UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF ENFORCEMENT AND COMPLIANCE ASSURANCE
OFFICE OF CRIMINAL ENFORCEMENT, FORENSICS AND TRAINING
EPA-330/9-97-002R
Compliance-Focused Environmental
Management System -
Enforcement Agreement Guidance
August 1997
Revised January 2000
Revised December 2001
Revised August 2002
Revised June 2005
Steven W. Sisk
NATIONAL ENFORCEMENT INVESTIGATIONS CENTER
Diana A. Love, Director
Denver, Colorado
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CONTENTS
INTRODUCTION 3
SYNOPSIS 3
BACKGROUND 3
COMPLIANCE-FOCUSED ENVIRONMENTAL MANAGEMENT SYSTEM
ELEMENTS ,,5
Environmental Policy 5
Organization, Personnel, and Oversight of Ems 5
Accountability and Responsibility 6
Environmental Requirements 6
Assessment, Prevention, and Control 6
Environmental Incident and Non-compliance Investigations 7
Environmental Training, Awareness, and Competence 7
Environmental Planning and Organization Decision-Making 7
Maintenance of Records and Documentation 8
Pollution Prevention 8
Continuing Program Evaluation and Improvement 8
Public Involvement/Community Outreach 8
APPENDICES
A Model Settlement Agreement Language for Ems Improvements (7 Pages)
B Supplementary Requirements for Iso 14001-2004 (second edition) (3 pages)
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INTRODUCTION
SYNOPSIS
Since the late 1980s, civil multimedia compliance investigations conducted by the EPA
National Enforcement Investigations Center (NEIC) have increasingly involved identifying causes
of observed noncompliance. In many cases, the causes arise from inadequate environmental
management systems (EVISs).1 NEIC, in response, developed key elements for a compliance-
focused EMS (CFEMS) model, which have been used as the basis for EMS requirements in many
enforcement settlement agreements. The purpose of this guidance is to present those key elements
and to show, through the "Model Settlement Agreement Language" [Appendix A], how the elements
are typically incorporated into such agreements.
BACKGROUND
EPA has determined that properly designed and implemented EMSs can help promote
positive environmental outcomes. The EPA Office of Enforcement and Compliance Assurance
(OECA) supports the Agency's EMS policy, as expressed in the USEPA EMS Position Statement,
to encourage the widespread use of EMSs across a range of organizations and settings, with
particular emphasis on adopting EMSs to achieve improved environmental performance, including
compliance, pollution prevention, and continual improvement in all areas, regulated and
unregulated.2
OECA strongly encourages all organizations interested in focusing their EMSs on
compliance to reference the CFEMS model as a potentially useful tool for supplementing existing
EMS standards. However, OECA does not advocate that EMSs associated with voluntary EPA
programs [e.g., National Environmental Performance Track (NEPT) and the Public Entity
Environmental Management System Resource (PEER) Center/Local Government Program3], need
to incorporate the CFEMS 12 elements. The CFEMS model has been developed for application in
The International Organization for Standardization (ISO) defines an EMS as "that part of the overall
management system which includes organizational structure, planning activities, responsibilities, practices,
procedures, processes and resources for developing, implementing, achieving, reviewing, and maintaining [the
organization's] environmental policy." The EMS provides the structure by which specific activities related
to environmental protection and compliance can be effectively and efficiently carried out.
The USEPA Position Statement on EMSs (EMS Position Statement; May 15, '02) is available at
.
The PEER Center is supported by a cooperative agreement between EPA "s Office of Water and the Global
Environment and Technology Foundation. OECA has supported andprovided funding for this program. The
PEER Center has developed a national clearinghouse ofEMS information with a focus on municipalities. In
July 2002, EPA also designated eight Local Resource Centers around the country to provide assistance to local
governments interested in adopting EMSs. The PEER Center website may be accessed at
.
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enforcement actions as injunctive relief for defendants with violations caused by management
failures. Increasingly, however, we are learning that organizations, domestic and international, are
consulting the CFEMS Guidance in enhancing their EMSs or voluntary EMS guidelines to better
address internal and external compliance concerns. OECA encourages this as beneficial to both the
implementing organizations and external stakeholders.
EPA's approach to EMSs in enforcement actions (as opposed to when EPA is promoting
EMSs through voluntary programs, compliance assistance, or other non-enforcement means) is to
focus on seeking the appropriate injunctive relief to return violators to compliance and minimize or
eliminate the potential for repeat violations.
