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I. OVERVIEW
The Research and Development (R&D) Stakeholders' Task Force held a conference call on January 7, 1998 to discuss regulations affecting R&D, R&D industry structure, and information needs for determining whether R&D should be listed as a category of major sources of hazardous air pollutants (HAP).
II. PARTICIPANTS
A list of attendees is provided in Attachment A.
III. ACTION ITEMS
1. The next conference call will be from 10:30 am to 12:30 p.m. (EST) on Friday, January 30, 1998. The purpose of the call will be to review information received and to discuss the mechanism for additional data gathering.
2. Keith Barnett will provide a summary of public comments on the Advanced Notice of Proposed Rulemaking (ANPR) [May 12, 1997; 62 FR 25877] by January 30, 1998.
3. Keith Barnett will provide a table of information collected by EPA on emissions from R&D by January 30, 1998.
4. Task Force members agreed to provide input to Keith Barnett on other regulations impacting R&D by January 21, 1998. This input will include state air regulation impacts on R&D, Occupational Safety and Health Administration (OSHA) regulation requirements for pilot plants and other R&D, and State and Federal building code requirements for R&D.
5. Task Force members agreed to provide input to Keith Barnett and Anne Gross concerning university pilot plants, manufacturing scale equipment, and contract manufacturing by January 21, 1998.
6. Task Force members agreed to provide input to Keith Barnett on industry structure as soon as possible, but no later than January 21, 1998 for the industry segments that do not have a large amount of R&D. This information should include details on the types of research conducted in various industry sectors. Input from industry sectors with a lot of research activities (such as the chemical and petroleum refining industries) will be provided by February 13, 1998.
7. Shannon Broome agreed to send data concerning HAP emissions from jet engine manufacturing to Keith Barnett.
8. Keith Barnett agreed to contact environmental groups regarding information on R&D.
IV. CONFERENCE CALL SUMMARY
The conference call attendees discussed the agenda items (Attachment B) in order, as follows. Recommendations concerning each item were developed.
1. Discuss other regulations affecting R&D and set schedule for stakeholder input.
Mr. Barnett presented information (Attachment C) concerning regulations affecting R&D, and requested input from Task Force members. Ms. Broome believed that Indiana has a pilot plant policy, and will confirm whether this is correct. Ms. Hoenke indicated that the Bay Area Air Quality Management District (San Francisco, CA) has a pilot plant policy. Mr. Cerchiaro stated that New Jersey has a policy that impacts R&D laboratories, but that it is expected to be discontinued.
Ms. Hoenke mentioned the Toxic Substances Control Act (TSCA), Resource Conservation and Recovery Act (RCRA), and Superfund Act Reauthorization Authority (SARA 313) as other statutes impacting R&D. She also noted that the preamble to the Hazardous Organic National Emission Standard for Hazardous Air Pollutants (HON) rule contained a lengthy discussion of applicability for R&D. Mr. Barnett replied that RCRA concerns solid waste, not air emissions. Mr. Dholakia believed that the environmental groups might have useful information on R&D. Mr. Barnett indicated that they have been contacted regarding participation in the Task Force and declined to participate, but he agreed to contact them again.
Mr. Goldhammer noted that TSCA exempts R&D. The group then discussed whether examples of statutory and regulatory exemptions for R&D, in particular those outside of the Clean Air Act (CAA), would be useful for making a listing decision under the CAA. Mr. Barnett acknowledged that the rationale for exempting R&D may be useful. Mr. Barnett asked that Task Force members send statutory and regulatory citations concerning R&D, including exemptions, by January 21, 1998.
2. Discuss industry structure information and set schedule for stakeholder input.
Mr. Barnett presented information (Attachment D) concerning R&D industry structure, and asked for input from Task Force members. He explained that the purpose of the information was to list all sectors where R&D occurs to provide a framework for data gathering. The EPA would like to obtain information concerning the R&D industry to determine which sectors may be eliminated from the listing decision.
Mr. Barnett emphasized that the likelihood column on the table in Attachment D referred to the probability that research was conducted in a particular sector, and the amount of information that would likely need to be collected to make a listing decision. It did not indicate the amount of emissions or the probability that a particular segment would be regulated. Task Force members objected to this labeling, however, and it was agreed that this column would be deleted from future versions of the table.
Mr. Bernson questioned why universities were not included on the table, stating that the semiconductor industry has given manufacturing scale equipment to universities for them to conduct research. He was concerned that industry would be at a competitive disadvantage if university research was not regulated. Other Task Force members shared his concern. Mr. Goldhammer was aware of approximately 12 universities with fairly large biotechnology pilot plants. Mr. Barnett indicated that the EPA is interested in information concerning university pilot plants. The Task Force members agreed to send information concerning pilot plants, contract research, or manufacturing scale equipment at universities to Mr. Barnett and copy to Ms. Gross by January 21, 1998.
