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Standards Applicable to Generators of Hazardous Waste; Alternative Requirements for Hazardous Waste Determination and Accumulation of Unwanted Material at Laboratories Owned by Colleges and Universities and Other Eligible Academic Entities Formally Affiliated With Colleges and Universities
PDF Version (50 pp, 497K, About PDF) [Federal Register: December 1, 2008 (Volume 73, Number 231)] [Rules and Regulations] [Page 72911-72960] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01de08-16] [[Page 72912]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 261 and 262 [EPA-HQ-RCRA-2003-0012; FRL-8743-9] RIN 2050-AG18 Standards Applicable to Generators of Hazardous Waste; Alternative Requirements for Hazardous Waste Determination and Accumulation of Unwanted Material at Laboratories Owned by Colleges and Universities and Other Eligible Academic Entities Formally Affiliated With Colleges and Universities AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Environmental Protection Agency (EPA or the Agency) is finalizing an alternative set of generator requirements applicable to laboratories owned by eligible academic entities, as defined in this final rule. The rule provides a flexible and protective set of regulations that address the specific nature of hazardous waste generation and accumulation in laboratories at colleges and universities, as well as other eligible academic entities formally affiliated with colleges and universities. This final rule is optional and colleges and universities and other eligible academic entities formally affiliated with a college or university have the choice of managing their hazardous wastes in accordance with the new alternative regulations as set forth in this final regulation or remaining subject to the existing generator regulations. DATES: This final rule is effective December 31, 2008. ADDRESSES: EPA has established a docket for this action under Docket ID No. RCRA-2003-0012. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the EPA RCRA Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the RCRA Docket is (202) 566-0270. FOR FURTHER INFORMATION CONTACT: For further information regarding specific aspects of this notice, contact Kristin Fitzgerald, Office of Solid Waste, (703) 308-8286, Fitzgerald.Kristin@epa.gov; Patricia Mercer, Office of Solid Waste, (703) 308-8408, Mercer.Patricia@epa.gov; or Jessica Biegelson, Office of Solid Waste, (703) 308-0026, Biegelson.Jessica@epa.gov. Mail inquiries may be directed to the Office of Solid Waste, (5304P), 1200 Pennsylvania Avenue NW., Washington, DC 20460. SUPPLEMENTARY INFORMATION: I. General Information A. Entities Potentially Affected by This Rule The rule establishes a new Subpart K within 40 CFR part 262. Entities potentially affected by this final action are colleges and universities; non-profit research institutes that are either owned by or have a formal written affiliation agreement with a college or university; and teaching hospitals that are either owned by or have a formal written affiliation agreement with a college or university, that generate hazardous waste in laboratories. Today's final rule refers to these collectively as ``eligible academic entities.'' This final action is optional for eligible academic entities. That is, eligible academic entities that are large quantity generators (LQGs), small quantity generators (SQGs), or conditionally exempt small quantity generators (CESQGs) may choose to have their laboratories be subject to 40 CFR part 262, Subpart K in lieu of the existing generator regulations. In States authorized to implement the RCRA program, Subpart K would only be available as an option once it has been adopted by the State in which the eligible academic entity is located. Only eligible academic entities can participate under Subpart K for the laboratories they own. The following are examples of entities that are not eligible because they do not satisfy the definition of ``eligible academic entity:'' government facilities; commercial research and development (R&D) facilities; non-profit research institutes that are not owned by nor have a formal written affiliation agreement with a college or university; non-teaching hospitals; and teaching hospitals that are not owned by nor have a formal written affiliation agreement with a college or university. To determine whether the laboratories owned by an eligible academic entity are covered by this action, interested parties should examine 40 CFR part 262, Subpart K carefully. If there are questions regarding the applicability of the rule to a particular entity, consult your State, EPA Regional office, or the person(s) listed in the section of this preamble entitled, FOR FURTHER INFORMATION CONTACT. NAICS Codes of Entities Potentially Affected by This Final Rule ------------------------------------------------------------------------ NAICS codes Description of NAICS code ------------------------------------------------------------------------ Colleges & Universities ------------------------------------------------------------------------ 6112, 61121, 611210.................... Junior Colleges. 6113, 61131, 611310.................... Colleges, Universities, and Professional Schools. 6115, 61151............................ Technical and Trade Schools. 611519................................. Other Technical and Trade Schools. 61161, 611610.......................... Fine Arts Schools. ------------------------------------------------------------------------ Teaching Hospitals ------------------------------------------------------------------------ 54194, 541940.......................... Veterinary Services (Animal Hospitals). 622.................................... Hospitals. 6221, 62211, 622110.................... General Medical and Surgical Hospitals. 6222, 62221, 622210.................... Psychiatric and Substance Abuse Hospitals. 6223, 62231, 622310.................... Specialty (except Psychiatric and Substance Abuse) Hospitals. ------------------------------------------------------------------------ [[Page 72913]] Non-profit Research Institutes ------------------------------------------------------------------------ 5417, 54171, 541710.................... Research and Development in the Physical, Engineering, and Life Sciences. 