factored into threshold or release determinations by the facility. This exemption applies to ail mixtures or trade name products imported, processed, or otherwise used at the facility. EPA defined "mixture" in the final rule to cover combinations of chemicals that are mixed together, as well as relatively pure chemicals which have impurities present. Thus, if a toxic chemical were present as an impurity with another chemical at a level lea than I percent or 0.1 percent in the case of a carcinogen, the de minimis exemption would apply, and the person processing or using the toxic chemical impurity would aot be required to count the quantity present as an impurity toward the threshold determination. They would also not be required so consider that quantity when determining releases to the environment. The de minimis exemption applies only to die presence of the toxic chemical in the mixture. If a person formulates a mixture by mixing various chemicals together, including a toxic chemical, the person is a processor of the toxic chemical. The person exist consider the quantity of the toxic chemical added to the mixture, both for threshold determinations and release reporting, including releases from the formulation activity. However, aucha person would not be required to consider releases of the toxic chemical resulting from its presence in the mixture at less than 1 percent or 0.1 percent as appropriate. If a person manufactures a chemical and in the process creates a toxic chemical impurity present at less than 1 percent or 0.1 percent, as appropriate. the person is trot required to consider the amount of the toxic chemical so manufactured for threshold determinations or release reporting (provided that the impurity is not separated from the commercial product). EPA plans to revimw this de minimis policy end the assumptions upon which it is based in light of data that will be collected under this rule. B. User Determination Versus Supplier Notification As stated m the introduction to this unit. EPA proposed a detailed approach for users to make a reasonable determination of the presence of section 313 chemicals in products they use. In response to the proposed approach, one commenter stated that the standard in the statute is "known to be present at the facility" and asserted that a facility has no affirmative obligation to seek information where there is no apparent information about a section 313 chemical in a mixture beyond such readily available sources as die MSDS for that prodect Others commented on the options in the proposed rule preamble for suppliers to notify customers or EPA about the presence and percent composition of covered toxic chemicals is their products. A number of commenters stated that a supplier should be required to notify its customers about the presence and composition of listed toxic chemicals in the product. From an overall burden standpoint, these commenters stated that there are naturally fewer suppliers than users. Without a supplier notification provision, user* would have to contact each of their suppliers each year. These commenters stated that a supplier notification requirement would ultimately place less burden on the suppliers themselves because their staffs would not have to be constantly responding to user requests. Also, most suppliers could "piggyback" such notice with the OSHA HCS required MSDS for the product and thereby not incur a significant additional burden. Other commenters agreed with the supplier notification concept but preferred that EPA allow a voluntary customer/ supplier interaction, not require such notification as part of the rule. Other commenters stated that EPA does not have the authority under section 313 to require this type of notification nor would it be appropriate to invoke the general rulemaking authority under section 328 ofTitie UI to authorize such requirement. Other comments addressed trade secret related implications of e supplier ABD00291785 4510 Federal Register / Vol. 53. No. 30 / Tuesday. ;v-b~-iry 16. 1986 / Rules and Regulations notification requirement as follows: The OSHA HCS allows mixture component identities to be claimed trade secret. In addition, the firm is not required to supply percentage composition data on the MSDS. Some firms do provide composition data voluntarily in the form of a specific percentage, a range, or some upper bound. A supplier requirement may conflict with the MSDS requirements because some composition information will have to be disclosed. In addition, the criteria for claiming and substantiating the protection of specific chemical identity is more stringent under Title 111 than it is under the OSHA HCS requirements. 1. Supplier notification requirement. EPA has carefully considered the implications of a detailed user determination requirement versus a supplier notification requirement EPA has determined that the most effective and least burdensome approach is a supplier notification requirement. EPA agrees with comments that a supplier notification system provides the most efficient means of moving the information about the presence and composition of listed toxic chemicals into the hands of the facilities that must report. Providing more complete information about mixture composition in particular will give the facility the information it needs to make threshold and release determinations. Under the Anal rule persons who must develop and distribute the notice are those who own or operate facilities in SIC codes 20 through 39 that manufacture or process listed toxic chemicals, and who distribute products containing such toxic chemicals to facilities in SIC codes 20 through 39. or to others who in turn distribute them to such facilities. Therefore the types of products covered by these notices are products that will be further processed or used by facilities potentially required to report. Notices are not required for products sold for individual consumer use. Exemptions similar to those found in the OSHA HCS and rule implementing sections 311 and 312 of Title III are incorporated into this supplier notification provision. The supplier notification requirement in S 372.4$ is structured to give processors and users of mixtures and trade name products positive information about the presence of listed toxic chemicals as follows: a. If listed toxic chemicals are present in the mixture or trade name product above the de minimis cut-off level, the notice must identify those specific components as they appear in the list of toxic chemicals in f 372.65 of the rule and provide their percen' composition in minimis concentration limit which was the product. present previously but unknown, the b. If the supplier maintains that the supplier must modify the notification identity of a toxic chemical is a trade within 30 days and provide the revised secret under provisions of the OSHA notice with the first shipment after that HCS. the notice must identify the 30 day period to each recipient: this chemcial as subject to section 313 and notice must identify prior shipments in provide a generic identity that is that calendar year to which it also structurally descriptive of the chemical. applies. c. If the supplier contends that specific 2. Phase-in of the supplier notification composition information for a toxic requirement. One commenter suggested chemical in a mixture or trade name that if mixtures are to be factored into product represents a trade secret the the reporting of listed chemicals that supplier must provide a maximum such requirement be phased-in over a l- concentration level of that chemical in or 2-year period. According to the the mixture or product. For example, the commenters. such a phase-in approach notice would indicate that toluene would allow time for both suppliers and constitutes not more than 15 percent of users to gear-up for mixture the product. The supplier must choose a determinations. level that is only large enough to EPA does not agree that mixtures in effectively mask the relevant trade total should be excluded for the 1987 secret associated with the chemical reporting year. Mixtures make up a large component A basis for the level chosen part of potential use of listed toxic must be placed in the supplier's records chemicals. Therefore, importers, pertaining to this notice. This maximum processors, and users of mixtures must concentration level is critical to users of use the best available information at the mixture because they will be using it hand to determine whether the as part of their threshold and release components of a mixture have to be determinations. Gross over factored into threshold and release representations of such maximum determinations under this rule. concentrations in a mixture may result However, the concept of a phase-in in unnecessary reporting by that for the related supplier notification customer or overestimation of releases requirement does have merit. In ?A's of the chemical from the customer's opinion, it would be both unreasonable facility. and impractical for suppliers to develop The notice must be in writing and modifications to their MSDS or develop must clearly indicate that it pertains to additional notices and distribute such the presence of chemicals covered by notices in 1988. Therefore, the supplier section 313 of SARA Title IQ. If a MSDS notification requirement does not take must be distributed with the product. effect until the first shipment of a EPA requires that the notification be product in 1989. However, as a practical attached to the MSDS and that it clearly matter, suppliers should begin as soon indicate that the notice is not to be as possible to develop the notice detached from the MSDS. relevant to those products that contain litis requirement is included because covered toxic chemicals. Until the the Agency is concerned about the supplier notification goes into effect notification process breaking down users and processors of mixtures are when distributors not covered by this only required to use readily available rule are handling and redistributing the data regarding such mixtures. products. The OSHA HCS requires such 3. Making threshold determinations distributors to pass along an MSDS for a and reporting for toxic chemical product. Therefore. EPA determined that components of a mixture or trade name the most efficient and least burdensome product. Until the supplier notification approach of assuring that the notice under this rule begins. EPA assumes that would reach the intended recipient is to some suppliers have provided or will require that it be attached to or provide information to customers about incorporated into the MSDS. the presence of toxic chemicals in their The notice must be provided with at mixtures or trade name products. The least the first shipment of the product to information provided is likely to vary each recipient during the calendar year. from specifically identifying a toxic When the supplier changes the formulation of the product to affect the chemical and its concentration to advising only that there is a section 313 composition of the toxic chemical in the product a revised notice must be sent with the first shipment of the changed toxic chemical present but providing no chemical identity or concentration information. product to each recipient If the supplier Once supplier notification begins determines that the product contains a under the rule, most customers will at section 313 chemical in excess of the de least be told that a toxic chemical is ABD00291786 Federal Register / VoL 53, No. 30 / Tuesday, February 16, 1988 / Rules and Regulations 4511 present, its generic chemical identity, and its upper bound concentration in the mixture or trade name product However, even after supplier notification begins, customers may receive such mixtures or trade name products from persons not in SIC codes 20 through 39 or from foreign suppliers. Neither of these suppliers would be subject to the supplier notification requirements. Therefore, customers might receive less information about toxic chemicals in such mixtures and products. Accordingly. EPA has included in the Goal rule and instructions detailed provisions for reporting by owners and operators of covered facilities who import, process, or otherwise use toxic chemicals as part of mixtures or trade name products. All reporting by persons who import, process, or use mixtures or trade name products containing toxic chemicals is predicated on those persons knowing that toxic chemicals are present in the mixture or trade name product If such a person receives a mixture or trade name product, the person must determine whether it meets an applicable reporting threshold in either of the following situations: (i)The person was told, or had determined through chemical analysis or otherwise, the specific identity or CAS Registry Number of a chemical in the mixture or trade name product and that chemical appears in 5 372.65 of the role: or fii) the person was told that the mixture or trade name product contains a toxic chemical subject to section 313. If either of these situations applies, the person is not required to inquire further about the mixture or trade name product. Section 313 and the final rule do not impose any obligation to test a mixture or trade name product to determine whether it contains a toxic chemical. However, if a person has tested such a mixture or trade name product for its own reasons, it must consider the results in determining whether to report. The final rule identifies six scenarios for persona making reporting determinations for taxic chemicals in mixtures or trade name products: 1. The person knows the specific chemical identity of the toxic chemical in the mixture or trade name product, and a. The person know its specific concentration in the mixture or prodoct; b. The person knows only its upper bound concentration in the mixture or product or c. The person has no m/oiraation about its concentration in the mixture or product 2. The person does not know the spedfic chemical identity of the toxic chemical in the mixture or trade name product, and a. The person knows its specific concentration in the mixture or product; b. The person knows only its upper bound concentration in the mixture or product: or c. The person has no information about its concentration in the mfxture or product. When the person knows the specific chemical identity of the toxic chemical in the mixture or trade name product, making the threshold determination will involve combining the amount of the chemical in that mixture or product with amounts of the same chemical also manufactured, processed, or otherwise used at the facility. However, the person 19 only required to consider the weight of the toxic chemical in the mixture or trade name product, not the total weight of the mixture or trade name product. Determining the weight of the toxic chemical in the mixture or trade name product depends on the information the person has about the percentage composition of the chemical in the mixture or product. If the person knows the specific concentration, determining the weight of the chemical is straightforward. However. If the person knows only the upper bound concentration, the person is required to assume that the toxic chemical is present at that concentration and calculate the weight accordingly. In the event that the person does not know the specific concentration or the upper bound concentration then the person is not required to further estimate or otherwise factor that chemical in that mixture or product into threshold or release calculations. Where the person does not know the specific chemical identity of the toxic chemical in the mixture or trade name product, the person is required oaly to consider the quantity of that chemical component in that mixture or product in making a threshold determination. Since the person does not know the specific identity of the chemical, the person cannot combine the weight of the chemical in the mixture with any other toxic chemicals manufactured, processed, or otherwise used at the facility because the person cannot determine that they are the same chemical Accordingly, the threshold determinations and the reporting, if any. will be specific to the toxic chemical in the mixture or product Determining the weight of the toxic chemical m the mixture or product in this case is the same as for determining the weight when the specific chemical identity is known. Determining the weight of the toxic chemical in the mixture or product in this case is the same at for determining the weight when the specific chemical identity is known. Once the applicable thresh. Id is met. reporting the chemical identity varies with the degree of knowledge. If the specific identity is known, the person must report the identity and CAS Registry Number, if any. in Part HI. Section 1 of Form R. If only a generic chemical name is known, that name must be reported in Part ill. Section 2 of Form R. If no generic name is known, the trade name or other name applied to the chemical, or to the mixture or product of which it ts a component, must be reported in Part Ul. Section 2 of Form R. With respect to estimating releases, such estimates must be based on the concentration of the toxic chemical in the mixture or trade name product. VII. Fora Spedfic Issues A. Certification Statement Section 313 requires that a senior management official siyi a certification statement for submitted forma. The proposed statement would have required that the pereem certify that the submitted information is true, accurate, and complete based upon his or her personal examination of the completed forms. The Agency received several comments on certification relating to three issues: (1) The definition of a senior management official. 