To achieve maximum benefit from the CFEMS elements, the overall EMS, in which they
are incorporated, should embody the "plan, do, check, and act" model for continual improvement
and address both regulated and unregulated aspects and impacts. Consequently, the CFEMS
Guidance is intended to supplement, not replace, EMS standards such as ISO 14001 developed by
voluntary consensus standards bodies. The CFEMS 12 elements support the broad, multimedia,
beyond-compliance approaches that are the hallmarks of an effective, functioning EMS. They
supplement existing EMS voluntary consensus standards by filling potential compliance-related
gaps.
Settlement agreements that require EMS improvements typically require that the
organization conduct an initial review of its current environmental management practices, followed
by development of a comprehensive CFEMS that must be documented in a manual. The EMS
manual must contain overarching policies, procedures, and programs that compose the facility-wide
(or organization-wide) EMS framework, and describe respective management systems, subsystems,
and tasks for the 12 key elements. After the organization has had sufficient time to implement and
refine the EMS (usually 1 to 3 years), the agreement should require at least one EMS audit by an
independent third-party auditor to verify implementation, with results reported to both the
organization and EPA. However, additional audits, including compliance audits, are often required,
as individual circumstances dictate. The audits also serve to promote further EMS improvement and
more effective implementation.
The intended result of this approach is twofold: first, to have the organization develop an
EMS that will both improve its compliance with applicable environmental requirements and, second,
to improve its environmental performance through setting and achieving the organization's
environmental targets and objectives.
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The 12 key elements of a CFEMS addressed in this guide were compiled from a number of
sources, as mentioned in previous revisions, and notably include: EMS assessment protocols
developed by Deloitte and Touche LLP of San Francisco for the Global Environmental Management
Initiative (1992) and an industrial client (1994); and ISO 14001 "Environmental management
systems - Specification with guidance for use" (1996 and 2004).
The current revision involved expanding the Introduction to better describe the relationship
of the CFEMS Guidance to EPA's overall EMS policy and its consistency with that policy, as well
as revising the elements and the model settlement agreement language in Attachments A and B
(new).4
COMPLIANCE-FOCUSED ENVIRONMENTAL MANAGEMENT SYSTEM ELEMENTS
1. Environmental Policy
a. This policy, upon which the EMS is based, must clearly communicate management
commitment to achieving compliance with applicable federal, state, and local
environmental statutes, regulations, enforceable agreements, and permits (hereafter,
"environmental requirements"), minimizing risks to the environment from unplanned
or unauthorized releases of hazardous or harmful contaminants, and continual
improvement in environmental performance. The policy should also state
management's intent to provide adequate personnel and other resources for the EMS.
2. Organization, Personnel, and Oversight of EMS
a. Identifies and defines specific duties, roles, responsibilities, and authorities of key
environmental staff in implementing and sustaining the EMS (e.g., could include
position descriptions and/or performance standards for all environmental department
personnel, and excerpts from others having specific environmental duties, and
regulatory compliance responsibilities).
b. Includes organization charts that identify units, line management, and other
individuals having environmental duties and regulatory compliance responsibilities.
c. Includes ongoing means of communicating environmental issues and information
among the various levels and functions of the organization, to include all persons
working for or on behalf of the organization (e.g., on-site service providers and
contractors who function as de facto employees), and for receiving and addressing
their concerns.
The 12 elements are closely inter-related components of an EMS for which subsystems and procedures must
be developed and fully integrated if the entire program is to be effective. They are usually included in
settlement agreements as a complete group; however, individual elements may need to be modified to reflect
site-specific conditions and circumstances.
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3. Accountability and Responsibility
a. Specifies accountability and environmental responsibilities of organization's
managers, and managers of other organizations acting on its behalf for environmental
protection and risk reduction measures, assuring compliance, required reporting to
regulatory agencies, and corrective actions implemented in their area(s) of
responsibility.
b. Describes incentive programs for managers and employees to perform in accordance
with compliance policies, standards, and procedures.
c. Describes potential consequences for departure from specified operating procedures,
including liability for civil/administrative penalties imposed as a result of
noncompliance.