54172, 541720.......................... Research and Development in the Social Sciences and Humanities. ------------------------------------------------------------------------ List of Acronyms ------------------------------------------------------------------------ ------------------------------------------------------------------------ APA.......................................... Administrative Procedures Act. ACE.......................................... American Council on Education. AAMC......................................... Association of American Medical Colleges. AIRI......................................... Association of Independent Research Institutes. BR........................................... Biennial Report. BMPs......................................... Best Management Practices. CAA.......................................... Central Accumulation Area. CAS.......................................... Chemical Abstract Service. CESQG........................................ Conditionally Exempt Small Quantity Generator. CFR.......................................... Code of Federal Regulations. C2E2......................................... Campus Consortium for Environmental Excellence. CSHEMA....................................... Campus Safety Health and Environmental Management Association. EH&S......................................... Environmental Health and Safety. HHMI......................................... Howard Hughes Medical Institute. HSWA......................................... Hazardous and Solid Waste Amendments of 1984. ICR.......................................... Information Collection Request. LDR.......................................... Land Disposal Restrictions. LMP.......................................... Laboratory Management Plan. LQG.......................................... Large Quantity Generator. NACUBO....................................... National Association of College and University Business Officers. NTTAA........................................ National Technology Transfer Advancement Act. OMB.......................................... Office of Management and Budget. OSHA......................................... Occupational Safety and Health Administration. PRA.......................................... Paperwork Reduction Act. Project XL................................... eXcellence and Leadership. R&D.......................................... Research and Development. RCRA......................................... Resource Conservation and Recovery Act. RFA.......................................... Regulatory Flexibility Act. SAA.......................................... Satellite Accumulation Area. SQG.......................................... Small Quantity Generator. SWDA......................................... Solid Waste Disposal Act. TSDF......................................... Treatment, Storage or Disposal Facility. UMRA......................................... Unfunded Mandates Reform Act. ------------------------------------------------------------------------ Outline I. Statutory Authority II. Background A. History and Summary of the Proposed Rule B. Rationale of the Final Rule C. Summary of the Final Rule D. Effective Date of the Final Rule III. Detailed Discussion of the Final Rule A. Scope of Eligible Academic Entities Covered Under the Final Rule 1. Hazardous Waste Generation Data 2. Laboratories Owned by Teaching Hospitals 3. Laboratories Owned by Non-profit Research Institutes 4. Laboratories Owned by Eligible Academic Entities that are Conditionally Exempt Small Quantity Generators (CESQGs) 5. Facilities with Laboratories Not Eligible to Participate in Subpart K a. Government Research Laboratories b. Commercial R&D Laboratories 6. Non-laboratory Facilities at Eligible Academic Entities B. Discussion of Definitions 1. Definitions that Have Not Changed from the Proposed Rule 2. Definitions that Have Changed from the Proposed Rule 3. Definitions that Are New C. Specific Requirements of the Alternative Regulations 1. Notification 2. Labeling Standards 3. Container Standards 4. Training Requirements 5. Removal Frequency of Unwanted Materials a. Reactive Acutely Hazardous Unwanted Materials b. Transferring Unwanted Materials or Hazardous Wastes from the Laboratory to an On-site CAA or On-site TSDF c. On-site Consolidation Areas 6. Making the Hazardous Waste Determination 7. Laboratory Clean-outs a. Summary of the Proposed Laboratory Clean-out Provisions b. Changes Made to the Laboratory Clean-out Provisions c. Changes Not Made to the Laboratory Clean-out Provisions d. Clarifications About the Laboratory Clean-out Provisions 8. Laboratory Management Plan a. Part I of the LMP b. Part II of the LMP 9. How CESQGs Comply with Subpart K and How They Differ from LQGs and SQGs 10. Off-site Consolidation a. Off-site Consolidation by CESQGs b. Off-site Consolidation by CESQGs, SQGs, and LQGs 11. Topics that Are Outside the Purview of this Rulemaking D. Reporting and Recordkeeping 1. Reporting to the Biennial Report for Eligible Academic Entities that are LQGs 2. Recordkeeping E. Implementation and Enforcement IV. State Authorization A. Applicability of Rules in Authorized States B. Effect on State Authorization V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review 1. Introduction to the Economic Assessment for the Final Rule [[Page 72914]] 2. Baseline Specification 3. Analytical Methodology, Primary Data Sources, and Key Assumptions 4. Key Analytical Limitations 5. Findings B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments G. Executive Order 13045: Protection of Children from Environmental Health and Safety Risks H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Usage I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act I. Statutory Authority These regulations are promulgated under the authority of Sec. Sec. 2002, 3001, 3002, and 3004 of the Solid Waste Disposal Act (SWDA) of 1970, as amended by the Resource Conservation and Recovery Act (RCRA) of 1976, as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA), 42 U.S.C. 6921, 6922, 6923, and 6924. II. Background A. History and Summary of the Proposed Rule This rulemaking is a culmination of many years of investigation and participation by EPA in efforts designed to better understand the challenges that the academic community faces when managing hazardous wastes generated in laboratories under the hazardous waste regulations. As discussed at length in the preamble to the proposed rule (see 71 FR 29715), these efforts include two Reports to Congress; a project under EPA's eXcellence and Leadership program (Project XL) with three colleges and universities in New England; a pilot project led by the Howard Hughes Medical Institute (HHMI) to develop and implement a performance-based approach to the management of laboratory waste at ten colleges and universities; and a public meeting on June 18, 2003, sponsored by EPA to discuss the management of hazardous waste in research and/or academic laboratories. (See the announcement of the public meeting at 68 FR 33121, June 3, 2003. The comments submitted to EPA in response to the public meeting are included in the docket for today's rulemaking.) As a result