Syncor International Corp. - Ruling, August 6, 1997
Ruling, August 6, 1997
STATE OF NEW YORK: DEPARTMENT OF ENVIRONMENTAL CONSERVATION
In the Matter of an Application for permits
to store and transfer regulated medical waste,
and to discharge radioactive materials at a
radiopharmaceutical facility pursuant to
Article 27, Title 7 and Article 37 of the NYS
Environmental Conservation Law (ECL),
and Parts 360 and 380 of Title 6 of the
Official Compilation of Codes Rules and
Regulations of the State of New York
(6 NYCRR) in the Bronx by
RULING ON REQUESTS FOR
PARTY STATUS AND ISSUES,
2-6005-123/1 and 2
SYNCOR INTERNATIONAL CORPORATION
2300 Westchester Avenue
August 6, 1997
Based on previous decisions of the Commissioner regarding other Applicants' records of compliance, and the competent offer of proof made by the Bronx Community Board No. 10, there is a substantive and significant issue about the Applicant's compliance history. I grant the Bronx Community Board No. 10's request for full party status, and the joint request for amicus status filled by NYS Senator Guy J. Velella and NYS Assemblyman Stephen B. Kaufman.
Further proceedings to consider the Applicant's compliance history, however, are not necessary because the record on this issue is complete and fully developed. At the Issues Conference, the Parties agreed on which documents to include in the hearing record. These documents establish the uncontroverted facts of the case. Consequently, no factual disputes need to be resolved through an adjudicatory hearing. The Parties also have had opportunities to present oral and written argument about the Applicant's compliance history.
Since the record concerning this issue is complete, this ruling includes a recommended decision. Based upon my review of the record, I conclude that the Applicant is able to operate the Bronx facility in a lawful and environmentally protective manner. A schedule for filing appeals with the Commissioner concerning the ruling and the recommended decision is provided below.
At an existing nuclear (or radio-) pharmacy at 2300 Westchester Avenue, Bronx, NY (the Facility), the Syncor International Corporation (20001 Prairie Street, Chatsworth, CA) proposes to store and transfer regulated medical waste, and to discharge Iodine-131 and Xenon-133 to the environment from a laboratory exhaust hood. The Facility would generate about 750 lbs/month The estimated amount of regulated medical waste that may be generated per month is greater than the amount initially identified in the June 6, 1996 Notice of Complete Application. The Department Staff should review the terms of Additional General Condition 2 of the draft Part 360 permit [Exhibit 2-3, page 3 of 3], and if necessary change the weight limit for the amount of regulated medical waste that the Applicant may store at the Bronx facility. of regulated medical waste. The medical waste would consist of syringes, originally dispensed from the Facility, used in the diagnosis and treatment of medical disorders, and then retrieved by Syncor. The Applicant would temporarily store the medical waste in an appropriate containment area at the Facility until any residual radioactive materials decay to background levels. Subsequently, the non-radioactive medical waste would then be transported off site for final disposal.
REGULATORY AGENCIES AND THEIR RESPECTIVE APPROVALS
Syncor's Bronx facility is a pharmacy that dispenses unit dose prescriptions based on physicians' orders. Therefore, as required by NYS Education Law Article 137, Section 6808, the Facility has registered with the NYS Board of Pharmacy (Registration No. 021810). The registration is effective through December 31, 1998 [Exhibit 16].
Because the prescriptions compounded and dispensed at Syncor's Bronx pharmacy contain radioactive materials, additional regulatory agencies have jurisdiction over the Facility's operations. These include the NYS Departments of Labor, and Environmental Conservation. The following briefly explains the basis for the agencies' regulatory authority and the scope of that authority.
To regulate the use of radioactive materials, the US Congress passed the Atomic Energy Act (AEA), which created the Atomic Energy Commission. In the late 1950's, Congress amended the AEA to provide for agreements between the US Atomic Energy Commission and the states (AEA 2021). Subsequent amendments to the AEA abolished the Atomic Energy Commission and transferred its regulatory functions to the Nuclear Regulatory Commission (NRC).
The agreements authorized by AEA 2021 transfer federal regulatory authority from the NRC to the states provided the state programs adequately protect the public health and safety. The transfer process authorized by AEA 2021 is different from the delegation process which the US Environmental Protection Agency administers through grant programs.
New York State became an agreement state in 1962. The current agreement between the NRC and New York State identifies the NYS Departments of Health, Labor, and Environmental Conservation as well as the New York City Department of Health as agencies that can issue radioactive materials licenses to facilities located in the state.
For commercial and industrial facilities, like Syncor's Bronx facility, the NYS Department of Labor is responsible for reviewing applications and issuing licenses to possess and use radioactive materials. The NYS Department of Health issues similar licenses for medical, academic and governmental facilities outside New York City. The New York City Department of Health has authority to issue licenses to medical, academic and governmental facilities within the City of New York.
With the creation of the NYS Department of Environmental Conservation (DEC) in 1970, the DEC obtained regulatory authority over the discharge and disposal of any radioactive materials to the environment, as well as the transport of all low-level radioactive waste. Between 1962 and 1970, the NYS Department of Health had regulated these activities.