4. Environmental Requirements
a. Describes process for identifying potentially applicable environmental requirements;
interpreting their applicability to specific operations, emissions, and waste streams;
and effectively communicating those applicable environmental requirements to
affected persons working for or on behalf of the organization.
b. Describes a process for developing, implementing and maintaining ongoing internal
compliance monitoring to ensure that facility activities conform to applicable
environmental requirements. Compliance monitoring shall include inspections and
measurements, as appropriate.
c. Describes procedures for prospectively identifying and obtaining information about
changes and proposed changes in environmental requirements, and incorporating
those changes into the EMS (i.e., regulatory "change management").
d. Describes a procedure for communicating with regulatory agencies regarding
environmental requirements and regulatory compliance.
5. Assessment, Prevention, and Control
a. Identifies an ongoing process for assessing operations, for the purposes of preventing,
controlling, or minimizing reasonably foreseeable releases, environmental process
hazards, and risks of noncompliance with environmental requirements. This process
shall include identifying operations and waste streams where equipment malfunctions
and deterioration, and/or operator errors or deliberate malfeasance, are causing, or
have the potential to cause; (1) unplanned or unauthorized releases of hazardous or
harmful contaminants to the environment, (2) a threat to human health or the
environment, or (3) noncompliance with environmental requirements.
b. Describes process for identifying operations and activities where documented
operating criteria, such as standard operating procedures (SOPs), are needed to
prevent noncompliance or unplanned/unauthorized releases of hazardous or harmful
contaminants, and defines a uniform process for developing, approving and
implementing the documented operating criteria.
c. Describes a system for conducting and documenting routine, objective, self-
inspections by department supervisors and trained staff, especially at locations
identified by the process described in (a) above, to check for malfunctions,
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deterioration, worker adherence to operating criteria, unusual situations, and
unauthorized or unplanned releases.
d. Describes a "management of change" process to ensure identification and
consideration of environmental requirements, the environmental aspects/impacts, and
potential operator errors or deliberate malfeasance during planning, design, and
operation of ongoing, new, and/or changing buildings, processes, equipment,
maintenance activities, and products.
6. Environmental Incident and Non-compliance Investigations
a. Describes standard procedures and requirements for internal and external reporting
of environmental incidents and noncompliance with environmental requirements.
b. Establishes procedures for investigation, and prompt and appropriate correction of
noncompliance. The investigation process includes root-cause analysis of identified
problems to aid in developing the corrective actions.
c. Describes a system for development, tracking, and effectiveness verification of
corrective and preventative actions.
7. Environmental Training, Awareness, and Competence
a. Identifies specific education and training required for organization personnel or those
acting on its behalf, as well as process for documenting training provided
b. Describes program to ensure that organization employees or those acting on its behalf
are aware of its environmental policies and procedures, environmental requirements,
and their roles and responsibilities within the environmental management system.
c. Describes program for ensuring that personnel responsible for meeting and
maintaining compliance with environmental requirements are competent on the basis
of appropriate education, training, and/or experience.
d. Identifies training on how to recognize operations and waste streams where
equipment malfunctions and deterioration, and/or operator errors or deliberate
malfeasance, are causing, or have the potential to cause: (1) unplanned or
unauthorized releases ofha/ardous or harmful contaminants to the environment, (2)
a threat to human health or the environment, or (3) noncompliance with
environmental requirements.
8. Environmental Planning and Organizational Decision-Making
a. Describes how environmental planning will be integrated into organizational
decision-making, including plans and decisions on capital improvements, product
and process design, training programs, and maintenance activities.
b. Requires establishing, on an annual basis, written targets, objectives, and action plans
for improving environmental performance, by at least each operating organizational
subunit with environmental responsibilities, as appropriate, including those for
contractor operations conducted at the facility, and how specified actions will be
tracked and progress reported. Targets and objectives must include actions that
reduce the risk of noncompliance with environmental requirements and minimize the
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potential for unplanned or unauthorized releases of hazardous or harmful
contaminants.
9. Maintenance of Records and Documentation
a. Identifies the types of records developed in support of the EMS (including audits and
reviews), who maintains them and, where appropriate, security measures to prevent
their unauthorized disclosure, and protocols for responding to inquiries and requests
for release of information.
b. Specifies the data management systems for any internal waste tracking,
environmental data, and hazardous waste determinations.
c. Specifies document control procedures.
