Occupational health and safety professionals are responsible for communicating with workers about regulatory requirements, and this task becomes more challenging when the governing federal agencies have different definitions for applicable terms.

Workplace procedures and educational materials should incorporate terminology from relevant agencies, including CDC, EPA, and the Food and Drug Administration in addition to OSHA. At the very least, workers need to know which regulatory authority or authorities are appropriate for the task and where they can find clarification and other definitions that may help them understand critical information.  Let’s consider sodium hypochlorite as an example. Sodium hypochlorite, better known as bleach, is one of the most common workplace chemicals and has a variety of uses. When diluted to appropriate levels, bleach is used as a disinfectant in healthcare, remediation services, housekeeping, and disaster response. At high concentrations, bleach can be used as a pesticide. Workers in the food industry use bleach to sanitize food and equipment.
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RESOURCES CDC: Guideline for Disinfection and Sterilization in Healthcare Facilities—Chemical Disinfectants (2008). CDC: Guideline for Disinfection and Sterilization in Healthcare Facilities—Cleaning (2008). CDC: Guideline for Disinfection and Sterilization in Healthcare Facilities—Glossary (2008). CDC: Guideline for Disinfection and Sterilization in Healthcare Facilities—Introduction, Methods, Definition of Terms (2008). CDC: How to Clean and Disinfect Schools to Help Slow the Spread of Flu. EPA: Basic Information about Pesticide Ingredients. EPA: Letter to Christina Griffin on label amendment (PDF, November 2015). EPA: What Are Antimicrobial Pesticides? FDA: Guidance for Industry: Antimicrobial Food Additives (July 1999). FDA: Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). FDA: Q&A for Consumers: Health Care Antiseptics (December 2017). FDA: Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps. Federal Register: Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use (December 2017). National Pesticide Information Center: Understanding and Selecting Antimicrobial Pesticides. Oklahoma State University: Guidelines for the Use of Chlorine Bleach as a Sanitizer in Food Processing Operations (PDF). OSHA: Dental workers exposed to disinfectants as part of decontamination (April 1993). OSHA: General Decontamination (September 2005). U.S. Army Public Health Command: Preparing and Measuring High Chlorine Concentration Solutions for Disinfection (PDF).
Aligning Terminology Pests and disease-causing organisms are examples of hazards for which IHs may be asked to select control methods. The products used to control these hazards may be regulated by OSHA, whose standards IHs are familiar with; by EPA, if the products are designed to kill pests; or by FDA, if the products are used to prevent infection by inhibiting the growth of microorganisms, such as alcohol-based hand sanitizers. The OSHA standards for which terminology alignment with overlapping EPA and FDA regulations seems most suited are the Hazard Communication (29 CFR 1910.1200) and Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR 1910.1450) standards. Alignment reduces the chance that critical hazard information will be miscommunicated and helps workers wade through complicated regulatory jargon.