12] the requirement that the certifier has "personally examined and is familiar with" the submitted information, and (3) the requirement that the company must certify that the submitted information is true, accurate, and complete. l. Senior management official. Section 313(g)(1)(B) defines a senior management official as "a senior official with management responsibility for the person or persons completing the report." In the preamble to the proposed rule. EPA stated that a senior management official could be an officer of a company, a facility manager (rather than a corporate officer), or the manager of environmental programs (for the facility or for the corporation) responsible for certifying similar reports under other environmental regulatory requirements. Commenters were concerned that neither definition appeared in EPA's regulations or in the instructions to the proposed fora. Also, commenters wanted to maintain flexibility of having either e facility management officer or ABD00291787 4512 Federal Register / Vol. 53, No. 30 / Tuesday, February 16, 1966 / Rules and Regulations corporate manager sign the certification statement by allowing signature by a manager of the persons preparing the report or by the manager of environmental programs for either the facility or the corporation. The Agency has added a definition of senior management official to $ 372.3 of the rule. The definition gives facilities appropriate flexibility in determining who may sign the form while retaining the emphasis that the person have management responsibility over the persons preparing the form. 2. Review ofprepared form. The proposed rule required that the person certify that "I have personally examined and am familiar with the information * * Commenters stated that this statement was too stringent because it would require that the senior management official duplicate all the calculations performed in the preparation of the form. A few commenters suggested that EPA adopt the certification statement used in the National Pollutant Discharge Elimination System (NPDES) regulations. Those regulations require a certification that the information was prepared under a system designed to assure that qualified personnel property gathered and evaluated the information submitted, and that the certifying official has queried those persons responsible for the system. Commenters noted that the NPDES certification has already received full notice and comment and has been tested in court. However, the conference report states that "(tjhe purpose of the certification requirement is to assure that a senior management official reviews the report for accuracy and completeness." The Agency believes that the NPDES certification, because it does not require the certifying official to review the form, does not meet the intent of Congress. However, the proposed certification statement could be interpreted to require more than a view of the submitted information. Therefore, the certification statement was modified and now requires a review by the official, which EPA believes fulfills the intent of Congress. 3. Submissions that are "true, accurate, and complete. ''TTie proposed certification statement would have required the certifying official to state that the submitted information is true, accurate, and complete. Commenters objected to this statement, stating that it is unreasonable because much of the information, particularly release estimates, can be subject to considerable uncertainty. They point to section 313(g)(2). which allows facilities to use available data collected under other provisions of law or to provide "reasonable estimates of the amounts involved." Because estimates are allowed, these commenters stated that "accuracy" must be set in context of the estimating procedures used. Commenters further noted that a facility may choose to use emissions factors developed by EPA for the purposes of reporting, even though the facility does not believe the estimates are accurate. Commenters suggested a variety of changes to the certification statement to correct the problem. Several commenters suggested that the burden of the accuracy of reports be placed on the Agency's.instructions to the form. Another proposed approach would provide a certification that the information is "substantially accurate and complete." The Agency has decided to modify the certification statement to tie the concept of accuracy with reasonable estimates of amounts and values reported. Such estimates must be based on the information available to the preparer of the report. This revision addresses the commenters' concerns and sets accuracy of reporting within the context set forth by Congress. The revised certification statement reads as follows: "I hereby certify that I have reviewed the attached documents and. to the best of my knowledge and belief, that the submitted information is true and complete and that the amounts and values in this report report are accurate based on reasonable estimates using data available to the preparers of this report." B. Facility Identification 1. Technical contact, addition ofa public contact. In the proposed rule EPA asked for a technical contact to be listed. The primary purpose for including a technical contact on the proposed form was to allow EPA to follow up reporting with questions pertaining to the completeness and technical integrity of the data. Commenters stated that only EPA or State officials should be designated to contact the "technical contact" of a facility. In addition, commenters recommended that they be allowed to provide a public contact different from the technical contact. EPA has done two things regarding the technical contact. First, for clarification, it should be noted that the technical contact does not have to work at the geographic location for which the report is submitted. The technical contact can be: (a) Someone at the facility: (b) someone at the same company, but at a different location: or. (c) a consultant. The name and telephone number of the technical contact must be provided on the form. The technical contact information will not be included in the public data base. Second, in addition to the technical contact. EPA is requiring facilities to provide the name and telephone number of a public contact for the facility. The public contact may be the same as the technical contact, or someone different. EPA added a public contact to provide firms within the flexibility of designating types of personnel most appropriate to the task of handling technical inquiries about the submission versus general information inquiries from the public. The public contact information will be included in the public data base. 2. Latitude/longitude. EPA did not propose to require companies to submit the latitude and longitude of their facilities in the proposed form. Several commenters expressed great interest in having this data included as a facility identifier. The primary reason for asking for this information is its importance for geographic information systems. These computer-based systems enable EPA and other ogranizations to model exposures resulting from chemical releases and produce graphic representations of such exposures. In addition, these coordinates help to verify the location of facilities and will help EPA and other users of the section 313 data base interface with other data bases containing such geographic coordinates. Therefore. EPA has added latitude and longitude as a reporting element for identifying the facility. However. EPA is adopting a phase-in approach for providing this data. For reports due by July 1.1986 (covering 1987). EPA is requiring firms that have the information readily available to report it. For example, certain environmental permits held by a facility may already contain this information. Also, county property records or facility plans or blueprints may show the latitude and longitude coordinates. Latitude and longitude information for all facilities is required on the forms due by )uly 1.1969 (covering the 1988 calendar year). EPA believes that the approach adopted serves two basic purposes: (1) Latitude and longitude information is provided, which is important to geographic information systems: and (2) there is a low burden of developing the data. 3. EPA l.D. Number. NPDES permit, and receiving streams. In the proposed rule, EPA provided a single line each for listing the EPA Identification Number (the identification number assigned to a facility in connection with hazardous waste generation and disposal activities under the Resource Conservation and ABD00291788 Federal Register / Vol. 53, No. 30 / Tuesday, February 16. 1968 / Rules and Regulations 4513 Recovery Act (RCRA)). the NPDES permit numbers, eod the receiving stream or body of water for the facility. Commenters pointed out that some multi-establishment facilities can have more than one of these identifiers or permits, or may discharge a reported toxic chemical into two or more streams or bodies or water. Therefore, the Agency has provide additional lines on the form for these reporting elements. C. Releases to the Environment 1. Total reiecse. EPA proposed that reporting und>>r section 313 account for the total amount of toxic chemicals entering each environmental medium from the facility. EPA based this interpretation on the statutory provisions. The definition of "releases" contained in section 329 of Title III covers all types of releases, both intentional as well as unintentional. Section 313 requires reporting of "the annual quantity of the toxic chemical entering each environmental medium" This led EPA to ask for information on total releases from the facility. Commenters cited the conference report to support their claim that Congress did not intend for facilities to include accidential or unintentional type of releases in the quantities reported under section 313. In discussing section 313 the conference report begins by saying that: This section establishes requirement* for annual reporting on releases of certain toxic chemicals to the environment. This reporting covers r-leases that occur as a result of normal business operations, as distinct from abnormal, emergency releases which must be reported under section 304. Thus, commenters would argue, the statutory definition of release is modified by the conference report. EPA believes that the above-quoted conference report language was provided for the purpose of clarifying differences betw een the basic types of reporting that occur under section 313 versus section 304 of Title III. A section 313 report is an annual report involving annual aggregate estimates of releases to all environmental media. A report under section 304 is an emergency notification. EPA does not find language in section 313 or any other conference report language that precludes the quantity of a toxic chemical released during an "abnormal, emergency release" from being included in the total annual amount reportable under section 313. One of the purposes of section 313 is assessment of cumulative exposure to toxic chemicals. EPA believes that die best way to accomplish this assessment is to include all releases of toxic chemicals over the reporting year release, facilities would indicate regardless of the mode of release. EPA whether the toxic chemical is also believes that most facilities will specifically cited in a permit by calculate their releases based on a total checking a "yes" or "no" box. The intent release concept. Therefore, it could be of the permit indication was to provide a more burdensome to require a facility to starting point for the public to obtain "back-out" the section 304 releases and relevant permit information on the other "accidential" type releases than to specific chemical released. It was also a just leave them as part of the total. Also, way of providing some kind of if the quantities of section 304 releases information on air permits without were excluded from '.be annual requiring facilities to list numerous air aggregate total, most data users would permit numbers. Most of the comments not have ready access to this additional on this issue were negative. There was data. This is because section 304 strong corccm that this check-box releases quantities will not be entered would be misleading and confusing to into a nationally accessible computer the public. Commenters asserted that a data base as will section 313 data. Thus "no" answer may lead the public to the public can do no automated enss- believe the release is unpermitted or matching of facilities in order to obtain "unallowed" and thereby imply that a this additional release data for exposure analysis purposes. Therefore. EPA is retaining its interpretation of total releases for the purpose of section 313 facility is in violation of the law. The permit indication also does not reveal how much of the release is covered by permits. Some commenters noted that reporting. 2. Removing the section 304 release indicator. EPA proposed that companies indicate by checking a box whether or not any part of the reported release was an accidental release reported under section 304 of Title III. Section 304 releases are certain accidental releases of specific chemicals listed under section 302 of Title 111 as well as section 103 of CERCLA (RQ chemicals). The purpose of asking about section 304 releases on the section 313 form was to provide the public with an additional means of obtaining information about total releases (both routine and accidental) of chemicals subject to reporting under section 313. Several commenters protested that asking for information about section 304 was not in keeping with congressional intent and created trade secret problems. Concerning trade secrets, commenters were concerned about linkages that t ould be made between the section 313 report and the section 304 report. Under section 304. companies are not allowed to claim chemical identity aa trade secret: under section 313, chemical identity is the only information element that can be claimed as a trade secret. The situation could arise where the release of a particular chemical reported under section 304 was the only release of that chemical during the calendar year. By checking the section 304 box on the section 313 form, commenters asserted that competitors could find the chemical identity by referring to the section 304 report. EPA believes that the section 304 check-box would create unnecessary reporting complications. Therefore. EPA has decided to delete the check-box. 3. Deletion of the permit indication. confusion is bound to result on the part of the reporting facilities as to when the permit indication should apply since most permits do not cite or limit releases by specific chemical. For example, most air permits apply to categories of chemicals, such as volatile organic compounds (VOCs) and particulates. In addition, many permits may limit the release of a chemical by specifying that a control device or particular type of treatment be employed. Therefore, many permitted releases would not be allowed to be checked under the proposed rule's approach. Certain commenters believed that EPA should broaden the permit indication to include most other types of permitted releases or drop it altogether. Because the permit indication has a high potential to provide misinformation to the public, EPA has decided not to include the permit check box in the final fom. EPA believes that it would inevitably lead to misunderstanding and confusion, not only on the part of the public, but also by the reporting community. EPA chose not to broaden the interpretation of which releases would be covered by a permit because this would no longer serve the original purpose of providing a link to chemicalspecific permit data. Additionally, it would be difficult in some situations to give a clear indication of when a permit actually controls the release of a specific chemical versus other components in the wastestream. EPA requires the listing of specific permit numbers in the facility identification part of the form. EPA believes that these permit numbers provide a useful link between the release information and any relevant permit data. 4. Accuracy ofreporting. EPA EPA proposed that for each aggregate proposed that the annual release dat ABD00291789 4514 Federal Register / Vol. 53, No. 30 / Tuesday. February 16. 1988 / Rules and Regulations be estimated as accurately as possible and that figures be rounded off to the nearest pound. Recognizing, however, the aggregate nature of the data and potential error in the estimates. EPA asked for comment on other reporting alternatives. EPA received comment on three proposed alternative reporting options. (1) Report in ranges. (2) Report to I to 2 significant figures. (3) Report to a specified degree of precision. Many commenters on this issue were in favor of either option 1 or 2, because they believed that the data will not be exact due to the error involved in measurements and estimates, and that these options would not misrepresent the accuracy of the data. Several commenters expressed concerns about the liabilities involved for verifying the accuracy of the data and the potential for public misperception of the data accuracy. Certain disadvantages of reporting in ranges were noted by some commenters. Use of ranges could misrepresent data accuracy because the low or high end range numbers may not really be that close to the estimated valye, even taking into account its inherent error. For example, a release of 11.000 pounds/ year with a 50 percent error could be misinterpreted as 100.000 pounds/year if reported as a range of 10.000 to 100.000 pounds/year. Reporting in ranges may not only misconstrue the data accuracy, it would also make analysis and use of the data more difficult according to these commenters. Because facilities are not required to do additional monitoring and are allowed to provide "reasonable estimates." it would be infeasible to dictate that they report to a specified degree of precision that cannot be attained given the range of error inherent in the estimates. Therefore. EPA is requiring that estimates of releases and transfers of toxic chemicals to off-site locations be expressed as a figure rounded to a degree of accuracy no greater than two significant digits. As noted in the discussion in Unit XV.B- EPA has adopted an optional range reporting concept for releases to an environmental medium of less than 1.000 pounds. Where the facility believes that it has no release in relation to a particular line item it could check a box for "0". If the release is estimated to be between 1 and 499 pounds, or 500 to 999 pounds, the facility has the option of checking a range box or entering a specific figure. For releases of 1.000 pounds or more the facility is required to provide a figure rounded to no more than two significant digits. This range reporting is for calendar years 1987. 