Safety First: Avoiding Chemical Storage Hazards
by Lynn L. Bergeson and Robin J. Schoeps
Healthcare facilities must maintain sterile environments to prevent the spread of infection and disease. To do so, facilities rely upon various disinfectant and sterilizing products of which some ingredients are considered to be toxic by the US Environmental Protection Agency (EPA) and other federal agencies. To prevent injury to patients, employees, and others, these chemical products must be used, managed, stored, and disposed properly. Most people recognize the hazards associated with the misuse of a chemical substance. If, however, the chemicals are stored improperly, additional hazards arise, and problems may occur. To avoid such dangers, healthcare facilities should be mindful of all chemical labeling and on-site management requirements under federal, state, and local law.
Federal Regulatory Overview
Healthcare facilities have an affirmative duty to store antibacterials and sterilants in a manner so as to not to endanger patients, employees, and others. Under Clean Air Act (CAA) Section 112®, a healthcare facility has a general duty to ensure that extremely hazardous substances (EHSs) are managed and stored safely. An EHS is a substance that is "known to cause or may reasonably be anticipated to cause death, injury, or serious adverse effects to human health or the environment" if accidentally released. Ethylene oxide (EO), a common ingredient found in sterilants, is a listed EHS as is peracetic acid. Healthcare facilities must identify all products that contain EHSs from which a release may occur 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 112® 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. Individual facilities should investigate if their facility stores an EHS at or above the threshold quantity requirements for any listed substance. Although it is unlikely that a healthcare facility would maintain such large quantities of any listed EHS so as to trigger RMP requirements, it is prudent to confirm that the requirements do not apply. Even if they do not, a facility may wish to implement an "RMP-like" plan to discharge its obligation under the general duty requirement.
The first step in creating an RMP is to review and document the chemicals present at the facility. The healthcare facility should identify all potential hazards, including the likelihood that there may be a spill or leak from a container, and evaluate the consequences if such an event were to occur. To avoid such an occurrence, the healthcare facility should prepare standard operating procedures (SOPs) for using and storing chemicals of concern. The SOPs should address employee training on proper storage practices and the elements of a preventive maintenance program. The program should also include provisions to compel regularly scheduled container inspections to confirm that there are no container leaks or potentials for leaks, the temperature of the storage area is in accordance with requirements specified for that chemical, incompatible active ingredients are not stored together, and that containers have not been misplaced in incorrect storage areas. Safety audits should be conducted regularly to ensure that the SOPs are being followed and that instances of noncompliance are identified and addressed appropriately.
Similar requirements to ensure worker safety are administered by the Occupational Safety and Health Administration (OSHA) under the Hazard Communication Standard (HCS) regulations. Many states also have "right-to-know" laws, which impose additional requirements. The HCS gives employees a "right-to-know" about chemical hazards that are present in the workplace. The hazards covered by the HCS include all chemicals to which the employee may be exposed, either under normal operating conditions or in a foreseeable emergency. Employers, such as a medical or healthcare facility, are required to prepare and implement a written hazard communication program 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 potentially exposed employees participate in a training program. An MSDS is a document that includes specified information, including the identity of the chemical, its physical and chemical characteristics, the physical hazards associated with the chemical, emergency and first aid measures, and related information. In addition to creating a hazard communication program, employers are under a general duty pursuant to the Occupational Safety and Health Act to protect employees from workplace hazards.
For certain chemicals, OSHA has issued storage guidelines to protect workers. Examples of such standards are those in place for ethylene oxide and hydrogen peroxide. Ethylene oxide is an OSHA hazardous chemical, and OSHA has promulgated a specific exposure standard for this chemical. OSHA requires that ethylene oxide be stored in tightly closed containers "in a cool, well-ventilated area, away from heat, sparks, flames, strong oxidizers, alkalines, and acids, strong bases, acetylide-forming metals such as cooper [sic], silver, mercury and their alloys."