Every two years, the NRC inspects the agencies that administer the New York State agreement. As part of the NRC's review of the Department's program, NRC Staff accompany DEC inspectors when visiting facilities permitted by the Department. In particular, NRC Staff have accompanied the Department Staff on inspections of Syncor's facilities in New York State.
Since New York State is an agreement state as described above, the NYS Departments of Labor and Environmental Conservation have jurisdiction over Syncor's Bronx facility. Although the captioned permit applications relate to a facility located in the Bronx, the New York City Department of Health does not have jurisdiction over this facility because Syncor's Bronx facility is a commercial rather than a medical, academic or governmental facility.
The NYS Department of Labor, Division of Safety and Health, Radiological Health Unit issued a Radioactive Materials License [Exhibit 15] for the Bronx facility on January 20, 1994. The License authorizes Syncor to receive, possess, use and transfer the radioactive materials identified in the License for the purpose of preparing radiopharmaceuticals to licensed recipients. Unless otherwise permitted by the NYS Department of Environmental Conservation, the License does not authorize any discharge to the environment except as provided by 12 NYCRR 38.23 [Exhibit 15, Condition 13].
The DEC's regulatory authority over the Facility relates to two program areas: (1) the transport and storage of regulated medical wastes [6 NYCRR Part 360], and (2) the discharge of radioactive materials to the environment [6 NYCRR Part 380]. The Department has jurisdiction over the Facility pursuant to Part 360 because Syncor takes back the spent syringes from the doctors and medical facilities that order prescriptions from Syncor. The spent syringes are regulated medical waste as defined by 360-17.2(h).
An Order on Consent dated May 2, 1997 (DEC Case No. R2-0160-97-01) [Exhibit 12] allows Syncor's Bronx facility to undertake activities regulated by Part 360 pending a final determination on the captioned permit applications. The Applicant temporarily stores the spent syringes at the Facility until any residual radioactive material decays to background levels. Then, the spent syringes are removed from the Facility by a certified regulated medical waste hauler to a final disposal facility [Exhibit 2-7, Page 2]. In addition, the Applicant has agreed to the terms of a draft permit prepared by the Department Staff [Exhibit 2-3]. The draft permit conditions are essentially the same as the terms of the Consent Order.
Activities regulated by 6 NYCRR Part 380 relate to compounding and dispensing prescriptions containing Iodine-131 and Xenon-133. Preparations containing these particular isotopes are volatile and must be prepared under a laboratory exhaust hood that would be vented to the roof of the building currently occupied by Syncor. The proposed laboratory exhaust hood system includes a carbon filter that would trap most of the volatilized radioactive particles to prevent their release to the environment. The radioactive substances currently compounded and dispensed at the Facility are authorized by the NYS Department of Labor Radioactive Materials License. The compounds authorized by the License do not trigger the regulatory requirements outlined in 6 NYCRR Part 380 because those substances are not volatile.
At the present time, Syncor is not discharging any radioactive substances to the environment. The Applicant has agreed to the terms of a draft permit prepared by the Staff [Exhibit 2-1] which limit the annual discharges of Iodine-131 to 500 microcuries (Ci), and Xenon-133 to 200 millicuries (mCi).
The terms of the draft permits require the Applicant to obtain any other necessary permits or approvals [Exhibits 2-1 and 2-3, General Condition 8].
STATE ENVIRONMENTAL QUALITY REVIEW ACT (SEQRA)
The Applicant's proposal is an unlisted action according to ECL Article 8 (State Environmental Quality Review Act) and its implementing regulations, 6 NYCRR Part 617. The Region 2 Department Staff issued a Negative Declaration on June 6, 1996.
The Notice of Public Hearing, dated April 28, 1997, (the Notice) appeared in the Department's Environmental Notice Bulletin on May 2, 1997. The Applicant published the Notice in El Dario, a Spanish language newspaper, on May 7, 1997, as well as the Bronx Times Reporter and the Bronx News on May 8, 1997. As provided by the Notice, Administrative Law Judge Daniel P. O'Connell presided over legislative hearing sessions concerning the applications on June 2, 1997 at the Knights of Columbus, 3243 Ampere Avenue, Bronx, NY at 1:00 PM and again at 7:00 PM.
About 110 people attended the two legislative hearing sessions. The 33 speakers included federal, state and local officials, residents from the community, the Applicant's representatives, and the Department Staff. Other individuals and organizations submitted written statements. Although there is some support for the Facility from the medical community who uses the services provided by Syncor, most oppose the Facility. In general, the comments made at the public hearing focused on the proximity of the proposed Facility to residential areas, public health impacts, and the Applicant's activities at its other facilities in New York State and throughout the country.
An Issues Conference was held on June 10, 1997 at the Knights of Columbus, 3243 Ampere Avenue, Bronx, NY. Bronx Community Board No. 10 (the Community Board) timely filed a petition for full party status. NYS Senator Guy J. Velella and NYS Assemblyman Stephen B. Kaufman timely filed a joint request for amicus status.
