News & Industry Insights

0417_Non-HazardousPharmaWaste

What Is Non-Hazardous Pharmaceutical Waste and What Should You Do with It?

Non-hazardous pharmaceutical waste sounds benign enough. After all, it’s got “non-hazardous” in the name. And if it’s non-hazardous, it can be disposed of along with the regular trash, right? Not so fast.

Classifying Non-Hazardous Pharmaceutical Waste

Non-hazardous pharmaceutical waste is a bit of a misnomer in that it’s not as harmless as it sounds. It still poses health risks to the environment. Better terminology is non-RCRA pharmaceutical waste. RCRA stands for Resource Conservation and Recovery Act, the legislation through which the Environmental Protection Agency governs how hazardous waste must be treated and disposed of.

Non-hazardous or non-RCRA waste is waste that is not governed by RCRA laws. But it still must be disposed of properly in order to protect our communities and comply with other state and federal regulations.

Non-RCRA pharmaceutical waste accounts for about 85 percent of all hospital pharmacy inventory waste, and includes:

Disposing of Non-Hazardous Pharmaceutical Waste

The best way to keep non-RCRA pharmaceutical waste out of our landfills and water supply is to segregate it and have it incinerated. Non-RCRA pharmaceutical waste often is disposed of in white containers with blue lids. Pharmaceutical waste containers should be clearly labeled “for incineration.” It’s important to train all staff on what should be disposed of in this way versus RCRA hazardous waste and biohazardous waste containers.

As a reminder, all medical waste should be housed in a secure area away from the public. Non-RCRA pharmaceutical waste, hazardous waste and biohazardous waste should be collected and disposed of by a state- and federally-compliant pharmaceutical waste disposal service.

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5 Things You Need to Know About Pharmaceutical Waste Disposal

The Resource Conservation and Recovery Act (RCRA) was written by legislators — and it shows. While the act outlines endless “don’ts,” it can be difficult to determine how you should handle pharmaceutical waste. Fortunately, you’ve come to the right place. Here’s how to dispose of pharmaceutical waste.

1. All Pharmaceutical Waste Isn’t Created Equal

Hazardous (RCRA), non-hazardous, trace chemotherapy and controlled substances — it all has to be handled separately and properly according to its classification. It’s also subject to the rules of a number of regulatory agencies. Some (but not all) pharmaceutical waste must be treated as hazardous waste and handled accordingly.

2. Biohazardous Waste and Pharmaceutical Waste Must Be Treated Differently

Some assume that treating pharmaceutical waste as biohazardous waste is the appropriate thing to do, but that’s not the case. Biohazardous waste is sterilized to remove the infectious potential and then delivered to a landfill for final disposal. When you dispose of pharmaceutical waste with biohazardous waste, it will ultimately end up in a landfill and seep into our water supply (or end up in surface water). Because of this, pharma waste needs to be segregated properly and treated by incineration. This breaks down the complex chemicals to render them safe.

3. Fines Aren’t the Only Thing to Worry About

Regulatory angencies often publicize waste disposal violators, so be sure to consider how negative headlines could harm your business when deciding how to dispose of pharmaceutical waste.

4. Chemotherapy Waste Must Be Kept Separate and Treated Appropriately

Chemotherapy waste must be segregated and disposed of separately from biohazardous waste and pharmaceutical waste. Miscategorizing it is not only against Arizona regulations, but ADEQ requires chemotherapy waste to be incinerated or disposed of at either an approved solid waste or hazardous waste disposal facility.

5. Disposal of Controlled Substances Must Meet the Stringent Requirements of the DEA

The United States Drug Enforcement Agency requires that all expired and/or unused controlled substances be returned to the manufacturer or destroyed at a DEA/EPA-licensed incinerator. Both processes require using a DEA-licensed reverse distributor to transport the pharmaceuticals and file the required paperwork.

Save Yourself from Regulatory Headaches

Proper pharmaceutical waste disposal is complex, and there’s a ton of bad information out there. Working with an experienced pharmaceutical waste disposal company like US Bio-Clean can keep your business in compliance with federal and state regulations, and out of hot water with the ADEQ, EPA, USDOT and the DEA.