of these and other efforts, on May 23, 2006, EPA proposed alternative generator requirements applicable to college and university laboratories that generate hazardous waste (71 FR 29712 \1\ ). This preamble will refer to the alternative generator requirements as ``Subpart K,'' because it establishes a new Subpart K of 40 CFR part 262. The proposed rule provided a flexible and protective set of regulations that addressed the specific nature of hazardous waste generation and accumulation in college and university laboratories. The proposed rule was optional and colleges and universities had the choice of managing their hazardous wastes in accordance with the proposed alternative Subpart K requirements or remaining subject to the existing generator regulations. Although the applicability of the proposed rule was limited to colleges and universities, the Agency requested comment on whether it would be appropriate to expand the applicability of the final rule to other organizations that also have research or teaching laboratories. In addition, since the Agency assumed that CESQGs would not want to be subject to the increased burden of Subpart K, the proposed rule was limited to colleges and universities that are SQGs and LQGs. However, we solicited comments on whether CESQGs should be allowed to be subject to Subpart K. --------------------------------------------------------------------------- \1\ Please see page 29716 of the preamble to the proposed rule for information on other EPA efforts to improve hazardous waste management at colleges and universities through compliance assistance centers and more. --------------------------------------------------------------------------- Throughout the years of working with academic institutions, EPA has heard consistently that the greatest challenge that academic institutions face in managing their laboratory hazardous wastes under the existing generator regulations is making the RCRA hazardous waste determination at the point of generation pursuant to 40 CFR 262.11 (i.e., determining whether their solid waste is hazardous waste and assigning the proper hazardous waste code(s) in the laboratory at the time the hazardous waste is generated). This is largely because the individuals in the laboratory generating the hazardous waste and other materials are students, who are often not trained to make a hazardous waste determination. We, therefore, proposed to remove the responsibility for the hazardous waste determination from the students in the laboratory and place it in the hands of trained environmental health and safety (EH&S) professionals. While the hazardous waste remains in the laboratory, we proposed that it would be referred to as ``unwanted material,'' since the hazardous waste determination had not yet been made and some portion of the unwanted materials may be unused and therefore still usable, or may not be hazardous waste when discarded. We proposed that while in the laboratory, the P-listed commercial chemical products that were listed for reactivity would be referred to as ``reactive acutely hazardous unwanted materials.'' In lieu of making the hazardous waste determination at the point of generation, the Agency proposed that the hazardous waste determination must be made prior to removing the unwanted materials from the laboratory (but not at the time the unwanted materials are first generated), or within four calendar days of arriving at an on-site central accumulation area (CAA) or on-site interim status or permitted treatment, storage, or disposal facility (TSDF). The Agency also proposed that the unwanted materials would be regulated in the laboratory by performance-based container labeling and container management standards. These performance-based standards for the management of unwanted materials in the laboratory were coupled with a requirement for a Laboratory Management Plan (LMP). This combination provided flexibility by allowing the college or university to specify in its LMP how it would comply with the performance-based standards. The Agency co-proposed two options regarding the enforceability of the contents of the individual LMPs that colleges and universities developed. One option was that the contents of the LMP would be enforceable; the second option was that the contents of the LMP would not be enforceable. Additionally, we proposed that all containers of unwanted materials would have to be removed from the laboratory on a regular basis, not to exceed six months. However, if a laboratory accumulated more than 55 gallons of unwanted material before the regularly scheduled removal, then all containers of unwanted material would have to be removed from the laboratory within ten calendar days. Likewise, if a laboratory accumulated more than 1 quart of reactive acutely hazardous unwanted material prior to the regularly scheduled removal, then the reactive acutely hazardous unwanted materials would have to be removed from the laboratory within ten calendar days. Finally, to address the problem of laboratories keeping old, unneeded, or expired chemicals (i.e., ``legacy chemicals''), the Agency proposed regulatory provisions that would give colleges and universities incentives for conducting laboratory clean-outs: a [[Page 72915]] laboratory clean-out could occur over a 30 day period, even if the 55- gallon limit of unwanted material was exceeded; and the hazardous waste generated during a laboratory clean-out would not have to be counted toward the college or university's generator status. However, we proposed that colleges and universities could only utilize the clean- out incentives once per 12 months per laboratory. The comment period for the proposed rule was originally due to close on August 21, 2006. However, EPA received a request from the National Association of College and University Business Officers (NACUBO), on behalf of the American Council on Education (ACE), the Campus Safety Health and Environmental Management Association (CSHEMA), and the Campus Consortium for Environmental Excellence (C2E2) to extend the comment period for 45 days. On August 21, 2006, EPA extended the public comment period by 30 days (see 71 FR 48500). The comment period for the proposed rule closed on September 20, 2006. The Agency received 111 comments on the proposed rule. Approximately two-thirds of the comments were from colleges and universities, or trade groups that represent colleges and universities. In general, colleges and universities were very supportive of the Agency's effort to address the challenges they face in complying with the RCRA hazardous waste regulations in their laboratories. However, many of these commenters also suggested specific changes to the rule. Thirteen States also submitted comments. Some States expressed