10. Pollution Prevention
a. Describes an internal process or procedure for preventing, reducing, recycling,
reusing, and minimizing waste and emissions, including incentives to encourage
material substitutions. Also includes mechanisms for identifying candidate materials
to be addressed by the pollution prevention program and tracking progress.
11. Continuing Program Evaluation and Improvement
a. Describes program for periodic (at least annually) evaluation of the EMS, which
specifies a process for translating assessment results into EMS improvements. The
program shall include communicating findings and action plans to affected
organization employees or those acting on its behalf.
b. Describes a program for periodic audits (at least annually) of facility compliance with
environmental requirements by an independent auditor(s). Audit results are reported
to upper management and instances of noncompliance are addressed through the
process described in element 6 above.
12. Public Involvement/Community Outreach
a. Describes a program for ongoing community education and involvement in the
environmental aspects of the organization's operations and general environmental
awareness.
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APPENDIX A
MODEL SETTLEMENT AGREEMENT LANGUAGE FOR EMS IMPROVEMENTS
(7 pages)
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Appendix A
MODEL SETTLEMENT AGREEMENT LANGUAGE FOR EMS IMPROVEMENTS
I. Definitions [includes only those definitions that are specifically relevant to the EMS
Improvement provisions]
(a) "Action Plan" shall mean a comprehensive plan for bringing the Facility, as defined
below, into full conformance with the EMS provisions specified in Paragraph 20 of
this Consent Decree and fully addressing all Audit Findings identified in the Audit
Report.
(b) "Audit Finding" shall mean a written summary of all instances of nonconformance
with the provisions of Paragraph 20 of this Consent Decree noted during the EMS
audit, and all areas of concern identified during the course of the audit that, in the
EMS Auditor's judgement, merits further review or evaluation for potential EMS,
environmental, or regulatory impacts.
(c) "Audit Report" shall mean a report setting forth the Audit Findings resulting from
the audit of a Facility by the EMS Auditor, which meets all the requirements set forth
in Paragraph 18 of this Consent Decree.
(d) "EMS Auditor" (change made throughout document) shall mean the independent
third-party hired by the COMPANY and approved by EPA to conduct an EMS audit
at the Facility, and who meets the requirements set forth in Paragraph 8 of the
Consent Decree.
(e) "Contractor" shall mean [contractor one name], any successor to [contractor one
name] located on facility, [contractor two name], any successor to [contractor two
name] located at the Facility and contractors providing the following services at the
facility: [list of specific services such as asbestos removal, demolition, painting,
waste handling, including vacuum truck operators, and construction].
(f) "Corrective Measures" shall mean those measures or actions appropriate to bring a
Facility into full conformance with the EMS provisions of Paragraph 5 of this
Consent Decree.
(g) "Environmental Requirements" shall mean all applicable federal, state, and local
environmental statutes and regulations, including permits and enforceable agreements
between the COMPANY and the respective environmental regulatory agency(ies).
(h) "Facility" as used in the term "the Facility" or in the term "the COMPANY'S
Facility" shall mean the [COMPANY name], facility located at [facility address (e.g.,
600 South Kipling Road in Denver, Colorado)].
(i) "EMS Consultant(s)" shall mean individual(s) meeting the requirements of Paragraph
1. below, who are selected and/or contracted to perform the Initial EMS Review and
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Appendix A (continued)
Evaluation and/or assist the COMPANY in developing and implementing the EMS
required by this Decree,
A. ENVIRONMENTAL MANAGEMENT SYSTEM
Initial Review
1. Within ten (10) days following entry of this Decree, the COMPANY shall provide
to EPA, in writing, a notification with information concerning the person(s) or
organization(s) identified by the COMPANY [the "Proposed EMS Consultant(s)"]
to perform an evaluation (commonly called a "gap analysis") of any environmental
management practices existing at the Facility (the "Initial Review and Evaluation").
The notification shall include: (a) the name, affiliation, and address of the Proposed
EMS Consultant(s); (b) information demonstrating how each Proposed EMS
Consultant(s) satisfies the EMS auditor qualification requirements of Table 1 in ISO
19011 (First edition, 2004-10-01) and has experience in developing and
implementing an EMS; (c) information demonstrating that the team conducting the
Initial EMS Review and Evaluation, in composite, has a working process knowledge
of Facility or similar operations, and has a working knowledge of federal and state
environmental requirements which apply to the Facility; and (d) evidence that the
Proposed EMS Consultant(s) have at least a bachelor's degree from an accredited
institution. The written notification submitted by the Company pursuant to this
identify the schedule, including milestones, for conducting the Initial EMS Review
and Evaluation.
