310 CMR, § 30.864

Current through Register 1536, December 6, 2024

Section 30.864 - Research Facility License

(1)Applicability.

(a)310 CMR 30.864 is intended to protect public health, safety, and welfare, and the environment, by regulating the handling of hazardous waste on which a research study, as defined in 310 CMR 30.010, is being conducted. 310 CMR 30.864 applies to hazardous wastes on which a research study is being conducted, and does not apply to non-hazardous wastes on which such study is being conducted.

(b)310 CMR 30.864 is promulgated pursuant to the authority set forth in 310 CMR 30.001. 310 CMR 30.864 is also promulgated pursuant to the authority set forth in M.G.L. c. 21C, § 4 to waive regulation where there is no significant potential hazard to the public health, safety, or welfare, or the environment.

(c) Except as otherwise provided in 310 CMR 30.864, all procedures and requirements for licensing hazardous waste facilities, set forth in 310 CMR 30.000, are presumed to apply unless the Department is persuaded by the applicant for, or the holder of, a research facility license that the waiver of any of these requirements will not present a significant potential hazard to the public health, safety, or welfare, or the environment. The burden shall be on the applicant for, or the holder of, a research facility license to persuade the Department that the waiver of any of these requirements will not present a significant potential hazard to the public health, safety, or welfare, or the environment. The Department may deem any license requirement in 310 CMR 30.800 to be applicable. The Department may modify or waive any requirements in 310 CMR 30.800, except that the Department may modify, but may not waive, requirements regarding financial responsibility, including insurance, or procedures regarding public participation.

(d) Nothing in 310 CMR 30.864 shall preclude a site or works licensed or otherwise authorized pursuant to 310 CMR 30.099, 30.104(3)(b) and (c), 30.200, 30.801, 30.862 or 30.863 from being licensed additionally as a research facility pursuant to 310 CMR 30.864, provided that such site or works shall obtain and have in effect a valid research facility license prior to commencing construction, operation or maintenance directly associated with research study activity.

(e) Nothing in 310 CMR 30.864 shall preclude a research facility licensed pursuant to 310 CMR 30.864 from being licensed or otherwise authorized pursuant to 310 CMR 30.099, 30.104(3)(b) and (c), 30.200, 30.801, 30.862 or 30.863, provided that such research facility shall obtain and have in effect such license or authorization prior to commencing construction, operation or maintenance directly associated with such license or authorization.

(f) A license issued pursuant to 310 CMR 30.864 authorizes the licensee to store, treat, dispose or recycle hazardous waste, or otherwise to accept, handle or process hazardous waste at the research facility, only for the purpose of conducting research study activity, and only in strict compliance with the terms and conditions of such license. If any person intends to store, treat, dispose or recycle hazardous waste for a purpose other than to conduct research study activity, such person shall be licensed or otherwise authorized pursuant to 310 CMR 30.099, 30.104(3)(b) and (c), 30.200, 30.801, 30.862, or 30.863.

(2)License Application Process and Requirements.

(a)Application Form and Completeness.

1. Any person required to have a research facility license shall complete, sign, and submit an original application, plus five copies, to the Department. The Department may prescribe a form(s) which shall be used by all applicants.

2. The applicant shall be required to submit such information concerning the proposed research facility or activity as the Department may require.

3. An application, or any part thereof, shall be deemed complete when the Department receives the application or partial submission, and determines that all required information has been submitted and all applicable fees have been paid to the Department. If, however, the Department determines at any time during the review of the application that additional information is required in order to understand and evaluate the proposed research facility or activity, the Department may require such information. The Department shall request such additional information in writing.

4. The Department may either deem a license application incomplete or deny a license if an applicant fails or refuses to correct deficiencies in the application.

5. The Department may deny a research facility license before receiving a complete application for a license.

6. Research facility license applications are designated as individual rule projects and subject to the requirements set forth in 310 CMR 4.05.