support for the rule, while others were very skeptical of the need for the rule. Most of the rest of the comments were from organizations that were not eligible to participate in Subpart K, as proposed. These commenters, which included non-profit research organizations, commercial companies that conduct research and manufacture pharmaceuticals and other products, as well as several Federal governmental agencies, requested that the Agency expand the scope of the final rule to allow them to be subject to Subpart K. The more significant comments on the proposal are addressed later in this preamble, in section III, but all are addressed in the Response to Comments Document for today's final rule found in the docket at http://www.regulations.gov (EPA-HQ-RCRA-2003-0012). B. Rationale of the Final Rule In the proposal, the Agency discussed how the hazardous waste generation and management practices at college and university laboratories differ from both industrial production and industrial laboratory operations in several meaningful ways (see 71 FR 29714). These differences, which were confirmed by many of the commenters, provide the rationale for today's final rule. Specifically, the Agency identified four primary differences between laboratory operations at colleges and universities and typical industrial production facilities. First, laboratories at colleges and universities have a large number of points of generation (i.e., points where waste is originally generated), such as multiple laboratory benchtops within a single laboratory and laboratories located at several areas on a single campus. Second, these laboratories tend to generate relatively small volumes of each hazardous waste at each of these points of generation. Third, the hazardous wastes generated in these laboratories tend to vary over time, as areas of research change. In contrast, industrial generators tend to have a different hazardous waste generation pattern; they tend to generate a smaller number of predictable wastestreams in large quantities at relatively few generation points. Fourth, and of particular note, is that most individuals involved in hazardous waste generation activities at college and university laboratories are students. Students are inherently transient, which makes it more difficult to train them. This fourth difference sets college and university laboratories apart not only from typical industrial production facilities, but also from non- academic, government and commercial R&D laboratories. At both industrial production facilities and non-college or university, commercial laboratories, employees who generate hazardous waste are professionally trained in managing hazardous wastes and are held accountable due to their employee status. The proposal addressed challenges faced by colleges and universities that result from these differences, and proposed to establish a new, optional Subpart K under 40 CFR part 262 for making the hazardous waste determination, and accumulating and removing unwanted materials from laboratories at colleges and universities. Comments from colleges and universities and their trade associations confirm EPA's conclusion that differences in hazardous waste generation and management activities at laboratories at academic institutions warrant this alternative set of requirements. Because of these differences, the alternative generator requirements found in Subpart K are directed at the management of unwanted materials in the laboratory and not in other areas on the same site where hazardous waste may be generated or managed. Therefore, today EPA is finalizing an alternative set of generator regulations for the management of hazardous waste generated in laboratories at specific types of academic facilities (i.e., eligible academic entities). Based on comments received on the proposed rule, as well as additional analysis, the Agency is finalizing the rule with some changes from the proposal. The Agency believes that today's final rule is better suited to the circumstances specific to these laboratories, and that it promotes environmental protection and public health through safer management of laboratory hazardous wastes. C. Summary of the Final Rule This section provides a brief overview of today's final rule and describes the major ways in which today's rule differs from the proposal. For a detailed description and justification of the changes in today's final rule, see Section III of today's preamble. The final rule establishes a set of alternative generator regulations for laboratories owned by eligible academic entities under a new Subpart K in 40 CFR part 262. Eligible academic entities may choose to be subject to Subpart K in lieu of the existing generator requirements for the management of the hazardous waste generated in the laboratories that they own. Laboratories operating under Subpart K must comply with the performance-based standards, while the unwanted materials remain in the laboratory. The eligible academic entity also must develop an LMP that reasonably addresses the nine elements that are required to be part of the LMP and that describes how the eligible academic entity will comply with the performance-based standards. The final rule also provides incentives for eligible academic entities to conduct laboratory clean-outs of old, unneeded chemicals. One of the major changes from the proposed rule found in today's final action is the Agency's decision to expand the applicability of the rule. Specifically, the scope of the final rule includes colleges and universities, non-profit research institutes that are owned by or have a formal written affiliation agreement with a college or university, and teaching hospitals that are owned by or have a formal written affiliation agreement with a college or university. In addition, although the proposed rule specifically precluded laboratories [[Page 72916]] at colleges or universities that are CESQGs from choosing to be subject to Subpart K, the final rule allows laboratories that are owned by eligible academic entities that are CESQGs, SQGs or LQGs to operate under Subpart K. We also have modified the definition of laboratory, so that additional areas within an eligible academic entity, such as photo laboratories, field laboratories, and art studios are considered laboratories. In addition, chemical stockrooms and preparatory laboratories and other areas that provide a support function to research and teaching laboratories, are allowed to operate under Subpart K. EPA recognizes that the details of hazardous waste management operations vary widely among campuses and some eligible academic entities have developed programs consistent with the existing generator regulations that have proven to be successful. Thus, these institutions may