RegulatoryAgenciesandCompliance

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Title: Piping and Instrumentation Diagrams: Regulatory Agencies and Compliance

Authors: Jayshree Mahajan, Bradley Anderson, Aaron Bennick, Michael Salciccioli

Stewards: Jocelyn Anleitner, Stephanie Combs, Diane Feldkamp, Heeral Sheth

Contents

Introduction

Regulatory agencies govern various sections of chemical plants from emissions and water treatment to personnel behaviors and company policy. Understanding of the types of organizations that demand high performance from chemical plants on a national and local level are extremely important for the safety of the employees, community and environment.

Regulatory Compliance

Compliance is an integral part of ensuring the safety of all that work in close contact with the chemical plant as well as minimizing fines and fees that come with violating regulations. Compliance can be organized into two main categories; plant safety and environmental safety. Plant safety ensures employees and the surrounding community are adequately protected during full-operation of the plant. Environmental safety comprises protecting and treating the environmental carefully when it comes to various contaminated streams in the plant.

Plant Safety for Employees and the Community

Safety is paramount in any chemical process, and alarms are essential for compliance with safety constraints. OSHA has established guidelines that must be followed in any plant when dealing with chemicals defined as highly hazardous. Limits for temperature, pressure, flow rates, and compositions need to be regulated. Alarms should be in place to warn operators when a limit is near so that steps can be taken to ensure the safety of people in the plant. An example of this is a safe temperature limit for a CSTR. The alarm signals that the temperature is too high and action is needed to prevent a runaway scenario. If the corrective action is not taken, or not taken quickly enough, a critical alarm can signal a computer program to automatically shut down the entire process or specific unit operation.

Some industries may expect product quality to be closely regulated by the FDA or other government agencies. Typically, this will be in a process where the final product is directly used by people and the margins for error are small. These processes include food processing and manufacturing consumer products, especially pharmaceuticals. These industries usually require systems in place that frequently validate alarms, as well as documentation for all critical alarm events. Measurements such as the weight percent of a pharmaceutically active compound in a solution must be carefully monitored, with recorded uncertainty analysis.

Environmental Safety

Emissions of solids, liquids, and gases in a plant are heavily regulated by government agencies. Regulations apply for processes that emit chemicals to the atmosphere (either directly or following a scrubber), processes that discharge material into a body of water, or processes that require containment control devices like check valves and rupture disks. Alarms are frequently used to comply with these regulations by measuring things such as pH and organic solvent concentration. Typically, a warning alarm will alert personnel that a threshold may be breached if action is not taken, allowing time to avoid an incident requiring a formal report. Critical alarms can alert operators that a threshold has been passed and automatically trigger the appropriate action, such as a systematic shutdown of the process.

Regulatory Agencies

Federal and national agencies maintain smaller state subsections of various programs and administrations. In most cases, the state level requires stricter compliance and lower limits. Solely state-controlled programs usually handle the air and water quality since any regulation violation results in the consequences for the immediate community.

Federal and National Agencies or Programs

Plant safety and environmental safety programs regulated on the national or federal level are monitored by three main agencies; the Environmental Protection Agency (EPA), the U.S. Department of Labor, the Food and Drug Administration, and the Department of Homeland Security. These three governing bodies have created numerous acts, committees, administrations and policies that protect the welfare of the employee, community, and environment.

The EPA at the federal level, provides acts, laws, and regulations, that help maintain and improve the air and water quality. The risk management program (RMP) is a mandatory program that "require facilities that produce, handle, process, distribute, or store certain chemicals to develop a Risk Management Program". A Risk Management Plan (RMP) must be submitted to the EPA for approval. Overall, risk management is a large part of process control as control systems must adequately function and maintain compliance of an entire facility. Failure logic for instrumentation, redundant sensors, and critical alarms are essential in maintaining compliance, but a RMP is crucial for handling low-likelihood emergency situations.

The U.S. Department of Labor maintains the Occupational Safety and Health Administration (OSHA) which provides rules and regulations for employers and employees on safe workplace practices. Although individual states may maintain their own occupational health and safety plans, OSHA is the governing body and authority on those programs. Inspections are performed to ensure that all employees have a clean and safe working environment that is hazard-free and risk-mediated. OSHA also maintains the Process Safety Management Program (PSM) which regulates requirements for facilities that handle highly hazardous chemicals. A list of chemicals that qualify include chlorine, formaldehyde, and hydroflouric acid. Requirements of PSM include frequent process hazard analysis (PHA), pre-startup safety review (PSSR), and incident investigations. A cooperative program that OSHA maintains is The Voluntary Protection Programs (VPP). These programs aim to bring together management and labor to provide comprehensive safety and health guidelines and regulations that keep all employees safe while on the job. Each facility must submit application for entry into the program and upon acceptance will follow a set of standards to ensure continued safety.

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA regulates food, drugs, cosmetics, biologics, medical devices, radiation-emitting devices and vetenary products manufactured in the United States. The main goal of the FDA is to maitain that the products they regulate are safe, effective, and secure. The FDA is also responsible that the products are accurately represented to the public. State and local governments also help regulate these products in cooperation with the FDA. The FDA does not regulate alcohol, illegal drugs, and meat and poultry.

The Department of Homeland Security has recently taken a role in regulating chemical plants because of 9/11. Chemical plants are seen by the government as targets for terrorists and security in and around the plant is a major concern. Although the laws are typically state run, the Department of Homeland Security has required mandatory national security standard to chemical plants throughout the nation. Although the mandates were fought by legislative for years, the Department of Homeland Security has influence in the security in chemical plants. The law requires the plant to prepare a vulnerability test and submit a site security plan. In order to validate these activities, audits and site visits are/will be performed by government officials.

State Regulations

State regulations vary greatly from state-to-state depending on the main concern. For instance, beach quality is more important in California than Nebraska due to the geographical location. Similarly state legislative acts and administrations can expect high performance from the chemical industry as it has the capability to affect all parts of a community for many generations.

References

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