The document provides guidance on preparing for and responding to environmental inspections at facilities. It recommends that facilities develop an inspection policy that includes designating a response team to escort inspectors and make contact with legal counsel. When inspectors arrive, company representatives should request identification and the purpose and scope of the inspection. Inspectors may request documents and question employees. The guidance advises being cooperative while protecting confidential information, and having a closing meeting to understand next steps. Developing an inspection protocol and conducting mock inspections can help facilities prepare.
El software incluye programas, instrucciones y reglas que permiten ejecutar tareas en una computadora. Existen tres tipos principales de software: el software de sistema como los sistemas operativos que controlan el hardware y soportan otros programas; el software de aplicación que permite llevar a cabo tareas específicas; y el software de programación que proporciona herramientas para desarrollar nuevos programas e aplicaciones.
Venezuela atraviesa una profunda crisis política, económica y social. La constitución actual establece que solo se pueden hacer reformas parciales que no modifiquen la estructura fundamental, pero los cambios propuestos buscan una nueva constitución. Las reformas políticas recientes no han sido suficientes para resolver la crisis del sistema, que se debe a causas internas en su organización. Se proponen cambios como un nuevo sistema electoral, descentralización del poder, y permitir la reelección presidencial.
Dr. Surabhi Pandey has over 8 years of experience in academia and research focused on cloud computing, SaaS, ERP, and digital marketing. She has published several research papers in international journals and conferences and has taught at the postgraduate level. Currently, she is an Assistant Professor at ARMY Institute of Management & Technology where she coordinates various programs and events.
Aditya Electro Projects is an electrical contracting and manufacturing company founded in 2008 and headquartered in Noida, India. The company specializes in electrical panel manufacturing, contracting services, and provides a full range of electrical solutions. It has a team of 70 professionals and fabricates electrical panels in its 5,500 square foot facility. Some of Aditya's ongoing and completed projects include electrical contracting for residential, commercial and industrial developments. The company aims to provide high quality electrical solutions and complete customer satisfaction.
Braulio Stalin Morocho Pizarro estudió temas de ofimática, Gmail, Google Drive, Dropbox, blogs y Flickr durante el segundo bimestre de su carrera de Electrónica y Telecomunicaciones. Aprendió a compartir archivos en Google Drive seleccionando el archivo, dando a la opción "Compartir", seleccionando la forma de compartir y la persona con quien compartir, y dando a "Compartir".
This document discusses how new regulations in Illinois requiring the evaluation of indoor air vapor intrusion concerns have changed the scope and costs of environmental due diligence. Key points:
1) New IEPA regulations and updated standards now mandate investigating vapor intrusion from contaminated soil and groundwater. This has increased costs for Phase I and II assessments and obtaining no further remediation letters.
2) Evaluating vapor intrusion is now required to obtain an NFR letter from the IEPA, increasing the time and costs associated with the review and approval process.
3) Older NFR letters that do not address vapor intrusion may not provide full assurance about a property's environmental status, as they do not rule out
El software incluye programas, instrucciones y reglas que permiten ejecutar tareas en una computadora. Existen tres tipos principales de software: el software de sistema como los sistemas operativos que controlan el hardware y soportan otros programas; el software de aplicación que permite llevar a cabo tareas específicas; y el software de programación que proporciona herramientas para desarrollar nuevos programas e aplicaciones.
Venezuela atraviesa una profunda crisis política, económica y social. La constitución actual establece que solo se pueden hacer reformas parciales que no modifiquen la estructura fundamental, pero los cambios propuestos buscan una nueva constitución. Las reformas políticas recientes no han sido suficientes para resolver la crisis del sistema, que se debe a causas internas en su organización. Se proponen cambios como un nuevo sistema electoral, descentralización del poder, y permitir la reelección presidencial.
Dr. Surabhi Pandey has over 8 years of experience in academia and research focused on cloud computing, SaaS, ERP, and digital marketing. She has published several research papers in international journals and conferences and has taught at the postgraduate level. Currently, she is an Assistant Professor at ARMY Institute of Management & Technology where she coordinates various programs and events.
Aditya Electro Projects is an electrical contracting and manufacturing company founded in 2008 and headquartered in Noida, India. The company specializes in electrical panel manufacturing, contracting services, and provides a full range of electrical solutions. It has a team of 70 professionals and fabricates electrical panels in its 5,500 square foot facility. Some of Aditya's ongoing and completed projects include electrical contracting for residential, commercial and industrial developments. The company aims to provide high quality electrical solutions and complete customer satisfaction.