2. EPA shall notify the COMPANY whether the Proposed EMS Consultants are
qualified to perform the Initial Review and Evaluation relative to the standards set
forth in the previous Paragraph. If EPA disapproves of the COMPANY'S selection
of any Proposed EMS Consultant, then the COMPANY shall submit to EPA the
identity of different Proposed EMS Consultant(s) within thirty (30) days of the
COMPANY'S receipt of EPA's determination. Both the COMPANY'S initial
proposal and EPA's review of any different Proposed EMS Consultants shall be
governed by Paragraphs 1 and 2 of this Decree until such time as EPA notifies the
COMPANY that these initial EMS Consultants are qualified to conduct the Initial
Review and Evaluation.
3. The COMPANY shall direct the qualified initial EMS Consultant(s) identified
pursuant to paragraph 2 above to conduct and complete an Initial EMS Review and
Evaluation for both COMPANY [and any on-site Contractor operations]. The
designated EMS Consultant(s) shall review and evaluate the current environmental
management practices and documents, using the elements set forth in paragraph 5.
below. The purpose is to identify where systems or subsystems have not been
adequately developed or implemented, or need to be enhanced, or new management
systems or subsystems developed, to adequately address the twelve elements set forth
in Paragraph 5, below. The COMPANY shall require the EMS Consultants to prepare
a report of the results of the Initial Review and Evaluation and provide such report
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Appendix A (continued)
to the COMPANY within 90 days of the date that EPA notified the COMPANY that
the initial EMS Consultants are qualified to conduct the Initial Review and
Evaluation. This report shall also be provided to EPA, upon request.
Comprehensive EMS Development and Implementation
4. Based on the Initial EMS Review and Evaluation results and other information, the
COMPANY, assisted by the EMS Consultant(s), shall develop, implement, and
maintain a Comprehensive EMS for the Facility addressing, at a minimum, the 12
key elements presented in Paragraph 5, below. The purpose of developing the
Comprehensive EMS is to assist the COMPANY in its efforts to comply with
federal, state and local environmental requirements, as well as to improve
environmental performance.
5. EMS Manual. Within nine (9) months of the date that EPA notified the COMPANY
that the EMS Consultant(s) is qualified to assist in development of a Comprehensive
EMS, the COMPANY shall submit to EPA for review and approval, an
"Environmental Management System Manual" which describes and documents the
Comprehensive EMS and contains an EMS implementation schedule for each of the
described systems and subsystems not already fully implemented. The
Environmental Management System Manual shall describe or contain, as appropriate,
overarching policies, procedures, and programs that compose the facility-wide EMS
framework, and respective management systems, subsystems, and tasks for the
following elements:
NOTES: (a) The 12 key elements of the compliance-focused EMS are inserted here or
referenced as an Appendix.
(b) If the COMPANY chooses ISO 14001:2004 (second edition) as the EMS
model, then this language will need be modified to reference that model AND
the supplementary provisions included in Appendix B need to be incorporated
into the settlement agreement.
6. EPA shall approve the EMS Manual if it satisfactorily addresses the CFEMS
elements. Subsequent to EPA's initial approval of the EMS Manual, the COMPANY
may revise and/or update the EMS Manual for the Facility. Substantial revisions or
updates to the EMS Manual made by the COMPANY before the EMS Audit required
by Paragraph 16 below, shall be submitted to EPA for review and approval. Upon
approval by EPA, the changes shall be incorporated into the EMS Manual. The EMS
Manual as approved pursuant to this Paragraph shall be used during the EMS Audit
as further described in Paragraphs 8 to 19, below.
7. Upon the COMPANY'S receipt of EPA's approval of the EMS Manual, The
COMPANY shall commence implementation of the EMS in accordance with the
schedule contained in the EMS Manual. The COMPANY shall submit
implementation status reports to EPA on a quarterly basis (i.e., reports due in
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Appendix A (continued)
January, April, July, and October), beginning not earlier than sixty (60) days from
receipt of EPA's approval of the manual. The status reports shall be due on the 15th
day of the reporting month and every quarter thereafter until implementation is
complete. [Status report details may be added here.]