1988. and 1989 only. 5. Peak release. Several commenters raised the issue of having the release data reported in terms of its frequency, duration, or peak value in addition to the annual release amounts. EPA did not discuss this issue in the proposed rule. Commenters from environmental and public interest groups stated that the annual release data may not give enough information to assess some risks accurately. Knowing how often and/or how long the releases occur, and the maximum (peak) amount of chemical released per day would allow a better evaluation of exposure and risk to the public according to these commenters. One commenter stated that the annual estimates may be appropriate for evaluating potential cancer risks but that hourly or daily emission estimates are useful for assessing risks for chemicals with acute effects, other short-term exposure effects, and environmental effects. Some industry commenters maintained that more detailed information about the frequency, duration, and peaks of releases will be difficult or impossible to provide. They stated that many facilities have numerous operations or processes involving a chemical. They claim that peak data would be misused and misinterpreted. They fear that users of the data would assume that such peaks occur every day. They also state that the annual data should be used as a screening tool and that further studies should then be undertaken to gather the information needed to fully characterize exposure. EPA considers the need for more detailed release information to be valid and considered the following options for possible inclusion in the final rule: (1) Days of release. (2) Indication of intermittent versus continuous release. (3) Peak data (maximum daily amount). (4) Days of operation. In reviewing the options. EPA considered how the data would be used in a screening for levels of risk with the currently used exposure models. Days of release is not currently used for modeling exposure in ambient air to carcinogens or chemicals with chronic (long-term) health effects. Current air dispersion models for these types of effects use the toUl annual release for estimating exposure. The number of days of release is used for estimating drinking water exposure for chemicals with non-carcinogenic health effects and environmental effects. EPA considered that facilities may have difficulty in providing the number of days per year over which the chemical is released into tiie environment. Facilities may not have this information available, especially fur the first year's reporting and may find it difficult to provide in some cases. Also this data may not be meaningful in cases of multiple releases of different magnitude and durations. Reporting whether the release is largely continuous or intermittent may be less burdensome for facilities to do. but it may not be as useful as other potential indicators. This is because it does not provide quantitative information needed for a risk assessment and may be meaningless for an aggregate release amount that is compiled for all releases from many types of processes or sources at one facility. Peak release data in the form of maximum daily amounts is useful fur analysis of risks from chemicals released to air or water with acute or chronic non-carcinogenic effects, and also for chemicals with environmental effects. Peak release data can be used to model the highest one-day acute exposure to human and environmental receptors on a worst-case basis to determine if a more detailed investigation is warranted. EPA is uncertain about possible difficulties that facilities may have in providing this datum, given that several release sources and several activities at the facility may contribute to a single daily release amount. It may not be possible to estimate the maximum daily release using some estimation techniques, such as overall mass balance or emission factors, which are available for estimating the annual release data. The number of days of operations invok ing the chemical may be easier for facilities to provide than other types of indicators. It could be used to estimate an average daily release using the annual data, but there are weaknesses for using this data in modeling because the releases may not actually occur during all the days of operation. EPA has not included an additional peak release type reporting element in the final rule. Such an additional reporting element would require a significant change to the form. The Agency believes that it will be necessary to further analyze the above options and to investigate additional options. In its analysis the Agency will determine what type of data is needed to better characterize exposure and risk, and determine how this data can best be reported by facilities. Because of the need for further analysis and input from ABD00291790 Federal Register / Vo). S3, No. 30 / Tuesday, February 16. 1986 / Rules end Regulations 4515 the public and regulated community. EPA plans to propose an amendment to this rule dealing with this issue within the second quarter of 1988. At that time. EPA will seek comment on this issue in order to develop (he most appropriate way of obtaining this data. 8. Disuggregalion of air emissions. EPA proposed that fugitive or non-point air emissions be reported separately from stack or point source air emissions. Facilities would include all emissions to air of a listed chemical and separate such omissions quantities into fugitive or stack type emissions. The instructions gave clarification as to how to differentiate between the two types of sources. EPA proposed to distinguish between these two source categories for two reasons. First, estimates of stack emissions are likely to be more accurate than estimates of fugitive emissions because stack emissions can be directly measured. Better overall information on air releases can be obtained if fugitive emissions are reported separately and the accuracy of the data on stack emissions is preserved. Second, separate reporting of fugitive and stack emissions will enable regulatory agencies and other users of the data to judge the relative significance of the two sources of releases. Many commenters thought EPA should not require this disaggregation. Two commenters agreed with the proposal while one commenter stated that the form should collect five categories of release on air emissions: Process fugitive, storage, transfer operations, and waste treatment emissions. Some commenters thought EPA should require only reporting of point source releases because fugitive emissions are too difficult to estimate accurately. EPA has retained the reporting of air emissions as proposed. This issue received much discussion and review before the rule was proposed and the reasons for not further disaggregating air emissions still remain the same. First, further disaggregation would not be consistent with EPA's approach of not requiring specific information on the sources of releases to minimize trade secret claims. Second, the burden on facilities would increase tremendously if further disaggregation were required. For example, a facility will be able to estimate an aggregate non-point a>r release using a mass balance approach, but it would be very difficult for it to further divide this amount into releases from transfer operations, leaks, and waste treatment emissions. Because the majority of measured data available will be on stack emissions, this is one mechanism available to facilities to monitoring data depending on when the distinguish between two type* of air permit was issued. Also, most permitted emissions. EPA believes that requiring stormwater releases are required to be disaggregation only into point and non monitored for conventional pollutants point source categories is the best such as biological oxygen demand balance of data usefulness and industry (BOO), total organic carbon (TOC), etc.. burden for this reporting requirement. rather than specific chemicals. 7. Releases to water--a. Therefore. EPA is requiring facilities Disaggregation of releases by receiving to indicate the stormwater contribution stream. For direct discharges, the issue to surface water releases only if the of how to report multiple receiving facility has monitoring data on the streams for one facility was raised by section 313 chemicals in such one commenter. The proposed form stormwater and a measurement or allowed only one line on page 1 of the estimate of flowrate. If so. the facility form to report a stream or body of water must enter the percent of the release that receives a facility's wastewater that is attributable to stormwater in Part flow. EPA has revised the form to allow III. Section 5.3C of the form. If the reporting of up to three receiving facility does not have periodic streams. These streams are to be measurements of the chemical releases numbered and the applicable stream but has submitted chcmical-specific numbers reported in connection with the monitoring data in its permit direct discharge release amount to that application, it should use these data as a stream. basis for its estimate. Flowrate data can b. Inclusion ofstormwater releases. either be data submitted in a permit HPA proposed that the total releases of application or measurements as required a chemical to surface waters include the by the permit (either periodic or contribution from stormwater if the continuous), or can be estimated by facility's permit included stormwater multiplying the annual rainfall times the sources. Given the potential difficulty in land area times the degree of estimating the contribution of imperviousness or by another stormwater to the total release of a appropriate method. chemic.il. EPA specifically asked for Appropriate responses to be entered comment on the inclusion of stormwater on the form include: (1) A numerical discharges and how these releases figure representing the percent should be estimated and reported. contribution to the total release. (2) "O'* Many commenters thought that EPA if die facility has monitored but not should not require reporting on release detected the chemical in stormwater in stormwater because it is very difficult discharges, and (3) "N/D" if the facility to estimate amounts of toxic chemicals has no monitoring information relative present and intermittent flowrates to the chemical in stormwater without monitoring and measurement. discharges. Without such information, it would be 8. Specific line for reporting virtually impossible to estimate these underground injection reiecse. One types of releases to any degree of commenter raised the issue of how accuracy. Several commenters pointed releases to groundwater are reported on out that EPA has not yet developed final the form. The commenter stated that stormwater regulations or guidelines EPA should break out reporting of direct under the Clean Water Act because of and indirect groundwater discharges as the technical problems involved. Two a category distinct from releases to land. commenters believed that facilities By looking at the form only, it is not should be required to include clear how and where facilities would stormwater releases to surface waters report releases via underground and publicly owned treatment works injection discharges. On the proposed (POTWs) and that these should be form, these releases were to be reported reported separately on the form. in ti e Release To Land section by Some facilities have submitted permit entering a disposal code for applications relative to stormwater underground injection next to the annual discharges. As a result of passage of the amount. To further clarify releases by Clean Water Act Amendments in nnderground injection of listed toxic February 1987, EPA is currently drafting chemicals. EPA has included a separate new stormwater regulations. Some sub-section in the Anal reporting form facilities may have stormwater entiled Underground Injection (Part (II. discharges permitted under NPDES Sec ion 5.4). industry subcategory effluent limitations 9. Basis of estimate. For each or through the discretion of the permit writer. Even if a facility's stormwater is aggtegnte release. EPA proposed to require an indication of the basis used covered by a permit, however, it may (0 account for the estimation of the not have any specific chemical largest portion of the release quantity. ABD00291791 4516 Federal Register / VoL 53. No. 30 / Tuesday, February 16. 1986 / Rules and Regulations The basis of estimates provided in the instructions were: (1) Based on monitored or measured data. (2) Based on mass balance calculations. (3) Based on published emission factors. (4) Based on other approaches (engineering judgment, etc.) Each method would be indicated on the form by the use of a code. The basis of estimate provides some indication of data quality and will identify situations in which monitoring data might be obtained in follow-up activities by EPA or the States. This indication would also allow EPA to identify facilities and industries that may be having difficulty estimating releases so that further guidance may be developed for them. Several commented thought that EPA should require more detailed information on how the releases were estimated, such as the percentage of the release for each method, the emission factors used, or a brief explanation for how other approaches were applied. Most of the commenters representing industry supported the use of the proposed basis of estimate. One commenter wanted clarification on whether indicating the use of emission factors applied only to the use of EPA emission factors. Requiring reporting of the emission factors could result in revealing production volume or throughput amount of the chemical: information that many companies consider trade secret. Also, requiring reporting of the specifics of the calculations used to develop the estimates would be similar to collecting information on each source of release, as opposed to the aggregate release. Such data could involve information on quantities of process streams, also often considered proprietary. EPA wishes to minimize trade secret claims so that most of the data on the specific chemicals will be available and useful to the public. Collecting this sort of detailed information would be more of a "mass balance" reporting approach, and EPA does not have the authority to collect mass balance information from facilities under section 313. Such ao approach will undergo study by the National Academy of Sciences as required by section 313(1) to determine the feasibility of its use for future toxic chemical release inventory reporting. The final rule requires the basis of estimation as proposed. Any reasonable emission factor may be used to estimate releases. It is not EPA's Intent that facilities be constrained or limited to the use of any one estimation method. The burden is on the facilities to provide the most accurate and "reasonable" estimate of releases, and they should use all available data and means to provide these estimates. The data or methods used must be documented in the facility's records and made available for review upon request by EPA inspectors. EPA will use the basis of estimate provided on the form as a tool to ascertain data quality, availability of information, and reporting problems for facilities. D. Off-Site Transport EPA proposed that facilities report the amount of the toxic chemical in waste transferred to the off-site treatment and disposal facilities (including POTWs). the name and address of the off-site location, whether the off-site location is under the control of the reporting facility, and the treatment/disposal methods used off site, if known. The rationale for inclusion of the off-site waste transfers was to complete the picture of chemical waste generated from a facility and enhance the public's understanding of the locations of toxic chemicals in their community. Off-site locations would also include waste brokers, storage facilities, privately or publicly owned wastewater treatment works, and off-site underground injection wells. Most industry commenters objected to the reporting of off-site waste transfers for several reasons. First, commenters stated that such information is not required by the statute, was not intended by Congress, and is duplicative because of RCRA reporting requirements for hazardous waste. The strongest objection, however, was that the off-site chemical, transfers do not constitute "a release into the environment" by the reporting facility and should not be reported as such on the form. Other comments focused on whether reporting of off-site treatment/disposal methods is required or not and how to report recycling and reuse of the chemical waste off-site. A few commenters suggested that EPA should require the EPA Identification Number of the off-site facility because these numbers would help provide a better identification of the off-site facility and would aid in access to related information in other data bases. EPA has interpreted the statute to require reporting on wastes sent off-site because the conference report states that reportable releases shell also include releases "to waste treatment and storage facilities." Also. EPA believes that reporting wastes sent off site is important because the absence of this information regarding the generation of chemical wastes by a facility could be misleading to the public. Many facilities transfer a significant portion of their chemical wastes to off-site locations. The information to be collected on off site waste transfers is different from that required under RCRA because this information is chemical-specific and makes no distinction between wastestreams which are hazardous and non-hazardous. This type of chemicalspecific information is not currently available to the public or EPA for many chemical wastes. Facilities are to report the amount of the listed toxic chemical in waste transferred off-site. Facilities are not to report the total amount of the waste containing the chemical. EPA has retained the requirement to report transfers of a chemical in waste to off-site locations. However. EPA has revised the form so that off-site transfers are distinguished from direct facility releases to the environment, because the disposal fate is not always known and the off-site treatment may reduce the amount of chemical ultimately released into the environment. The off-site transfers of chemicals are to be reported in a separate section (Part 111. Section 6) of the form. Reporting of treatment/ disposal methods is required only if this information is readily available to the reporting facility. Transfers to a reprocessor or recycler of chemical waste are not reportable as off-site transfers under the final rule. First, the material being sent is not bound for ultimate disposal. Second, these types of facilities may themselves be covered as manufacturers or processors of the chemical and. thus, would be accounting for any releases to the environment. EPA agrees with the comment that an EPA Identification Number should be included in connection with the name and address of off-site locations (to be reported in Part II. Section 2 of the form). If the chemical is part of a hazardous waste, this information element should be readily available from information that the facility must supply on the Uniform National Hazardous Waste Manifest Form. If the facility does not know the EPA Identification Number of this off-site location, it would enter N/A in this space on the form. E. Waste Treatment information 1. Wastestream and treatment methods. Section 313(g)(i)(c)(iii) states that facilities must report "for each wastestream. the waste treatment or ABD00291792 Federal Register / Vol. S3. No. 30 / Tuesday. February 16. 