Braulio Stalin Morocho Pizarro estudió temas de ofimática, Gmail, Google Drive, Dropbox, blogs y Flickr durante el segundo bimestre de su carrera de Electrónica y Telecomunicaciones. Aprendió a compartir archivos en Google Drive seleccionando el archivo, dando a la opción "Compartir", seleccionando la forma de compartir y la persona con quien compartir, y dando a "Compartir".
This document discusses how new regulations in Illinois requiring the evaluation of indoor air vapor intrusion concerns have changed the scope and costs of environmental due diligence. Key points:
1) New IEPA regulations and updated standards now mandate investigating vapor intrusion from contaminated soil and groundwater. This has increased costs for Phase I and II assessments and obtaining no further remediation letters.
2) Evaluating vapor intrusion is now required to obtain an NFR letter from the IEPA, increasing the time and costs associated with the review and approval process.
3) Older NFR letters that do not address vapor intrusion may not provide full assurance about a property's environmental status, as they do not rule out
4888e - What to Expect When an Environmental Officer Inspects Your FacilitySteven Momy
This document provides information about environmental inspections conducted by Environmental Officers in Ontario. It explains that EOs are authorized to inspect facilities to evaluate compliance with environmental legislation. During an inspection, EOs will identify themselves, explain the purpose, tour facilities, interview staff, collect samples and review records. They are looking for compliance with requirements regarding operations, waste management, emissions, discharges and water systems. EOs will advise facilities after inspections about any non-compliance identified and next steps, which could include orders, tickets or requests for corrective action. The document provides contact information for more questions.
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
Essential Regulatory Documents in Clinical TrialsAnand Butani
Maintaining and storing the essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s.
In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
After the Panic Subsides – What Should You Do When the Inspector Leaves?Burns White LLC
The steps taken after a bad inspection, be it environmental, OSHA, labor, or anything else, are often “outcome determinative.” This presentation addresses some key things to consider in the days and weeks ahead.
The document discusses compliance procedures and voluntary disclosure criteria for export control violations. It provides an overview of how to conduct internal investigations of suspected violations and outlines the elements that should be included in a voluntary disclosure filing, such as a description of the violations and corrective actions. The document advises implementing thorough corrective actions and not trying to hide bad facts when filing a disclosure. It also summarizes a consent agreement between the United States and United Technologies for unauthorized exports and failure to maintain effective export controls.
The objective of Annex A.11.2 of ISO 27001:2013 is to prevent loss, damage, theft or compromise of assets and interruption to the organization's operations. It contains controls for equipment siting and protection, supporting utilities, cabling security, equipment maintenance, removal of assets, security of equipment off-premises, secure disposal or re-use of equipment, and unattended user equipment. The controls are aimed at protecting equipment from environmental threats, unauthorized access, power failures and other disruptions through measures such as proper siting, backup power, cable protection, maintenance, and policies for off-site use, removal, and disposal of assets.
The document summarizes new sentencing guidelines in the UK that apply to organizations convicted of corporate manslaughter, health and safety, food safety, and hygiene offenses. The guidelines may result in higher penalties, especially for large organizations that created risks of death or serious injury. The guidelines address determining offense categories, starting points and ranges, factors that could warrant adjustment, and reductions for assistance and guilty pleas. Recent cases that applied the guidelines are highlighted. Commercial concerns for organizations given increased prosecutions and larger potential fines are also noted.
Internal Investigations
Chapter 11
Learning Objectives
Situations requiring investigation or audit
Steps in conducting an internal investigation
Interviewing employees and third parties
Reviewing documents and records
Contents of a thorough investigation report
Sources of a government investigation
Responses to a government investigation
When to conduct an internal compliance audit
Taking advantage of attorney-client privilege
Introduction
An organization conducts an internal investigation to discover whether a violation of law has occurred or is likely to occur.
Internal sign or report that a violation has occurred
Organization learns that a government agency has launched an investigation
As a preventive measure, the organization conducts periodic audits
Investigations in a Compliance Program
Key component of an effective compliance program
Discover problems before a government agency learns of them
Opportunity to control resolution of the problems
Once government initiates its an inquiry, the organization is compelled to conduct its own parallel investigation
Multi-Step Investigation Procedure
Use trained, trusted employees to carry out the investigation
Consider using an attorney and a consultant
Fit the investigation to the suspected misconduct
Investigative techniques: personnel interviews, records and document reviews
Report based on investigation findings
After the investigation is complete
Use Trained, Trusted Employees
Starts with the Compliance Officer. Other staff should be ….