EMS Audit
8. Within 1 year of EPA's approval of the EMS Manual, the COMPANY shall propose
to EPA for approval, the selection of an independent EMS Auditor who (a) was not
involved in the Initial EMS Review and Evaluation, (b) meets the qualification
requirements of ISO 19011 (First edition, 2002-10-01); (c) has expertise and
competence in the regulatory programs under federal and state environmental laws;
and (d) has at least a bachelor's degree from an accredited institution. In addition,
the Proposed EMS Auditor must be capable of exercising independent judgment and
discipline in performing an EMS Audit at the Facility, as described in Paragraph 16,
below. The EMS Auditor must have no direct financial stake in the outcome of the
EMS Audit conducted pursuant to this Consent Decree. If the COMPANY has or
has had any other contractual or financial relationship with the Proposed EMS
Auditor, the COMPANY shall disclose to EPA such past or existing contractual or
financial relationships when the Proposed EMS Auditor(s) is identified.
9. EPA shall notify the COMPANY whether the Proposed EMS Auditor meets the
qualifications set forth in the previous Paragraph. If EPA determines that the
Proposed EMS Auditor does not meet the qualifications set forth in the previous
paragraph, or that past or existing relationships with the Proposed EMS Auditor
would affect the EMS Auditor's ability to exercise the independent judgment and
discipline required to conduct the EMS Audit, such Proposed EMS Auditor shall be
disqualified and another EMS Auditor shall be proposed by the COMPANY within
thirty (30) days of the COMPANY'S receipt of EPA's determination.
10. Both the COMPANY'S initial proposal and EPA's review of any different Proposed
EMS Auditor shall be governed by Paragraphs 8 and 9 of this Decree until such
time as EPA notifies the COMPANY that the EMS Auditor(s) is qualified.
11. Within ten (10) business days of the date that EPA notifies the COMPANY of the
approval of the Proposed EMS Auditor, the COMPANY shall retain the Proposed
EMS Auditor, thereafter designated the "EMS Auditor," to perform an EMS Audit
of the Facility as further described in Paragraph 16 below.
12. THE COMPANY shall identify any and all site-specific safety and training
requirements for the EMS Auditor(s), and shall ensure that the requirements are met
prior to conducting the audit.
13. THE COMPANY shall require the EMS Auditor to prepare a draft EMS Audit Plan
and provide it to THE COMPANY and EPA for review and comment. The audit
criteria shall include the provisions set forth in Paragraph 5, the EMS Manual
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Appendix A (continued)
approved pursuant to Paragraph 6 of this Decree, above, and any other EMS
standards or criteria deemed appropriate by the COMPANY. The EMS Audit Plan
shall provide for an evaluation of the adequacy of EMS implementation relative to
the audit criteria, from top management down, throughout each major organizational
unit at the Facility, and to identify areas of concern. The draft EMS Audit Plan shall
be submitted within two (2) months after the EPA's approval of the EMS Auditor.
14. Within 3 0 days of receipt of EPA's comments the COMPANY shall direct the EMS
Auditor to develop a final audit plan that incorporates EPA's comments which shall
be followed during conduct of the EMS Audit performed pursuant to this Consent
Decree. The COMPANY shall direct the EMS Auditor to concurrently submit the
final EMS Audit Plan to EPA and the COMPANY upon completion. The audit shall
be completed within 60 days of submission of the final EMS audit plan.
15. EPA shall approve the EMS Audit Plan if it satisfactorily addresses the elements of
Paragraph 13.
16. Within sixty (60) days after the COMPANY'S receipt of EPA's approval of the EMS
The EMS Audit shall be conducted in accordance with ISO 19011 (First edition,
2002-10-01). The EMS Auditor shall assess conformance with the criteria specified
in Paragraph 13 above, and shall determine the following:
a. Whether there is a defined system, subsystem, program, or planned task for
the respective EMS element
b. To what extent the system, subsystem, program, or task has been
implemented, and is being maintained
c. The adequacy of each operation's internal self-assessment procedures for
programs and tasks composing the EMS
d. Whether the COMPANY is effectively communicating environmental
requirements to affected parts of the organization, or those working on behalf
of the organization
e. Whether further improvements should be made to the EMS to better conform
to the audit criteria
f. Whether there are observed deviations from the COMPANY'S written
requirements or procedures
g. Whether continual improvement is occurring
17 Designated representatives from EPA, the COMPANY, and other environmental
regulatory agencies may participate in the EMS audit as observers, but may not
interfere with the independent judgement of the EMS Auditor. The COMPANY
shall notify EPA at least ten (10) days before the commencement of the on-site
portion of the EMS Audit to designated regulatory contacts regarding audit
scheduling in order to make arrangements for observers to be present.