Clifford Case III, Esq. and William H. Sloane, Esq. from Carter, Ledyard & Milburn, New York, NY represented the Applicant. Laurie Silberfeld, Esq., Assistant Regional Attorney, appeared for the Region 2 Department Staff. The Community Board was represented by its District Manager, James Vacca. James Heekin, Esq. represented Senator Velella and Assemblyman Kaufman. Mr. Heekin is Assemblyman Kaufman's Counsel.
At the Issues Conference, ALJ O'Connell took official notice of the Department's Record of Compliance Enforcement Guidance Memorandum dated March 5, 1993. The EGM had been distributed to the Parties with a memorandum dated June 4, 1997.
The Office of Hearings and Mediation Services received the stenographic transcripts for the legislative hearing sessions on June 9, 1997, and the Issues Conference on June 18, 1997. The record of the Issues Conference closed on August 4, 1997 upon the timely receipt of the replies from the Issues Conference participants concerning Exhibit 17 and a newspaper article submitted by the Community Board.
RULINGS ON REQUESTS FOR FULL PARTY STATUS AND AMICUS STATUS
As provided by 6 NYCRR 624.5, the Parties to any adjudicatory hearing are the Applicant, the Department Staff and those who have been granted full party status. The criteria for determining whether the Administrative Law Judge should grant petitions for full party status are provided in 624.5(d)(1).
Upon review of these criteria and the petition for full party status, I find that the Bronx Community Board No. 10 has filed an acceptable petition [624.5(b)(1) and (2)]. As explained in detail below, the Community Board has raised a substantive and significant issue about the Applicant's compliance history. Finally, the Community Board has shown an adequate environmental interest. Therefore, I grant the Community Board's request for full party status.
NYS Senator Guy J. Velella and NYS Assemblyman Stephen B. Kaufman jointly filed a petition for amicus status. The criteria for determining whether the Administrative Law Judge should grant petitions for amicus status are provided in 624.5(d)(2). After reviewing these criteria and the petition for amicus status, I find that Senator Velella and Assemblyman Kaufman filed an acceptable petition [624.5(b)(1) and (3)]. Therefore, I grant their joint request for amicus status.
RULINGS ON ISSUES FOR ADJUDICATION
At the Issues Conference, the Staff stated that the Facility, as conditioned by the draft permits, would conform to all applicable statutory and regulatory requirements. Accordingly, the Staff stated there are no issues for adjudication provided the Applicant accepts the terms of the draft permits.
The Applicant accepted the terms of the draft permits, and contended there were no issues for adjudication.
Standards for Determining Issues
Section 624.4(c) outlines the standards for adjudicable issues. When, as here, the Department Staff has determined that the Project, as conditioned by the draft permits, would conform to all applicable statutory and regulatory requirements, the burden of persuasion is on the potential party advancing the issue to show that the proposed issue is both substantive and significant [624.4(c)(4)].
An issue is substantive if there is sufficient doubt about the Applicant's ability to meet the applicable statutory or regulatory criteria such that a reasonable person would inquire further. To determine whether an issue is substantive, the ALJ must consider the proposed issue in light of the application and related documents, the draft permits, the content of any petitions filed for full party status and amicus status, the record of the Issues Conference, and any subsequent written arguments authorized by the ALJ [624.4(c)(2)]. An issue is significant if the adjudicated outcome can result in permit denial, a major modification to the proposed project, or the imposition of significant conditions in addition to those proposed in the draft permit [624.4(c)(3)].
At the legislative hearing, many speakers stated that the Commissioner should deny Syncor's permits because the Facility, which is currently operating at 2300 Westchester Avenue in the Bronx, is not compatible with other activities on the site. The site includes a large, three-story building with a parking lot. Adjacent to the building is a small outdoor playground. Syncor leases a portion of the basement. Other tenants in the building at 2300 Westchester Avenue include a day-care center and physicians' offices. Members of the public also objected to having a nuclear pharmacy at this location due to the residential nature of the surrounding neighborhood.
During the Issues Conference, Mr. Vacca contended that the City of New York owns the building located at 2300 Westchester Avenue, and stated that the Westchester Creek Development Corporation manages the building for the City. According to Mr. Vacca, a letter dated July 14, 1997 from Delores Barbieri from the NYC Department of Administrative Services confirms that the City owns the building.
In a letter dated July 30, 1997, Mr. Vacca requested that the Applicant obtain a letter of approval from a representative of the City of New York before the Department issues the pending permits. Mr. Vacca argued that if the City knew that Syncor was operating a nuclear pharmacy at 2300 Westchester Avenue, then the City would not let Syncor stay at the site.
Before operations began in February 1994, Syncor's Bronx facility obtained a Certificate of Occupancy from the NYC Building Department. Subsequently, the City of New York Environmental Control Board issued Syncor a Notice of Violation on August 1, 1996 [NOV #34139938Z]. An administrative hearing was held on September 30, 1996 to consider the Notice of Violation.