Trained in investigation techniques
Knowledgeable about area where misconduct suspected, but preferably not working there
People of good judgment and discretion
Willing to make hard decisions
Able to maintain confidentiality
Consider Using an Attorney
For all but trivial incidents, consult an attorney
For serious matters, conduct investigation under the guidance of an attorney
Take advantage of work-client or work-product privileges whenever possible
Attorney will direct the investigation, communicate with top management, and control information flows about the events
7
Consider Using a Consultant
If the organization lacks the time, the experienced personnel, or the expertise to carry out the investigation
Consultant performs work that is channeled through the attorney
Consultant lacks close relationship with the organization
Consultant duties should be carefully defined
Fit the Investigation to the
Suspected Misconduct
As the investigation proceeds and the gravity of the misconduct is revealed, efforts can be scaled up or down.
Investigative techniques should be discussed with management and the attorney.
Anticipate effects of the investigation on workforce morale and productivity.
Focus of the Investigation
Nature and scope of the problem incident
Statutes and regulations related to the incident
Clarity or ambiguity of the relevant st ...
The document discusses licensing requirements for animal establishments in the UK. It notes that local authorities have a duty to license certain commercial animal establishments under various legislation. When deciding on licenses, the local authority must ensure animals will be properly accommodated, fed, exercised, protected from disease and fire. Licenses may contain conditions set by the local authority. Inspections of licensed establishments are carried out to ensure compliance with license conditions. Unannounced additional inspections may occur, and complaints are investigated impartially.
OFCCP Compliance Review Steps and StrategiesCarla Irwin
The document outlines the steps and strategies for managing an Office of Federal Contract Compliance Programs (OFCCP) compliance review. It discusses responding to the notice of audit, preparing documentation for the desk audit, cooperating with an on-site review if required, and working with the OFCCP to resolve any issues identified in the review process. Possible outcomes include closure of the audit with no findings, findings of violations requiring corrective actions, or in rare cases, debarment from future government contracts.
The document discusses employee safety and health, outlining the Occupational Safety and Health Act and the responsibilities of OSHA to set and enforce safety standards in the workplace. It also covers the process for OSHA inspections, including how citations and penalties are issued for violations, and the rights and responsibilities of both employers and employees to ensure a safe work environment.
Responding to Grand Jury: Subpoenas & Search WarrantsNexsen Pruet
The document discusses responding to criminal subpoenas, with a focus on subpoenas duces tecum for documents. It notes that criminal subpoenas are broader than civil subpoenas and provides tips for initial review of a subpoena, potential challenges, document search and production process, and expenses of compliance. It also discusses responding if a search warrant is executed, including establishing an advance planning and response protocol to protect legal interests while cooperating.
This document summarizes an inspection report submitted by three students at Sarhad University of Science and IT Peshawar. The report was approved by an internal and external examiner. The abstract introduces inspections as organized examinations that involve measurements, tests and gauges to evaluate if an object meets specified requirements. Inspections can be visual, involve sensing technologies like ultrasonic testing, and be done manually or automatically. The introduction provides background on inspections and their objectives to prevent incidents and identify hazards. The literature review discusses the history of occupational health and safety standards and inspections. It also outlines advantages like detecting equipment issues and disadvantages like additional costs and training needs.
- Federal antitrust investigators may first notify a company of an investigation through executing a search warrant at the company's offices to seize documents and electronics. Such searches, known as "dawn raids", are coordinated across multiple jurisdictions.
- If searched, it is important for a company to immediately contact legal counsel, preserve documents, and designate representatives to handle inquiries while advising employees of their rights regarding speaking to investigators. Proper preparation and response can help minimize the impact of an antitrust investigation.
The document provides an overview of Ontario's Environmental Bill of Rights (EBR) and the Environmental Registry. It discusses key aspects of the EBR including increasing public participation, government accountability and transparency. It also outlines the purpose and process for proposal notices, decision notices, applications for review/investigation, and use of the Environmental Registry website.
Environmental Compliance Audits - Cheap Insurance Against Regulatory Entangle...Larry Falbe
This document provides an overview of environmental compliance audits (ECAs) and their benefits. ECAs assess a facility's compliance with environmental regulations to avoid penalties from violations. While ECAs require paying consultants and lawyers, they provide a "cheap insurance policy" against costly regulatory issues. The document explains how ECAs are performed, including using attorneys to protect audit results from disclosure and consultants to inspect facilities and review documentation. ECAs can identify compliance issues to correct quietly or through voluntary self-disclosure programs, which reduce penalties. The document distinguishes ECAs from Phase I assessments, which evaluate property for real estate transactions rather than ensuring ongoing compliance.
The document summarizes recent developments in whistleblower law, including jury verdicts awarding millions of dollars in damages in Sarbanes-Oxley (SOX) retaliation cases. It discusses expansions to the types of conduct protected under SOX, Dodd-Frank, the False Claims Act, and the National Defense Authorization Act. It also notes increased enforcement by the SEC of Dodd-Frank's anti-gag provision and compares the differences between protections offered under the various whistleblower statutes.