Table 1. Antimicrobial Public Health Terminology
Tap on the table to open a larger version in your browser.
Whether bleach is used as a disinfectant, a pesticide, or a sanitizer determines which regulations apply to the product’s use in a workplace also covered by OSHA—and, thus, which regulatory agencies have overlapping oversight. The various regulatory definitions become more of a generalized starting point when task-based applications of a product introduce unique conditions that affect the general definition. For example, recommendations for bleach-based disinfection of PPE may call for about 500 ppm free available chlorine with one-minute contact time; in contrast, disinfecting excreta on general, hard surfaces requires 5,000 ppm free available chlorine with 10-minute contact time. The ability of workers to purchase bleach at various initial concentrations means that the starting concentration must be clearly specified in workplace procedures before instructions for dilution. TERMINOLOGY Sanitizing, disinfecting, sterilizing, decontaminating—these terms describe tasks workers may regard as virtually indistinguishable but for which federal agencies have established distinct definitions. In addition, industries may have specific standards of practice or there may be unique needs for a task. Consequently, it is important to ask which definitions apply to a task and whether any take precedence due to the unique needs of an industry.  
Antimicrobial public health products. According to EPA, “public health products” are intended to control microorganisms infectious to humans in any inanimate environment.  To provide an example for a unique industry, Table 1 compares some of CDC’s healthcare terminology in “Guideline for Disinfection and Sterilization in Healthcare Facilities” with EPA terminology for antimicrobial public health products. Information that may be useful for understanding the definition was added. The terms in Table 1 are common to many workplaces, though the comparison is specific between EPA regulation and a CDC healthcare reference to show differences and similarities. Hopefully, this helps demonstrate why it is important to search for relevant terminology while considering application to the specific industry. More information can be found from EPA; from CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities” (PDF); and from The National Center for Emerging and Zoonotic Infectious Diseases. CDC provides information on factors affecting the efficacy of disinfection and sterilization on its website. Antimicrobial non-public health products. EPA defines non-public health products as those used to control the growth of microorganisms of economic and aesthetic significance that are not considered related to human health. These products include those used to treat microorganisms infectious only to animals, algae growths, and odor- and spoilage-causing bacteria. Products used in cooling tower treatments are also considered non-public health products. EPA pesticide registration. All pesticides registered with EPA will have an EPA registration number. A registration number in the format 12345-11 indicates that the product is a primary registrant; the presence of an additional four-digit number (such as 12345-11-3333) indicates a product sold by a distributor with identical formulation and efficacy as the primary product but under a different brand name. Thus, alternative brand names are linked to the primary registration on file with EPA.  EPA maintains a database of the chemicals used in pesticides. The National Pesticide Information Center has useful information on reading the product label, understanding ingredient lists, and understanding the “signal words”—information on product labels that describes the product’s acute toxicity. See the sidebar below for information about how to report exposures to pesticides.
Reporting Exposures to Pesticides Responsibility for regulating pesticides was transferred to EPA in 1970, but healthcare providers should be aware of state agencies responsible for the regulation of pesticides because of possible reporting requirements. The lead agency responsible for regulated pesticide investigation varies by state and U.S. territory. The National Pesticide Information Center maintains a list of state pesticide regulatory agencies. National Pesticide Information Center’s publication Medical Case Profile (PDF) lists 28 states that implemented regulations for the surveillance of suspected or confirmed pesticide-related illnesses occurring in or outside of the workplace. In general, reporting requirements are provided by state health departments.  For pesticide incidents, EPA has some requirements for reporting exposure to people, fish, wildlife, and the environment. Other EPA reporting requirements include reporting of spills and improper disposal of pesticides. See EPA's website for more information.