18. EMS Audit Report - The COMPANY shall direct the EMS Auditor to develop and
concurrently submit an EMS Audit Report to the COMPANY and EPA for the EMS
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Appendix A (continued)
Audit as required by this Consent Decree, within sixty (60) days following the
completion of the on-site portion of the audit. The EMS Audit Report shall present
the Audit Findings and shall contain the following information:
a. Audit scope, including the period of time covered by the audit
b. The date(s) the on-site portion of the audit was conducted
c. Identification of audit team members
d. Identification of the COMPANY representatives and regulatory
agency personnel observing the audit
e. The distribution for the EMS Audit Report
f. A summary of the audit process, including any obstacles encountered
g. Detailed Audit Findings, including the basis for each finding and each
Area of Concern identified
h. Identification of any Audit Findings corrected or Areas of Concern
addressed during the audit, and a description of the corrective
measures and when they were implemented
i. Certification by the EMS Auditor that the EMS Audit was conducted
in accordance with the provisions of this Decree.
19. If the EMS Auditor believes that additional time is needed to analyze available
information or to gather additional information, the COMPANY may request that
EPA grant the EMS Auditor such additional time as needed to prepare and submit
the Audit Report. EPA's decision whether to grant additional time shall be final and
. unreviewable.
Follow-Up Corrective Measures
20. Audit Response and Action Plan. Upon receiving the Audit Report, the COMPANY
shall review and evaluate the Audit Findings and any need for conducting a root
cause analysis of the identified Audit Findings, and shall investigate all Areas of
Concern. Within sixty (60) days of receiving the Audit Report for each Facility, the
COMPANY shall develop and submit to EPA for review and comment a response
to the EMS Audit Report, (the "Audit Response and Action Plan"). The Audit
Response and Action Plan shall provide a response to the findings and areas of
concern identified in the EMS Audit Report and provide an action plan for
expeditiously bringing the Facility into full conformance with the EMS provisions
in Paragraph 5 of this Decree and the EMS Manual, and fully addressing all Areas
of Concern. The Audit Response and Action Plan shall include the result of any root
cause analysis, specific deliverables, responsibility assignments, and an
implementation schedule for the identified actions and measures, including those that
may have already been completed.
2*1. Final Audit. Response and Action Plan - EPA will provide comments on the Audit
Response and Action Plan and the COMPANY shall, within thirty (30) days of
receipt of EPA's comments on the Audit Response and Action Plan, submit to EPA
a Final Audit Response and Action Plan.
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Appendix A (continued)
22. After making any necessary modifications to the Audit Response and Action Plan
based on EPA comments, if any, the COMPANY shall implement the Audit
Response and Action Plan in accordance with the schedules set forth therein.
23. Certification of EMS Implementation
a. Within 10 days after completion of an EMS Audit in which no instances of
nonconformance with the EMS Standard were found at the respective audited
Facility, the COMPANY shall submit a Request for Certification of EMS
Implementation to the EMS Auditor. Within ten (10) days after the receiving
the certification request, the EMS Auditor shall issue to The COMPANY a
Certification of EMS Implementation for the respective Facility, indicating
that the EMS is fully implemented and conforms to the EMS Standard.
b. Alternately, within 10 days after completion of actions or measures identified
in the Final Audit Response and Action Plan, The COMPANY shall submit
to the EMS Auditor a Request for Certification of EMS Implementation.
c. As soon as practicable, but in no event later than 30 days after it has received
the certification request pursuant to Subparagraph b. of this Paragraph, the
EMS Auditor shall, as necessary, reinspect the respective Facility (i.e.,
conduct a "Certification Review") and submit to the COMPANY a written
statement identifying those Audit Findings which have been addressed and
any which have not, including an explanation describing the failure to address
or correct, as appropriate, any Audit Findings. The COMPANY shall use its
best efforts to address in a timely manner any outstanding Audit Findings
identified during the Certification Review.
d. When the EMS Auditor concludes that all Audit Findings have been
addressed at the respective Facility, the EMS Auditor shall issue to the
COMPANY a Certification of EMS Implementation for the respective
Facility, indicating that the EMS is fully implemented and conforms to the
EMS Standard.
e. Within ten (10) days of receipt, the COMPANY shall submit a copy of each
Certification of EMS Implementation to EPA.