Hydrogen peroxide is regulated differently. OSHA recommends that hydrogen peroxide be stored in a "cool, dry, well-ventilated area." The containers should be sealed tightly to prevent fumes from escaping and protected from physical damage. OSHA recommends storing hydrogen peroxide separately from combustible materials such as wood, paper, and oil; organic materials such as cotton, alcohols, acetone, and other ketones; metals including iron, copper, metal salts, metal alloys, and metal oxides; and mineral acids. OSHA provides additional guidance on the storage of hazardous or toxic chemicals in laboratories.
|Under Clean Air Act (CAA) Section 112®, a healthcare facility has a general duty to ensure that extremely hazardous substances (EHSs) are managed and stored safely. An EHS is a substance that is "known to cause or may reasonably be anticipated to cause death, injury, or serious adverse effects to human health or the environment" if accidentally released.|
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires chemical manufacturers to register with EPA those chemicals considered "pesticides," including certain antimicrobials and antibacterials. The regulations specify chemical storage requirements and mandate that they be listed on the label of the product container. Storage requirements vary and may include temperature, humidity, and ventilation control specifications. A healthcare facility must strictly follow such storage requirements. The US Food and Drug Administration (FDA) similarly requires distributors of liquid chemical sterilants and high-level disinfectants to list storage requirements on containers. FDA requires that the expiration date, the storage conditions, and the use period be included on the label.
So how does a facility comply with these mandatory protections when storing toxic chemicals? There is no one specific set of regulations or guidance detailing what a healthcare facility should and should not do. Various sources of 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. Professional associations may provide general industry practice codes and related materials that could prove helpful.
Other Sources of Information Exist
The National Research Council (NRC) has prepared guidance recommendations concerning chemical hygiene in laboratories. Such guidance is non-mandatory and can be found at 29 CFR § 1910.1450, App. A. The guidelines include recommendations on storing toxic chemicals in stockrooms and in laboratories. The guidelines recommend that in stockrooms, toxic substances be stored in separate locations from other substances. Storage locations should be well-identified and have local exhaust ventilation. NRC recommends that "highly" toxic chemicals or chemicals with open containers be in unbreakable secondary containers. The guidelines state that the stored chemicals should be inspected regularly to detect if there is any deterioration, container damage or wearing, and/or necessary replacement.
NRC makes specific recommendations for laboratory storage. Laboratory storage should be as small as practicable, avoiding any direct sunlight or heat sources. NRC advises that periodic inspections be conducted so that chemicals no longer needed in the laboratory are discarded or returned to the main storage area.
Additional guidance on storing toxic chemicals can be obtained from the National Institutes of Health (NIH). NIH created a clinical center design policy and guidelines for NIH buildings. The guidance, although not directly applicable to private buildings, serves as an example on how to implement safe and effective storage practices for toxic chemicals. NIH recommends that healthcare facilities 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 the facility. This would include materials that are delivered in 220 L drums or larger. NIH recommends that the building receiving area be capable of storing up to 10 drums. According to the NIH plan, these storage areas will have spill containment systems for any leaking or spillage that occurs. NIH recommends the following management standards for a spill containment area: a curb around the area; use of secondary containment bins; specially designed shelving to contain spilled material; or a combination of each of these measures. To assist in cleaning a spill, NIH recommends that a chemical-resistant coating be applied to the walls and floor. In addition, safety equipment should be provided in each area.
For individual modules, NIH requires that the containment area be small to discourage storing excessive amounts of hazardous substances. According to the NIH guidelines, the modules must contain an approved flammable materials storage cabinet that can be ventilated as necessary. There should be separate modules for incompatible materials and the area should be designed with spill containment and clean-up in mind. Table 1 notes Web addresses that provide useful, additional information. Other sites exist, and the cited references are not intended to be exhaustive.
|Table 1: Helpful Web Page Information
National Research Council Recommendations:
Food and Drug Administration:
EPA, Risk Management Program:
National Institutes of Health--Office of Research
OSHA Health Communication Standard:
Below is a checklist for healthcare facilities to use to determine if the toxic chemicals at the facility are being stored properly to protect the patients 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 hazardous substance and thus subject to OSHA storage requirements? If so, are these requirements being followed?
* If the product is considered dangerous when released in reasonably foreseeable circumstances, is the employer's duty to store the product in a safe manner so as to prevent injury to employees and patients satisfied?
* Is a spill containment system required, and if so, does the facility have one?
Conducting routine compliance audits to ensure regulatory requirements are met and precautions are observed will go a long way in preventing problems and ensuring 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 in
pesticide/chemical product approval and regulation and in environmental, health
and safety, and associated business issues. Robin J. Schoeps is an associate
with the firm.
For a complete list of references click here