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New England Universities Laboratories

Memo from Thomas Balf to EPA, Q & A on EMP


From: Thomas Balf, ML Strategies

To: EPA Re: Project XL - New England Laboratories.

A number of questions and concerns have been raised with respect to issues that are fundamental to the proposal. This "Question and Answer" provides requested guidance.

Question: How does the new model work and what are the benefits?

Answer: In revising the Laboratory Environmental Management Standard, our goal was to a) rely on existing language and concepts in current RCRA regulations b) try to avoid new terminology and regulatory concepts and c) address certain concerns and recommendations suggested by regulatory agencies and other stakeholders. We believe that our revisions benefit many stakeholders, but perhaps most importantly RCRA enforcement personnel who would benefit from generally familiar terms and enforcement concepts.

The proposed Laboratory Environmental Management Standard works as follows. First, the standard applies to "laboratories" and no longer refers to laboratories as laboratory process units or LPUs. It is important to note that the institution will define which laboratories are covered by the Environmental Management Plan (EMP). Thus, for example, laboratories that do not generate any hazardous waste could be excluded from coverage. Second, laboratory wastes will now be called laboratory wastes (rather than byproducts) to avoid semantic challenges. Third, laboratory wastes will be strictly regulated under RCRA at the point of consolidation (i.e., accumulation or storage) by the institution. Quite simply, we seek regulatory relief to move the point of waste determination to the institution's consolidation point(s) which is under the management of the Environmental Department. Certain procedures in the EMP, together with the minimum performance criteria, act to ensure that chemical waste stockpiling - which is to nobody's benefit - does not occur. Fourth, hazardous materials and waste in the laboratory will be managed in accordance with the EMP, OSHA standards, fire codes and other relevant standards. These regulations, in total, provide adequate regulation within the laboratory to protect human health and the environment from the hazards associated with chemicals. While EPA does not have jurisdiction over OSHA or local fire codes, EPA will have legal basis to enforce conformance with the institution's EMP (see below) within the laboratory. Finally, compliance/conformance with RCRA may be audited by inspectors at the institutional level. Compliance/conformance with the EMP may be assessed/audited by inspectors at the laboratory level.

In addition to any revisions described above, the proposed Laboratory Environmental Management Standard now includes a requirement to conduct an annual, documented survey of "hazardous chemicals of concern" and language to promote reuse/recycle and other pollution prevention measures. These requirements advance the effectiveness of the EMP to affect upstream activities affecting hazardous waste generation, and revised measures will evaluate environmental performance at the front end (e.g., pollution prevention activities evaluations, reuse) and back end (e.g., hazardous waste disposal).

Question: Is this standard auditable?

Answer: Yes. First, an environmental management system (EMS) is worthless as a conformance or continuous improvement tool unless audit criteria are developed against which effectiveness, quality and performance can be evaluated. Perhaps the current confusion with the enforceability of the Laboratory Environmental Standard is centered around the more general policy language found in the section "Environmental Management Plan - General." Each institution will define EMS procedures, specific to their organization, that define how the EMP-General policies or criteria defined in the standard will be achieved. EMS records, data and interviews will serve as "objective evidence" to judge conformance. For example, a procedure will be defined for conducting an annual management review. An inspector reviews the procedure. The procedures states that the review takes place in March of each year and that top management must be present Management meeting minutes or other records are evaluated to measure conformance with the policy and procedures. Another example is conformance with a procedure for conducting at least annually a survey of "hazardous chemicals of concern." The institution's procedure would define the list of "hazardous chemicals of concern" and how the surveys are completed, by whom and when. Survey records and their identified surveyors and dates could be evaluated for conformance.

Second, XL Project participants have included minimum performance criteria in the standard to ensure that all institutions conform to agreed-upon, core requirements. In part, the purpose of this core list is to (1) assure regulatory agency personnel that certain key RCRA type requirements, with certain modifications, will continue to be complied with in the laboratory to ensure protection of human health and the environment; and (2) provide regulatory agency enforcement personnel with auditable standards with which they are already familiar.

Question: What is the performance in this performance-based standard?

Answer: Compliance with current RCRA regulations at the institutional level. Protection of human health and minimization of environmental impacts in the laboratory through the development and implementation of an EMP that meets the requirements of the Laboratory Environmental Management Standard. Our environmental performance measures have therefore been defined to address environmental performance, environmental compliance, pollution prevention and laboratory worker awareness and understanding. MLSDOCS: 1011492.1 (l_h001!.doc)

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