At issue was whether Syncor's Bronx facility could operate its nuclear pharmacy in a district zoned M-1. In the Decision and Order dated March 3, 1997 [Exhibit 13], Administrative Law Judge Joanne F. Furner determined that Syncor's operations at 2300 Westchester Avenue meet the criteria for Use Group 17, which is permitted within an M-1 zoning district. The ALJ's Decision and Order does not explain what the criteria for Use Group 17 are. Consequently, ALJ Furner dismissed the Notice of Violation against Syncor.
Any question about whether Syncor's facility located at 2300 Westchester Avenue, Bronx, NY, complies with local zoning has already been decided by ALJ Furner of the New York City Environmental Control Board. Moreover, the NYS Department of Environmental Conservation has no authority to decide disputes concerning local approvals. [See Hingston v. New York State Dept. of Environmental Conservation, 202 AD2d 877, 609 NYS2d 446 (3d Dept. 1994); Town of Poughkeepsie v. Flacke, 84 AD2d 1, 445 NYS2d 233 (2d Dept. 1981), lv. denied, 57 NY2d 602, 454 NYS2d 1026 (1982).]
Mr. Vacca's request for a letter of approval from a representative of the City of New York appears to be redundant of the Applicant's obligation to obtain a Certificate of Occupancy from the NYC Building Department. ALJ Furner of the New York City Environmental Control Board has already ruled on Syncor's Certificate of Occupancy. In addition, Mr. Vacca's request relates to a dispute concerning local approvals. Based on the case law cited above, I have no authority to grant Mr. Vacca's request. Therefore, I deny it. As noted above, however, the draft permits require the Applicant to obtain any other necessary permits or approvals [Exhibits 2-1 and 2-3, General Condition 8].
The discussion at the Issues Conference focused primarily on the Applicant's compliance history. The following briefly summarizes the positions of the Issues Conference participants with respect to this proposed issue.
The Bronx Community Board No. 10 wants the Commissioner to deny Syncor's permits for the Bronx facility based on the Applicant's poor record of compliance. In its petition for full party status, the Community Board asserted that Syncor violated various provisions of the ECL and implementing regulations at its other facilities in New York State. To support these assertions, the Community Board offered correspondence from the Department's files which document these violations.
In addition, the Community Board alleged that Syncor violated federal requirements at its facilities in Kansas City, Missouri and Pittsburg, Pennsylvania. To support these claims, the Community Board referred to documents from the US Nuclear Regulatory Commission.
Finally, the Community Board contended that an inquiry into the Applicant's compliance history is necessary because the Bronx facility has operated for three years without a Part 360 permit. The Community Board argued that Syncor's compliance history is a substantive and significant issue which should be considered further.
NYS Senator Guy J. Velella and NYS Assemblyman Stephen B. Kaufman, are concerned because the Facility is located in a residential community. The Legislators asserted that the documents and correspondence identified by the Community Board establish a pattern of non-compliance by the Applicant. The Senator and Assemblyman are concerned that operations at the Bronx facility could have an adverse effect on the safety and health of the people in the communities they represent. Consequently, Senator Velella and Assemblyman Kaufman argued that the Commissioner should consider the Applicant's compliance history a substantive and significant issue.
The Department Staff argued there were no factual disputes concerning the Applicant's compliance history that require adjudication. Referring to the September 27, 1993 Consent Order [Exhibit 5], the Staff explained there were problems at Syncor's New York facilities in the early 1990's. Subsequent inspections, however, show that Syncor implemented all the terms of the compliance schedule outlined in the September 1993 Consent Order.
According to the Applicant, there are no disputed facts because the documents identified during the Issues Conference show what has occurred at Syncor's facilities, and the action that the Department Staff has taken. The Applicant contended that the intervening Parties do not disagree about what the facts are. Rather, they disagree with the way that the Department exercised its regulatory authority. Such disagreement, the Applicant contended, does not identify an adjudicable issue.
Ruling and Discussion: Based on previous Commissioners' decisions, the fact that Syncor undertook activities related to the storage and transport of regulated medical waste at its Bronx facility before obtaining the necessary authorization from the Department requires the Applicant to demonstrate its fitness as part of its overall burden of proof on the pending applications [In the Matter of Conover Transfer Station and Recycling Corp., Interim Decision of the Commissioner, August 21, 1992; In the Matter of All-City Paper Fibers, Interim Decision of the Commissioner, October 27, 1992]. Consequently, there is a substantive and significant issue concerning Syncor's compliance history.
The issue is substantive because there is doubt about the Applicant's ability to meet the applicable statutory and regulatory criteria. The doubt arises from Syncor undertaking regulated activities without first obtaining approval from the Department. The issue is significant because the adjudication could result in permit denial, modification of the proposal, or imposition of significant permit conditions in addition to those proposed in the draft permit.
Further proceedings on this only issue, however, are not necessary. When a substantive and significant issue has been identified, an adjudicatory hearing is convened to allow each Party an opportunity to present factual evidence that supports its respective position, and to examine the other Parties' evidence. Through the hearing process, conflicting facts can be evaluated and resolved so that a final decision can be made. In addition, the hearing process provides the Parties with an opportunity to present argument about how the factual information presented during the hearing should be considered, and how this factual information relates to the applicable regulatory criteria. These two requirements have already been met.
