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Safety First: Avoiding Chemical Storage Hazards
by Lynn L. Bergeson and Robin J. Schoeps
Healthcare facilities must maintain sterile environments to prevent thespread of infection and disease. To do so, facilities rely upon variousdisinfectant and sterilizing products of which some ingredients are consideredto be toxic by the US Environmental Protection Agency (EPA) and other federalagencies. To prevent injury to patients, employees, and others, these chemicalproducts must be used, managed, stored, and disposed properly. Most peoplerecognize the hazards associated with the misuse of a chemical substance. If,however, the chemicals are stored improperly, additional hazards arise, andproblems may occur. To avoid such dangers, healthcare facilities should bemindful of all chemical labeling and on-site management requirements underfederal, state, and local law.
Federal Regulatory Overview
Healthcare facilities have an affirmative duty to store antibacterials andsterilants in a manner so as to not to endanger patients, employees, and others.Under Clean Air Act (CAA) Section 112Â®, a healthcare facility has a generalduty to ensure that extremely hazardous substances (EHSs) are managed and storedsafely. An EHS is a substance that is "known to cause or may reasonably beanticipated to cause death, injury, or serious adverse effects to human healthor the environment" if accidentally released. Ethylene oxide (EO), a commoningredient found in sterilants, is a listed EHS as is peracetic acid. Healthcarefacilities must identify all products that contain EHSs from which a release mayoccur and must take affirmative steps to prevent such a release.
To prevent injury to patients, employees, and others, chemical products must be used, managed, stored, and disposed properly.
CAA Section 112Â® requires also that facilities containing over a"threshold" quantity of an EHS prepare a Risk Management Plan (RMP).The threshold quantity for EO and peracetic acid is 10,000 pounds. Individualfacilities should investigate if their facility stores an EHS at or above thethreshold quantity requirements for any listed substance. Although it isunlikely that a healthcare facility would maintain such large quantities of anylisted EHS so as to trigger RMP requirements, it is prudent to confirm that therequirements do not apply. Even if they do not, a facility may wish to implementan "RMP-like" plan to discharge its obligation under the general dutyrequirement.
The first step in creating an RMP is to review and document the chemicalspresent at the facility. The healthcare facility should identify all potentialhazards, including the likelihood that there may be a spill or leak from acontainer, and evaluate the consequences if such an event were to occur. Toavoid such an occurrence, the healthcare facility should prepare standardoperating procedures (SOPs) for using and storing chemicals of concern. The SOPsshould address employee training on proper storage practices and the elements ofa preventive maintenance program. The program should also include provisions tocompel regularly scheduled container inspections to confirm that there are nocontainer leaks or potentials for leaks, the temperature of the storage area isin accordance with requirements specified for that chemical, incompatible activeingredients are not stored together, and that containers have not been misplacedin incorrect storage areas. Safety audits should be conducted regularly toensure that the SOPs are being followed and that instances of noncompliance areidentified and addressed appropriately.
Similar requirements to ensure worker safety are administered by theOccupational Safety and Health Administration (OSHA) under the HazardCommunication Standard (HCS) regulations. Many states also have"right-to-know" laws, which impose additional requirements. The HCSgives employees a "right-to-know" about chemical hazards that arepresent in the workplace. The hazards covered by the HCS include all chemicalsto which the employee may be exposed, either under normal operating conditionsor in a foreseeable emergency. Employers, such as a medical or healthcarefacility, are required to prepare and implement a written hazard communicationprogram informing employees of the hazards that are present in the workplace.Under the program, employers must ensure that all containers are labeled,employees have access to material safety data sheets (MSDS), and all potentiallyexposed employees participate in a training program. An MSDS is a document thatincludes specified information, including the identity of the chemical, itsphysical and chemical characteristics, the physical hazards associated with thechemical, emergency and first aid measures, and related information. In additionto creating a hazard communication program, employers are under a general dutypursuant to the Occupational Safety and Health Act to protect employees fromworkplace hazards.
For certain chemicals, OSHA has issued storage guidelines to protect workers.Examples of such standards are those in place for ethylene oxide and hydrogenperoxide. Ethylene oxide is an OSHA hazardous chemical, and OSHA has promulgateda specific exposure standard for this chemical. OSHA requires that ethyleneoxide be stored in tightly closed containers "in a cool, well-ventilatedarea, away from heat, sparks, flames, strong oxidizers, alkalines, and acids,strong bases, acetylide-forming metals such as cooper [sic], silver, mercury andtheir alloys."