The document summarizes the roles and powers of Ontario Ministry of Labor (MOL) health and safety inspectors. Inspectors are authorized to enter and inspect workplaces without a warrant to ensure compliance with health and safety laws. They can issue orders requiring corrections, conduct investigations of injuries and complaints, and recommend prosecutions. The inspections have benefited workplaces by reducing injuries and costs while improving safety compliance and productivity.
The document outlines the key responsibilities of sponsors in clinical research. Sponsors initiate clinical investigations and are ultimately responsible for the quality and integrity of the research. They can transfer duties like protocol design and monitoring to contract research organizations but remain accountable. Sponsors must ensure proper quality assurance and control, select qualified investigators, and manage trial conduct, data handling, and independent oversight committees. They are also responsible for regulatory approvals, safety monitoring, audits, and reporting results.
This document outlines AB Roofing Solutions Ltd's health and safety policy. It includes their commitment to complying with relevant legislation and ensuring risks are properly assessed. It assigns roles and responsibilities for health and safety to managers and employees. It also describes the company's arrangements for various health and safety matters like safety audits, guidance, asbestos handling, training records and risk assessments. The policy aims to protect employees, customers and the public from health and safety risks from the company's operations.
More Related Content
Similar to Surviving_Environmental_Inspections_-_Falbe
4888e - What to Expect When an Environmental Officer Inspects Your FacilitySteven Momy
This document provides information about environmental inspections conducted by Environmental Officers in Ontario. It explains that EOs are authorized to inspect facilities to evaluate compliance with environmental legislation. During an inspection, EOs will identify themselves, explain the purpose, tour facilities, interview staff, collect samples and review records. They are looking for compliance with requirements regarding operations, waste management, emissions, discharges and water systems. EOs will advise facilities after inspections about any non-compliance identified and next steps, which could include orders, tickets or requests for corrective action. The document provides contact information for more questions.
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
Essential Regulatory Documents in Clinical TrialsAnand Butani
Maintaining and storing the essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s.
In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
After the Panic Subsides – What Should You Do When the Inspector Leaves?Burns White LLC
The steps taken after a bad inspection, be it environmental, OSHA, labor, or anything else, are often “outcome determinative.” This presentation addresses some key things to consider in the days and weeks ahead.
The document discusses compliance procedures and voluntary disclosure criteria for export control violations. It provides an overview of how to conduct internal investigations of suspected violations and outlines the elements that should be included in a voluntary disclosure filing, such as a description of the violations and corrective actions. The document advises implementing thorough corrective actions and not trying to hide bad facts when filing a disclosure. It also summarizes a consent agreement between the United States and United Technologies for unauthorized exports and failure to maintain effective export controls.
The objective of Annex A.11.2 of ISO 27001:2013 is to prevent loss, damage, theft or compromise of assets and interruption to the organization's operations. It contains controls for equipment siting and protection, supporting utilities, cabling security, equipment maintenance, removal of assets, security of equipment off-premises, secure disposal or re-use of equipment, and unattended user equipment. The controls are aimed at protecting equipment from environmental threats, unauthorized access, power failures and other disruptions through measures such as proper siting, backup power, cable protection, maintenance, and policies for off-site use, removal, and disposal of assets.
The document summarizes new sentencing guidelines in the UK that apply to organizations convicted of corporate manslaughter, health and safety, food safety, and hygiene offenses. The guidelines may result in higher penalties, especially for large organizations that created risks of death or serious injury. The guidelines address determining offense categories, starting points and ranges, factors that could warrant adjustment, and reductions for assistance and guilty pleas. Recent cases that applied the guidelines are highlighted. Commercial concerns for organizations given increased prosecutions and larger potential fines are also noted.
Internal Investigations
Chapter 11
Learning Objectives
Situations requiring investigation or audit
Steps in conducting an internal investigation
Interviewing employees and third parties
Reviewing documents and records
Contents of a thorough investigation report
Sources of a government investigation
Responses to a government investigation
When to conduct an internal compliance audit
Taking advantage of attorney-client privilege
Introduction
An organization conducts an internal investigation to discover whether a violation of law has occurred or is likely to occur.
Internal sign or report that a violation has occurred
Organization learns that a government agency has launched an investigation
As a preventive measure, the organization conducts periodic audits
Investigations in a Compliance Program
Key component of an effective compliance program
Discover problems before a government agency learns of them
Opportunity to control resolution of the problems
Once government initiates its an inquiry, the organization is compelled to conduct its own parallel investigation
Multi-Step Investigation Procedure
Use trained, trusted employees to carry out the investigation
Consider using an attorney and a consultant
Fit the investigation to the suspected misconduct
Investigative techniques: personnel interviews, records and document reviews
Report based on investigation findings
After the investigation is complete
Use Trained, Trusted Employees
Starts with the Compliance Officer. Other staff should be ….