Here, there are no facts in dispute because the Parties have essentially stipulated to them. During the Issues Conference, the documents cited in the Community Board's petition for full party status were identified. In addition, the Applicant and the Department Staff identified other documents concerning Syncor's compliance history. All Parties acknowledged there were no other documents or information about the Applicant's compliance history that should be included in the hearing record. Consequently, the factual record concerning Syncor's compliance history is described in Exhibits 5 through 17. Since the Parties have agreed that no additional information is necessary, there is no need to convene an adjudicatory hearing to present and examine additional evidence.
The Parties have also presented argument about how the circumstances outlined in Exhibits 5 through 17 relate, if at all, to the guidance provided in the Department's Record of Compliance Enforcement Guidance Memorandum dated March 5, 1993 (the EGM). The Applicant presented oral argument at the Issues Conference. The Community Board filed a letter dated July 2, 1997, and the Department Staff filed a letter dated July 3, 1997. By letter dated July 22, 1997, the Applicant responded to the Community Board's July 2, 1997 letter and the Staff's July 3, 1997 letter. The Parties had an opportunity to comment about a letter dated July 15, 1997 from Rita Aldrich, Principal Radiophysicist, Radiological Health Unit, NYS Department of Labor (Exhibit 17). Ms. Aldrich's unit reviewed Syncor's application for the Radioactive Materials License.
Based on the existing record before me, a determination can be made about whether to issue the captioned permits given the Applicant's record of compliance.
In deciding whether to deny, suspend, modify or revoke a permit, the Record of Compliance Enforcement Guidance Memorandum dated March 5, 1993 states that the Department should consider events that have occurred within the last ten years. The EGM further states that the Department will also consider evidence offered by an applicant which shows that a violator is rehabilitated and has re-established a reasonable record of compliance with the relevant laws (p. 4).
The EGM then lists six categories of events that should be considered. Of the six categories listed, only the second one, (b), is relevant to the captioned permit applications. The entire text is:
b. Whether a permittee or applicant has been determined in an administrative, civil or criminal proceeding to have violated any provision of the ECL, any related order or determination of the Commissioner, any regulation of the Department, or any similar statute, regulation, order or permit condition of the federal or other state government, or agency, on one or more occasions and in the opinion of the Department, the violation that was the basis for the action posed a significant potential threat to the environment or human health, or is part of a pattern of non-compliance (pp. 4-5).
As explained further below, Exhibits 5, 12, and 14 identify events that should be considered in evaluating the Applicant's compliance history. The factual information presented in the following discussion is based on Exhibits 5 through 17, statements made at the June 10, 1997 Issues Conference, as well as the correspondence filed by the Parties subsequent to the Issues Conference.
Presently, Syncor International Corporation (Syncor) operates six nuclear pharmacies in New York State at the following locations: (1) East Syracuse, Onondaga County, (2) Cheekto-waga, Erie County, (3) Franklin Square, Nassau County, (4) Troy, Rensselaer County, (5) Rochester, Monroe County, and (6) New York City, Bronx County. Except for the Bronx facility, which began operations in February 1994, the other New York facilities began operations in the early 1990's.
A. Exhibit 5 - Order on Consent dated September 27, 1993
Exhibit 5 is a copy of Order on Consent (DEC Case No. D7-0002-93-09) dated September 27, 1993 concerning violations of 6 NYCRR Part 380 and various permit conditions at the Syracuse, Franklin Square, and Cheektowaga facilities. The discharge records filed with the Department showed that these Syncor facilities exceeded the annual emission limit of 250 microcuries (Ci) for Iodine-131 [Exhibit 5, Paragraphs 3, 4, and 12]. The Consent Order does not state that the excessive emissions of Iodine-131 adversely impacted the environment or human health.
In addition, Syncor's Syracuse, Cheektowaga, and Franklin Square facilities did not keep any records about Xenon-133 emissions [Exhibit 5, Paragraphs 5, 6, 7, and 8]. Since Syncor did not keep records about Xenon-133 emissions, it cannot be determined whether Syncor had exceeded the emission limit for Xenon-133.
To settle the violations identified in the September 1993 Consent Order, Syncor agreed to the terms of a compliance schedule. The compliance schedule required Syncor to take corrective measures and to avoid further violations. The corrective measures included restricting the release of Iodine-131 to the emission limit authorized by the permits, and keeping records about Xenon-133 emissions. In addition, the Department assessed Syncor a civil penalty of $20,000.
In a letter dated March 13, 1995, the Department Staff stated that Syncor had complied with all the terms outlined in the compliance schedule attached to the September 1993 Consent Order [Exhibit 11]. The Staff based this determination on inspections of Syncor's facilities that had occurred between September 1993 and March 1995 [Exhibits 8, 9, and 10]. When Exhibits 5 and 11 are considered together, I conclude that the Applicant has re-established a reasonable record of compliance with respect to the operations at its upstate New York facilities, which are regulated pursuant to Part 380.
