HLT-49-09-00006-P Environmental Testing for Critical Agents Using Autonomous Detetection Systems (ADS)

12/9/09 N.Y. St. Reg. HLT-49-09-00006-P

NEW YORK STATE REGISTER

VOLUME XXXI, ISSUE 49

December 09, 2009

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-49-09-00006-P

Environmental Testing for Critical Agents Using Autonomous Detetection Systems (ADS)

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:

Proposed Action:

Amendment of Subpart 55-2 of Title 10 NYCRR.

Statutory authority:

Public Health Law, section 502

Subject:

Environmental Testing for Critical Agents Using Autonomous Detetection Systems (ADS).

Purpose:

Establishes standards for certification of environmental labs using new technologies to analyze samples for critical agents.

Substance of proposed rule (Full text is posted at the following State website:www.health.state.ny.us):

This amendment to Subpart 55-2, which revises Sections 55-2.10 and 55-2.13, as well as adds a new Section 55-2.14, establishes standards for the certification and operation of environmental laboratories that seek approval to engage in critical agent testing by means of new technologies, including polymerase chain reaction (PCR)-based methods and immune-based bioassays employed at a fixed-base facility, or by use of an autonomous detection system (ADS) deployed in the field. An ADS is, generally speaking, an automated, real-time, self-contained sampling and analytical system for detection of critical agents situated outside a fixed-base laboratory.

Section 55-2.10(d) is amended by replacing "section" with "Subpart" to clarify that the requirement to designate a temporary director in the extended absence of the technical director, with notice to the Department whenever the absence exceeds sixty-five days, applies to environmental laboratories whose technical directors qualify under Section 55-2.13 or 55-2.14.

Section 55-2.13(a) is amended by adding "component of an organism" to the definition of critical agent, and clarifying that select agents as designated by the federal Centers for Disease Control and Prevention are also included within that definition. The amendment also clarifies that the terms "chemical element" and "chemical compound" include radioactive substances.

Subdivisions (b) through (d) of Section 55-2.13 are amended to incorporate several references to ADSs in written policies and procedures already prescribed in Subpart 55-2, and to authorize the Department to consider, as part of the certification process, a laboratory's capacity to assume an appropriate role in the public health and safety emergency response to detection of critical agents. Air is added to the list of example sample matrices, as all ADSs now commercially available sample air. Time of specimen collection is added to requisite report content. The timeframe for reporting results is changed to "as soon as practicable, but no later than 24 hours," and a maximum of one hour is specified for the laboratory's notification following an ADS signal. Definitions are included for "supplemental testing" and "confirmatory testing," and laboratories conducting such testing in response to an ADS signal are required to make available their findings to the approved laboratory operating the ADS.

Personnel requirements in existing Section 55-2.13 (f) have been modified to include, as director-qualifying experience, work performed using technologies other than conventional microbiologic techniques, i.e., experience in analysis using the specific technology of the device, instrument or system for which the laboratory is seeking approval (e.g., nucleic acid detection by the PCR technique). "Conventional microbiologic techniques" are defined as culture, use of differential media, stains and/or biochemical reactions, and morphologic examination of colonies and/or organisms. Additional flexibility has been afforded to substitute coursework in the specific technology for one year's such experience.

A new Section 55-2.14 is added to establish certification and operational requirements for laboratories engaged in testing for critical agents in environmental samples using an ADS. An "autonomous detection system" is defined as a fixed or portable self-contained analytical system that: automatically, continuously or periodically samples the environment; analyzes sample(s); and triggers an alert that a critical agent, as defined in Section 55-2.13, has been detected. "Deploy" is defined as engaging an ADS in real time collection and analysis of environmental samples for purposes of detecting incidental release of a critical agent. The section includes an express exception for six commonly used devices, and makes clear the authority of the Commissioner of Health to make determinations whether Department oversight is required for any environmental sampling and/or testing device that is or has been deployed for a purpose other than detecting incidental release of a critical agent.