1988 / Rules and Regulations 4517 disposal method* employed, and an estimate 0/ the treatment efficiency typically achieved * * EPA proposed that a wastestream be considered as the aggregate wastes treated in a particular manner or the influent stream to a single treatment method. For example, aggregate waste going to secoodary wastewater treatment on site would be considered as a wastestream and reporting would not be required for each of the numerous waters from various process points that are combined for treatment. EPA proposed that the wastestream be characterized as gaseous emissions, wastewater. noo-aqueous liquid waste, and solid waste (includes sludge and slurries). In the proposed rule EPA also requested comment on a more detailed wastestream characterization approach. The example used would have required each individual wastestream containing the reported toxic chemical to be identified by an appropriate RCRA waste code. Where a wastestream did not have a RCRA waste code, other source codes would have to be developed. Commenters representing industry trade groups and individual companies supported EPA's proposed aggregate wastestream approach. Commenters representing environmental or public interest groups disagreed with the proposal and urged EPA to adopt a source-specific wastestream characterization system, such as requiring individual wastestreams to be identified by the RCRA codes. These commenters claimed that an aggregate wastestream approach would severely reduce the utility of (he data and that EPA will lose the ability to identify particularly efficient means of treatment. EPA has determined that it will retain the aggregate wastestream characterization approach as proposed. EPA was not convinced by comments received that a source-specific wastestream characterization would add materially to the data received or to understanding more about relative efficiencies of particular treatment methods applied to those wastestreams. EPA remains concerned that a very specific wastestream approach would add a significant degree of complexity to the form. It would also increase the burden associated with completing the form without a commensurate increase in benefits. For example, io larger facilities several different individually coded wastestreams. containing the same chemical may be sent to one type of treatment The form would have to provide for multiple entries for each of these wastestreams. Yet the type of treatment and the relative efficiency of removal of the chemical would be the same. There also remains the concern about disclosure of trade secret information if facilities were required to identify source-specific wastestreams. For example, many of the RCRA waste codes are themselves specific toxic chemicals as listed in section 313. If a facility can substantiate that the manufacture, processing, or use of a toxic chemical at their facility is a trade secret and they must then identify a treated wastestream as that same chemical, then trade secret protection is effectively negated. Furthermore, to the degree that process specific wastestream information could reveal sensitive process related trade secret information, companies that might otherwise not claim the chemical identity as a trade secret may have more reason to do so in order to protect the linkage to process detail This result would adversely affect the public's access to information. Finally, in many cases where more detailed wastestream information may be of use, such information would be of use only in conjunction with other detailed information, such as the characterization of the wastestream. It is EPA's belief that such detailed information is more appropriately gathered in followup activities after the reports under this rule have been screened to identify particular facilities or classes of facilities of greatest interest. EPA believes that the level of detail in the final form will satisfy the needs for such screening. EPA proposed a list of treatment codes in the instructions from which facilities could specify the treatment methods used for each wastestream. This list has been revised slightly to be more consistent with treatment methods and codes that will be used for future RCRA annual/biennial reporting. Such consistency will result in less confusion and burden for many facilities who will be reporting waste treatment information under two different EPA rules. Treatment methods are to be reported for all wastestreams containing reportable chemicals whether this treatment actually removes the specific chemical or not. 2. Treatment efficiency. EPA proposed that treatment efficiency, expressed as percent removal would represent any destruction, biological degradation, chemical reaction or conversion, or physical removal of the listed chemical in the wastestream being treated. A few commenters noted that some of the treatment methods, suds as encapsulation and fuel blending, could be reported as 100 percent efficient from the standpoint of protection of health and the environment. EPA proposed that these treatment methods be reported with a 0 percent efficiency because they do not remove the chemical by any of the previously mentioned mechanisms. For the final rule. EPA does not believe that "removal efficiency" should be stretched to include wastes rendered "safe." "harmless." or "non-toxic" to health and the environment without being removed from the wastestream because such determinations are abstract and subjective, and would result in inconsistent and confused reporting, and would be misleading to the public. Knowledge of the treatment method used should be sufficient to indicate to data users the mechanism of the "treatment" employed and how it works. Several commenters were confused about how to report the efficiency of neutralization processes because this type of treatment involves a change in pH and they believed that the concept of percent removal would not apply. Neutralization does involve a chemical reaction or conversion, such as an acid reacting with a base to form a salt or vice versa. Therefore, percent removal would apply to the percent of add (or base) in the wastestream that was reacted during treatment. Neutralization also involves pH adjustment because pH is just a measure of the acid or base concentration in the wastestream. A pH of 7 or above after neutralization would indicate 100 percent treatment effidency of an acidic influent wastestream while conversely, a post-treatment pH of 7 or below would indicate 100 percent efficiency for a basic influent wastestream. 3. Sequential treatment. In the proposed rule, the reporting form did not allow tracking of sequential treatment processes, and an efficiency was to be reported for each treatment method. Several commenters pointed out that for sequential treatments, an overall efficiency for the process would be more useful data than a separate efficiency for each treatment without an indication that they are part of a sequence. EPA also realizes that, in many cases, facilities may not know the individual treatment step efficiencies for a sequential process, but would have a good estimate of the efficiency of the overall treatment process. EPA has revised the waste treatment section of the form to allow the option of reporting sequential treatment methods and an overall treatment efficiency if the ABD00291793 4518 Federal Register / Vol. 53, No. 30 / Tuesday, February 16. 1988 / Rules and Regulations individual treatment step efficiencies are not known. The sequential treatment steps would be linked together by checking a box next to each step to indicate that it is part of a sequence. See Part III. Section 7. column D of the form. This revision will allow facilities to report more accurate and relevant (in the case of sequential treatment) data, will reduce their reporting burden, and will increase the usefulness and understanding of the treatment data reported. For sequential treatments, facilities are to list the individual treatment codes for the various steps in the process, report the influent concentration for the entire process by entering the code next to the first treatment step, and report the overall sequential treatment efficiency next to the last treatment step in the sequence. 4. Influent concentration. EPA proposed that facilities report the pre* treatment concentration of the chemical in the wastestreacn for each treatment method. Submitters would enter a code corresponding to one of five ranges of concentration. Each range covers 2 to 3 orders of magnitude, relieving facilities of the burden of having to report the exact concentration which may not be measured and may fluctuate. Influent concentration data will enhance die evaluation and comparison of waste treatment methods by helping users of the data determine the effectiveness of treatment methods for wastestreams containing different amounts of a given chemical. Most commenters on this issue stated that this information should not be required because it was not specified in the statute, but little comment was received on the burden or technical difficulties of supplying this data. EPA has retained the reporting of the influent concentration for each treatment method in the final rule. The influent concentration will aid in the evaluation of treatment methods used throughout industry by putting the treatment efficiency data into better perspective. This requirement should not significantly increase a facility's reporting burden because it can report the data in fairly broad ranges. For sequential treatments, the influent concentration will be required only for the firs* treatment step in the overall treatment sequence. F. Optional Reporting on Waste Minimization The proposed form included an optional section to allow the respondent to indicate any action taken in the past year (other than the waste treatment methods specified in Part 111. Section 8 of the form) to minimize the generation of waste related to the chemical being known carcinogens should be on the list. reported. This section was made Many other comments were made optional because the reporting of this suggesting specific chemical deletions type of information is not required in from the list of section 313 chemicals. section 313. However, the information EPA realizes that some of these that would be provided about waste recommendations may be valid. reduction is considered by EPA to be an However, the Agency chose not to use important indicator of how industry is this initial rulemaking as means to responding to the Agency's emphasis on modify the list of covered toxic better waste management through waste chemicals. EPA plans to begin an in- reduction. depth review of the list of chemicals In comments on the proposed rule, the currently subject to reporting and an regulated community stated that this evaluation of chemicals that should be request went beyond the scope of the added to the initial list beginning in the statute and that the Agency was not first quarter of 1988. The comments authorized to collect such information which the Agency has received will be under Title 111. Reporting on waste useful in helping the Agency develop its minimization puts an additional burden methodology for this list review. Any and cost on the regulated community. changes to the section 313 list of One commenter noted that if a facility chemicals that appear appropriate chooses not to report on waste based upon this review will be proposed minimization, readers of the report may for public comment. conclude that no emissioo reduction is in place at that facility. On the other B. Nomenclature band, public interest groups stated that 1. CAS preferred name versus information on waste minimization common trade name. The list of would be very useful to the public and chemicals mandated by section 313 requested that this reporting element be contained certain entries identified by made mandatory. trade names, not chemical names. For The Agency has decided to retain the example. Parathion is a trade name. The optional section on waste minimization. chemical name with the corresponding EPA has no coercive intent in requesting CAS registry number is Phosphoric acid. this optional information. On the 0.0-dimethyl-0-(4-nitrophenyl)ester. contrary. EPA believes that this section EPA stated in the proposed rule that will provide respondents with a positive reporting facilities should not have to way to demonstrate to the public the use a competitor's trade name for beneficial waste reduction activities reporting purposes and so. in the case of they have undertaken. EPA believes that a listed trade name, an alternative CAS the information provided by industry preferred name was offered in solid can indicate longer-term trends in waste brackets. The Agency intends to use the reduction activities. However, the CAS registry number as the unique Agency has attached a 3 year sunset to identifier for all chemicals except for the this optional section. EPA intends to 20 chemical categories. Therefore, study the benefits of this section and reporting facilities can use either the will review the potential overlap trade name or the CAS preferred name between this reporting question and that appears in 8 372.65 (a) and (b) of the reporting on waste minimization under rule as long as the corresponding CAS RCRA regulations. registry number appears on the form. The proposed optional reporting 2. Cyanide compounds. Although section also included spgce for cyanide compounds are described with providing a narrative description of waste minimization activities. The Agency has decided to drop the narrative space because it will be difficult for the computerized data base to accommodate such textual data. a CAS registry number, cyanide compounds are considered a chemical category as defined in 8 372.65(c) of the rule. The CAS registry number refers to the cyanide anion (CN--). which is not a discrete reportable chemical without a VIII. Chemical List Issues A. Modifications to the List counterion. Therefore the CAS registry number listing for cyanide compounds in 8 372.65 (a) and (b) of the rule has been EPA received many comments removed. suggesting modifications to the list of 3. Metal and metal compounds. The chemicals subject to section 313 original committee print of the list of reporting. Among these comments were chemicals subject to reporting under suggested additions to the list section 313 listed metals and their corresponding to other regulated compounds with the CAS registry chemicals such as the 47 toxic pollutants number which corresponded to the regulated under the Clean Water Act. metal only. In its proposal. EPA sought Another comment reflected that all to separate the metal from metal ABD00291794 Federal Register / Vo!. 53. No. 30 / Tuesday. February 16. 1988 / Rules and Regulations 4519 compounds. The distinct metal appears with its CAS registry number in 9372.85 (a) and (b). and the corresponding metal compounds category appears in 9 372.65(c) because cUs a chemical category. 4. Dyes and Color Index names. EPA received comment that some dye chemicals are listed by a common name whereas others are listed by a Color Index (Cl.) name. For example, Auramine (CAS No. 492-80-8) has the Color Index name of C.I. Solvent Yellow 34. It was suggested that the list would be much clearer if all of the dye chemicals were listed by their Color Index names. Furthermore, the chemicals Direct Black 36. Direct Blue 6. and Direct Brown 95 should also be listed with the "C.l." prefix. The Agency agrees with these suggestions. Listing these chemicals using the Color Index name makes the list consistent. In 9 372.65(a) of the rule all of these dye chemicals are listed together. EPA has included the common name in brackets in the case or Auramine. 5. Glycol ethers. Commenters suggested that the Agency should include specific glycol ethers in the chemical specific listings of 9 372.65 (a) and (b) of the rule and remove it as a category from 9 372.65(c). EPA considers this an amendment or modification to the list of chemicals and is not changing the list in this rulemaking. C. Reporting Substances ofa Certain Form Certain of the chemicals listed in the Committee Print have parenthetic qualifiers listed next to them. EPA attempted to clarify these qualifiers in its proposal. A chemical that is listed without a qualifier is subject to reporting in all forms in which it is manufactured, processed, and used. 1. Fume or dust. Three of the metals on the list (aluminum, vanadium, and zinc] contain the qualifier '`fume or dust." EPA interprets this qualifier to mean that a facility is manufacturing, processing, or using the metal in the form of fume or dust Fume or dust does not refer to "wet" forms, solutions, or slurries, for example, but only dry or anhydrous forms of these metals. As explained in Unit IVA. of this preamble, the term manufacture includes the generation of a chemical as a byproduct or impurity. In such cases, a facility should determine if. for example, it generated more than the 1987 threshold of 75.000 pounds per year of aluminum fume or dust as a byproduct of its activities. If so then the facility must report that it manufactures aluminum (fume or dust). Similarly, there may be certain technologies in which one of these metals is processed in the form of D. Reporting Chemical Solutions a fume or du9t to make other chemicals or other products for distribution in commerce. In reporting releases, the facility would only report releases of the fume or dust. 2. Manufacturing qualifiers. Two of the entries contain a qualifier relating to manufacture. For isopropyl alcohol the qualifier read "mfg.