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Dental Waste Disposal: How to Handle 6 Types of Dental Waste

A dental office is a busy place. Patients coming and going throughout the day. Cleanings, X-rays, fillings, crowns, root canals. All of that activity makes for a challenging logistical problem — what to do with the resulting hazardous waste.

Here, we offer advice on how to dispose of the six most common types of dental waste so you can keep your patients safe, the environment clean and your business compliant.

1. Mercury Amalgam Waste

Amalgam is a combination of metals chemically bonded by mercury, a toxic element that can enter the environment through waste water, vapors or scrap. Never dispose of dental amalgam in the garbage, in a sharps container or down the drain — this dental waste should always be managed by amalgam removal specialists.

In December 2016, the Environmental Protection Agency issued a federal regulation requiring amalgam separators in dental offices. These devices can increase the capture of dental amalgam waste from 80 percent to 95 percent. Check the American Dental Association’s best management practices for amalgam waste.

2. Silver-Containing Wastes

With its high silver content, used X-ray fixer should not be washed down the drain. Instead, you can install an in-house silver recovery unit, which allows you to salvage the silver. Or the waste can be collected by a biomedical waste disposer. Many practices now avoid the challenges of X-ray fixer waste disposal by using digital imaging equipment.

3. Lead-Containing Wastes

X-ray packets and lead aprons contain lead foil, which has a leachable toxin that can contaminate soil and groundwater if sent to landfills. To avoid this issue, lead disposal should be handled by a licensed hazardous waste disposal company.

4. Blood-Soaked Gauze

For this biohazardous medical waste, proper disposal steps include packaging it in a leak- and puncture-resistant red disposable plastic bag or a leak-proof reusable container with a universal biohazard symbol. Learn more about the rules for dealing with bloodborne pathogens.

5. Sharps

Sharps containers must be appropriately labeled, puncture resistant and leak-proof. The container should be visible and easily reachable by the person using the sharps, and not placed in high-traffic areas, under sinks, inside cabinets or near light switches.

6. Chemicals, Disinfectants and Sterilizing Agents

Some of these substances are federally regulated and must be treated as hazardous waste because they can also have a detrimental effect on the environment. If possible, sterilize instruments with steam or dry heat. And ask your biomedical waste provider for guidance on the proper disposal of all chemicals used in your dental office.

Need Some Help?

As a partner of the Arizona Dental Association, US Bio-Clean can provide cost-effective disposal solutions for your dental office.

Blood sampling in the medical laboratory

OSHA and Bloodborne Pathogens: 7 Must-Know Rules

If you’re responsible for handling medical waste as part of your job, you’ve probably come across the OSHA Bloodborne Pathogens standard. The regulation is meant to protect employees who have occupational exposure to blood or other potentially infectious materials (OPIM).

Published by the Occupational Safety and Health Administration (OSHA), the bloodborne pathogens standard is a maze of definitions, prohibitions and mandates that can make your head spin. But noncompliance can put people at risk and subject your business to citations and penalties. To help you get a handle on things, here are some of the standard’s key requirements.

1. Have a Plan

An exposure control plan details in writing the steps an employer will take to eliminate or minimize exposure to blood or OPIM. This includes a list of job categories in which all employees have exposure and a list of job categories in which some employees have exposure. Employers must seek input for this plan from frontline workers.

2. Assume It’s All Infectious and Implement Controls

Under OSHA’s concept of universal precautions, all human blood and OPIM should be treated as if they contain bloodborne pathogens. Engineering and work practice controls must be implemented, such as safer medical devices, sharps disposal containers and hand hygiene.

3. Provide PPE

Personal protective equipment (PPE) is specialized clothing that includes gloves, gowns, lab coats, face shields or masks, eye protection, mouthpieces and resuscitation bags. Employers must provide and maintain this equipment at their own expense.

4. Offer Vaccinations

The hepatitis B vaccination must be offered to all occupationally exposed employees within 10 working days of initial assignment, after they complete the mandated bloodborne pathogens training.