be reluctant to change from the generator regulations under which they are currently operating. Therefore, today's final rule, like the proposal, remains an optional, alternative set of requirements to the existing generator regulations and eligible academic entities may continue to manage their laboratory hazardous wastes under the current hazardous waste generator regulations. Eligible academic entities that would like the additional flexibility of today's rule may choose to manage their laboratory hazardous wastes according to the set of generator regulations we are finalizing today. Public comments received on the proposed rule confirmed that the primary difficulty with managing laboratory hazardous wastes under current regulations is making the hazardous waste determination at the point of generation. As with the proposal, the final rule addresses this challenge by providing flexibility with regard to where and when the hazardous waste determination can be made (i.e., in the laboratory before it is removed from the laboratory, or within four calendar days of arriving at an on-site CAA, or on-site TSDF), provided all unwanted materials (as defined by the rule) that are generated in the laboratory are managed according to the requirements promulgated in today's rule. EPA continues to stress that today's final rule does not alter or move the point of generation of any hazardous waste, but merely allows the hazardous waste determination to be made at an on-site CAA or on- site TSDF; or in the laboratory, but at a point in time after the initial generation of the waste. The point of generation of the hazardous waste continues to be the location and time at which the hazardous waste is first generated. Therefore, the applicability of the land disposal restrictions (LDRs) to hazardous wastes generated in the laboratory are not affected by today's rule and continue to ``attach'' at the point of generation of the hazardous waste. In addition, RCRA's statutory inspection and enforcement authorities continue to apply in the laboratory, even though under Subpart K the hazardous wastes are referred to as ``unwanted materials,'' while they remain in the laboratory. Today's final rule maintains the proposed requirement that unwanted materials must be removed from the laboratory primarily on a time basis, and secondarily on a volume basis. That is, we are requiring that eligible academic entities conduct removals of unwanted materials from the laboratory on a regular basis, not to exceed six months, although we have included some additional flexibility. If a laboratory accumulates more than 55 gallons of unwanted material (including reactive acutely hazardous unwanted material) before the regularly scheduled removal, then all unwanted materials (including reactive acutely hazardous unwanted material) must be removed within ten calendar days. And if a laboratory accumulates more than 1 quart of reactive acutely hazardous unwanted material before the regularly scheduled removal, then the reactive acutely hazardous unwanted material must be removed from the laboratory within ten calendar days. Another key issue identified by the academic community that we addressed in the proposal focused on incentives for discarding unneeded or expired chemicals that can accumulate in college and university laboratories and chemical store rooms. The academic community contends that the existing generator regulations result in discouraging laboratory clean-outs (because the increased quantities of hazardous waste generated can change the eligible academic entity's generator status) and therefore, laboratories often hold on to expired chemicals, some of which become dangerous over time. EPA believes that revising the regulations to encourage laboratories to remove legacy chemicals will result in greater protection of human health and the environment, as well as increased environmental compliance. Thus, an important part of this final rule is the laboratory clean-out provisions: once per 12 months per laboratory, a laboratory will have 30 days to conduct a clean-out and will not have to count the hazardous waste that consists of unused commercial chemical products (either listed or characteristic) generated during those 30 days towards the eligible academic entity's generator status. As in the proposed rule, today's final rule pairs a performance- based approach for management of unwanted materials in the laboratory with a requirement for the eligible academic entity to develop and implement an LMP. We believe that a performance-based approach will allow eligible academic entities greater flexibility by allowing them to tailor their laboratory waste management program with respect to container labeling, container management, and training, while ensuring better environmental results. Like the proposal, under today's final rule, the LMP must describe how an eligible academic entity will meet the required provisions (i.e., the performance-based standards) by reasonably addressing all the required elements. However, unlike the proposal, the LMP under today's final rule must include two distinct parts (Parts I and II). The eligible academic entity must comply with the specific contents it includes in Part I of its LMP, while Part II will comprise the institution's best management practices (BMPs). Thus, EPA and authorized States may take enforcement action against an institution if it fails to meet the specifics of Part I of its LMP. However, EPA and authorized States may not take enforcement action if an institution's actions vary from the specific procedures contained in Part II of its LMP, but may take enforcement action if the institution fails to reasonably address all the required elements in Part II of its LMP. In summary, the Agency believes that today's rule will lead to the safe management of unwanted materials and greater environmental protection by requiring that the RCRA hazardous waste determination be performed by trained personnel, rather than by untrained students. We also believe that today's final rule will promote the protection of human health and the environment by ensuring that all unwanted materials which may, in whole or in part, be RCRA hazardous wastes, are safely managed while in the laboratory prior to the time that the hazardous waste determination is made. In addition, EPA believes that the requirement to develop and implement an LMP will improve the coordination and integration of hazardous waste management procedures and enhance environmental awareness among researchers and students at eligible [[Page 72917]] academic entities, leading to a transfer of good environmental management practices to the larger community. D. Effective Date of the Final Rule This final rule is effective on December 