--strong acid process/' For saccharin, the qualifier simply reads `'manufacturing.'' In the case of isopropyl alcohol EPA interprets the qualifier to mean that only persons 1. De minimis cut-off for chemical solutions. The list of chemicals in 99 372.65 (a) and (b) contain the qualifier "solution" for some entries such as sodium sulfate (solution). This qualifier is defined in C.3. of this Unit. Technically, a solution is a mixture or formulation. Certain commenters suggested that a de minimis cut-off be applied to the reporting of chemical solutions consistent with the concept of a de minimis limitation for mixtures. EPA agrees with this suggestion because who manufacture isopropyl alcohol by reporting on these four substances is the strong acid process are required to consistent with mixture reporting. report In the case of saccharin, only Chemicals with the qualifier "solution." manufacturers of saccharin are required such as sodium sulfate that are to be reported. A facility that processes manufactured, processed, or otherwise or otherwise uses either chemical would used in excess of the de minimis levels not be required to report for those must be factored into threshold and chemicals. In both of these cases, release reporting requirements of this supplier notification does not apply. rule. 3. Solutions. Four substances on the 2. neutralizations and pH list are qualified by the term "solution." These substances are ammonium nitrate, ammonium sulfate, sodium hydroxide, and sodium sulfate. EPA adjustments. EPA received comment regarding neutralization of solutions such as dye baths and pH adjustments of wastewater. interprets the term "solution" to refer to Neutralization is interpreted by EPA the physical state of these chemicals. Only facilities that manufacture, process, or use these chemicals in the form of a solution would be required to report these chemicals. See D. of this Unit for a further discussion of solutions. In these cases supplier notification applies only if the chemical is distributed as a solution. 4. Phosphorus (yellow or white). The listing for phosphorus is qualified by the term "yellow or white." TTiis refers to a chemical state of phosphorus meaning that only manufacturing, processing, or use of phosphorus in the yellow or white states triggers reporting. Conversely, manufacturing, processing, or use of "black" or "red" phosphorus would not trigger reporting. Supplier notification applies to distribution of yellow or while phosphorus. 5. Asbestos (friable). The listing for asbestos is qualified by the term "friable.'' This term refers to a physical characteristic of asbestos. EPA interprets "friable" as being crumbled, as chemical reaction. For example, sodium hydroxide solution is used to neutralize a dye bath and a solution of sodium sulfate is formed. Assuming that other reporting requirements are met. this facility is viewed by EPA as a user of sodium hydroxide (solution), and a manufacturer of sodium sulfate (solution), even if the sodium sulfate is destined for disposal. Releases of sodium hydroxide (solution) and of sodium sulfate (solution) would be reported. Adjustments of the pH of a solution present a more complex circumstance in establishing reporting with respect to threshold requirements. Tie input of a chemical such as sodium hydroxide (solution) into wastewater for pH adjustment constitutes a use of that chemical and is reportable. Therefore EPA is requiring facilities that use section 313 chemicals for pH adjustments and neutralizations to report if they meet an applicable threshold, even if these chemicals are consumed and no releases result. pulverized, or reducible to a powder However. EPA realizes that there may with hand pressure. Again, only be many situations where pH manufacturing, processing, or use of adjustments are made to complex asbestos in the friable form triggers mixtures such as wastewater, where it reporting. Similarly, supplier notification may be very difficult to determine applies only to distribution of friable whether a section 313 chemical is being asbestos. EPA received comment to include other forms of asbestos. As "manufactured" during this neutralization. Furthermore, quantifying noted above, the Agency has chosen not to use this rulemaking as a vehicle for modifying the initial list of chemicals. these chemicals for the purposes of meeting reporting thresholds may be just as difficult. The facility must report if it 4520 ABD00291795 Federal Register / Vol. 53. No. 30 / Tuesday, February 18, 1988 / Rules and Regulations 1 knows that a listed toxic chemical is generated as a result of such neutralization and has data that allows for a reasonable estimate of the quantity generated. IX. Trade Secret Provision* A. General Trade Secret Issues The Agency received a number of comments relating to the trade secrecy implications of certain proposed form elements. Many of these comments have been addressed in the applicable units of this preamble. EPA also received a number of other general comments on trade secrecy as they relate to claims under section 313. EPA proposed a rule in the Federal Register of October 15,1987 (52 FR 38312). Part of this proposed rule contains procedures for claims of trade secrecy under Title 111. including a proposed trade secret claim substantiation form. General comments on trade secrecy under the proposed section 313 rule will be reviewed and considered as part of the above* referenced proposed rule. Until such time as the trade secret rule is finalized, persons subject to this final rule are required to comply with section 322. Accordingly, to do so persons who claim the chemical identity of a toxic chemical as a trade secret should follow the provisions of the proposed trade secret rule. (One exception is noted in B. of this unit regarding the generic chemical name which is required to be provided in the section 313 submission.) Fersons should also use the proposed trade secret claim substantiation form until a final form is published. D. Identifying Adverse Health and. Environmental Effects Information in the Data Base Suction 322(h)(2) of Title 01 requires F.PA to identify the adverse health and environmental effects associated with a loxic chemical that is claimed trade secret and assure that such information is included in the computer data base. The conference report further explains that "(tjhe adverse effects identified should be described in general terms so as not to provide a unique identifier of a particular trade secret chemical." EPA identified several options in its proposed rule for meeting this requirement of providing adverse effects information relating to trade secret claims. One option would be to develop a cumulative, worst-case effects characterization for the predefined generic class of the chemical. A second option discussed was a modified generic identification approach v.hcre companies would be required to develop and submit a generic identity for the chemical, and the EPA would develop the associated adverse health effects description that relates to the genera] class or category of the chemical. A third approach mentioned in the proposed rule would be to attempt to develop individual adverse effect profiles that would be substance- specific but would mask any particular effect that is unique and that could divulge its chemical identity. EPA received comments on the above options. Comments generally pointed towards the obvious difficulty of maintaining chemical identity as trade secret while providing adverse health and environmental effects information. It is the EPA's intention to provide the public with as much detailed information as possible on adverse effects. However, the Agency is also obligated to protect the chemical identity from disclosure through the data base when a legitimate trade secret claim is made. EPA approached this issue by developing a matrix of the 309 listed chemicals against the 10 health and environmental effects specifically mentioned in section 313(d). Toxicity data were accumulated from standard literature sources and, where applicable, interpreted using Agency guidelines. The results showed that there were approximately 70 chemicals that exhibited unique toxicity patterns within the 10 effects. EPA proceeded with this analysis by collapsing the 10 adverse effects categories to attempt to arrive at a point where there were no chemicals that exhibited a unique toxicity pattern. To reach the "no unique" result it was necessary to collapse the categories to the following 4 general categories: Carcinogenicity, acute toxicity, other human health effects, and environmental toxicity. EPA was surprised by the results of this analysis. EPA believes that Congress did not anticipate that its mandate to balance trade secret protection with the ready availability of effects information would lead to such a low degree of specificity for the effects information. EPA will continue to explore alternatives for providing the public with more specific effects information in connection with chemicals claimed trade secret. The Agency plans to publish the analysis mentioned above for comment sometime in the second quarter of 1988 before making any final decisions on the adverse effects identified in the data base. The only impact of this analysis on the final rule is that EPA will not use the predefined generic classes as originally proposed. "Hie analysis indicated that even the four-effects matrix, when put in the context of these generic classifications, created unique patterns for certain chemicals. As a result the Agency has decided to require the reporting facility to provide a suitable generic chemical name that is structurally descriptive of the chemical that is claimed trade secret. X. Recordkeeping EPA proposed a 5-year recordkeeping period. Several commentere objected to this proposed provision. They asserted that 5 years was an excessively long period of time to require facilities to maintain records relative to the reports under section 313. They asserted that a 3-year recordkeeping period would be sufficient and would be consistent with the 3-year recordkeeping period in other EPA regulations relative to air, solid waste, and water. One reason EPA proposed a 5-year recordkeeping period for section 313 submissions is the expected high number of facilities potentially subject to reporting- A 5-year period would allow EPA to inspect a larger number of facilities. However, after a review of the issue EPA believes that a 3-year recordkeeping period will be sufficient given that EPA will be receiving submissions annually from covered facilities. Therefore, the recordkeeping period is 3 years from the date of submission of a report for ail information relative to the preparation of that report. In addition to persona who must submit reports under the final rule, a supplier of a mixture or trade name product must keep records of the fact that they provided the required notification relative to the presence and composition of covered toxic chemicals in products they distribute in commerce. Such records must, where applicable, include an explanation of why the specific chemical identity was determined to be a trade secret and the appropriateness of the generic chemical name provided in the notification relative to that chemical. If the supplier provides an upper bound concentration value instead of a specific concentration, the supplier must provide in its records an explanation of why the specific concentration is deemed a trade secret and the basis for the upper bound concentration limit. XI. Economic Impact EPA has prepared a Regulatory Impact Analysis (RIA) in connection with this final rule. The RIA assesses i ABD00291796 Federal Register / Vol. 53. No. 30 / Tuesday. February 16. 1966 / Rules and Regulations 4521 the economic impact of the final regulation on the affected industry (manufacturing. SIC codes 20 through 39] and State and Federal governments. The following cost results are presented in the analysis document titled. "Regulatory Impact Analysis in Support of Final Rulemaking Under Section 313 of the Superfund Amendments and Reauthorization Act of 1986." Three alternatives are considered in the RLA for implementing section 313: Alternative 1--Facilities report by letter. Alternative II--Facilities report on the proposed version of Form R. Users must contact supplier concerning mixtures and trade name products. Alternative UI--Facilities report on the final version of Form R. Supplier notification. The population of facilities that would be required to submit reports under section 313 is based on three sources: census data for national totals of facilities engaged in manufacturing, surveys of toxic substances use conducted by 6 States and localities involving a subset of the substances contained in the list of 329 chemicals convered by section 313. and production of toxic chemicals reported for the Toxic Substances Control Act Inventory. Section 313 requires annual reports on releases of toxic chemicals from an estimated 31.800 facilities. Overall, the Agency may receive an estimated 318.000 reports annuaily. This equals an average of 10 reports per facility. The total costs per average facility, as well as per chemical report costs, are shown in Table I below. Table I.--Total Costs Per Average Reporting Facility and Per Chemical Report (S/Vr.) Regulatory alternative l Regulatory altamative Regulatory alternative > First year Subse quent years First year Subse quent years Fast yea; Subse quent years Report completion < io chenscals)______________ --------------- ----- ----------- -......... ....... .... identifica&on ol matures_____ __ ___ _____ . ......... ............................. ...... Rtport completion (3 mtanres).................... ....... -...... .......... -............ -............................. Mailing........................ ........ .......... ..................................... ...... ........ ...................................... Total costs per facility............................................................................----- ------------ Total coats per chemical report......... .........................................-___ ____ __ -........ Souto RIA 1967. 1.195.20 101 76 1,223.12 9.036.69 2.222.93 232.66 6.94 14.019.30 1.401.93 296.80 41.92 6.144.96 200.72 156.34 6.94 6.651.70 665.17 1.195.20 101.76 11.295.60 2^22.93 291.22 6.94 15.113.85 1,511.39 296.60 41.92 7.660.60 200.72 197.76 6.94 8.426.76 642.66 1.195.20 101.78 11.595 00 0.00 0.00 6.04 12.696.00 1,269.80 296 SO 41 92 7.864.C6 96.34887.78 0.00 6.04 8,327.169.116 S6 632.72911.66 The costs represented in Table 1 are for reporting facilities. The final rule will cause costs to be incurred by more facilities than will actually be subject to reporting. All facilities with 10 or more full time employees in SIC codes 20 through 39 will incur some costs associated with compliance determination* (i.e.. becoming familiar with the rule and the form, and determining if they meet the threshold requirements for any of the section 313 chemicals). An estimated 140.450 facilities will incur the compliance determination costs. These costs, which do not vary across the alternatives, are included in the aggregate industry costs shown in Table below. Table II.--Aggregate Costs for Industry: First and Subsequent Reporting Years [Minion doners per year) The other major costs that will be incurred by non reporting facilities involve mixtures and trade name required that processors and users of products. The proposed rule would have mixtures and trade name products ABD00291797 4522 Federal Register / Vol. 53, No. 30 / Tuesday, February 16. 1988 / Rules and Regulations contact suppliers and document the information provided by suppliers. If informaiton were not provided by suppliers, processors tad users were required to submit partial nporta /or mixtures and trade name products. The final rule places the burden on the supplier to provide the information to users. Suppliers and users would incur costs under all alternatives, as shown in Table II. Supplier costs are lower for the final rule, because suppliers would be initiating the information, rather than responding to requests from users. The costs of users will also be lower for the final rule, as the information on mixtures will be made available to them and consequently there will be no costs for contacting suppliers and documenting the contacts. To compare costs of the proposed rule to the final rule it is necessary first to understand that the costs for the proposed rule have been revised. The four major reasons for revisions to the cost estimates are summarized as follows: 1. The number of chemcial reports per facility increased from 4 to 10. Basis for change: Public comments, section 313 pretest, aod data from five additional State and local data bases on chemical use. 2. Costs for compliance determinations increased by 33.0 percent Basis for change: Revisions to costs developed in the R1A for the proposed Comprehensive Assessment Information Rule (CAIR). 3. Estimates for calculating releases in the proposal were based on pretest of CAIR form and contractor estimates. These estimates have been reduced by 30 percent. Basis for change: Revisions to proposed CAIR costs and section 313 pretest. 4. Costs for suppliers (screening mixtures and informing users) and users (screening mixtures) were not originally included. These costs are compared in Table III below. Table III.--Summary of Cost Comparison Between Proposed ano Final Rule [Frit-year cost) Proposad I Revised proposed final j Total nunbar oi cftanucai raporta--.---------- 132.3*0- ....... Total numear of partial mixbra............. ........ 32.760......................... - 1 ; iis ion si?ano .............. J 318.000,318.000 .......... ...... .. ............. j 95.400 Raporta par facility........... * cnemcai, 1 mature............... ..... 3 cnenteai. 7 tut rapona-maturea, 3 | partial rsporta-mtttaa. 3 eftameal. 