(b)Preliminary Application. All research facility license applications shall include at least the following information:

1. All information required in 310 CMR 30.803;

2. A checklist of all requirements applicable to hazardous waste facilities, as set forth in 310 CMR 30.000, on a form provided by the Department, and on which the applicant preliminarily identifies those requirements that may be applicable to the research facility; and

3. A detailed description of the proposed research study activity, including, but not limited to, the following information:

a. A discussion of the purposes of the research study activity, as set forth in the definition of research study, 310 CMR 30.010, and the goals and objectives of each proposed technology, process or activity, and the methods by which the applicant will evaluate whether the proposed technology, process or activity has achieved the specified goals and objectives;

b. An analysis indicating the benefits of each proposed technology, process or activity;

c. A description of the applicability of each proposed technology, process or activity to hazardous waste management in general;

d. Identification of all types and quantities of hazardous wastes, including chemical names and waste codes, proposed to be received, handled and processed at the research facility at any one time, and to be necessary for purposes of determining the efficiency and performance capabilities of each proposed technology, process or activity;

e. A description of how the applicant intends to provide for the receipt, sampling, screening, handling, processing and ultimate treatment or disposal after processing of those types and quantities of hazardous waste proposed to be necessary for purposes of determining the efficiency and performance capabilities of each technology, process or activity;

f. A technical analysis indicating environmental, public health and safety benefits and risks from each proposed technology, process or activity to the extent such benefits and risks can be evaluated at the time of application;

g. A site plan indicating the location of the research facility if a location has been selected at the time of application, provided that if a location has not been selected at the time of application, a license decision may be granted, but shall not become final and effective until a site plan has been submitted and reviewed by the Department;

h. A preliminary operational plan generally outlining operations of the research facility, including a flow diagram, the particular types of equipment required for proper operation, and a discussion of measures to be taken to ensure the protection of public health, safety and the environment;

i. Such other descriptions, plans or information as the applicant may believe, or the Department may deem necessary to review the preliminary application.

(c)Public Notice of Preliminary Application.

1. Within ten days of determining that a preliminary application is complete, the Department will issue public notice inviting comment on the scope of the preliminary application.

2. Public notice issued pursuant to 310 CMR 30.864(2)(c) shall allow at least 15 days from the date of the notice for public comment.

3. Public notice shall be given, at a minimum, by:

a. publication, paid for by the applicant, in a daily newspaper of general circulation within the locality affected by the research facility, or in a daily newspaper of general circulation statewide if a site has not been selected at the time of preliminary application;

b. mailing notice to each city or town having jurisdiction over the area in which the facility is proposed to be located;

c. mailing notice to the board of health and the fire department of the city or town in which the research facility is proposed to be located; and

d. mailing notice to such other persons as the Department may identify.

4. All public notices issued pursuant to 310 CMR 30.864(2)(c) shall, at a minimum, contain the following information:

a. the name and address of the offices of the Department processing the license application for which notice is being given;

b. the name and address of the applicant and, if different, of the facility which is the subject of the application;

c. the name, address, and telephone number of an individual(s) from whom interested persons may obtain further information, including the locations where copies of the preliminary application may be reviewed;

d. a brief description of the research facility licensing and public comment procedures; and

e. any additional information considered necessary or appropriate.

(d)Applicability Determination. Within 15 days of the close of the public comment period provided in 310 CMR 30.864(2)(c), the Department may either:

1. Approve the scope of the application, as proposed by the applicant pursuant to 310 CMR 30.864(2)(b)2. and 3., at which time the Department shall establish, consistent with the provisions of 310 CMR 4.05, a schedule with dates by which the applicant shall supplement the preliminary application by submitting information concerning requirements identified by the applicant as being applicable to the research facility; or

2. Hold a scoping meeting, or otherwise determine, with the applicant whether any license application requirements in 310 CMR 30.800, not identified by the applicant as applicable, should be deemed applicable, modified or waived. Upon such determination, the Department shall establish, consistent with the provisions of 310 CMR 4.05, a schedule with dates by which the applicant shall supplement the preliminary application by submitting information concerning requirements determined to be applicable to the research facility.

(e)Final Application, technical Review and Decision Schedule.

1. A final application shall consist of all preliminary application submittals and all information submitted as required by the Department after public comment on the preliminary application and an applicability determination.

2. Within 30 days of deeming a final license application administratively complete for the purpose of initiating the technical review process, the Department shall prescribe the form of public participation and opportunity for comment appropriate for the level of public interest in the research facility, and establish, consistent with the provisions of 310 CMR 4.05, a decision schedule estimating dates by which it intends to conduct the technical review of the application, give public notice, complete the public comment period and issue a final license decision.