Trained in investigation techniques
Knowledgeable about area where misconduct suspected, but preferably not working there
People of good judgment and discretion
Willing to make hard decisions
Able to maintain confidentiality
Consider Using an Attorney
For all but trivial incidents, consult an attorney
For serious matters, conduct investigation under the guidance of an attorney
Take advantage of work-client or work-product privileges whenever possible
Attorney will direct the investigation, communicate with top management, and control information flows about the events
7
Consider Using a Consultant
If the organization lacks the time, the experienced personnel, or the expertise to carry out the investigation
Consultant performs work that is channeled through the attorney
Consultant lacks close relationship with the organization
Consultant duties should be carefully defined
Fit the Investigation to the
Suspected Misconduct
As the investigation proceeds and the gravity of the misconduct is revealed, efforts can be scaled up or down.
Investigative techniques should be discussed with management and the attorney.
Anticipate effects of the investigation on workforce morale and productivity.
Focus of the Investigation
Nature and scope of the problem incident
Statutes and regulations related to the incident
Clarity or ambiguity of the relevant st ...
The document discusses licensing requirements for animal establishments in the UK. It notes that local authorities have a duty to license certain commercial animal establishments under various legislation. When deciding on licenses, the local authority must ensure animals will be properly accommodated, fed, exercised, protected from disease and fire. Licenses may contain conditions set by the local authority. Inspections of licensed establishments are carried out to ensure compliance with license conditions. Unannounced additional inspections may occur, and complaints are investigated impartially.
OFCCP Compliance Review Steps and StrategiesCarla Irwin
The document outlines the steps and strategies for managing an Office of Federal Contract Compliance Programs (OFCCP) compliance review. It discusses responding to the notice of audit, preparing documentation for the desk audit, cooperating with an on-site review if required, and working with the OFCCP to resolve any issues identified in the review process. Possible outcomes include closure of the audit with no findings, findings of violations requiring corrective actions, or in rare cases, debarment from future government contracts.
The document discusses employee safety and health, outlining the Occupational Safety and Health Act and the responsibilities of OSHA to set and enforce safety standards in the workplace. It also covers the process for OSHA inspections, including how citations and penalties are issued for violations, and the rights and responsibilities of both employers and employees to ensure a safe work environment.
Responding to Grand Jury: Subpoenas & Search WarrantsNexsen Pruet
The document discusses responding to criminal subpoenas, with a focus on subpoenas duces tecum for documents. It notes that criminal subpoenas are broader than civil subpoenas and provides tips for initial review of a subpoena, potential challenges, document search and production process, and expenses of compliance. It also discusses responding if a search warrant is executed, including establishing an advance planning and response protocol to protect legal interests while cooperating.
This document summarizes an inspection report submitted by three students at Sarhad University of Science and IT Peshawar. The report was approved by an internal and external examiner. The abstract introduces inspections as organized examinations that involve measurements, tests and gauges to evaluate if an object meets specified requirements. Inspections can be visual, involve sensing technologies like ultrasonic testing, and be done manually or automatically. The introduction provides background on inspections and their objectives to prevent incidents and identify hazards. The literature review discusses the history of occupational health and safety standards and inspections. It also outlines advantages like detecting equipment issues and disadvantages like additional costs and training needs.
- Federal antitrust investigators may first notify a company of an investigation through executing a search warrant at the company's offices to seize documents and electronics. Such searches, known as "dawn raids", are coordinated across multiple jurisdictions.
- If searched, it is important for a company to immediately contact legal counsel, preserve documents, and designate representatives to handle inquiries while advising employees of their rights regarding speaking to investigators. Proper preparation and response can help minimize the impact of an antitrust investigation.
The document provides an overview of Ontario's Environmental Bill of Rights (EBR) and the Environmental Registry. It discusses key aspects of the EBR including increasing public participation, government accountability and transparency. It also outlines the purpose and process for proposal notices, decision notices, applications for review/investigation, and use of the Environmental Registry website.
Environmental Compliance Audits - Cheap Insurance Against Regulatory Entangle...Larry Falbe
This document provides an overview of environmental compliance audits (ECAs) and their benefits. ECAs assess a facility's compliance with environmental regulations to avoid penalties from violations. While ECAs require paying consultants and lawyers, they provide a "cheap insurance policy" against costly regulatory issues. The document explains how ECAs are performed, including using attorneys to protect audit results from disclosure and consultants to inspect facilities and review documentation. ECAs can identify compliance issues to correct quietly or through voluntary self-disclosure programs, which reduce penalties. The document distinguishes ECAs from Phase I assessments, which evaluate property for real estate transactions rather than ensuring ongoing compliance.