7 ful rport*uTu*s. The number of chemical reports per facility increased 2.5 times but initial doubling of CAIR estimates was found to be unnecessary and inclusion of supplemental time to estimate releases was also found to be double counting. First year costs per reporting facility increased from about $12,500 in the June RIA to $15,100 for this same (proposed) version of the form, reflecting the above factors and an increase from the more thorough accounting for the responsibilities attributed to mixtures. Phase-in of mixtures and placement of the burden upon suppliers rather than users account for the Anal rule's (Alternative 111) lower cost of $12,900 per facility. EPA has chosen to develop the form and rule in order to provide for uniform reporting, so that a computerized data base of high quality and utility can be created and maintained. EPA will incur costs to process, check, store, and make available the data reported under section 313. EPA's costs will vary depending upon its choice of data management systems and policies, but are estimated to range from between $7.7 and $28.4 million per year. States will also have some expenses for processing, storing, and distributing reports sent to them. State costs are estimated to be from $17 to $2.2 million per year. XII. Duplication of Reporting Under both section 313 of SARA and section 103 of CERCLA. EPA requires companies to submit information on chemical releases into the environment. While the two statutory provisions are similar in their reporting requirements, they differ in both scope and purpose. Section 313 requires reporting only by facilities in SIC codes 20 through 39. Section 103(f)(2) places no such restrictions on its applicability. Also, some chemicals covered under CERCLA section 103 are not subject to SARA section 313 reporting requirements, and certain additional chemicals not subject to CERCLA notification are included in section 313 notification requirements. The two statutory provisions also differ in purpose. While the purpose of section 313 of SARA is to create a Federal inventory of the listed___ chemicals, the purpose of the CERCLA section 103 reporting requirements is to gather information for emergency response. A review of the issue found that significant amounts of duplication do not exist between these two requirements. Xm. Public Data Base Section 313(jj states that the Administrator shall establish and maintain in a computer data base national toxic chemical inventory base i on data submitted to the Administrator under section 313. EPA shall make this data accessible by computer telecommunications and other means to any person on a cost reimbursable basis. EPA is reviewing potential options through which the toxic chemical inventory can be made available to the public. There are numerous vehicles and mechanisms under consideration by EPA for the wide dissemination and accessibility of the inventory to the public on a cost reimbursement basis with the potential for fee reductions or waivers. EPA developed early draft options as examples of potential vehicles and mechanisms for the public availability of a toxic chemical inventory data base. This preliminary draft options paper was the subject of a public meeting held on April 20.1987. Comments from this public meeting and subsequent discussions with other Federal agencies, industry. States, and environmental groups are serving as the basis for further analysis by EPA. After further review of public availability options. EPA will determine which set of products and services will provide the most feasible and widest dissemination of the toxic chemical inventory to the public. EPA expects to be able to make the data base svailable in the first quarter of 1989. J ABD00291798 Federal Register / Vol. 53. No. 30 / Tuesday. February 16. 1988 / Rules and Regulations 4523 XIV. Rulemaking Record The following documents constitute the rulemaking record for this rule (docket control number OPTS-400002A). All documents, including the index of this record, are available to the public in the OTS Reading Room from 6 a.m. to 4 p.m.. Monday through Friday, excluding legal holidays. The OTS Reading Room is located at EPA Headquarters. Rm. NE-C004. 401 M St.. SW.. Washington. DC 20460. The record includes the following information considered by the Agency in developing this rule: 1. Documents in docket no. 400002 at the date of publication of the proposed rule. 2. The proposed rule. 3. Transcripts of public meetings held July 24 and 27. and August 4.1987. 4. Written comments received on the proposed rule. 5. Summaries of meetings held with representatives of industry, public interest groups, and State government officials. 6. The document titled "Regulatory Impact Analysis in Support of the Final Rulemaking Under section 313 of the Superfund Amendments and Reauthorization Act of 1986" (1987). XV. Regulatory Assessment Requirements A. Executive Order 12291 Under Executive Order 12291. EPA must judge whether a rule is "major" and therefore requires a R1A. EPA has developed a RIA as described in Unit XI. This RIA shows that the combination of impacts of the statutory provisions of section 313 and the interpretive provisions of this rule may create a first year impact of $527 million and a second year impact of S299 million. EPA has determined that this rule is "major" because it may have an effect of $100 million or more on the economy. EPA does not. however, anticipate that this rule will have a significant effect on competition, costs, or prices. This rule was submitted to the Office of Management and Budget (OMB) for review as required by Executive Order 12291. B. Regulatory Flexibility Act Section 313 and the final rule exempt certain small businesses from reporting, i.e.. those facilities in SIC codes 20 through 39 with fewer than 10 full-time employees. The statutory exclusion of facilities with fewer than 10 full-time employees exempts 48 percent of all manufacturing facilities in SIC codes 20 through 39. After also considering the volume thresholds. EPA estimates that section 313 will require reporting from approximately 3.0 percent (9.400 of 277.100) of all small manufacturing facilities with less than 50 employees. Analysis to support the proposed rule indicated that for some segments of the manufacturing sector the compliance costs of reporting will have a significant impact. Specifically, reporting costs are estimated to be between 1.0 and 2.0 percent of median sales for facilities with fewer than 50 employees: and between 2-0 and 4.0 percent of median sales for facilities with 10 to 19 employees. Subsequent to proposal, the Agency developed and included a Regulatory Flexibility Analysis in the RIA to examine options that might reduce the burden to small businesses. The Agency received extensive comments on the impacts of the proposed rule on small businesses from the small Business Administration (SBA). SBA presented several alternatives designed to reduce the burden to small businesses, based on the premise that small facilities (those with fewer than 100 employees) have nothing significant to report. These alternatives are discussed below. SBA proposed the development of thresholds based on risks posed by various emission sources. SBA maintains that data exists from the Agency's regional studies that would allow the Agency to calculate risks from air and water emissions, from which the Agency could develop thresholds for reporting based on specific risks. From its review of the data. SBA concludes that "small firms collectively contribute only a small fraction, generally less than 10 to 15 percent, of the toxic chemical emissions included in the local area studies." SBA acknowledges that "there may be a lack of information on toxicity which would make (a risk) analysis infeasible for certain chemicals." SBA's second proposed alternative is to combine section 313 with CERCLA section continuous release reporting, using 10 pounds a day Reportable Quantity (RQ) for any section 313 chemicals not covered under CERCLA. SBA states that this would ensure that "facilities of primary concern (those with significant emissions) are included." SBA believes this approach would also alleviate the significant economic burden on small businesses. SBA recommends as a third alternative a de minimis reporting range of 0 to 1 pound of emissions per day or 0 to 250 pounds per year. SBA's fourth alternative was a total exemption of small facilities (defined by SBA as those with fewer than 100 employees) from reporting: and/or an abbreviated or shortened reporting form. The Agency received comments both in support of an in opposition to SBA's position. The Agency identified 8 regulatory alternatives as part of the Regulatory flexibility Analysis for this rule;. The alternatives, evaluated on the basis of cost and economic criteria, represent options for reducing the reporting burden for small businesses. Each alternative is described and discussed below. Alternative 1: Rule as proposed: statutory exclusion of facilities having fewer than 10 employees. This alternative allows complete coverage of reporting on emissions, but provides no reduction in burden to small facilities. Alternative 2: Exempt all small businesses (defined as facilities with fewer than 50 employees). (The RIA analyzes alternative definitions of small businesses.) This alternative not only reduces the reporting burden for small businesses, but eliminates any burden of compliance determination from small facilities. However, this alternative would result in no reporting of emissions from small facilities, which could lead to substantial gaps in the Emissions Inventory, especially at the community level. The costs are summarized in Table IV below. Table IV.--Regulatory Flexibility Stuoy Options: Costs Per Facility (Present Value for 10 Years of Reporting) Coet(') Option: 1.................................. $54,320 2 ..................... 0 3 ................................ * $54,320 4 ................................ $5,100 to $54,320 5 ........................ -..... $5,100 6 ................................ $24,680 7 ................................ $47,130 10 1 $52,630 6.................................. $34,410 to 14 $*5*0,990 1 in present value 1987 oottars at a 10 percent discount rate for years 1988-1997. * Given me ibsence of any SIC codes mat would meet exemption cntena. * Average cost but ttos oooon would otter me benefit of limiting me extent to wnn momdoaJ facilities would exceed me average. 4 Assumes til 10 chemicals per lacrtity enjoy 10 to SO percent cost savings for estimates of t* and water releases m ranges. Alternative 3: Exempt facilities in specific SIC codes if they account for low aggregate emissions. This alternative would exempt small businesses in particular industries that might trigger the need to report based on the volume threshold for use. but have little actual emissions. However, after examining the available data (six State and local data bases that contain emissions data for some of the section ABD00291799 4524 Federal Register / Vol. 53, No. 30 { Tuesday, February 16, 1988 / Rules and Regulations 313 chemicals), no SIC codes were identified that met the criterion. Alternative 4: Require nnrm*j reporting by small businesses only of Parts 1 through VI of proposed Form fc provided in the data base. However, in the intervening yean until facilities have reported on ail section 313 chemicals, the data base will not be as complete or as accurate. difficult from the data available to EPA to estimate exact burden savings associated with this approach. Savings for any individual small facility will depeod upon the number of chemicals Parts Vll through X of the proposed form Alternative 8: Allow small businesses being reported and the number of would be due only upon request by EPA to mark ranges check-boxes for release environmental media to which each This alternative would.eliminate the less than 1.000 pounds per year to any chemical is released. For example, a most onerous part of the reporting burden (i.e.. estimating releases). However, while small facilities would be identified in the data base, the most important information (i.e.. emissions) would not be captured. Therefore the utility to the public of the date base would be reduced. There also would be likely increased administrative costs with such an approach when the emissions data are requested- These costs would be incurred by the public (for requesting information), industry (for having to essentially fill out a form for some chemicals twice), and the Agency (for establishing procedures of how and to whom the request should be environmental medium. The check boxes would apply to 0.1 to 499 pounds per year, and 500 to 999 pounds per year. The facility would have the option of reporting a specific figure rather than checking a box Tbe facility would have to provide a specific figure estimate for releases of 1.000 pounds or more per year. The reporting burden would be reduced by not requiring small facilities to further refine estimates of these lower level releases. A certain degree of precision might be lost relative to analyzing the releases reporting in such ranges. However, the data base would maintain a higher degree of completeness relative to other options simple mass balance around a process may be adequate to show that air releases are less than 1.000 pounds. Tbe information necessary to complete such a mass balance should be readily available and tabulated, at least partly, to determine whether the reporting threshold is met. By relying on a rough mass balance calculation, the facility could avoid calculating releases from individual process points (for example, valve and flanges leaks, or storage tanks vents). Completing these calculations requires that additional information be tabulated (e.g., the number of valves, or the size of storage tanks). made, response times, etc.). (except option 1) because all data For a release to a single medium, the Alternative 5: Require aonual required by the form would be reported savings could be as high as 50 percent of reporting by small busioesaes only of Parts 1 through VI of proposed Form R plus data on quantity used or produced; EPA estimates releases from small business facilities. This alternative would eliminate the most onerous pari of the reporting burden as described in Alternative 4. EPA would provide emissions estimates in the data base ihat were more consistently derived. However, the information that EPA would have to require to estimate releases may actually increase the information required on the form. For example. EPA would have to require each year by all facilities. Conclusions: The Agency has the authority to establish different thresholds for a chemical, class of chemicals, or categories of facilities. However, any revised threshold must obtain reporting on a substantial majority of total releases of the chemicals at all facilities subject to reporting. Based on the limited available data the Agency cannot support any modification of thresholds based on size of facility, and still be able to maintain that a substantial majority of the total releases would be captured through the time for completion of the release section of the form (12 of 24 hours). For releases of a chemical to several media the savings are likely to be approximately 10 percent because of the time required to determine how such releases are apportioned per media. These savings are reflected in the cost per facility for option 6 in Table IV. SBA believes that EPA's estimates of savings are conservative and that small facilities would benefit substantially from this approach. EPA expects that small facilities will production, processing, or use volume reporting. EPA analyzed certain limited realize the most benefit from the information. This approach would use and release data available on a optional range reporting concept increase Agency costs for calculating subset of the section 313 chemicals from because larger facilities are more likely releases. It would also require industry's the states of New [ersey. Michigan, and to have the technical capabilities to willingness to report such potentially Massachusetts. These data were used to develop more specific estimates. confidential or trade secret information as a tradeoff for the lowered burden. Alternative 6; Require reporting by small businesses every thud year, rather than annually. This alternative would reduced the burden to small facilities over time, while still providing data on small facilities and their emissions in the data base. However, the frequency of reporting cannot be changed until 1993 under section 313(i). Alternative 7: Require small businesses tc report only ap to a certain estimate the potential impact on coverage of aggregate emissions, coverage ofchem/cal-by-chemical emissions, and coverage of emissions at the community level. This analysis shows that facilities with fewer than 49 employees account for a least 30 percent of the air releases for 12 of 87 chemicals listed in the New jersey data base. EPA concluded that exempting facilities of' this size range from reporting may lead to lack of coverage of certain chemicals. Therefore, the Agency is not modifying However. EPA believes that this optional range reporting provision could provide a burden reducing benefit to any subject facility regardless of size. Therefore. EPA has extended tbe optional range reporting provision to all subject facilities. EPA believes that it will be necessary to evaluate the relative costs and benefits of this alternative in light of the first few years of section 313 submissions. Therefore, a 3*year number of chemicals per year. This the thresholds (i.e~ the annual pounds of limitation has been attached to this alternative would place s cap on the a toxic chemical manufactured, provision. The limited range reporting number of chemicals that small processed, or otherwise used) for small option will apply to the 1987,1988. and businesses would report each year. The facilities. 1989 reporting years unless EPA takes burden would be reduced for those However, aa a result of this analysis action to extend or permanently adopt small facilities with more than the average number of chemicals per facility. Data on small facilities and estimates of emissions would still be and consultation with S8A. the Agency has incorporated alternative No. A limited range reporting, into the reporting requirements of the rule, ft is this reporting provision. EPA will publish its analysis prior to allowing the provisions to expire. ABD00291800 Federal Register / Vol. S3. No. 30 / Tuesday, February 16. 