Pursuant to subdivision (b) of new Section 55-2.14, a laboratory engaged in the analysis of environmental samples using an ADS must: ensure that the system is operated in a secure and safe manner to prevent accidental or deliberate tampering that could compromise the integrity of its operation; establish and validate the minimum concentration(s) of specified critical agent(s) that will trigger a signal; develop a laboratory response plan acceptable to the Department, to be immediately implemented whenever a signal is triggered; retain documentation that the response plan has been developed in collaboration with the client(s) on whose property an ADS is situated and with State and local public health and emergency preparedness authorities; and maintain a standard operating procedure manual (SOPM) containing specific protocols for ADS operation as detailed in subdivision (b). The requisite response plan must include procedures for: notification of a signal to the client(s) on whose property an ADS is situated; notification of a signal to State and local public health and emergency preparedness authorities; emergency shutdown of any ADS suspected to be malfunctioning; communication between the laboratory's technical director and authorities responding to a signal; timely verification that any signal triggered was neither a false positive nor false negative signal, including review of results of any supplemental tests; and remediation for any false signal. The new provisions require the SOPM to include, at a minimum: (i) the laboratory's process for selecting locations where each ADS would be situated, or, if a system is portable, a description of the types of locations where a system may be deployed; (ii) procedures to ensure adequate oversight by the technical director of each ADS deployed by the laboratory, including, but not limited to, review of quality assurance and quality control data, and, as available, the results of any post-signal confirmatory testing; (iii) protocols for monitoring multiple systems or monitoring from a remote location; (iv) protocols for timely communication between the system's operator and the technical director, and between the client and the laboratory; and (v) the laboratory's response plan. Subdivision (b) also stipulates that the laboratory must retain documentation of local government approval of the response plan, where appropriate, which may be a copy of the permit allowing deployment in the local authority's jurisdiction.

New subdivision (b) of Section 55-2.14 also stipulates that the laboratory's immediate response to an ADS signal must include: adherence to the Department-approved response plan; timely notification to the Department; and review of records of any supplemental testing conducted in response to the triggered signal. Should results of such supplemental testing be inconsistent with the expected reason for the signal, this amendment requires the laboratory to render inoperable the ADS that triggered the signal until the cause of the discrepancy is determined and remediated.

New subdivision (c) of Section 55-2.14 requires the laboratory to maintain a fixed-base location at which all records are retained for periods stipulated in the Subpart. Records include, but are not limited to, calibration, testing, quality assurance, quality control, operator training, client notification protocols, supplemental testing, and required registration of critical agent inventory.

New subdivision (d) of Section 55-2.14 allows a laboratory to operate more than one ADS under the direction of one technical director, provided procedures for direct oversight by the technical director of the systems and their operators shall be acceptable to the department.

New subdivision (e) of Section 55-2.14 requires the laboratory to engage the services of one or more persons as ADS operators to monitor the systems continuously, and allows the director to act as an operator. The subdivision also requires that the operator: receive adequate training specific to the operation of each specific make and model of ADS in use by the laboratory; provide written attestation to reading and understanding the general policies and procedures of the laboratory, and those specific to the autonomous detection system(s) in use, including the laboratory's response plan and the operator's responsibilities under that plan; and undergo a successful demonstration of capability.

Text of proposed rule and any required statements and analyses may be obtained from:

Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

45 days after publication of this notice.

Summary of Regulatory Impact Statement

Statutory Authority:

Public Health Law Section 502 authorizes the Commissioner of Health to issue certificates of approval to environmental laboratories, and empowers him or her to adopt and amend regulations for implementing the provisions and intent of Section 502. Section 502 requires all laboratories performing environmental analysis on samples collected in New York State to hold certificates of approval and authorizes the Commissioner to establish standards, and technical and educational qualifications for staff, to ensure that tests are performed in an accurate and reliable manner.

Legislative Objectives:

This proposed amendment is consistent with the Commissioner's authority to amend regulations as necessary to carry out the intent of Public Health Law Section 502, which includes the protection of private and public health. The Legislature granted the Commissioner broad authority to certify environmental laboratories for the testing of materials, such materials encompass essentially any environmental matrix and material. It is consistent with the Legislature's objective to regulate emerging technologies used for environmental analyses to ensure that any testing performed is accurate and reliable.