31, 2008 section 3010(b) of RCRA allows EPA to promulgate a rule with an effective date shorter than six months where the Administrator finds that the regulated community does not need additional time to come into compliance with the rule. This rule is optional for those eligible academic entities that choose to follow it. For those entities, this rule provides an alternative set of requirements that are intended to provide them flexibility from current applicable regulations. Therefore, the Agency finds that the regulatory community does not need six months to come into compliance. III. Detailed Discussion of the Final Rule Today, EPA is publishing a final rule establishing alternative regulations (40 CFR part 262, Subpart K) for the management of unwanted materials generated in laboratories in eligible academic entities. This section discusses in detail the major features of the final rule and the rationale for the changes made from the proposal to today's final rule. In today's final rule and preamble, we introduce and use several new terms. We are including here a brief description of how we will use the terminology in today's preamble. First, we will use the terms ``choose to become subject to,'' ``participate under,'' ``operate under'' and ``opt in'' to Subpart K interchangeably. Second, the regulations require that in order to be eligible to opt into Subpart K, a non-profit research institute must be owned by or have a formal written affiliation agreement with a college or university, and a teaching hospital must be owned by or have a formal written affiliation agreement with a college and university. In the preamble, we will generally refer to eligible academic entities other than colleges and universities as non-profit research institutes and teaching hospitals that are owned by or formally affiliated with a college or university. Third, many eligible academic entities have multiple EPA Identification Numbers for different sections of the same ``campus,'' typically because the sections of the eligible academic entity are separated by public roads. When referring to the individual sections of an eligible academic entity, we will use the term ``site'' or ``EPA Identification Number.'' When referring collectively to all the sections of the eligible academic entity, we will use the term, ``campus,'' or ``eligible academic entity,'' or ``institution.'' As an example, when an eligible academic entity opts into Subpart K for its laboratories, it must notify the Agency for each EPA Identification Number on a campus that is opting in. A. Scope of Eligible Academic Entities Covered Under the Final Rule EPA proposed that this alternative set of generator regulations would apply only to laboratories at colleges and universities. As discussed in section II.A of today's preamble, EPA has had a long history of interaction with colleges and universities. From these interactions, the Agency has learned about the unique hazardous waste generation pattern in teaching and research laboratories at colleges and universities. However, EPA recognized that there may be additional types of facilities with laboratories that may fit the rationale for Subpart K. Thus, while the proposal was limited to colleges and universities, EPA solicited comment on whether to expand the scope of the final rule to other institutions that fit the rationale of Subpart K. Public comments from trade groups, such as the Association of American Medical Colleges (AAMC), the Association of Independent Research Institutes (AIRI), the Campus Safety Health and Environmental Management Association (CSHEMA), and individual comments submitted by non-profit research institutes, teaching hospitals, private research and development companies, governmental research laboratories, and colleges and universities with teaching hospitals and/or non-profit research institutes all asserted that their research laboratories fit the hazardous waste generation pattern rationale of today's rule. That is, these commenters assert that given the nature of research, research laboratories share the same hazardous waste generation patterns, regardless of what type of institution they are found in. In addition, EPA has conducted site visits in various research laboratories at teaching hospitals and private R&D companies, among others, and has seen similar hazardous waste generation patterns and activities of these laboratories. Based on the comments EPA received and additional research by EPA regarding the presence of students in laboratories at institutions other than colleges and universities, we have expanded the scope of the final rule to include specific additional entities that fit all aspects of the rationale for this rule. This rationale includes not only a hazardous waste generation pattern that is similar to that found at college and university laboratories, but also a significant student population. EPA did not expand the scope of the final rule to include certain entities because they did not fit all aspects of the rationale for this rule. Therefore, today's final rule allows colleges and universities, teaching hospitals that are owned by or have a formal written affiliation agreement with a college or university, and non- profit research institutes that are owned by or have a formal written affiliation agreement with a college or university, to opt into Subpart K. This expansion includes laboratories at facilities that we and many commenters believe are closely integrated with laboratories at colleges and universities. Collectively, we are calling the entities that are eligible to opt into today's final rule, ``eligible academic entities.'' Details on these entities are contained in the following sections. (For information regarding changes to the definition of laboratory, see section III.B.2 and Sec. 262.200.) 