1988 / Rules and Regulations 4525 C. Paperwork Reduction Act OMB has reviewed the information collection requirements contained in this rule under the provisions of the Paperwork Reduction Act of 1980.44 U.S.C. 3501 et seq. and has assigned OMB control number 2070-0093. List of Subjects in 40 CFR Part 372 Environmental protection. Recordkeeping, reporting, and notification requirements. Toxic chemicals. Dated: February 2.1988. A. lames Barnes. Acting Administrator. Therefore. Chapter I of 40 CFR is amended by adding a new Part 372 to read as follows: PART 372--TOXIC CHEMICAL RELEASE REPORTING; COMMUNITY RIGHT-T04CN0W Subpart A--GenerN Provisions Sec 372.1 Scope and purpose. 372.3 Definitions. 372J Persons subject to this Part 372.10 Recordkeeping. 372.18 Compliance and enforcement Subpart S--Reporting Requirement* 372.22 Covered facilities for toxic chemical release reporting. 372.2S Thresholds for reporting. 372-30 Reporting requirements and schedule for reporting. 372.38 Exemption*. Subpart C SuppBar Notification Requirements 372.45 Notification about toxic chemicals. Subpart D--Specific Toxic Chemical Listings 372.65 Chemicals and chemical categories to which this Part applies. Subpart 6--forma and Instructions 372.85 Toxic chemical release reporting form and instructions. Authority: 42 U.S.C. 11013.11028. Subpart A--General Proviaiona 372.1 Scope and purpose. This Part sets forth requirements for the submission of information relating to the release of toxic chemicals under section 313 of Title 111 of the Superfund Amendments and Reauthorization Act of 1986. The information collected under this Part is intended to inform the general public and the communities surrounding covered facilities about releases of toxic chemicals, to assist research, to aid in the development of regulations, guidelines, and standards, and for other purpose*. This Part also sets forth requirements for suppliers to notify persons to whom they distribute mixtures or trade name products containing toxic chemicals that they contain such chemicals. 372.3 Definition*. Terms defined in sections 313(b)(1)(c) and 329 of Title III and not explicitly defined herein are used with the meaning given in Title 111. For the purpose of this Part: "Acts" means Title UL "Article" means a manufactured item: (1) Which is formed to a specific shape or design during manufacture: (2) which has end use functions dependent in whole or in part upon its shape or design during end use: and (3) which does not release a toxic chemical under normal conditions of processing or use of that item at the facility or establishments. "Customs territory of the United States" means the 50 States, the District of Columbia, and Puerto Rico. "EPA" means the United States Environmental Protection Agency. "Establishment" means an economic unit, generally at a single physical location, where business is conducted or where services or industrial operations are performed. "Facility" means all buildings, equipment, structures, and other stationary items which are located on a single site or on contiguous or adjacent sites and which are owned or operated by the same person (or by any person which controls, is controlled by. or under common control with such person). A facility may contain more than one establishment "Full-time employee" means 2.000 hours per year of full-time equivalent employment. A facility would calculate the number of full-time employees by totaling the hours worked during the calendar year by all employees, including contract employees, and dividing that total by 2.000 hours. "Import" means to cause a chemical to be imported into the customs territory of the United States. For purposes of this definition, "to cause" means to intend that the chemical be imported and to control the identity of the imported chemical and the amount to be imported. "Manufacture" means to produce, prepare, import, or compound a toxic chemicaL Manufacture also applies to a toxic chemical that is produced coincidentally during the manufacture, processing, use, or disposal of another chemical or mixture of chemicals, including a toxic chemical that is separated from that other chemical or mixture of chemicals as a byproduct and a toxic chemical that remains in that other chemical or mixture of chemicals as an impurity. "Mixture" means any combination of two or more chemicals, if the combination is not. in whole or in part, the result of a chemical reaction. However, if the combination was produced by a chemical reaction but could have been produced without a chemical reaction, it is also treated as a mixture. A mixture also includes any combination which consists of a chemical and associated impurities. "Otherwise use" or "use" means any use of a toxic chemical that is not covered by the terms "manufacture" or "process" and includes use of a toxic chemical contained in a mixture or trade name product. Relabeling or redistributing a container of a toxic chemical where no repackaging of the toxic chemical occurs does not constitute use or processing of the toxic chemical. "Process" means the preparation of a toxic chemical, after its manufacture, for distribution in commerce: (1) In the same form or physical state as. or in a different form or physical state from, that in which it was received by the person so preparing such substance, or (2) As part of an article containing the toxic chemical. Process also applies to the processing of a toxic chemical contained in a mixture or trade name product "Release" 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 toxic chemical. "Senior management official" means an official with management responsibility for the person or persons completing the report or the manager of environmental programs for the facility or establishments, or for the corporation owning or operating the facility or establishments responsible for certifying similar reports under other environmental regulatory requirements. `Title 111" means Title III of the Superfund Amendments and Reauthorization Act of 1986. also titled the Emergency Planning and Community Right-To-Know Act of 1988. "Toxic chemical" means a chemical or chemical category listed in f 372.65. "Trade name product" means a chemical or mixture of chemicals that is distributed to other persons and that incorporates a toxic chemical component that is not identified by the applicable chemical name or Chemical ABD00291801 4526 Federal Register / Vol. 53. No. 30 / Tuesday. February 16. 1966 / Rules and Regulations Abstracts Service Registry nurr.bcr listed in $ 37Z65. 372.5 Persons sub{eel to this Part Owners and operators of facilities described in $ 37Z22 and 372.45 are subject to the requirements of this Part. If the owner and operator of a facility are different persons, only one need report under 3 372.17 or provide a notice under 372.45 for each toxic chemical in a mixture or trade name product distributed from the facility. However, if no report is submitted or notice provided. EPA will hold both the owner and the operator liable under section 325(c) of Title 111, except as provided in 53 372.38(e) and 37Z4S(g). $372.10 RCOrdk*#ptng. (a) Each person subject to the reporting requirements of this Part must retain the following records for a period of 3 years from the date of the submission of a report under 9 372.30: (1) A copy of each report submitted by the person under 9 372.30. (2) All supporting materials and documentation used by the person to make the compliance determination that the facility or establishments is a covered facility under 9 372.22 or 5 372.45. (3) Documentation supporting the report submitted under 9 372.30 including: (i) Documentation supporting any determination that a claimed allowable exemption under 9 372.38 applies. (ii) Data supporting the determination of whether a threshold under 9 372.25 applies for each toxic chemical. (iii) Documentation supporting the calculations of the quantity of each toxic chemical released to the environment or transferred to an off-site location. (iv) Documentation supporting the use indications and quantity on site reporting for each toxic chemical, including dates of manufacturing, processing, or use. (\) Documentation supporting the basis of estimate used In developing any release or off-site transfer estimates for each toxic chemical. (vi) Receipts or manifests associated with the transfer of each toxic chemical in waste to off-site locations. (vii) Documentation supporting reported waste treatment methods, estimates of treatment efficiencies, ranges of influent concentration to such treatment, the sequential nature of treatment steps, if applicable, and the actual operating data, if applicable, to support the waste treatment efficiency estimate for each toxic chemical. (b) Each person subject to the notification requirements of this part must retain the following records for a period of 3 years from the date of the submission of a notification under 9 372-45. (1) All supporting materials and documentation used by the person to determine whether a notice is required under 372.45. (2) All supporting materials and documentation used in developing each required notice under 9 372.45 and a copy of each notice. (c) Records retained under this section must be maintained at the facility to which the report applies or from which a notification was provided. Such records must be readily available for purposes of inspection by EPA. 9 372.16 Compliance and anforcemant Violators of the requirements of this Part shall be liable for a civil penalty in an amount not to exceed $25,000 each day for each violation as provided in section 325(c) of Title III. Subpart B--Reporting Requirements 5 372.22 Covered facilities for toxic chemical release reporting. A facility that meets all of the following criteria for a calendar year is a covered facility for that calendar year and must report under 5 372.30. (a) The facility has 10 or more full time employees. (b) The facility is in Standard Industrial Classification Codes 20 through 39 (as in effect on January 1. 1967) by virtue of the fact that it meets one of die following criteria: (1) The facility is an establishment with a primary SIC code of 20 through 39. (2) The facility is a multiestablishment complex where all establishments have a primary SIC code of 20 through 39. (3) The facility is a multiestablishment complex in which one of the following is true: (i) The sum of the value of products shipped and/or produced from those establishments that have a primary SIC code of 20 through 39 is greater than 50 percent of the total value of all products shipped and/or produced from ail establishments at the facility. (ii) One establishment having a primary SIC code of 20 through 39 contributes more in terms of value of products shipped and/or produced than any other establishment within the facility. (c) The facility manufactured (including imported), processed, or otherwise used a toxic chemical in excess of an applicable threshold quantity of that chemical set forth in 9 372.25. 372.25 Thresholds tor reporting. The threshold amounts for purposes of reporting under 9 372.30 for toxic chemicals are as follows: (a) With respect to a toxic chemical manufactured (including imported) or processed at a facility during the following calendar years: 1967--75.000 pounds of the chemical manufactured or processed for (he year. 1988--50.000 pounds of the chemical manufactured or processed for the year. 1989 and thereafter--25.000 pounds of the chemical manufactured or processed for (he year. (b) With respect to a chemical otherwise used at a facility, 10.000 pounds of the chemical used for the applicable calendar year. (c) With respect to activities involving a toxic chemical at a facility, when more than one threshold applies to the activities, the owner or operator of the facility must report if it exceeds any applicable threshold and must report on all activities at the facility involving the chemical, except as provided in | 372.38, (d) When a facility manufactures, processes, or otherwise uses more than one member of a chemical category listed in 9 372.65(c). the owner or operator of the facility must report if it exceeds any applicable threshold for the total volume of all the members of the category involved in the applicable activity. Any such report must cover all activities at the facility involving members of the category. (e) A facility may process or otherwise use a toxic chemical in a recycle/reuse operation. To determine whether the facility has processed or used more than an applicable threshold of the chemical, the owner or operator of the facility shall count the amount of the chemical added to the recycle/reuse operation during the calendar year. In particular, if the facility starts up such an operation during a calendar year, or in the event that the contents of the whole recycle/reuse operation are replaced in a calendar year, the owner or operator of the facility shall also count the amount of the chemical placed into the system at these times. (f) A toxic chemical may be listed in 9 372.65 with the notation that only persons who manufacture the chemical, or manufacture it by a certain method, are required to report. In that case, only owners or operators of facilities that manufacture that chemical as described in 9 372.65 in excess of the threshold applicable to such manufacture in 9 37Z25 are required to report. In ABD00291802 Federal Register / Vol. 53. No. 30 f Tuesday. February 16. 1908 / Rules and Regulations 4527 completing the reporting form, the owner or operator is only required to account for the quantity of the chemical so manufactured and releases associated with such manufacturing, but not releases associated with subsequent processing or use of the chemical at that facility. Owners and operators of facilities that solely process or use such a chemical are not required to report for that chemical. (g) A toxic chemical may be listed in 372.65 with the notation that it is in a specific form (e.g., fume or dust, solution, or friable) or of a specific color (e.g.. yellow or white). In that case, only owners or operators of facilities that manufacture, process, or use that chemical in the form or of the color, specified in 9 372.65 in excess of the threshold applicable to such activity in $ 372.25 are required to report. In completing the reporting form, the owner or operator is only required to account for the quantity of the chemical manufactured, processed, or used in the form or color specified in 9 372.65 and for releases associated with the chemical in that form or color. Owners or operators of facilities that solely manufacture, process, or use such a chemical in a form or color other than those specified by | 372.65 are not required to report for that chemical. (h) Metal compound categories are listed in 8 372.65(c). For purposes of determining whether any of the thresholds specified in f 372.25 are met fur metal compound category, the owner or operator of a facility must make the threshold determination based on the lota! amount of all members of the metal compound category manufactured, processed, or used at the facility. In completing the release portion of the reporting form for releases of the metal compounds, the owner or operator is only required to account for the weight of the parent metal released. Any contribution to the mass of the release attributable to other portions of each compound in the category is excluded. $ 372.30 Reporting requirements and schedule for reporting. (a) For each toxic chemical known by the owner or operator to be manufactured (including imported), processed, or otherwise used in excess of an applicable threshold quantity in 372.25 at its covered facility described in $ 372.22 for a calendar year, the owner or operator must submit to EPA and to the State in which the facility is located a completed EPA Form R (EPA Form 9350-1) in accordance with the instructions in Subpart E. (b) (1) The owner or operator of a covered facility is required to report as described in paragraph (a) of this section on a toxic chemical that the owner or operator knows is present as a component of a mixture or trade name product which the owner or operator receives from another person, if that chemical is imported, processed, or otherwise used by the owner or operator in excess of an applicable threshold quantity in 8 372.25 at the facility as part of that mixture or trade name product. (2) The owner or operator knows that a toxic chemical is present as a component of a mixture or trade name product (i) if the owner or operator knows or has been told the chemical identity or Chemical Abstracts Service Registry Number of the chemical and the identity or Number corresponds to an identity or Number in 9 372.65, or (ii) if the owner or operator has been told by the supplier of the mixture or trade name product that the mixture or trade name product contains a toxic chemical subject to section 313 of the Act or this Part. (3) To determine whether a toxic chemical which is a component of a mixture or trade name product has been imported, processed, or otherwise used in excess of an applicable threshold in 9 372.25 at the facility, the owner or operator shall consider only the portion of the mixture or trade name product that consists of the toxic chemical and that is imported, processed, or otherwise used at the facility, together with any other amounts of the same toxic chemical that the owner or operator manufactures, imports, processes, or otherwise uses at the facility as follows: (i) If the owner or operator knows the specific chemical identity of the toxic chemical and the specific concentration it which it is present in the mixture or ide name product, the owner or jperator shall determine the weight of the chemical imported, processed, or otherwise used as part of the mixture or trade name product at the facility and shall combine that with the weight of the toxic chemical manufactured (including imported) processed, or otherwise used at the facility other than as part of the mixture or trade name product. After combining these amounts, if the owner or operator determines that the toxic chemical was manufactured, processed, or otherwise used in excess of an applicable threshold in 9 372.25. the owner or operator shall report the specific chemical identity and all releases of the toxic chemical on EPA Form R in accordance with the instructions in Subpart E. (ii) If the owner or operator knows the specific chemical identity of the toxic chemical end does not know the specific concentration at which the chemical is present in the mixture or trade name product, but has been told the upper bound concentration of the chemical in the mixture or trade name product, the owner or operator shall assume that the toxic chemical is present