Needs and Benefits:

Accurate and reliable identification of critical agents in environmental samples is crucial to appropriate and timely public health response to potential biological or chemical terrorism events, and/or other such incidents posing a significant public health threat. This amendment would add a new section to Subpart 55-2 that sets forth standards for certification of environmental laboratories that examine samples for critical agents using an autonomous detection system (ADS), an automated, real-time, self-contained sampling and analytical system for detection of critical agents, with the capability of issuing real-time alerts. The Department believes this amendment would clarify any ambiguity about the Department's intent to impose statutory certification requirements on entities seeking to deploy an ADS in the commercial marketplace. The newly proposed ADS standards build on Section 55-2.13 requirements in place for critical agent testing, as well as the general standards for environmental laboratory certification and operations stipulated in Subpart 55-2's preceding sections. In addition to establishing requirements for laboratories seeking to deploy an ADS, the proposal would modify certain provisions of existing Section 55-2.13 that now address only conventional microbiologic techniques, to provide alternative pathways for qualifying directors to oversee testing using new technologies in fixed-base laboratories, including polymerase chain reaction-based methods (PCR) and immune-based bioassays.

The need for timely and accurate response to adverse incidents (including terrorist events involving intentional airborne release of critical agents) has resulted in development of new approaches for sampling and analyzing indoor and outdoor ambient air. The Department believes that the use and range of application of ADS technology are likely to expand and must be addressed as part of the State's public health emergency preparedness. Results obtained from an ADS situated at the site of an incident or within the resulting plume's track will have significant impact on public health decision making; therefore, the accuracy and reliability of these devices is crucial. To deal with novel issues raised by real-time analysis, this amendment calls for: oversight by highly qualified personnel experienced in the technology; Department approval of a response plan to be implemented by the laboratory whenever an ADS signal is triggered; procedures for ongoing ADS monitoring, security and emergency shutdown; model-specific training of ADS operators; adequate protocols for director-level oversight of multiple and/or remote ADS stations, and documented collaboration among laboratories and the appropriate authorities. The regulation requires laboratories to notify the Department of any analytical finding indicating the presence of a critical agent to use the findings of confirmatory testing as an indicator of a system's functioning; to implement security systems and to notify appropriate parties within specified timeframes. The amendment's requirements promote clear communication of test results for various agents and permits the Department to determine the need for confirmatory testing. In addition, it facilitates an accurate assessment of each incident's public health threat potential and of the need for further governmental intervention. The amendment also establishes minimum qualifications for operators charged with monitoring critical agent testing using an ADS.

Costs:

Costs to Private Regulated Parties:

Facilities already certified for anthrax testing by conventional microbiological methods would incur no costs related to structural or security-related modifications in order to qualify for certification in new methodologies for anthrax and/or toxin analysis. The Department expects that any previously unregulated business enterprises (i.e., commercial concerns) that voluntarily incur costs by electing to become certified as an environmental laboratory with critical agent testing capacity will be able to offset operational costs with income from charges on clients.

The costs of compliance for any laboratory proposing to bring new technology into the laboratory for the first time are relative to the technology. For PCR, a laboratory would incur start-up costs estimated to be in the range of $50,000 - $60,000, for instruments, reagents, consumables, training for existing personnel, and documentation of new procedures. Laboratories seeking initial approval for critical agent testing would incur costs to hire a qualified technical director. The Department estimates a hiring rate for scientists with a bachelor's degree and one to three years' experience to range from $40,000 to $60,000, depending on geographical location.

For laboratories seeking to engage in critical agent testing with an ADS, costs include purchase or lease of one or more ADS units. Costs following such purchase will be minimal; since each ADS is a self-contained discrete unit, a laboratory deploying an ADS would incur no renovation or construction costs. ADSs available for commercial (private) applications are priced from $75,000 to $500,000, with additional costs for reagents or reagent cartridges, and other consumables, installation and maintenance of the ADS unit, installation and maintenance of security systems and remote monitoring equipment, materials to conduct required quality control activities, and hiring technical directors and ADS operators. Costs related to security and remote monitoring systems vary greatly, depending on the components of the system (i.e., electronic or manual), and the costs of maintenance and service contracts. It is not possible to estimate total operating costs for an ADS.

Parties applying for approval under these amended regulations will also incur expenditures of $3.00 to $20.00 to submit to the Department all policies and procedures relevant to the operation of one or more ADSs for critical agent testing. Clinical laboratories and previously unregulated business enterprises (i.e., commercial concerns) seeking certification as environmental laboratories will need to pay an annual base fee of $500 plus an annual fee calculation stipulated in Subpart 55-3, which considers, for each laboratory, the number of certified analytes and test volume for each.

Costs for Implementation and Administration of the Rule:

Costs to State Government:

New York State would incur costs to the same extent as private regulated parties, should any State-operated environmental laboratory take on critical agent testing using any new technology, except approval fees would be less than those paid by private regulated parties. Pursuant to Public Health Law Section 502(6), the Department has waived the test volume component of the approval fee for government-operated laboratories.