The document summarizes recent developments in whistleblower law, including jury verdicts awarding millions of dollars in damages in Sarbanes-Oxley (SOX) retaliation cases. It discusses expansions to the types of conduct protected under SOX, Dodd-Frank, the False Claims Act, and the National Defense Authorization Act. It also notes increased enforcement by the SEC of Dodd-Frank's anti-gag provision and compares the differences between protections offered under the various whistleblower statutes.
The document summarizes the roles and powers of Ontario Ministry of Labor (MOL) health and safety inspectors. Inspectors are authorized to enter and inspect workplaces without a warrant to ensure compliance with health and safety laws. They can issue orders requiring corrections, conduct investigations of injuries and complaints, and recommend prosecutions. The inspections have benefited workplaces by reducing injuries and costs while improving safety compliance and productivity.
The document outlines the key responsibilities of sponsors in clinical research. Sponsors initiate clinical investigations and are ultimately responsible for the quality and integrity of the research. They can transfer duties like protocol design and monitoring to contract research organizations but remain accountable. Sponsors must ensure proper quality assurance and control, select qualified investigators, and manage trial conduct, data handling, and independent oversight committees. They are also responsible for regulatory approvals, safety monitoring, audits, and reporting results.
This document outlines AB Roofing Solutions Ltd's health and safety policy. It includes their commitment to complying with relevant legislation and ensuring risks are properly assessed. It assigns roles and responsibilities for health and safety to managers and employees. It also describes the company's arrangements for various health and safety matters like safety audits, guidance, asbestos handling, training records and risk assessments. The policy aims to protect employees, customers and the public from health and safety risks from the company's operations.
Similar to Surviving_Environmental_Inspections_-_Falbe (20)
1. Reproduced with permission from Daily Environment Report,
06 DEN B-1, 01/09/2015. Copyright 2015 by The Bureau
of National Affairs, Inc. (800-372-1033) http://www.bna.com
E N F O R C E M E N T
E n v i r o n m e n t a l I n s p e c t i o n s
Potentially affected facilities should take some basic steps to prepare for environmental
inspections by federal, state or local authorities, Lawrence Falbe, a partner in the Chicago
office of the national law firm of Quarles & Brady LLP, notes below. This includes prepar-
ing an inspection policy and conducting mock inspections. Company officials should be po-
lite and respectful to inspectors, but not necessarily deferential, he advises.
Surviving and Thriving Through Environmental Inspections
BY LAWRENCE W. FALBE
E
nvironmental inspections by regulatory authorities
may occur at any time at any facility subject to en-
vironmental rules and regulations as a result of op-
erations conducted at the facility1
. Because environ-
mental regulatory inspections may become the basis for
civil or criminal enforcement actions or other claims
against your company or client’s company, a systematic
and coordinated approach to preparing for and re-
1
This article provides information of a general nature.
None of the information contained herein is intended as legal
advice or opinion relative to specific matters, facts, situations
or issues. Additional facts and information or future develop-
ments may affect the subjects addressed in this article. You
should consult with a lawyer about your particular circum-
stances before acting on any of this information because it may
not be applicable to you or your situation.
Lawrence W. Falbe is a partner in the Chi-
cago office of the national law firm of Quarles
& Brady LLP. Larry’s practice focuses on
energy development and facility siting, envi-
ronmental transactional support (both real
estate and corporate), environmental defense
and litigation, brownfields issues and envi-
ronmental compliance matters. For more
information, go to http://www.quarles.com/
lawrence-w-falbe.
This article does not represent the opinions of
Bloomberg BNA, which welcomes other points
of view.
COPYRIGHT 2015 BY THE BUREAU OF NATIONAL AFFAIRS, INC. ISSN 1060-2976
Daily Environment
Report™
2. sponding to an environmental inspection is critical for
the smooth operation of any facility.
Inspections may be performed for any number of rea-
sons under various statutory and regulatory authorities,
and they do not necessarily require a search warrant or
administrative order. For example, if the facility has
any kind of environmental permit (e.g., air emissions,
water discharges, hazardous waste generation, etc.),
the terms of some permits call for periodic inspections
(e.g., annually, every five years, etc.). If an inspection
has been performed for any reason in the past, often a
follow-up inspection may be performed to ascertain
whether previously identified violations or issues have
been corrected. Complaints regarding the operation of
the facility, either from neighbors or disgruntled
current/former employees (whistleblowers), can also
prompt an inspection. An incident in which a release of
hazardous materials to the environment occurs and is
reported (especially one in which injuries occurred or
the release escaped off-property) is also likely to
prompt an inspection.