5. Evaluate and Follow Up

Following an incident, an employer must make immediately available a confidential medical evaluation and follow-up (at the employer’s expense) that includes documentation of the circumstances surrounding the exposure.

6. Affix Labels

Warning labels are required on certain items, including containers of regulated waste and contaminated reusable sharps, as well as refrigerators and freezers housing blood or OPIM.

7. Keep Employees in the Know

Workers must undergo annual training on the standard’s requirements, including ways to control exposure, medical evaluation and follow-up protocols. Also, the employer must keep a sharps injury log, unless otherwise exempt.

US Bio-Clean provides streamlined, cost-effective disposal solutions that take the worry out of OSHA compliance. We also offer an online OSHA healthcare compliance system that gives users the ability to complete Bloodborne Pathogens training in less than an hour. Additionally, the system guides administrators through a step-by-step process to create a fully compliant exposure control plan.

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How to Prepare Biohazardous Medical Waste for Off-Site Treatment

In order to stay legal, you need to follow the guidelines for medical waste transportation when having your medical waste taken to a treatment facility. The first step is to package medical waste according to standards, such as using red bags, puncture-resistant containers for sharps and secondary containers as necessary. Also, waste must be transported by a licensed biohazardous medical waste transporter. Transporters of medical waste must provide generators with a copy of a tracking document that shows acceptance of the waste.

This document must be retained for one year and contain the following:

  • Name and address of the transporter, generator and the facility for medical waste treatment, storage, transfer or disposal.
  • Quantity of the medical waste, including weight, volume and number of containers.
  • The identification number attached to the bags or containers.
  • The date of medical waste collection.

Packaging Biohazardous Medical Waste for Disposal

Follow these guidelines when packaging biohazardous medical waste for collection for treatment or disposal:

  • Red bags must be leak-resistant, impervious to moisture, sealable and sufficiently strong enough to prevent tearing or bursting under normal use.
  • When packaging sharps, red bags must be puncture-resistant and placed in a secondary container that prevent breakage of bags during storage and handling.
  • The secondary container can be either disposable or reusable, and must bear a conspicuous biohazard symbol.
  • The secondary container, if reusable, must be completely leak-proof, closable with a fitted lid, cleanable and resistant to corrosion.
  • Secondary containers must never be used for purposes other than storing biohazardous medical waste.
  • Liners, red bags and other disposable packaging must never be reused and must be disposed as biohazardous medical waste.

Additional Guidelines to Follow When Preparing Medical Waste for Transport

In addition to the above regulations, there are specific rules for handling certain types of medical waste, such as cultures and stocks, human pathologic waste, waste containing chemotherapy agents and waste generated from experimental or research animals.

Cultures and Stocks

  • When shipped off-site for disposal or treatment, cultures and stocks must be placed in a primary container with absorbent lining. This container must be placed inside a secondary container, which then must be placed inside an outer container.
  • If federal and state laws prescribe specific requirements for packaging and transporting cultures and stock waste, the treatment facility must comply with those laws.
  • Cultures and stocks must be incinerated, autoclaved or treated with an Arizona Department of Environmental Quality-approved (ADEQ) alternative medical waste treatment method.

Human Pathologic Waste

  • This type of waste must be packaged in a covered, labeled and leak-proof container.
  • Human pathologic waste must be incinerated, autoclaved or treated with an ADEQ-approved alternative medical waste treatment method.
  • If not treated by incineration, the waste must be preprocessed by grinding and treated in compliance with ADEQ standards.
  • If the waste is processed by a combination of grinding and alternative treatment methods, grinding must be done in a closed system that prevents release of the waste into the environment.

Waste Containing Chemotherapy Agents

  • The waste must be packaged in a covered, labeled and leak-proof container.
  • Medical waste containing chemotherapy agents must be incinerated or disposed of in either an approved solid waste or hazardous waste disposal facility.

Experimental or Animal Research Waste

Waste from experimental sources or from animal research can be incinerated, autoclaved or packaged for off-site treatment or for land-filling. Complete animal carcasses must be incinerated for treatment in compliance with one of the following:

  • The waste must be packaged in a covered, labeled and leak-proof container, and sent to an incinerator or an ADEQ-approved landfill.
  • If not treated by incineration, the waste must be preprocessed by grinding and treated in compliance with ADEQ standards.