Following the triggering of a signal, the Department may determine a need for supplemental testing of sample archived by an ADS system. Costs for transport of an archived sample to the Wadsworth Center or another designated facility for confirmatory testing would likely be incurred by such law enforcement agencies as the State Police. Law enforcement offices transporting a sample would incur an anticipated maximum cost of $600, assuming an 800-mile round trip and a $25 hourly wage.

Costs to the Department:

The Department would incur costs to the same extent as private regulated parties, should a Department-operated laboratory undertake critical agent monitoring using ADSs, except approval fees would be less than those paid by private regulated parties. Pursuant to Public Health Law Section 502(6), the Department has waived the test volume component of the approval fee for government-operated laboratories. The Department would incur costs for supplemental testing performed by the Wadsworth Center whenever such testing has been determined to be necessary following the triggering of an ADS signal. The scope, frequency or costs of supplemental testing cannot be estimated.

Costs to Local Government:

Should any local government-operated facilities opt to provide regulated services under this proposal, the operator would sustain the costs described above for private regulated parties, except approval fees would be less than those paid by private regulated parties. Pursuant to Public Health Law Section 502(6), the Department has waived the test volume component of the approval fee for government-operated laboratories.

Local governments in general would incur no to minimal new costs directly attributable to this amendment. While local governments likely would incur costs for responding to an ADS signal, such costs would not be directly related to this rulemaking. In fact, since this amendment calls for oversight of ADSs to ensure quality testing and appropriate protocols for prompt response, it is expected to greatly reduce costs associated with responding to false signals and reduce overall costs for incident remediation by allowing commercial access to real-time detection systems.

Local governments that operate laboratories certified to perform critical agent testing may incur costs for supplemental testing whenever such testing has been determined to be necessary following the triggering of an ADS signal, and the Department designates the local laboratory to conduct such testing. The scope, frequency or costs of supplemental testing cannot be estimated. Local governments may incur costs for transport of an archived sample to the Wadsworth Center or another designated facility for confirmatory testing would likely be incurred by law enforcement agencies, and not the regulated laboratory. Law enforcement offices transporting a sample would incur an anticipated maximum cost of $600, assuming an 800-mile round trip and a $25 hourly wage.

Paperwork:

The only new paperwork requirements imposed by this regulation are: (1) documentation of ADS monitoring and security procedures; and (2) documentation of procedures to notify clients and appropriate State and local agencies that a signal has been triggered.

Local Government Mandates:

The proposed regulations impose no new mandates on any county, city, town or village government; or school, fire or other special district. If such an entity chooses to operate an environmental laboratory, it would be subject to these regulations to the same extent as a private regulated party.

Duplication:

These rules do not duplicate any other law, rule or regulation. Federal emergency preparedness procedures and recommendations for security and public health and safety serve as the underpinnings of this rule, but are not duplicated by it. Furthermore, this proposal does not duplicate, but rather harmonizes with emergency preparedness protocols related to critical agent incidents and response to such incidents developed by responsible agencies throughout the State.

Alternative Approaches:

The alternative to adopting the proposed amendments is to apply existing minimal requirements for conventional microbiologic testing for anthrax to newer technologies used in complex assays to detect a broad scope of critical agents. Scientifically, this is unacceptable, if not impossible. Moreover, because of the special public health, safety and security issues raised by ADS deployment with real-time, well-publicized alerts, the Department finds it necessary to provide specific, explicit direction, with no room for ambiguity, to facilities that undertake such testing, especially in light of the minimal analytical experience held by commercial firms likely to seek certification for the first time.

Federal Standards:

Since there is no federal certification program in place for environmental laboratories, these regulations do not duplicate any federal standards. To the extent that the U.S. Centers for Disease Control and Prevention (CDC) or the U.S. Department of Homeland Security has promulgated standards affecting detection of and related to adverse public health events, these regulations are consistent with, and complement, such standards.

Compliance Schedule:

The Department expects to identify approved methods, develop and make available application forms, and be otherwise prepared to assess laboratories' compliance with all aspects of these regulations as of their effective date, upon publication of a Notice of Adoption in the New York State Register. Regulated parties adequately staffed with qualified personnel and otherwise prepared to adopt newer methods for critical agent testing in the laboratory or through deployment of an ADS should be able to apply for the Department's approval as of the amendment's effective date. Approval may be granted following the laboratory's participation in an on-site assessment and correction of all deficiencies cited; timeframes for compliance may vary, considering each laboratory's ability and willingness to come into full compliance.