(f)Extending the Public Comment Period. The Department may extend any public comment period, prescribed pursuant to 310 CMR 30.864, and consistent with the provisions of 310 CMR 4.00, to give interested persons an opportunity to comment on information submitted. If the Department grants such an extension, notice thereof shall be given in the manner prescribed in 310 CMR 30.864(2)(c)3. Such notice shall specify any new issues to be considered.

(3)Additional Conditions of Research Facilities.

(a)Accumulation Limits and Inventory Control.

1. The research facility shall initiate, in any one day, processing on no greater total quantity of as received hazardous waste than is necessary for purposes of conducting a research study. The Department may specify limitations on the quantity of hazardous waste processed daily as a specific condition of the license.

2. The total quantity of hazardous waste accumulated at a research facility at any one time shall not at any time exceed the quantity specified in the license.

3. Until such time as the Department may issue to the research facility a license for the storage of hazardous waste pursuant to 310 CMR 30.800, the research facility shall accumulate hazardous waste, in compliance with the quantity specified in the license, for a period not to exceed 90 days from the date of generation of such wastes. The date of generation shall be either:

a. The date of receipt of as received hazardous waste by the research facility from the original generator or sample collector; or

b. The date of the processing run from which hazardous waste results.

4. Except as otherwise provided in 310 CMR 30.864(3)(a), the research facility shall accumulate all hazardous waste in compliance with the requirements of 310 CMR 30.340.

5. The research facility shall maintain a daily inventory of the type and volume of hazardous waste in each accumulation, storage, flo-bin and processing unit.

6. Any deadline set forth in 310 CMR 30.864(3)(a) may be extended only by prior written approval of the Department.

(b)Disposition of Unprocessed As Received Hazardous Waste.

1. The research facility may return all as received hazardous waste which is not used in processing a specific waste stream to the original generator or sample collector if a contractual agreement exists for the return of such waste. All such waste returned to the original generator or sample collector is subject to all applicable provisions of 310 CMR 30.310 through 30.317.

2. If the research facility does not return unprocessed as received hazardous waste to the original generator or sample collector, the research facility shall be deemed the generator of all such as received hazardous waste. All such as received hazardous waste is subject to 310 CMR 30.305 and all other applicable provisions of 310 CMR 30.000.

(c)Disposition of Waste, Residue and Material Remaining After Processing.

1. All waste and residue which result from or remain after processing a specific waste stream shall be considered hazardous waste, subject to all applicable provisions of 310 CMR 30.000, and disposed of pursuant to 310 CMR 30.864(3)(c)3. and all other applicable provisions of 310 CMR 30.000, unless the licensee demonstrates to the satisfaction of the Department that:

a. where the as received waste is a characteristic hazardous waste, the processed waste does not exhibit any of the characteristics identified and defined in 310 CMR 30.120 through 30.125; and

b. where the as received waste is a listed hazardous waste, pursuant to 310 CMR 30.130, the processed waste does not contain any of the constituents listed in Appendix VII, 40 CFR Part 261, as incorporated by reference at 310 CMR 30.162, which caused the as received waste to be listed in 310 CMR 30.130 as a hazardous waste, and does not exhibit any of the characteristics identified and defined in 310 CMR 30.120 through 30.125.

2. All other material which results from or remains after processing a specific waste stream shall be considered hazardous waste, and disposed of pursuant to 310 CMR 30.864(3)(c)3., unless the licensee manages such material as a commodity, and demonstrates to the satisfaction of the Department that such material:

a. Is commodity-like by:

i. Having commercial application as an effective substitute for a similar or corresponding virgin material or commercial product;

ii. Meeting industry-recognized and/or customer-specific quality specifications;

and

iii. Being handled and stored in a manner consistent with its use as an analogous virgin material or commercial product substitute; and

b. Does not exhibit any of the characteristics identified and defined in 310 CMR 30.120 through 30.125; and either

c. Does not contain any of the constituents listed in Appendix VII, 40 CFR Part 261, as incorporated by reference at 310 CMR 30.162, which caused the as received waste to be listed in 310 CMR 30.130 as a hazardous waste; or

d. Contains constituents listed in Appendix VII, 40 CFR Part 261, as incorporated by reference at 310 CMR 30.162, which caused the as received waste to be listed in 310 CMR 30.130, and the licensee demonstrates to the Department, and obtains prior approval, that the presence of these constituents does not pose a threat to the public health, safety, and welfare, and the environment.