in the mixture or trade name product at the upper bound concentration, shall determine whether the chemical has been manufactured, processed, or otherwise used at the facility in excess of an applicable threshold as provided in paragraph (b)(3)(i) of this section, and shall report as provided in paragraph (b)(3)(i) of this section. (iii) If the owner or operator knows the specific chemical identity of the toxic chemical, does not know the specific concentration at which the chemical is present in the mixture or trade name product has not been told the upper bound concentration of the chemical in the mixture or trade name product and has not otherwise developed information on the composition of the chemical in the mixture or trade name product then the owner or operator is not required to factor that chemical in that mixture or trade name product into threshold and release calculations for that chemical. (iv) If the owner or operator has been told that a mixture or trade name product contains a toxic chemical, does not know the specific chemical identity of the chemical and knows the specific concentration at which it is present in the mixture or trade name product, the owner or operator shall determine the weight of the chemical imported, processed, or otherwise used as part of the mixture or trade name product at the facility. Since the owner or operator does not know the specific identity of the toxic chemical the owner or operator shall make the threshold determination only for the weight of the toxic chemical in the mixture or trade name product. If the owner or operator determines that the toxic chemical was imported, processed, or otherwise used as part of the mixture or trade name product in excess of an applicable threshold in 9 372.25, the owner or operator shall report the generic chemical name of the toxic chemical, or a trade name if the generic chemical name is not known, and all releases of the toxic chemical on EPA Form R in accordance with the instructions in Subpart E. (v) If the owner or operator has been told that a mixture or trade name product contains a toxic chemical, does not know the specific chemical identity of the chemical, and does not know the specific concentration at which the chemical is present in the mixture or ABD00291803 4528 Federal Register / Vol. S3. No. 30 / Tuesday. February 16, 1988 / Rules and Regulations trade name product but has been told the upper bound concentration of the chemical in the mixture or trade name product, the owner or operator shall assume that the toxic chemical is present in the mixture or trade name product at the upper bound concentration, shall determine whether the chemical has been imported, processed, or otherwise used at the facility in excess of an applicable threshold as provided in paragraph (b)(3)(iv) of this section, and shall report as provided in paragraph (b)(3)(iv) of this section. (vi) If the owner or operator has been told that a mixture or trade name product contains a toxic chemical, docs not know the specific chemical identity of the chemical, does not know the specific concentration at which the chemical is present in the mixture or trade name product including information they have themselves developed, and has not been told the upper bound concentration of the chemical in the mixture or trade name product, the owner or operator is not required to report with respect to that toxic chemical. (c) A covered facility may consist of more than one establishment. The owner or operator of such a facility at which a toxic chemical was manufactured (including imported), processed, or otherwise used in excess of an applicable threshold may submit a separate Form R for each establishment or for each group of establishments within the facility to report the activities involving the toxic chemical at each establishment or group of establishments, provided that activities involving that toxic chemical at all the establishments within the covered facility are reported. If each establishment or group of establishments Hies separate reports then for ell other chemicals subject to reporting at that facility they must else submit separate reports. However, an establishment or group of establishments does not have to submit a report for a chemical that ia not manufactured (including imported), processed, otherwise osed or released at that establishment or group of establishments. (d) Each report under this section for activities involving a toxic chemical that occured during a calendar year at a covered facility must be submitted on or before July 1 of the next year. The first such report for calendar year 1987 activities must be submitted on of before July 1.1988. (e) For reports applicable to activities for calendar years 1987,1988. and 1989 only, the owner or operator of a covered facility may report releases of a specific toxic chemical to an environmental medium, or transfers of wastes containing a specific toxic chemical to an off-site location, of less than 1.000 pounds using the ranges provided in the form and instructions in Subpart E. For reports applicable to activities in calendar year 1990 and beyond, theue ranges may not be used. $372^8 Exemptions. (a) De minimis concentrations of a toxic chemicol in a mixture. If a toxic chemical is present in e mixture of chemicals at a covered facility and the toxic chemical is in a concentration in the mixture which is below 1 percent of the mixture, or 0.1 percent of the mixture in the case of a toxic chemical which is a carcinogen as defined in 29 CFR 1910.1200(d)(4). a person is not required to consider the quantity of the toxic chemical present in such mixture when determining whether an applicable threshold has been met under 1372.25 or determining the amount of release to be reported under 1372.30. This exemption applies whether the person received the mixture from another person or the person produced the mixture, either by mixing the chemicals involved or by causing a chemical reaction which resulted in the creation of the toxic chemical in the mixture. However, this exemption applies only to the quantity of the toxic chemical present in the mixture. If the toxic chemical is also manufactured (including imported), processed, or otherwise used at the covered facility other than as part of the mixture or in a mixture at higher concentrations, in excess of an applicable threshold quantity set forth in 1372^5. the person is required to report under 1372JKX (b) Articles. If a toxic chemical is present in an article at a covered facility, a person is not required to consider the quantity of the toxic chemical present in such article when determining whether an applicable threshold has been met under I 372^5 or determining the amount of release to be reported under | 372.30. This exemption applies whether the person received the article from another person or the person produced the article. However, this exemption applies only to the quantity of the toxic chemical present in the article. If the toxic chemical is manufactured (including imported), processed, or otherwise used at the covered facility other than as part of the article, in excess of an applicable threshold quantity set forth in ( 372^5. the person is required to report under t 372.30. Persons potentially subject to this exemption should carefully review the definitions of "article" and "release" in | 372.3. If a release of a toxic chemical occurs as a result of the processing or use of an item at (he facility, that item does not meet the definition of "article." (c) Uses. If a toxic chemical is used at a covered facility for a purpose described in this paragraph (c). a person is not required to consider the quantity of the toxic chemical used for such purpose when determining whether an applicable threshold has been met under S 372^5 or determining the amount of releases to be reported under | 372.30. However, this exemption only applies to the quantity of the toxic chemical used for the purpose described in this paragraph (c). If the toxic chemical is also manufactured (including imported), processed, or otherwise used at the covered facility other than as described in this paragraph (c), in excess of an applicable threshold quantity set forth in S 372.25. the person is required to report under | 372.30. (1) Use as a structural component of the facility. (2) Use of products for routine janitorial or facility grounds maintenance. Examples include use of janitorial cleaning supplies, fertilizers, and pesticides similar in type or concentration to consumer products. (3) Personal use by employees or other persons at the facility of foods, drugs, cosmetics, or other personal items containing toxic chemicals, including supplies of such products within the facility such as in a facility operated cafeteria, store, or infirmary. (4) Use of products containing toxic chemicals for the purpose of maintaining motor vehicles operated by the facility. (5) Use of toxic chemicals present in process water and non-contact cooling water as drawn from the environment or from municipal sources, or toxic chemicals present in air used either as compressed air or as part of combustion. (d)Activities in laboratories. If a toxic chemical is manufactured, processed, or used in a laboratory at a covered facility under the supervision of a technically qualified individual as defined in | 720.3(ee) of this title. person is not required to consider the quantity so manufactured, processed, or used when determining whether an applicable threshold has been met under | 372.25 or determining the amount of release to be reported under | 372.30. This exemption does not apply in the following cases: (1) Specialty chemical production. (2) Manufacture, processing, or use of toxic chemicals in pilot plant scale operations. ABD00291804 Federal Register / Vol. 53. No. 30 / Tuesday. February 16. 1988 / Rules and Regulations 4529 (3) Activities conducted outside the laboratory. (e) Certain owners of leasedproperty. The owner of a covered facility is not subject to reporting under l 372J0 if such owner's only interest in the facility is ownership of the real estate upon which the facility is operated. This exemption applies to owners of facilities such as industrial parks, all or part of which are leased to persons who operate establishments within SIC code 20 through 39 where the owner has no other business interest in the operation of the covered facility. (0 Reporting by certain operators of establishments on leasedproperty such as industrialparks. If two or more persons, who do not have any common corporate or business interest (including common ownership or control), operate separate establishments within a single facility, each such person shall treat the establishments it operates as a facility for purposes of this Part. The determinations in | 372.22 and | 372.25 shall be made for those establishments. If any such operator determines that its establishment is a covered facility under I 372.22 and that a toxic chemical has been manufactured (including imported), processed, or otherwise used at the establishment in excess of an applicable threshold in i 372.25 for a calendar year, the operator shall submit a report in accordance with | 372.30 for the establishment. For purposes of this paragraph (f). a common corporate or business interest includes ownership, partnership, joint ventures, ownership of a controlling interest in one person by the other, or ownership of a controlling interest in both persons by a third person. Subpart C--Supplier Notification Requirement 1372.45 Notification about toxic cftemteate. (a) Except as provided in paragraphs (c). (d). and (e) of this section and 372.55. a person who owns or operates a facility or establishment which: (1) Is in Standard Industrial Classification codes 20 through 39 is set forth in paragraph (b) of 1372-22. (2) Manufactures (including imports) or processes a toxic chemical and (3) Sells or otherwise distributes a mixture or trade name product containing the toxic chemical to (i) a facility described in | 372.22. or (ii) to a person who in turn may sell or otherwise distributes such mixture or trade name product to e facility described in | 372.22(b). must notify each person to whom the mixture or trade name product is sold or otherwise distributed from the facility or establishment in accordance with paragraph (b) of this section. (b) The notification required in paragraph (a) of this section shall be in writing and shall include: (1) A statement that the mixture or trade name product contains a toxic chemical or chemicals subject to the reporting requirements of section 313 of Title U1 of the Superfund Amendments and Reauthorization Act of 1986 and 40 CFR Part 372. (2) The name of each toxic chemical, and the associated Chemical Abstracts Service registry number of each chemical if applicable, as set forth in | 372.65. (3) The percent by weight of each toxic chemical in the mixture or trade name product (c) Notification under this section shall be provided as follows: (1) For a mixture or trade name product containing a toxic chemical listed in I 373.65 with an effective date of January 1,1987, the person shall provide the written notice described in paragraph (b) of this section to each recipient of the mixture or trade name product with at least the first shipment of each mixture or trade name product to each recipient in each calendar year beginning January 1.1989. (2) For a mixture or trade name product containing toxic chemical listed in I 372.65 with an effective date of January 1.1989 or later, the person shall provide the written notice described in paragraph (b) of this section to each recipient of the mixture or trade name product with at least tha first shipment of the mixture or trade name product to each recipient in each calendar year beginning with the applicable effective date. (3) If person changes a mixture or trade name product for which notification was previously provided under paragraph (b) of this section by adding a toxic chemical, removing a toxic chemical or changing the percent by weight of a toxic chemical in the mixture or trade name product the person shall provide each recipient of the changed mixture or trade name product a revised notification reflecting the change with the first shipment of the changed mixture or trade name product to the recipient (4) If a person discovers (i) that a mixture or trade name product previosuly sold or otherwise distributed to another person during the calendar . year of tha discovery contain* one or more toxic chemicals and (ii). that any notification providied to such other persons in that calendar year for the mixture or trade name product either did not properly identify any of the toxic chemicals or did not accurately present the percent by weight of any of the toxic chemicals in the mixture or trade name product the person shall provide a new notification to the recipient within 30 days of the discovery which contains the information described in paragraph (b) of this section and identifies the prior shipments of the mixture or product in that calendar year to which the new notification applies. (5) If a Material Safety Data Sheet (MSDS) is required to be prepared and distributed for the mixture or trade name product in accordance with 29 CFR 1910.1200. the notification must be attached to or otherwise incorporated Into such MSDS. When the notification is attached to the MSDS. the notice must contain clear instructions that the notifications must not be detached from the MSDS and that any copying and redistribution of the MSDS shall include copying and redistribution of the notice attached to copies of the MSDS subsequently redistributed. (d) Notifications are not required in the following instances: (1) If a mixture or trade name product contains no toxic chemical in excess of the applicable de minimis concentration as specified in | 372.38(a). (2) If a mixture or trade name product Is one of the following (i) An "article" aa defined In 1 372.3 (ii) Foods, drugs, cosmetics, alcoholic beverages, tobacco, or tobacco products packaged for distribution to the general public. (iii) Any consumer product as the term is defined in the Consumer Product Safety Act (15 U.5.C 1251 et *?.) packaged for distribution to the general public. (e) If the person considers the specific identity of a toxic chemical in a mixture or trade name product to be a trade secret under provisions of 29 CFR 1910.1200. the notice shall contain a generic chemical name that is descriptive of that toxic chemical. (f) If the person considers the specific percent by weight composition of a toxie chemical in the mixture or trade name product to be a trade secret under applicable State law or under the Restatement of Torta section 757. comment b. the notice must contain a statement that the chemical is present at a concentration that does not exceed s specified upper bound concentration value. For example, a mixture contains 12 percent of a toxic chemicaL However, the supplier considers the specific concentration of the toxic chemical in ABD00291805 4530 Federal Register \ Vol. 53. No. 30 / Tuesday. February 16. 1980 / Rules and Regulations the product to be a trade secret. The notice would indicate that the toxic chemical te present to the mixture in a concentration of no more than 15 percent by weight. The upper bound veiue cnosen mint Be no larger than necessary to adequately protect the trade secret (g) A person rs not subject to the requirements of this section to the extent the person does not know that tne facility or establishments) is selling or otherwise distributing a toxic chemical to another person in a mixture or trade name product. However, for purposes of this section, a person has such knowledge If the person receives a notice under this section from a supplier of a mixture or trade name product and the person in turn sells or otherwise distributes that mixture or trade name product to another person. (h) If two or more persons, who do not have any common corporate or Duamess interest (including common ownership or control), as described in | 372.30(f). operate separate establishments within a single facility, each such persons shall treat the establishment) it operates as a facility for purposes of this section. The determination under paragraph (a) of this section shall be made for those establishments. INote: Suboarts D and E of the regulatory text are not reproduced nere Decause they appear in substance elsewnere in this document.]