Hydrogen peroxide is regulated differently. OSHA recommends that hydrogenperoxide be stored in a "cool, dry, well-ventilated area." Thecontainers should be sealed tightly to prevent fumes from escaping and protectedfrom physical damage. OSHA recommends storing hydrogen peroxide separately fromcombustible materials such as wood, paper, and oil; organic materials such ascotton, alcohols, acetone, and other ketones; metals including iron, copper,metal salts, metal alloys, and metal oxides; and mineral acids. OSHA providesadditional guidance on the storage of hazardous or toxic chemicals inlaboratories.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requireschemical manufacturers to register with EPA those chemicals considered"pesticides," including certain antimicrobials and antibacterials. Theregulations specify chemical storage requirements and mandate that they belisted on the label of the product container. Storage requirements vary and mayinclude temperature, humidity, and ventilation control specifications. Ahealthcare facility must strictly follow such storage requirements. The US Foodand Drug Administration (FDA) similarly requires distributors of liquid chemicalsterilants and high-level disinfectants to list storage requirements oncontainers. FDA requires that the expiration date, the storage conditions, andthe use period be included on the label.
So how does a facility comply with these mandatory protections when storingtoxic chemicals? There is no one specific set of regulations or guidancedetailing what a healthcare facility should and should not do. Various sourcesof information exist on how best to manage and store toxic chemicals. Plainly,facilities should consult appropriate experts to ensure that all federal, state,and local regulatory requirements are strictly observed. Professionalassociations may provide general industry practice codes and related materialsthat could prove helpful.
Other Sources of Information Exist
The National Research Council (NRC) has prepared guidance recommendationsconcerning chemical hygiene in laboratories. Such guidance is non-mandatory andcan be found at 29 CFR Â§ 1910.1450, App. A. The guidelines includerecommendations on storing toxic chemicals in stockrooms and in laboratories.The guidelines recommend that in stockrooms, toxic substances be stored inseparate locations from other substances. Storage locations should bewell-identified and have local exhaust ventilation. NRC recommends that"highly" toxic chemicals or chemicals with open containers be inunbreakable secondary containers. The guidelines state that the stored chemicalsshould be inspected regularly to detect if there is any deterioration, containerdamage or wearing, and/or necessary replacement.
NRC makes specific recommendations for laboratory storage. Laboratory storageshould be as small as practicable, avoiding any direct sunlight or heat sources.NRC advises that periodic inspections be conducted so that chemicals no longerneeded in the laboratory are discarded or returned to the main storage area.
Additional guidance on storing toxic chemicals can be obtained from theNational Institutes of Health (NIH). NIH created a clinical center design policyand guidelines for NIH buildings. The guidance, although not directly applicableto private buildings, serves as an example on how to implement safe andeffective storage practices for toxic chemicals. NIH recommends that healthcarefacilities have two primary types of storage areas for hazardous chemicals:building receiving areas and individual modules.
Building receiving areas are for hazardous chemicals to be used in thefacility. This would include materials that are delivered in 220 L drums orlarger. NIH recommends that the building receiving area be capable of storing upto 10 drums. According to the NIH plan, these storage areas will have spillcontainment systems for any leaking or spillage that occurs. NIH recommends thefollowing management standards for a spill containment area: a curb around thearea; use of secondary containment bins; specially designed shelving to containspilled material; or a combination of each of these measures. To assist incleaning a spill, NIH recommends that a chemical-resistant coating be applied tothe walls and floor. In addition, safety equipment should be provided in eacharea.
For individual modules, NIH requires that the containment area be small todiscourage storing excessive amounts of hazardous substances. According to theNIH guidelines, the modules must contain an approved flammable materials storagecabinet that can be ventilated as necessary. There should be separate modulesfor incompatible materials and the area should be designed with spillcontainment and clean-up in mind. Table 1 notes Web addresses that provideuseful, additional information. Other sites exist, and the cited references arenot intended to be exhaustive.
National Research Council Recommendations:
Food and Drug Administration:
EPA, Risk Management Program:
National Institutes of Health--Office of Research Services
Clinical Center Design Policy and Guidelines:
OSHA Health Communication Standard:
Below is a checklist for healthcare facilities to use to determine if thetoxic chemicals at the facility are being stored properly to protect thepatients and employees alike.
* Do the labels on the containers require specific conditions for storage?
* Are the label instructions being followed?
* Is the primary active ingredient in this product an OSHA hazardoussubstance and thus subject to OSHA storage requirements? If so, are theserequirements being followed?
* If the product is considered dangerous when released in reasonablyforeseeable circumstances, is the employer's duty to store the product in a safemanner so as to prevent injury to employees and patients satisfied?
* Is a spill containment system required, and if so, does the facility haveone?
Conducting routine compliance audits to ensure regulatory requirements aremet and precautions are observed will go a long way in preventing problems andensuring a safe and healthful workplace. P
Lynn L. Bergeson is a founding member and shareholder of Bergeson &Campbell, PC, (Washington, DC), a law firm specializing exclusively inpesticide/chemical product approval and regulation and in environmental, healthand safety, and associated business issues. Robin J. Schoeps is an associatewith the firm.For a complete list of references click here