General Guidelines for Grinding Waste

If the waste is processed by a combination of grinding and alternative treatment methods, grinding must be done in a closed system that prevents release of the waste into the environment. Also, medical sharps processed by grinding must be done in a way that renders the waste incapable of creating a stick hazard.

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Is Nitroglycerin Hazardous Waste?

It’s easy to get confused about the proper disposal of medicinal nitroglycerin due to the categorization of the drug. By definition, nitroglycerin is listed specifically as hazardous waste under the EPA Resource Conservation and Recovery Act (RCRA). It is further categorized as P-listed (P081) or Acutely Toxic.

But there is some good news regarding the proper disposal of medicinal nitroglycerin. The EPA has classified most if not all of the nitroglycerin used in healthcare settings as non-hazardous. In fact, in 2003 the EPA issued a guidance letter to clear up the hazardous waste listing for this product. The response confirmed under the revised mixture and derived-from rules [40 CFR 261.3(g)(1)], which went into effect February 1, 2002, that a waste that has been listed solely for the characteristic of ignitability, corrosivity or reactivity is not regulated as a hazardous waste if it does not exhibit any hazardous waste characteristic. Moreover, if the waste does not exhibit a characteristic at the point of generation, it is considered to have never been a hazardous waste and does not need to meet land disposal restrictions (LDRs) (66 FR 27286, May 16, 2001). The EPA determined that the scope of the P081 listing does not include medicinal forms of nitroglycerin. 

Until this clarification, nitroglycerin was classified and handled as RCRA hazardous waste. The new rules took immediate effect in states that have not been authorized to carry out the base hazardous waste program. However, because the revised mixture and derived-from rules are less stringent than the existing federal requirements, states which are authorized for the base RCRA program are not required to adopt them [40 CFR 271.1(i)]. The regulatory authority in Arizona (ADEQ) has adopted the federal position. Since this clarification, best management practices dictate that nitroglycerin be handled as non-hazardous pharmaceutical waste and sent to a medical waste incinerator or municipal incinerator for treatment.

Many medical waste disposal companies still advise their customers to treat nitroglycerin as a P-Listed RCRA waste. But this practice can be considerably more expensive given the more extensive manifesting and labeling requirements, not to mention the increase in final disposal costs.

One other consideration is that any facility producing 1kg (2.2 lbs.) of P-listed waste in a calendar month is categorized by the EPA as a large quantity hazardous waste generator. Large quantity generators must follow additional requirements specific to proper management of waste, time and storage limits, training, preparedness and prevention, contingency plans, and reporting to regulatory agencies. These facilities must also pay increased fees to regulatory agencies. US Bio-Clean, an Arizona medical waste disposal company, provides professional guidance in the proper categorization, segregation and disposal of pharmaceutical waste, including nitroglycerin.

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Proper Disposal of Epinephrine

Proper disposal of epinephrine can be very confusing due to the categorization of the drug. By definition, epinephrine is listed specifically as hazardous waste under the EPA Resource Conservation and Recovery Act (RCRA). It is further categorized as P-listed (P042) or Acutely Toxic.

But there’s good news: The EPA has classified most if not all of the epinephrine used in healthcare settings as one of several epinephrine salts. The EPA’s Office of Solid Waste sent a letter to all of its RCRA Division Directors on October 15, 2007 entitled: Scope of Hazardous Waste Listing P042 (Epinephrine). Written in response to inquiries as to whether the hazardous waste listing for epinephrine included epinephrine salts, the memo acknowledges that it is the EPA’s understanding that most if not all of the chemical that is used in healthcare settings is one of several epinephrine salts. The EPA determined that the scope of the P042 listing does not include epinephrine salts. 

Until this clarification, epinephrine salts were classified and handled as RCRA hazardous waste. But now, epinephrine salts can be handled as non-hazardous pharmaceutical waste and sent to a medical waste incinerator or municipal incinerator for treatment. Some states have specific regulations regarding epinephrine, but most states rely on the EPA’s determination.