Mr. Cerchiaro questioned
whether the information gathering would include research on existing
products and processes, in addition to the research on new products
and processes that is stated as the definition of R&D in 112(c)(7)
of the CAA. Mr. Barnett indicated that the information gathering should
initially focus on all aspects of R&D, including that on existing
products and processes. The EPA is not limited to focusing on new products
and processes, and would like to be sure all types of R&D are identified
before determining what may need to be listed.
Mr. Bernson wondered how this would impact R&D groups located at
manufacturing facilities, who are conducting research on existing products
and processes. Mr. Barnett replied that this had not been determined
yet.
Ms. Broome indicated that she had information concerning emissions from jet engine testing, which she would forward to Mr. Barnett. This information shows that HAP emissions are below major source threshold levels, she stated. Therefore, emissions from jet engine testing R&D should also be below the major source threshold levels.
Mr. Barnett advised the Task Force that he would be sending some information regarding R&D laboratories for their review. The information defines various types of laboratories. It would be used in a similar fashion to the industry structure information for other types of R&D-- to identify the spectrum of R&D laboratories as a framework for data collection and listing decisions.
3. Discuss information needs for listing decision. Discuss mechanism for collecting and reviewing data.
Mr. Barnett presented information (Attachment E) concerning EPA's information needs for the listing decision, and requested input from Task Force members. He explained that the Agency's goal is to identify the R&D universe and eliminate parts of the universe that would not need to be listed. Mr. Barnett indicated that the EPA is interested in receiving readily available information that has already been compiled, including information on actual annual emissions in tons per year (tpy). Emissions information is necessary to make the listing decision.
Task Force members objected to providing emissions information at this stage. They believed instead that the Task Force goal was to develop a strategy for getting the information. They also believed that there was no readily available information that would be useful, and that preparation of a specific detailed questionnaire would be necessary to obtain such information. Responding to the information request would also take time, as the issues are complex. Mr. Barnett maintained that existing emissions information, such as that submitted to States as part of permit applications, would be readily available and would assist in determining what types of R&D might not need to be listed.
It was agreed that the Task Force would focus on defining the industry structure by January 21, 1998, and delay information requests. Task Force members agreed that determining the mechanism for obtaining information was a critical goal, however. Mechanisms for collecting information will be discussed on the next conference call, scheduled for January 30, 1998.
Ms. Broome noted that control efficiency could not be assumed by comparing before and after emissions, as suggested in Attachment E. She explained that flow rate, type of throughput, and other factors impact control device efficiency. Mr Barnett acknowledged that these are important considerations in developing a regulation. However, the purpose of this information is to determine uncontrolled emissions for the listing decision.
Task Force members expressed their concerns regarding possible regulation of collocated R&D. Mr. Barnett explained that the current EPA Office of General Counsel (OGC) position is that R&D that is collocated at a major source would be subject to regulation. That is, if the HAP emissions from the R&D operations are below major source thresholds but the R&D is located on the same plantsite (contiguous and adjacent property that is co-owned) that is a major source of HAP, then R&D operations would be considered major for any R&D NESHAP rule that may be developed. Task Force members preferred the requirements in the Federal operating permit regulations at 40 Code of Federal Regulations (CFR) Part 70, which allow a separate applicability determination for collocated R&D. Mr. Barnett explained that the EPA would carefully consider technical information when received to determine whether it would be appropiate to include any collocated R&D facilities in the source category listing.
Mr. Cerchiaro questioned when the EPA would share information that it had collected. Mr. Barnett indicated that the summary of public comments on the ANPR and a table of emissions information would be available by the end of January, 1998.
Attachment C:
E-mail from Keith Barnett, dated 1/2/98:
One item that was discussed in the last conference call was other regulations that may affect air emissions form R&D facilities. I have complied a list of the regulations I am aware of. Please review this list and let me know if there are regulations I have not listed that impact R&D and that we should be considering in our listing decision.
State and Federal Regulations that Currently Impact R&D Facilities
1. State Air Emission Regulations
a. Laboratories - we know of no state that regulates or requires controls on bench scale laboratories. At one time the state of New York permitted R&D operations including lab hoods. However R&D operations in New York have recently been exempted form permitting.
b. Scale up operations and pilot plants - New Jersey has a pilot plant policy. Kentucky does not exempt pilot scale operations.
We are requesting input from stakeholders on other states that require permits and/or controls on scale up or pilot plant operations.
2. OSHA regulations.
OSHA has regulations concerning Occupational Exposure to Hazardous Chemicals in Laboratories. These regulations require that employers develop a written Chemical Hygiene Plan. The regulations also refer to Prudent Practices in the Laboratory developed by the National Research Council. These regulations are not specifically designed to reduce air emissions, some of the practices listed (such as requiring containers be closed when not in use, and prohibiting the evaporation solvents in lab hoods in lieu of proper disposal), will tend to reduce air emissions.
The OSHA laboratory regulations do not apply to pilot plant operations.
3. Building Codes
In some cases building codes have control requirements when toxic substances are used.
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