Cosmetics and drugs. The labels of some FDA- regulated products will include “drug facts” along with terms such as antiseptic, antibacterial, and sanitizer. FDA’s regulatory requirements and guidance on usage for over-the-counter products will differ from products intended for use by healthcare professionals. In 2017, FDA provided clarification via updated guidance and regulation for healthcare and over-the-counter antiseptics for human use. FDA also regulates antiseptics used in veterinary medicine.  Determining whether a product is regulated by FDA as a cosmetic or a drug is sometimes difficult. For example, a skin moisturizer is classified as a cosmetic, but if the manufacturer claims that the product also provides protection from the sun, it can be classified as a drug, too. The use and labeling of such products must comply with the requirements for both cosmetics and drugs. If you are providing workers something classified as a drug, it is even more critical to ensure their use is per manufacturer directions; the product could interact with a user’s medications, for example. You might expect that FDA regulates soaps as cosmetics, since (like shampoos) they’re used for cleansing. But FDA does not regulate normal soap—that is, soap meant only for cleansing—at all. Where applicable, FDA uses the definition of soap from the Consumer Product Safety Commission. According to CPSC, a product is a soap when “the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and the product is labeled, sold, and represented solely as soap” (21 CFR 701.20). FDA issued a final rule on safety and effectiveness of antibacterial soaps in 2016. See FDA for more information regarding the safety and effectiveness of antimicrobial soaps and topical antiseptic drug products such as hand sanitizers and antibacterial soaps. Food additives and agricultural products. In addition to cosmetics and drugs, FDA regulates antimicrobials used in or on processed food as food additives; applied to raw agricultural commodities where food is prepared, packed, or held for commercial purposes; added to water in a food processing facility when the water is to contact raw agricultural commodities or processed food in some circumstances; and incorporated in objects that have a food-contact surface in specified circumstances. See FDA’s “Guidance for Industry: Antimicrobial Food Additives” for more information, including a useful decision guide for determining whether FDA or EPA has regulatory authority for specific antimicrobial substances. PRODUCT SELECTION CONSIDERATIONS When choosing a product, consider whether it is appropriate as a control for all likely physical states of a hazard. For example, many fungi types are often present in both spore and non-spore form, and have a variety of surface structures and treatment requirements. Often a sequence of  products or treatments will be necessary to achieve desired results; the removal of gross debris (“cleaning”) might be required before the product is applied. Other considerations when selecting products include the following: Is the control listed as appropriate for the surface being treated? Different surface types often require different contact times. The product could degrade finishes and coatings on the treated surface; unfortunately, this may become apparent only after damage has become substantial enough to be noticed by the naked eye.  Are times required for application reasonable? For example, consider a product that needs to remain wet on a surface for 10 minutes. Will the product remain wet for the whole 10 minutes after initial application, or will someone need to watch the area and reapply the product to maintain surface conditions for the duration? Are environmental conditions appropriate? Some products may require ventilation or other controls to limit exposure. Are there any special considerations for the product or stakeholders that should be considered? For example, will the product require respirator usage or impose different chemical storage needs than those already in place at the facility? Is decontamination or cleaning required before use of the product? Decontaminating is “the process of removing or neutralizing contaminants that have accumulated on personnel and equipment,” according to OSHA. Returning to our healthcare example, CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities” uses OSHA’s definition for decontamination but defines “decontamination area” as an “[a]rea of a health-care facility designated for collection, retention, and cleaning of soiled and/or contaminated items.” Cleaning is often a critical step of physically removing gross debris, germs, dirt, and impurities from surfaces or objects before more thorough processes such as sterilizing, using sporicides, disinfecting, or sanitizing. In cleaning, a surfactant, such as basic soap and water, is commonly used to reduce infectious material on surfaces without necessarily killing it. Cleaning can be manual or mechanical (the use of ultrasonic devices is an example of mechanical cleaning). Some disinfection and sterilization processes require cleaning as a first step because organic matter on surfaces can interfere with those processes. PRODUCT VARIATIONS When educating workers about a product, don’t rely on general information found online or even on your previous experience with the product—it may have contained a different concentration of the chemical in question, or the chemical formula may have changed. Safety Data Sheets won’t necessarily reveal everything workers need to know, either. Something as simple as the size of a product’s container can affect what is reported on the SDS. Consider the specific batch for the products in your facility when reviewing product information. If in doubt, contact vendors and the manufacturer for additional information—it may save you headaches down the line and help ensure that you’re complying with all regulations that pertain to your operation.   VERONICA STANLEY, MSPH, CIH, CSP, CESCP, is a safety and occupational health specialist for U.S. Army Medical Command, Atlantic, and owner of Hygiene Health and Safety Consulting LLC in Brookville, Md., specializing in policy and regulation, research, integration, and technical writing. She is a member of the AIHA Construction and IEQ Committees. She can be reached via email Disclaimer: The author of the information herein is a federal government employee. The content is unrelated to official work and/or duties and does not necessarily represent any position or opinion of the government. Acknowledgment: The Synergist thanks Bruce Donato, CSP, CHMM, CECD, of K&A First Aid and Safety Inc. in Gaithersburg, Md., for reviewing a draft of this article.  Send feedback to The Synergist.

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Compliance Pitfalls for Common Workplace Chemicals under Multiagency Jurisdiction
BY VERONICA STANLEY

SOURCES of      CONFUSION
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Disadvantages of being unacclimatized:
  • Readily show signs of heat stress when exposed to hot environments.
  • Difficulty replacing all of the water lost in sweat.
  • Failure to replace the water lost will slow or prevent acclimatization.
Benefits of acclimatization:
  • Increased sweating efficiency (earlier onset of sweating, greater sweat production, and reduced electrolyte loss in sweat).
  • Stabilization of the circulation.
  • Work is performed with lower core temperature and heart rate.
  • Increased skin blood flow at a given core temperature.
Acclimatization plan:
  • Gradually increase exposure time in hot environmental conditions over a period of 7 to 14 days.
  • For new workers, the schedule should be no more than 20% of the usual duration of work in the hot environment on day 1 and a no more than 20% increase on each additional day.
  • For workers who have had previous experience with the job, the acclimatization regimen should be no more than 50% of the usual duration of work in the hot environment on day 1, 60% on day 2, 80% on day 3, and 100% on day 4.
  • The time required for non–physically fit individuals to develop acclimatization is about 50% greater than for the physically fit.
Level of acclimatization:
  • Relative to the initial level of physical fitness and the total heat stress experienced by the individual.
Maintaining acclimatization:
  • Can be maintained for a few days of non-heat exposure.
  • Absence from work in the heat for a week or more results in a significant loss in the beneficial adaptations leading to an increase likelihood of acute dehydration, illness, or fatigue.
  • Can be regained in 2 to 3 days upon return to a hot job.
  • Appears to be better maintained by those who are physically fit.
  • Seasonal shifts in temperatures may result in difficulties.
  • Working in hot, humid environments provides adaptive benefits that also apply in hot, desert environments, and vice versa.
  • Air conditioning will not affect acclimatization.
Acclimatization in Workers