Regulatory Flexibility Analysis

Effect of Rule:

The Department's Environmental Laboratory Approval Program (ELAP) now certifies 636 environmental laboratories. Of these, 204 are located out of State and do not qualify as small businesses. Of the remaining 432 laboratories, 193 are governmental laboratories, and 239 are commercial entities, of which 147 are estimated to be small businesses. For the most part, governmental laboratories, which are primarily drinking water and sewage treatment plant laboratories operated by counties, municipalities and townships, are not expected to apply for the environmental testing specialty of critical agents, for which this amendment sets new standards.

To date, seven laboratories have been granted certification in critical agent testing (i.e., for anthrax); of these, three are operated by local governments, and one is a small business.

Compliance Requirements:

This proposed rule establishes minimum standards necessary to protect the public and laboratory employees from the health and safety risks inherent in critical agent testing. Due to the increased complexity of methods employed for critical agent testing and special public health welfare safety and security issues presented by testing using autonomous detection systems (ADSs), this regulation establishes new requirements in addition to expanding several minimum standards now in place. The decision to engage in critical agent testing in any capacity is strictly voluntary, and small businesses and local governments need to comply with the new and expanded requisites only if they operate environmental laboratories approved for the specialty, and propose to initiate testing using detection methods other-than-conventional culture techniques (e.g., polymerase chain reaction (PCR) methods or immune-based bioassays) and/or deploy one or more ADSs in the field.

Laboratories applying for approval in the specialty of critical agent testing for the first time will be required to submit their policies and procedures to the Department for review and approval to ensure adherence to approved methods and the requirements of this amendment. Since such information, often in the format of manuals, is a universal component of all laboratories' operations, this should not pose a burdensome requirement to regulated parties.

Professional Services:

No need for additional professional services is anticipated.

Compliance Costs:

Any costs of compliance incurred by small businesses and local governments that take on critical agent testing following the effective date of this amended rule will be same as the cost incurred by other regulated parties. With the possible exception of environmental testing conducted for public health purposes by county- or city-operated laboratories, the Department expects that costs could be offset by income from per-test or per-site charges imposed by a laboratory on its clients. Local governments that operate laboratories certified to perform critical agent testing may incur costs for supplemental testing whenever such testing has been determined to be necessary following the triggering of an ADS signal, and the Department designates the local government's laboratory to conduct such testing. The scope, frequency or costs of supplemental testing cannot be estimated. For ADS models that archive samples, the Department may determine a need for supplemental testing of archived samples that have triggered a signal. This amendment stipulates no requirement that certified laboratories arrange or pay for sample supplemental/confirmatory testing. Costs for transport of an archived sample to the Wadsworth Center or another designated facility for confirmatory testing would likely be incurred by law enforcement agencies such as the State Police. Law enforcement offices transporting a sample would incur an anticipated maximum cost of $600, assuming an 800-mile round trip and a $25 hourly wage.

The costs of compliance will vary significantly. A laboratory already meeting U.S. Centers for Disease Control and Prevention (CDC) safety and security standards is expected to incur no new costs in adopting new technologies for in-house testing. No additional structural or security-related modifications would be necessary for facilities already certified in anthrax testing by conventional microbiological methods so that that they may qualify for approval to employ new methodologies for anthrax and/or toxins testing. On the other hand, an already-operating small business or government-operated facility minimally equipped for handling common infectious agents - because it limits microbiology testing to monitor drinking water, for instance - may accrue extensive renovation and/or construction costs in the unlikely event it wished to take on critical agent testing for the first time.

The Department expects that previously unregulated small business enterprises (i.e., commercial concerns) will seek approval as environmental laboratories expressly to deploy ADSs in the commercial market. Assuming approval is granted, costs of doing business would include purchase or lease of one or more ADS units. Costs following such a purchase will be minimal; since each ADS is a self-contained discrete unit, laboratories deploying an ADS would incur no renovation or construction costs. Commercial concerns and government operated facilities would incur costs for lease of space for retention of laboratory records.