Environmental inspections may be performed by the
federal environmental authorities (U.S. Environmental
Protection Agency), the state environmental authority
where the facility is located or even local authorities
(fire department, local publicly owned water treatment
works, etc.). At the federal level, environmental con-
cerns also may be identified as part of an OSHA inspec-
tion. A 1991 Memorandum of Understanding (MOU)
between OSHA and U.S. EPA provides that inspectors
from either agency will refer potential violations of EPA
and OSHA regulations to each other for subsequent
follow-up.
While a brief article cannot cover every detail inher-
ent in preparing for an inspection and is not a substitute
for legal advice specific to your facility, the checklist be-
low (in conjunction with consulting experienced envi-
ronmental counsel) can help in preparing an Inspection
Policy to cover what should happen when inspectors
knock on the door.
A. Arrival at the Facility
When inspection officials arrive at the entrance to the
facility, the security guard and/or receptionist should
immediately contact the highest-level manager avail-
able, typically the Plant Manager or the Environmental
Health and Safety (EH&S) Supervisor, to inform him or
her of the visit.
s Managers should escort the officials to a confer-
ence room; be pleasant and respectful; ask them the
purpose of the visit, and what areas of the facility they
wish to inspect.
s Request business cards and identification from
the officials. Ascertain which regulatory agency or
agencies they represent (e.g., U.S. EPA, OSHA, etc.)
and contact the respective regulatory agencies to con-
firm the identities of the inspectors (this has become
commonplace due to terrorism concerns and the ease of
falsifying official-looking credentials).
s Ask the officials to specify the authority on which
they are relying to be given access to the facility. If the
inspection is in relation to a specific permit, ask for that
permit to be identified, and then review the terms of
that permit to confirm such authority. Request a copy of
any specific orders or other authority (e.g., search war-
rants) under which the inspection is being conducted.
Note that most environmental inspectors will have ad-
ministrative authority as explained above and may not
have any specific authorizing documents, but in such
case should state the basis for their authority (e.g., un-
der the terms of a specific permit, under an environ-
mental statute or regulation, etc.).
s Ask the officials to wait while the manager con-
tacts outside legal counsel.
s Tell the officials that you wish to:
(i) have legal counsel speak with them by phone ini-
tially after stating or presenting the legal authority for
conducting the inspection (current contact information
for internal and/or external legal counsel should be in-
serted into the Inspection Policy to facilitate quick com-
munication), and
(ii) if a search warrant has been presented (usually
the sign of a very serious concern), politely request time
to contact legal counsel and have counsel present when
they commence their search pursuant to the search
warrant (note that if a search warrant is presented, the
inspecting officials may not agree—and are not legally
obligated—to wait until legal counsel can arrive).
s Do not admit citizen or environmental groups, re-
porters or any individuals not associated with the regu-
latory authority.
s Be polite and respectful (but not necessarily def-
erential) to the officials.
B. Conduct an Opening Conference
s Unless advised otherwise by legal counsel, before
giving access to operational areas of the facility, invite
the officials to sit down in a conference room and pro-
vide you with an overview of what is being requested in
terms of the scope of the inspection (the Opening Con-
ference).
s If the scope of the inspection seems overly broad,
or appears irrelevant to the stated purposes of the in-
spection, ask to discuss/negotiate those issues with the
officials. If an agreement cannot be reached, contact le-
gal counsel for advice, especially before refusing access
in whole or in part.
s During the Opening Conference, provide a proper
safety briefing that covers the areas of the requested in-
spection, and provide any needed personal protective
equipment.
C. Escort Officials on the Inspection
s You have the right to accompany the officials at
all times. Identify the in-house team that will accom-
pany the inspectors (preferably, this should be done in
advance as a contingency covered in the facility’s envi-
ronmental compliance program); at minimum, this
should include the EH&S Supervisor.
s Answer any questions by the officials only based
on specific knowledge, and keep answers brief and to
the point. You are not required to guess or speculate if
you do not know the answer to the question. You can
offer to provide such information as a follow-up if that
seems appropriate.