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APPENDIX B
SUPPLEMENTARY REQUIREMENTS FOR ISO 14001-2004 (second edition)
(3 pages)
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Appendix B
SUPPLEMENTARY REQUIREMENTS FOR ISO 14001-2004
(SECOND EDITION)
4.3.1 Environmental Aspects
Add new second paragraph after "b" as follows:
Consistent with 4.5.3, the aspects/impacts assessment carried out pursuant to this section 4.3.1 shall
specifically include, but not be limited to, identifying activities, products, or services where
equipment malfunctions and deterioration, operator errors or deliberate malfeasance are causing, or
have the potential to cause: (1) unplanned or unauthorized releases of hazardous contaminants to
the environment, (2) a threat to human health or the environment, or (3) noncompliance with legal
requirements.
4.3.2 Legal and Other Requirements
Add new subsections as follows:
(c) To communicate those requirements to affected organization personnel or those
acting on its behalf (i.e, those who function as de facto employees). Information
about applicable legal requirements shall be used to plan, develop, and implement
ongoing routine evaluation of compliance, consistent with 4.5.2, to ensure that the
organization's activities conform to those requirements
(d) For prospectively identifying and obtaining information about changes and proposed
changes in legal requirements, and incorporating those changes into the EMS (i.e.,
regulatory "change management")
(e) For communicating with regulatory agencies regarding legal requirements and
regulatory compliance.
4.3.3 Objectives, Targets, and Programme(s)
To end of second paragraph add:
Targets and objectives shall include, where appropriate, actions which reduce the risk of
noncompliance with legal requirements and minimize the potential for unplanned or unauthorized
releases.
4.4.1 Resources, Roles, Responsibility and Authority
Add to end of first paragraph as follows:
Management shall integrate environmental planning into organizational decision-making, including
plans and decisions on capital improvements, product and process design, training programs and
maintenance activities.
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Appendix B (continued)
4.4.2 Competence, Training, Awareness
Add to end of first paragraph
This requirement shall also extend to any person within the organization or acting on its behalf
whose activity has the potential to cause environmental regulatory noncompliance.
4.4.3 Communication
Replace opening paragraph and subsection as follows:
With regard to its environmental aspects, compliance with legal requirements and environmental
management system, the organization shall establish and maintain procedures for:
(a) An ongoing means of internal communication regarding environmental issues and
information among the various levels and functions of the organization, to include
all organization personnel and those working on its behalf, and a means for receiving,
documenting, and responding relevant communication from those individuals
Add new subsection as follows:
(c) As appropriate, implementing and maintaining security measures to prevent
unauthorized disclosure of environmental management system information (including
audits and reviews) and documentation, which shall include protocols for responding
to inquiries and requests for release of information.
4.4.6 Operational Control
Add new subsections as follows:
(d) Conducting and documenting routine, obj ective, self-inspections by supervisors and
trained staff to check for malfunctions, deterioration, worker noncompliance with
operating criteria, unusual situations and unplanned or unauthorized releases.
(e) Developing, implementing and maintaining a "management of change" procedure
to incorporate identification and consideration of legal requirements and
environmental aspects during the planning and design of new and/or changes to
buildings, operations, processes, equipment, maintenance activities, and products.
4.4.7 Emergency Response and Preparedness
Add to end of first paragraph
The procedures shall address internal and external reporting of environmental incidents and
noncompliance with legal requirements.
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Appendix B (continued)
4.5.2.1 Evaluation of Compliance
Add new paragraphs following the first paragraph as follows:
The compliance evaluations shall include:
(a) A compliance audit conducted at least annually, by an auditor(s) independent of the
facility being audited. Evaluation results are reported to senior management and
nonconformities (i.e., instances of noncompliance) are addressed through the process
developed pursuant to element 4.5.3, below. The organization's annual compliance
audit workplan, including any schedule, shall be based on the legal requirements
applicable to the evaluated facility, and the results of previous audits.
(b) Conducting and documenting routine, objective, self-inspections by supervisors and
trained staff.
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