1. Hazardous Waste Generation Data In the preamble to the proposed rule, we stated that 9% of the hazardous waste generated at college and university LQGs was from laboratories. We received several comments from colleges and universities asserting that we erred in our estimates and that at their campuses, laboratory hazardous waste constituted a much higher percentage of their total hazardous waste. The Agency sent follow-up letters to several commenters requesting additional information in support of their comments. In response to our inquiries, many of the commenters supplied detailed information about their hazardous waste generation and one commenter provided a detailed analysis of our methodology for determining the percentage of laboratory hazardous waste, including specific suggestions on how to improve the methodology for the final rule. The follow-up letters and the responses are all included in the docket for today's rule. As a result of these comments, EPA has significantly revised the methodology used in the proposal to determine the total quantity of hazardous waste and laboratory hazardous waste. Specifically, in the proposal, we used key-word searches of the description field on Biennial Report (BR) forms to identify laboratory hazardous waste as a percent of the total hazardous waste generated. Our revised methodology uses three source codes [[Page 72918]] from the BR to identify which hazardous wastes are from laboratories: (1) G11--Discarding off-specification or out-of-date chemicals or products (unused chemicals or products--corresponds to P and U hazardous waste codes); (2) G22--Laboratory analytical wastes (used chemicals from laboratory operations), and (3) G09--Other production or service-related processes from which the waste is a direct outflow or result. (Because hazardous waste from the source code G09 could also be generated in non-laboratory operations, these wastes were only considered laboratory wastes if the waste form codes indicated it was shipped in a lab pack (i.e., waste form codes W001 or W004)). Additional laboratory wastes were identified using key-word searches of the description field. This revised method resulted in a much higher estimate for laboratory hazardous waste as a percent of total hazardous waste at colleges and universities--73% under the revised methodology, compared to 9% under the original methodology used in the proposed rule. This revised methodology was used to calculate the amount of laboratory hazardous waste generated as a percent of the total hazardous waste generated for colleges and universities, as well as for other types of facilities with laboratories that we considered including in today's final rule: teaching hospitals, non-profit research institutes, governmental research laboratories, and commercial R&D laboratories. For a full explanation of the methodology used to determine the amounts of total hazardous waste and laboratory hazardous waste generated at colleges and universities, teaching hospitals, and non-profit research institutes, see the memo entitled, Lab Rule Data Analyses, from ICF International to Patricia Mercer, May 1, 2008; and for hazardous waste information for LQG government research laboratories and LQG commercial R&D laboratories see the memo entitled, Final Analyses of College and University Laboratory Hazardous Waste, from ICF International to Patricia Mercer, August 17, 2007. Copies of both memos are in today's docket. Below is a table of the hazardous waste data for eligible academic entities (i.e., those entities eligible to opt into Subpart K) that are LQGs. Using the revised methodology, we now estimate that for college and university LQGs, 73% of their total hazardous waste is from laboratories. The percent of hazardous waste coming from laboratories at teaching hospitals and non-profit research institutes is even higher--81% and 92%, respectively. Further, with all three types of eligible academic entities, nearly all LQGs generate laboratory hazardous waste. ---------------------------------------------------------------------------------------------------------------- Non-profit Colleges and Teaching research universities hospitals \1\ institutes \2\ ---------------------------------------------------------------------------------------------------------------- # LQGs generating laboratory hazardous waste............ 286 104 8 # LQGs generating hazardous waste....................... 293 109 8 % that generate laboratory hazardous waste...................... 98 95 100 Tons of laboratory hazardous waste.............................. 6,530 1,712 119 Tons of all hazardous waste \3\................................. 8,951 2,119 130 % of hazardous waste that is laboratory hazardous waste......... 73 81 92 ---------------------------------------------------------------------------------------------------------------- \1\ To be eligible to opt into Subpart K, a teaching hospital must be owned by or have a formal written affiliation agreement with a college or university \2\ To be eligible to opt into Subpart K, a non-profit research institute must be owned by or have a formal written affiliation agreement with a college or university \3\ Excludes remediation wastes because remediation wastes are not regularly generated hazardous wastes, but rather are hazardous wastes generated only when a clean-up or remediation project takes place. As discussed above, based on EPA's observations, as well as comments that we have received and given the nature of teaching and research, activities conducted at teaching and research laboratories in colleges, universities, teaching hospitals, and non-profit research institutes are comparable and therefore share similar hazardous waste generation patterns. EPA identified challenges associated with the specific hazardous waste generation patterns, such as difficulty making hazardous waste determinations with a large variety of wastestreams. These difficulties, along with the difficulties associated with the presence of a significant student population, form the basis of this rule. Even at proposal, when we estimated that 9% of a college or university's hazardous waste was generated in the laboratory, we believed that these challenges were sufficient to warrant the development of Subpart K. With the revised estimates indicating that the percentage of hazardous waste generated in laboratories by eligible academic entities being much higher, these specific challenges are shown to be even more pervasive and support the need for the flexibility offered by Subpart K for these particular entities. Given that these types of organizations with research and teaching laboratories share similar hazardous waste generation patterns, we focused on the extent to which these entities had a significant student presence, which is a very important basis of today's rule. Because students are inherently transient, and generally have less accountability than professionals employed in laboratories, it is unlikely that they will make a proper hazardous waste determination which requires detailed knowledge of RCRA. The following discussion of which entities are and are not eligible to opt into today's rule focuses on whether there is a significant student presence. However, there are limited data readily available about the number of students in laboratories even at colleges and universities much less for entities, such as teaching hospitals and non-profit research institutes. Thus, we used certain factors as indications that the organization did indeed have students in the laboratories. Examples of factors indicating student presence include programs for high school, undergraduate, or graduate students to conduct laboratory research, presence of medical residents/interns, co-sponsored degree programs with colleges or universities, or classes offered independent of the college or university. 