A laboratory that purchases an ADS would sustain significant costs; the ADSs now available for commercial (private) use are priced from $75,000 to $500,000. Manufacturers have projected costs for units expected to be available in the next year at $40,000 to $100,000. Additional costs would be incurred for: reagents or reagent cartridges and other consumables; installation and maintenance of the ADS unit; a power source and back-up system; installation and maintenance of security systems and remote monitoring equipment; materials to conduct required quality control activities; and salaries of technical directors and ADS operators. It is not possible to estimate total operating costs for ADSs in general terms.

Environmental laboratories certified for biological critical agent testing, specifically public health laboratories, would incur no costs related to hiring a qualified director, since they already employ technical directors who would also qualify under the proposed alternative educational and experiential criteria. Laboratories seeking initial approval for critical agent testing would incur costs to hire a qualified technical director. The Department estimates the hiring rate for scientists with a bachelor's degree and one to three years' experience at $40,000 to $60,000, depending on geographic location. A person with these credentials would meet the proposal's minimum requirements for a technical director of a laboratory performing critical agent testing using methods other-than-conventional microbiologic methods.

Costs related to security and remote monitoring systems vary greatly, depending on the complexity of the system (i.e., electronic or manual), and costs of maintenance and service contracts. For example, security may be maintained through use of card-key devices and/or locks, or stringent administrative controls, including sign-in logs and identification badges, at lower costs than mechanical or electronic systems. Previously unregulated business enterprises (i.e., commercial concerns) seeking initial certification as environmental laboratories to engage in critical agent testing using an ADS will need to pay Environmental Laboratory Approval Program (ELAP) approval fees, estimated at $500 base fee plus test volume and analyte fees calculated pursuant to Subpart 55-3. Entities applying for approval under these amended regulations will also incur costs of $3.00 to $20.00 to submit to the Department all policies and procedures relevant to operating one or more ADSs for critical agent testing.

Economic and Technological Feasibility:

The proposed regulation would present no additional economic or technological hardships to small businesses and local governments already undertaking critical agent testing in a safe and reliable manner. Appropriate equipment and supplies to perform critical agent testing in a safe and reliable manner are available, should a laboratory choose to begin testing in this specialty. The regulation does not require any laboratory, regardless of ownership type, to undertake testing for critical agents.

Minimizing Adverse Impact:

This regulation imposes requirements on only those laboratories that choose to undertake critical agent testing. Standards have been established at the absolute minimum level necessary for safe and reliable testing. The department did not consider different compliance requirements, or exceptions for small businesses or local governments because of the importance of this type of testing to public health, safety and welfare.

Small Business and Local Government Participation:

In the development of these regulations, the Department held informal discussions with the directors of government-operated environmental laboratories already certified to perform critical agent testing in order to assess their capabilities to meet the requirements set in this amendment. Preparedness officials from the City of New York participated in the workgroup assembled by the Department to solicit input for this rule. The New York State Association of County Healthcare Officials (NYSACHO), conveyed to the Department their concerns about a potential rise in local government expenditures due to an increased number of calls for local government services (i.e., first responders) linked to proliferation of ADSs in the commercial market. As this amendment calls for stringent oversight of ADSs, it should help prevent costs associated with responding to false signals and reduce overall costs for incident remediation by facilitating real-time detection.

While the Department cannot predict which commercial entities will seek approval to deploy an ADS, the intent of this rule was communicated to manufacturers of ADSs so that they could inform entities seeking to purchase such systems of the regulatory related requisites. The Department believes that the urgent need for public health and safety oversight in the area of critical agent testing obviates the need for more extensive solicitation of regulated party input at this time.

Rural Area Flexibility Analysis

Rural areas are defined as counties with a population under 200,000, and townships in counties with a population of more than 200,000 and a population density of 150 persons or fewer per square mile. Forty-two counties have a population under 200,000, and nine counties include townships with a population density of 150 persons or fewer per square mile.

The Department's Environmental Laboratory Approval Program (ELAP) certifies 432 environmental laboratories located in New York State; 217 of these are located in counties designated as rural. Of these 217 rural facilities, fewer than 60 hold certifications in bacteriology, and the vast majority only conducts procedures to monitor water treatment systems. Environmental laboratories in rural areas are not expected to apply for the environmental testing specialty of critical agents as a result of this amendment.