B. Exhibit 12 - Order on Consent dated May 2, 1997
Exhibit 12 is a copy of the May 2, 1997 Order on Consent. The Consent Order relates to the alleged Part 360 violations at Syncor's Bronx facility. The facility began operations in February 1994 after obtaining its Radioactive Materials License from the NYS Department of Labor a month earlier. Since February 1994, operations at the Bronx facility have included the retrieval and temporary storage of spent syringes -- an activity regulated by Part 360 [Exhibit 12, Paragraphs 8 and 9].
The terms of the May 2, 1997 Consent Order apply only to Syncor's Bronx facility and allow it to continue to take back spent syringes pending a final determination on the captioned permit applications. Continued operations are conditioned upon strict compliance with the applicable regulatory criteria outlined in Part 360 [Exhibit 12, Paragraphs 13, I and II]. In addition, the terms of the Consent Order include stipulated penalties if the Applicant should fail to comply with the terms of the Consent Order or the requirements outlined in Part 360 [Exhibit 12, Paragraph IV].
With respect to the May 2, 1997 Consent Order, the following circumstances are particularly noteworthy. First, Syncor's operations at the Bronx facility have substantially complied with the requirements outlined in Part 360, according to the Staff. Second, the Department Staff in Region 2 did not elect to suspend processing of the permit application for the Bronx facility as provided by 621.3(f). This provisions states that "[p]rocessing and review of an application may be suspended with written notice to the applicant if an enforcement action has been or is commenced against the applicant for alleged violations of law related to the activity for which the permit is sought or for alleged violations of the ECL related to the facility or site. Such suspension of processing and review may remain in effect pending final resolution of the enforcement action." Finally, the EGM establishes the policy that, when appropriate, the Department may allow a violator to continue to operate its facility pursuant to an Order on Consent, such as Exhibit 12, until the Department completes the review of any pending permit applications (p. 8).
In addition to the May 27, 1997 Consent Order, the Community Board asserted that two other concerns about the pending Part 360 application are related to the Applicant's record of compliance. First, the Community Board argued that the Part 360 permit application for the Bronx facility has been pending for an inordinate amount of time. Also, the Community Board contended that Syncor violated Condition 12 of its Radioactive Materials License [Exhibit 15] by not obtaining a Part 360 permit to store mixed waste. For the reasons provided below, the Community Board's concerns do not meet the criteria outlined in the EGM.
Given the necessary exchange of information between the Applicant and the Department, the permit review process can be time consuming. The Department Staff must thoroughly review all application materials and identify areas where more information is necessary. Applicants will then respond by submitting additional information, which the Staff must then review. When an application is complete [See 621.1(d)], the public has an opportunity to comment. Depending on the nature of the public comments, a public hearing may be scheduled.
The Applicant's Part 360 permit has been pending since May 1994. The Region 2 Department Staff issued a Notice of Complete Application on June 6, 1996 [Exhibit 2-11]. Based on the public comments, the Staff referred this matter to the Office of Hearings and Mediation Services for a public hearing on April 11, 1997. After providing due notice, the public hearing was held on June 2, 1997. Given the generally intricate nature of the permit review process, the Part 360 permit application for the Bronx facility has not been pending for an inordinate amount of time.
The Community Board contended that the DEC permit referenced in Condition 12 of the Radioactive Materials License [Exhibit 15] relates to the pending Part 360 permit. The Community Board, however, has erroneously alleged that Syncor violated Condition 12 by not obtaining the Part 360 permit to store mixed waste.
License Condition 12 requires Syncor to obtain a permit from the DEC if the Bronx facility stores any "mixed waste." Condition 12 defines the term, mixed waste, as a combination of hazardous waste, as defined in 6 NYCRR Part 371, and radioactive materials. As a matter of law, the regulated medical waste [360-17.2(h)] described in the pending Part 360 application materials is not a hazardous waste, as defined in 6 NYCRR Part 371. Therefore, the Applicant has not violated License Condition 12. If, in the future, however, the Applicant should decide to possess or store mixed waste at the Bronx facility, then the Applicant would have to comply Licence Condition 12.
Based on the foregoing discussion, I give significant weight to the Department Staff's decision not to suspend the review of Syncor's Part 360 permit application for the Bronx facility. In addition, the Staff's course of action is fully consistent with the guidance provided in the EGM. Furthermore, the assertions made by the Community Board concerning the lengthy permit review process and the Applicant's compliance with its Radioactive Materials License are without merit. I conclude that the alleged Part 360 violations described in the May 1997 Consent Order do not adversely reflect on the Applicant's ability to carry out regulated activities in a lawful and environmentally responsible manner.
C. Exhibit 14 - Out-of-State Violations
Syncor also operates nuclear pharmacies in Kansas City, Missouri, and Pittsburg, Pennsylvania. Since Missouri and Pennsylvania are not agreement states [AEA 2021], the US Nuclear Regulatory Commission regulates Syncor's facilities in these states.
Exhibit 14 is a copy of a letter dated July 25, 1996 from Thomas Martin, Regional Administrator, Region 1, US Nuclear Regulatory Commission, to Robert Funari, President and CEO, Syncor International Corp. The letter describes violations of NRC regulations at Syncor's Kansas City and Pittsburg facilities.