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3. s Generally, inspectors will not seek to take soil, air
or effluent samples or perform other invasive sampling
at the facility without advance notice; if such a request
is made, notify legal counsel immediately, as this is of-
ten an indicator of a serious concern of the regulating
authority. Note that the terms of a search warrant (if ap-
plicable) may entitle the officials to take such samples
as well as relevant paper or electronic documents or
other items specified in the search warrant.
s Officials will often request to see contingency
plans, sampling logs, or other documents and records
required under specific environmental statutes, regula-
tions or permit conditions, such as Spill Prevention
Control and Countermeasure Plans (SPCC Plans), Ma-
terial Safety Data Sheets (MSDSs), ‘‘Tier II Reports’’ or
other documentation. Prior to the inspection, proper
care should been taken to maintain such records sepa-
rately (and ensure that they are not intermingled with
non-related documents and/or sensitive documents that
contain confidential business information or attorney
communications) and in accordance with any statutory
or other legal requirements (for example, MSDSs must
always be available to employees for review). Access to
such records should be given to the officials at the time
of the request. If a request appears to be irrelevant to
the stated purposes of the inspection, overly burden-
some or otherwise inappropriate, contact legal counsel
for advice.
s Take notes during the inspection of what areas
are inspected, comments made by the inspectors, and
any questions asked. Keep your notes factual and non-
conclusory, as any notes not taken by attorneys may be
obtained later by the inspecting authority if an enforce-
ment action ensues.
s If the officials take photographs, take your own
photographs if possible as well, and the same applies to
any requested samples of materials. If copies of docu-
ments are requested, make a specific duplicate set of
whatever is given to the officials (the same goes for
electronic versions of documents).
s Provide only documents that are requested. If
documents are requested that appear to be beyond the
scope of the inspection, contact legal counsel for guid-
ance. If any documents might be subject to trade secret
protection or otherwise may constitute confidential
business information, ask for such protections from the
inspectors and contact legal counsel.
D. Conduct a Closing Conference
s At the conclusion of the inspection (Closing Con-
ference), ask the officials for their anticipated next
steps (e.g., will a letter be issued, are there specific is-
sues that will be requested to be corrected?). If any se-
rious compliance issues have been identified (whether
or not the inspector indicates that an NOV (Notice of
Violation) will be issued), do not admit any fault or li-
ability, but ask for the officials’ position on what is re-
quired to achieve compliance. Consult with upper man-
agement and legal counsel after the inspection to evalu-
ate the position taken by the officials and determine an
appropriate response.
s After the officials have departed the facility, notify
legal counsel and upper management of the pertinent
details of the inspection if they were not present, even
if no compliance concerns are identified. As noted
above, keep in mind that any internal communications
not from attorneys may be obtained later by the inspect-
ing authority.
E. FAQ’s
1. Will I get advance notice of the inspection? Some-
times. It depends greatly on the reason for the inspec-
tion and the specific authority under which the inspec-
tion is being conducted. Routine inspections intended to
ensure compliance with an environmental permit are
often scheduled in advance to make the inspection go
more smoothly both for the inspectors and the facility.
On the other hand, inspections intended to respond to a
complaint or a suspected violation of law are often done
without advance notice (especially where a search war-
rant has been issued).
2. Can we refuse to admit the inspectors? Possibly, but
such action is almost always unwise. Most inspections
will be performed under some clear legal authority such
as the terms of a permit (which might be revoked if ac-
cess is not provided), or statutory enforcement author-
ity given to the regulating agency under law. Most such
authority is very broad (and does not require a search
warrant or other such legal authority issuing from a
judge) and it is very difficult to completely bar access to
a facility from a determined regulatory agency. De-
pending on the specific authority invoked, civil mon-
etary penalties or even criminal penalties may be as-
sessed for failure to admit inspectors. At the very least,
trying to thwart access to a facility by inspectors is
likely to raise their ire. Consequently, such resistance
may result in adverse consequences when matters of
regulatory discretion are involved and may also give in-
spectors the sense that the facility ‘‘has something to
hide,’’ which will increase the level of scrutiny applied
to the facility when they finally gain admittance.
3. Can inspectors seize or demand copies of paper or
electronic documents? Yes, depending on the nature of
the inspection and the authority under which the in-
spection is being conducted.
4. Can inspectors talk to my employees? Does manage-
ment have a right to be present during such questioning?
Yes, inspectors usually have the authority to speak to
facility employees. If an inspector asks to speak to an
employee without management present, contact legal
counsel for guidance.
5. How do I prepare for an inspection? Always assume
an inspection may occur at any time. Consistently prac-
tice good environmental housekeeping and don’t as-
sume that things can be corrected just before (or after)
inspectors arrive. Engage in periodic (typically annual)
internal environmental compliance audits (which may
be performed by third-party consultants if needed, of-
ten with the assistance of legal counsel) to try to iden-
tify issues before the inspectors do, and conduct mock
inspections to train your response team. Prepare an In-
spection Policy to ensure a proper and consistent re-
sponse by facility personnel.
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