Of the approximately 232 facilities holding a New York State clinical laboratory permit that are located in areas designated as rural, only 90 hold permits in the bacteriology general or virology general categories, and would be potential candidates for testing microbiological critical agents. Of the 232 clinical laboratories designated as rural, approximately 100 hold permits in toxicology, and would be potential candidates for toxin critical agent testing. The vast majority of these restricts on-site toxicological analysis to screening for drugs of abuse in the emergency room setting, and would not likely be candidates testing for critical biological agents that are toxins.

Compliance Requirements:

The Department finds that this amendment will not result in adverse economic impact, nor impose record keeping, reporting, or other compliance requirements which would be uniquely burdensome to public or private parties in rural areas. The revision does not require any entity to take on critical agent testing of environmental samples, but merely recognizes alternative technologies for environmental laboratories that choose to engage in testing for critical agents. The demand for the newer technologies recognized in this amendment, and specifically for continuous monitoring for critical agents using an ADS, is expected to be minimal in areas with low population densities. It is extremely unlikely that a previously unregulated business enterprise located in a rural area will apply for certification as an environmental laboratory as a result of this rulemaking.

This proposed rule establishes minimum standards necessary to protect the public and laboratory employees from the health and safety risks inherent in critical agent testing. Due to the increased complexity of methods employed for critical agent testing and special public health and safety issues presented by testing using autonomous detection systems (ADSs), this regulation establishes new requirements in addition to expanding several minimum standards now in place. The decision to engage in critical agent testing in any capacity is strictly voluntary; firms in rural areas need to comply with the new and expanded requisites only if they operate environmental laboratories that are approved for the specialty, and propose to take on testing using detection methods other-than-conventional culture techniques (e.g.,polymerase chain reaction-based methods (PCR), or immune-based bioassays), and/or deploy one or more ADSs in the field.

Laboratories applying for approval in the specialty of critical agent testing for the first time, including previously unregulated business enterprises (i.e., commercial concerns), will be required to submit their policies and procedures to the Department for review and approval to ensure adherence to approved methods and the requirements of this amendment. Since such information, often in the format of manuals, is a universal component of all laboratories' operations, this should not pose a burdensome requirement to regulated parties.

Professional Services:

No need for additional professional services is anticipated.

Compliance Costs:

The demand for the technology, and specifically for continuous monitoring for critical agents using an ADS, is expected to be minimal in areas with low population densities. In the unlikely event that a laboratory or previously unregulated business enterprise located in a rural area were to apply for certification as an environmental laboratory as a result of this rulemaking, that laboratory's cost of compliance and cost offsets would be the same as the cost incurred by other regulated parties, regardless of location.

Those compliance costs will vary significantly. A laboratory already meeting U.S. Centers for Disease Control and Prevention (CDC) safety and security standards is expected to incur no new costs in adopting new technologies for in-house testing. No additional structural or security-related modifications would be necessary for facilities already certified for anthrax testing by conventional microbiological methods so that they could qualify for approval to employ new methodologies for anthrax and/or qualify for certification for toxins testing. On the other hand, regardless of location, a facility minimally equipped for handling infectious agents - because it limits testing to basic chemistry and microbiology analysis to monitor drinking water, for instance - may accrue extensive renovation and/or construction costs in the unlikely event it wished to take on critical agent testing for the first time. The Department anticipates that few if any previously unregulated business enterprises (i.e., commercial concerns) would choose to locate the requisite fixed site for ADS deployment in a rural area, since the technical director would be unable to oversee operations at ADS locations and have ready access to the rural fixed site records stored at which records are maintained, as required.

Assuming approval for the testing is granted, costs of doing business, regardless of location, would include purchase or lease of one or more ADS units. Costs following such a purchase will be minimal; since each ADS is a self-contained discrete unit, laboratories deploying an ADS would incur no renovation or construction costs. Previously unregulated business enterprises (i.e., commercial concerns) would incur costs for lease of space for retention of laboratory records. A laboratory that purchases an ADS would incur significant costs regardless of location; the ADSs now available for commercial (private) use are priced at $75,000 to $500,000. Manufacturers have projected costs for units expected to be available in the next year at $40,000 to $100,000. Additional costs would be sustained for: reagents or reagent cartridges and other consumables used during ongoing analyses; installation and maintenance of the ADS unit; a power source and back-up system; installation and maintenance of security systems and remote monitoring equipment; materials to conduct required quality control activities; and salaries of technical directors and ADS operators. It is not possible to estimate total operating costs for ADSs in general terms.