The violation at Syncor's Kansas City facility occurred in November 1994. It involved the use of a radioactive substance by a Syncor employee in a manner not authorized by the NRC license, which in New York State would be analogous to the NYS Department of Labor Radioactive Materials License. An aggravating factor associated with the Kansas City incident was the deliberate nature of the violation [Exhibit 14, page 2]. The NRC acknowledged that Syncor management used good judgment in dismissing the responsible employee. The NRC faulted Syncor's management, however, for not taking any corporate-wide action to emphasize the importance of complying with the terms of the NRC license. Although the NRC found a violation, it cannot be determined from Exhibit 14 whether the NRC assessed a civil penalty against Syncor.
The violation at the Pittsburg facility occurred in August 1995 when an employee's locker became contaminated with Technetium-99m [Exhibit 14]. It was never determined who was responsible for contaminating the locker. After considering a number of mitigating and aggravating circumstances, the NRC assessed Syncor a civil penalty of $2,500.
The mitigating factors include the following actions taken by Syncor: (1) issuing a memorandum to all corporate employees regarding deliberate violation, (2) containing and cleaning up the contamination at the Pittsburg facility promptly, (3) investigating the incident immediately, (4) reminding the staff at the Pittsburgh facility about their responsibility to comply with the terms of the license and applicable regulations, and (5) informing all Syncor employees that the deliberate misuse of hazardous materials is grounds for immediate dismissal [Exhibit 14, page 2]. The aggravating factors included: (1) the Kansas City incident only nine months prior, and (2) the deliberate nature of the violation at the Pittsburg facility. In deciding to assess a civil penalty, the NRC emphasized that Syncor must act aggressively to prevent deliberate violations in the future [Exhibit 14, page 3].
According to the Department Staff, the out-of-state violations at the Kansas City and Pittsburg facilities relate to inadequate employee training concerning the proper handling of licensed materials. To prevent similar situations from developing in New York, the Department staff has required Syncor to develop and implement an employee training program. The Staff initially required the training program as part of the compliance schedule in the September 1993 Consent Order. After implementing the training program at its other New York facilities, Syncor's record of compliance improved. The draft Part 380 permit for the Bronx facility [Exhibit 2-1, General Condition 9] similarly requires Syncor to implement an employee training program at the Bronx Facility. General Condition 9 of the draft Part 380 permit incorporates by references a letter dated December 27, 1995 [Exhibit 2-2], which outlines the employee training program. There is no dispute about the scope of the training program.
Given its success at Syncor's other New York facilities and the absence of any dispute about its scope, I find that the draft permit condition requiring the Applicant to provide an employee training program at the Bronx facility, adequately addresses the underlying concerns associated with the out-of-state violations.
D. Exhibits 7 and 8
The Community Board argued that incidents related in Exhibits 7 and 8 should also be considered in evaluating the Applicant's compliance history. Exhibit 7 is a Notice of Incomplete Application dated May 25, 1994 with a two page attachment dated May 24, 1994. The attachment describes three events that occurred during a pre-permit inspection of Syncor's Bronx facility by the Department Staff. First, Syncor's emission treatment system had been improperly installed. Second, Syncor's emission monitoring system had been disconnected. Third, there had been a "loss of control" of licensed materials at the Bronx facility, which means that radioactive materials were not accounted for properly.
Exhibit 8 is a letter dated January 31, 1995 from DEC Environmental Radiation Specialist John Abunaw to Radiation Safety Officer Richard Osnard at Syncor's Franklin Square facility. The letter states that the velometer at this Syncor facility does not respond consistently on its low and high scales, which could result in unreliable monitoring data. The letter recommended that Syncor obtain a new velometer for the Franklin Square facility.
The incidents related in Exhibits 7 and 8 should not be considered further. The principal reason is that the circumstances described above are not the demonstrated violations, and therefore, do not meet the criteria described in the EGM (pp. 4-5). Additional reasons include the following.
The first two incidents described in Exhibit 7 are associated with operations that would be regulated by the Applicant's Part 380 permit, if it is issued. As currently drafted, the Part 380 permit requires the Applicant to install and maintain emission treatment and monitoring systems [Exhibit 2-1, General Condition 9, and Exhibit 2-2]. During the pre-permit inspection, however, the Department Staff discovered problems with these systems. Consequently, the Staff informed the Applicant about these problems in the May 25, 1994 Notice of Incomplete Application. In addition, the Staff required the Applicant to correct the problems with the emission treatment and monitoring systems before the Staff would determine the pending Part 380 application to be complete. As a result, the Applicant complied with the terms of the draft Part 380 permit concerning emission treatment and monitoring before the Department Staff issued the Notice of Complete Application on June 6, 1996. The Applicant, therefore, has already complied with the terms of the draft Part 380 permit even though the Department has yet to make a final determination about the application.
The Notice of Incomplete Application also states there was a "loss of control" of over 200 mCi of Iodine-131 at the Bronx facility on March 21, 1994. The Notice states further that: "[h]ad the doses not been found in the pharmacy, this incident could have resulted in serious violations of both the general disposal requirements of 6 NYCRR Part 380-4.1 as well as the public dose limit specified pursuant to 6 NYCRR Part 380-5.1."