3. The research facility shall handle all waste, residue and material which is hazardous waste, and is not commodity-like, or if commodity-like, is not being managed as a commodity, by:

a. Returning the hazardous waste to the original generator or sample collector in full compliance with all applicable provisions of 310 CMR 30.310 through 30.317; or

b. Causing the hazardous waste, of which the research facility is deemed the generator, to be sent off-site in full compliance with 310 CMR 30.305 and all other applicable provisions of 310 CMR 30.000; or

c. Petitioning the Department to classify the waste as non-hazardous, pursuant to the terms of 310 CMR 30.142.

(d)Recordkeeping and Reporting.

1. The research facility shall prepare and submit a report to the Department by March 15 of each year, beginning in the 1995 reporting year due March 15, 1996, that estimates the number of research studies and the amount of waste expected to be used in each study during the current year, and includes, but is not limited to, the following information about activity during the previous calendar year:

a. The name, address and EPA identification number of the research facility;

b. The type (by process) of research study being conducted;

c. The total quantity and type, including waste code, of each hazardous waste subjected to research studies;

d. The total quantity of hazardous waste in storage each day, specifying:

i. The total quantity of as received hazardous waste; and

ii. The total quantity of hazardous waste which results from processing a specific waste stream;

e. The name, address and EPA identification number of each generator or sample collector for whom a research study is being conducted;

f. The date on which each shipment was received from each generator or sample collector, and the amount of each shipment;

g. The dates on which each research study was initiated and completed;

h. A detailed description of how each as received waste stream was processed throughout the course of a research study, reporting in either mass or volume as appropriate, and specifying:

i. The total volume or mass of each waste stream introduced into each processing run;

ii. The type and volume or mass of each co-reactant that may be introduced into each processing run;

iii. The type, volume or mass, and market value of each product that may be recovered from each processing run;

iv. The type, volume or mass, disposition and cost of disposal of all residual waste that may result from each processing run;

v. The net incremental operating cost of conducting each processing run; and

vi. The gross mass balance of hazardous waste, including total amount of as received waste received from the generator or sample collector, unprocessed as received waste, and the waste, residue and material which result from or remain after processing, including co-reactants and other treatment materials (including non-hazardous solid waste) added to as received waste.

i. The final disposition of all hazardous waste generated by the research facility, as defined in 310 CMR 30.864(3)(a)1., including:

i. The name, address and EPA identification number of each transporter employed by the research facility to transport such waste;

ii. The name, address and EPA identification number of each generator or sample collector to which the research facility returns hazardous waste pursuant to a contractual agreement, or each designated facility to which the research facility transports hazardous waste;

iii. Types of waste, including waste codes, returned to each generator or sample collector pursuant to a contractual agreement, or transported to each designated facility; and

iv. Dates of each shipment.

j. An evaluation, with supporting data, analyses and any other documentation necessary to demonstrate the degree to which the research facility is achieving the goals and objectives described in accordance with 310 CMR 30.864(2)(b)3.a., including the rate of treatment, recycling and/or disposal achieved;

k. Documentation to demonstrate that the research facility accumulated each waste stream in compliance with 310 CMR 30.864(3)(a) and the terms and conditions of its license; and

l. Documentation to demonstrate that the research facility processed each waste stream in compliance with 310 CMR 30.864(3)(a) and any term and condition that may be set forth in its license.

2. The research facility shall keep on-site a copy of each contractual agreement for each research study and all shipping papers associated with the transport of hazardous waste for each study to and from the facility for a period ending not less than three years from the completion date of each study, or for the duration of any unresolved enforcement action, whichever period is longer.

3. For three years following completion of each research study conducted, or for the duration of any unresolved enforcement action, whichever period is longer, the research facility shall maintain copies of all records, documentation and information required in 310 CMR 30.864(3)(c).

4. Except as other provided in 310 CMR 30.864(3)(c), all records and copies of all applications, reports, and other documents required by 310 CMR 30.000 and the terms and conditions of a license shall be subject to 310 CMR 30.543.

310 CMR, § 30.864