No environmental laboratories in areas designated as rural are currently certified for biological critical agent testing. Laboratories seeking initial approval for critical agent testing would incur costs to hire a qualified technical director. The Department estimates the hiring rate for scientists with a bachelor's degree and one to three years' experience at $40,000 to $60,000, depending on geographic location. A person with these credentials would meet the proposal's minimum requirements for a technical director of a laboratory performing critical agent testing using methods other-than-conventional microbiologic methods.

Costs related to security and remote monitoring systems vary greatly, depending on the complexity of the system (i.e., electronic or manual), and costs of maintenance and service contracts. For example, security may be maintained through use of card-key devices and/or locks, or stringent administrative controls, including sign-in logs and identification badges, at lower costs than mechanical or electronic systems. Previously unregulated business enterprises (i.e., commercial concerns) seeking certification as environmental laboratories to engage in critical agent testing using an ADS will need to pay approval fees equivalent to first-year Environmental Laboratory Approval Program (ELAP) fees, estimated at $500, and a fee of $500 for each technology in each ADS deployed. Entities applying for approval under these amended regulations will also incur costs of $3.00 to $20.00 to submit to the Department all policies and procedures for operation of one or more ADSs for critical agent testing. For ADS models that archive samples, the Department may determine a need for supplemental testing of archived samples that have triggered a signal. This amendment stipulates no requirement that certified laboratories arrange or pay for sample supplemental/confirmatory testing. Costs for transport of an archived sample to the Wadsworth Center or another designated facility for confirmatory testing would likely be incurred by law enforcement agencies, the cost of which would vary depending on the location's distance from Albany rather than the rural or urban nature of the location. Law enforcement offices transporting a sample would incur an anticipated maximum cost of $600, assuming an 800-mile round trip and a $25 hourly wage.

Economic and Technological Feasibility:

The proposed regulation presents no unique economic or technological hardship to facilities located in rural areas. Appropriate equipment and supplies to perform critical agent testing in a safe and reliable manner are now available, should a laboratory choose to begin testing in this specialty. The regulation does not require any laboratory, regardless of location, to undertake testing for critical agents.

Minimizing Adverse Impact:

This regulation imposes requirements on only those laboratories choosing to undertake critical agent testing. Standards have been set at the absolute minimum level necessary for safe and reliable testing. The department did not consider different compliance requirements or exceptions for facilities located in rural areas because of the importance of this type of testing to public health, safety and welfare, and because most, if not all, of the costs are reasonably consistent between rural and urban areas.

Participation by Parties in Rural Areas:

In developing these regulations, the Department solicited input from preparedness officials responsible for protection of persons and property located across New York State, and received input from the New York State Association of County Healthcare Officials (NYSACHO). Preparedness officials would be responsible for incident response in rural areas, and the NYSACHO includes representatives from rural counties. NYSACHO did express concern, although not specific to rural counties, regarding potential increased costs for response to false ADS.

While the Department cannot predict which firms will seek approval to deploy an ADS, the intent of this rule was communicated to manufacturers of ADSs in so that they may inform parties seeking to purchase such systems of the regulatory requisites. The Department believes that the urgent need for public health and safety oversight in the area of critical agent testing obviates the need for more extensive solicitation of regulated party input at this time.

Job Impact Statement

A Job Impact Statement is not required because it is apparent, from the nature and purpose of the proposed rule, that it will not have a substantial adverse impact on jobs and employment opportunities in New York State. The revision proposes minimum standards for a recently developed technology, autonomous detection system (ADS), for critical agent testing expected to be available to environmental laboratories within the next several months. No requirement is imposed on approved laboratories to apply for certification in the use of any specific technology, including autonomous detection systems, for critical agent testing. The Department expects that a limited number of commercial enterprises will seek certification as environmental laboratories in order to deploy ADS units, which will likely be marketed as early warning devices to mitigate the concerns of the occupants of large, privately-owned buildings in major metropolitan areas. Each such commercial enterprise would need to hire a technical director from a small pool of candidates with specialized scientific qualifications, many of whom are expected to be recruited from a small pool of qualified persons in the laboratory industry. Other than this extremely limited number of new job opportunities, it is likely, in light of training-only qualifications for ADS operators, few, if any, enterprises will need to take on additional capacity in the form of hiring new personnel. This amendment will have no adverse impact on job opportunities.