The term, loss of control of licensed material, has special regulatory meaning. The term is defined in 380-2.1(a)(41) as: "the unintended loss of containment of licensed material or licensed material whose location is unknown which may result in the unauthorized disposal or discharge of licensed material to the environment." Based on the Notice of Incomplete Application, the Iodine-131 had been misplaced and later found. No Iodine-131 was released to the environment. Consequently, the Applicant did not violate the general disposal requirements outlined in 380-4.1, or the public dose limit specified in 380-5.1.
Exhibit 8 includes a recommendation that Syncor obtain a new velometer for the Franklin Square facility [Item 2 of the Appendix to Exhibit 8]. By letter dated February 16, 1995, the Radiation Safety Officer for Syncor's Franklin Square facility stated that he had ordered a new velometer based on the Department Staff's recommendation [Exhibit 9].
E. Other Circumstances
In considering the Applicant's compliance history, I have relied on the following additional undisputed facts. First, Syncor's five other New York facilities have obtained the necessary approvals from the NYS Board of Pharmacy, the NYS Department of Labor, and the NYS Department of Environmental Conservation. The NYS Department of Environmental Conservation has no enforcement actions pending against any of Syncor's other New York facilities.
At the Department Staff's request, Rita Aldrich, Principal Radiophysicist, Radiological Health Unit, NYS Department of Labor filed a letter dated July 15, 1997 [Exhibit 17].
Ms. Aldrich's unit reviews the permit applications filed by commercial and industrial facilities for Radioactive Material Licenses pursuant to the agreement between the NRC and New York State [AEA 2021].
In her letter, Ms. Aldrich states that Syncor's Bronx facility is currently in compliance with NYS Department of Labor regulations. Ms. Aldrich explains that the Department of Labor requires radiopharmacies, like Syncor's, to retain the services of a qualified health physicist. The health physicist provides on-site assistance to maintain high levels of quality assurance and quality control. According to Ms. Aldrich, Syncor's Bronx facility has retained a qualified health physicist.
Based on Ms. Aldrich's letter, the health physicist is essentially an environmental monitor who will assure regulatory compliance. Syncor's willingness to hire or fund a health physicist clearly demonstrates the Applicant's commitment to carrying out regulated activities in a lawful and environmentally responsible manner.
Other Proposed Issues
With a letter dated July 30, 1997, Mr. Vacca from the Community Board enclosed an article published in The New York Times on Tuesday, July 29, 1997 entitled, "U.S. Atomic Tests in 50's Exposed Millions to Risk." The Community Board requested that the article be identified as an exhibit to the hearing record. Mr. Vacca contended that the information in the article "presents updated evidence about the harm Iodine-131 can inflict." Given the potential adverse effects from exposure to Iodine-131 and Syncor's record of compliance, the Community Board argued that the pending permit applications should be denied.
The information in The New York Times article relates to nuclear bomb testing in Nevada from 1951 to 1962. The article explains that US government agencies have information about the amount, and potential locations of the radioactive fallout from the tests. The article identifies Iodine-131 as the principal component of the fallout.
The news article is irrelevant to this proceeding. Therefore, I deny Mr. Vacca's request to mark The New York Times article entitled, "U.S. Atomic Tests in 50's Exposed Millions to Risk" as an exhibit to the hearing record.
The intervening Parties did not assert any other substantive and significant issues for adjudication.
For the reasons discussed above, further proceedings are not necessary.
Upon review of the Applicant's compliance history, the captioned permit applications should be remanded to the Department Staff to complete the environmental review process and to issue the requested permits.
Pursuant to 6 NYCRR 624.8(d), the Issues Conference participants may appeal these rulings on issues, and requests for full party status and amicus status. The Parties may also appeal the recommended decision.
The Commissioner must receive any appeals by August 25, 1997. Appeals shall be double-spaced and not longer than 25 pages. Replies are authorized, and the Commissioner must receive them by September 10, 1997. Replies shall be double-spaced and not longer than 15 pages. The Commissioner will not accept service of appeals and replies by fax.
Send one copy of any appeal and reply to the Commissioner, NYS Department of Environmental Conservation, Room 608, 50 Wolf Road, Albany, New York 12233-1010. Also, send one copy of any appeal and reply to everyone named on the Service List dated June 9, 1997. Finally, send one copy of any appeal and reply to the Administrative Law Judge. Parties who use word processing equipment to prepare the brief and reply must also submit a copy of their appeal and reply to the ALJ in electronic form on a 3.5 computer disk (double density, not high density) formatted in either WordPerfect 5.1 or ASCII.
Appeals and replies must be distributed to everyone at the same time and in the same manner.
Any request for an adjustment to the appeal schedule must be made to the Chief Administrative Law Judge, NYS Department of Environmental Conservation, Office of Hearings and Mediation Services, 50 Wolf Road, Albany, New York 12233-1550, Telephone: 518-457-3468, FAX: 518-485-7714.
Daniel P. O'Connell
Administrative Law Judge
Dated: Albany, New York
August 6, 1997
To: Service List, dated June 9, 1997
Attachment: Appendix A, Draft Permits