2. Laboratories Owned by Teaching Hospitals In the proposal, EPA specifically requested comment on whether laboratories in hospitals affiliated with colleges or universities should be included in the final rule. Previously, information about hospital laboratories led EPA to believe that their wastestreams are fairly routine and they [[Page 72919]] did not have the same challenges faced by college or university laboratories in training their workers. Through comments, EPA learned that many teaching hospitals owned by or formally affiliated with a college or university have research and teaching laboratories in addition to diagnostic laboratories dedicated to patient care. As stated earlier, research laboratories at teaching hospitals have similar hazardous waste generation patterns as research laboratories on a college or university campus. In addition, such teaching hospitals have students working in the laboratories to learn how to run various tests, how to operate equipment, or to conduct research with professors. In fact, one commenter asserted that, ``these types of laboratories [laboratories at college or university affiliated hospitals and other similar locations such as dental colleges, clinics and associated laboratories] are very similar to instructional and research laboratories. They are used by a large number of students; they are used for instructional and research purposes; while some processes are static and predictable, others are not; large numbers of different wastestreams are produced, but in relatively small quantities.'' Another commenter wrote, ``Research labs in a hospital are essentially the same as a research lab in a college or university and have similar waste generation patterns.'' Based on these comments, EPA conducted additional research into the types of laboratories that are present at teaching hospitals that are owned by or formally affiliated with a college or university. In particular, EPA identified three types of laboratories: (1) Clinical diagnostic laboratories that conduct typical laboratory tests related to patient care, (2) applied research laboratories that conduct clinical trials and (3) research laboratories that conduct basic medical research. While strictly speaking, clinical diagnostic laboratories may not exhibit the hazardous waste generation pattern identified in the rationale for this rule, we found that the setup in teaching hospitals makes it difficult to draw hard distinctions between the various types of laboratories. That is, each teaching hospital divides its laboratory space differently and oftentimes a single laboratory serves multiple functions, such as both diagnostic testing and research. Furthermore, in some cases, laboratory personnel perform multiple functions within a laboratory and are involved with both diagnostic and research activities. Thus, EPA has determined that it would be extremely difficult to implement a rule that made a distinction between the various types of laboratories at such teaching hospitals. The Agency also analyzed data from the BR which are sent to the Agency every other year by LQGs and housed in EPA's RCRAInfo database, to find out more about the universe of non-teaching and teaching hospitals owned by or formally affiliated with a college or university and their hazardous waste generation patterns. Notably, one of the main differences between the hazardous waste generation patterns at LQG teaching hospitals owned by or formally affiliated with a college or university and non-teaching hospitals is in the amount of laboratory hazardous waste as a percentage of the total amount of hazardous waste generated. Specifically, teaching hospitals showed approximately 80% of the total quantity of hazardous waste generated coming from laboratories, while non-teaching hospitals only had 13% of the total quantity of hazardous waste generated coming from laboratories. EPA attributes this disparity to be the result of the greater amount of research generally occurring in teaching hospitals owned by or formally affiliated with a college or university. In terms of the transient students, EPA has learned from its research that teaching hospitals instruct a variety of students-- interns, residents, nursing students, laboratory technicians, and more, in the hospital. Instruction of these students includes work in the laboratories to learn about the processes and tests conducted there, introducing similar difficulties as those encountered at colleges and universities in teaching and training transient students and making the hazardous waste determination. In fact, one commenter asserted that, ``the amount of time a student spends at a teaching hospital is comparable to that of a graduate student in another laboratory discipline.'' Also, medical research at a college and university oftentimes is shared between the college and university laboratories and teaching hospital laboratories. One commenter pointed out that professors, graduate students, and undergraduate students often go back and forth between laboratories at colleges and universities, and at teaching hospitals, to conduct research. EPA recognizes that a teaching hospital that is owned by a college or university will instruct students from its medical school. However, due to the complex healthcare system, many times medical students or residents from a medical school will train in a teaching hospital that is affiliated with a college or university, but not owned by the college or university. We do not want to preclude these teaching hospitals that are training students and have a significant transient student population from participating in Subpart K. Therefore, EPA looked for a way to define the concept of ``affiliated teaching hospital.'' We discovered that the Accreditation Council for Graduate Medical Education (ACGME) defines two types of agreements between a medical school and a teaching hospital: A master affiliation agreement and a program letter of agreement.\2\ EPA has determined that the presence of both these agreements indicates that a teaching hospital is formally affiliated with a college or university. --------------------------------------------------------------------------- \2\ The ACGME defines these terms in the ``Glossary of Terms'' that appears on its Web site at http://acgme.org/acWebsite/about/ ab_ACGMEglossary.pdf.The ACGME also describes these documents in more detail in a document called Frequently Asked Questions Related to Master Affiliation Agreements and Program Letters of Agreement that appears on its Web site at http://acgme.org/acWebsite/about/ ab_FAQAgreement.pdf.