Many medical waste disposal companies still advise their customers to treat epinephrine as a P-listed RCRA waste. But this practice can be considerably more expensive given the more extensive manifesting and labeling requirements, not to mention the increase in final disposal costs.  

One other consideration is that any facility producing 1kg (2.2 lbs.) of P-listed waste in a calendar month is categorized by the EPA as a large quantity hazardous waste generator. Large quantity generators must follow additional requirements specific to proper management of waste, time and storage limits, training, preparedness and prevention, contingency plans and reporting to regulatory agencies. These facilities must also pay increased fees to regulatory agencies. US Bio-Clean provides expert guidance in the proper categorization, segregation and disposal of pharmaceutical waste, including epinephrine.

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Proper Storage of Biohazardous Medical Waste

In Arizona there are very specific requirements for the proper storage of biohazardous medical waste. Many medical practices and businesses unintentionally break the rules set forth by the Arizona Department of Environmental Quality (ADEQ). Stay compliant by following the below rules for storing biohazardous medical waste in Arizona:

  • Generators must provide a storage area for packaged medical waste until it is collected for off-site treatment.

  • The area must be secure and must restrict contact by authorized persons to the waste and must display universal biohazard symbols and warning signs. Warning signs must be worded as follows: “CAUTION — BIOHAZARDOUS MEDICAL WASTE STORAGE AREA — UNAUTHORIZED PERSONS KEEP OUT” (English); “PRECAUCION — ZONA DE ALMACENAMIENTO DE DESPERDICIOS BIOLOGICOS PELIGROSOS — PROHIBIDA LA ENTRADA A PERSONAS NO AUTORIZADAS” (Spanish).

  • The room designated for biohazardous medical waste storage must never be used to store other substances like food, beverages or medical supplies.

  • The area must be protected from contamination and contact with water, rain, wind and animals (including birds). Generators must make sure that medical waste storage does not become a breeding ground for rodents and insects.

  • Biohazardous medical waste cannot be stored for more than 90 days, unless the generator has approved facilities in compliance with A.R.S. § 49-762.04 (rules governing waste regulation).

  • Putrescible medical waste may be left unrefrigerated if it does not cause undesirable odors. Otherwise, it must be refrigerated at or below 40°F. If any odor issues arise, the generator must minimize them. If the ADEQ finds that the generator did not perform measures to adequately control the odors, refrigeration must be used.

  • Generators may place conspicuously marked biohazardous medical waste containers alongside solid waste containers. However, the different waste types must never be comingled.

  • Medical waste containers that have spilled must be repackaged and re-labeled. Surfaces soiled by the spill must be thoroughly cleaned and disinfected.

The Arizona medical waste disposal company, US Bio-Clean, provides training in the proper handling, packaging and storage storage of biohazardous medical waste, pharmaceutical waste, chemotherapy waste and RCRA hazardous waste.

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What to Consider Before Buying Sharps Disposal Containers

Choosing the right sharps disposal containers makes it easier to properly dispose of used sharps, so it is important to select them carefully. Sharps waste can cause punctures, cuts and laceration injuries on contact. It may also contain body fluids that can transmit pathogens that cause HIV, hepatitis and other blood-borne diseases. Sharps present a danger to employees who process waste, which is why great care is taken to contain them. And the only safe method of containing them? Sharps waste disposal containers. These containers also allow waste disposal companies to haul and collect sharps waste properly. Some companies, like the Arizona-based medical waste disposal company US Bio-Clean, offer waste containers for sharps and training on how to use them.

Ask yourself these six questions when shopping for sharps disposal containers.

1. Is it Compliant with FDA Regulations?

The most important requirement: Choose containers that comply with FDA regulations. The FDA has simple rules for sharps disposal containers. They must be made of clear, rigid plastic; have tight-fitting lids; be stable and leak-resistant during use; and display proper warning labels. Choosing compliant containers keeps people safe and helps avoid health violations.

2. Is it the Right Size?

Choose sharps waste containers that can accommodate the level of waste output in your workplace. Sharps waste containers are designed for single-use only. That means using overly small containers can lead to the need to buy more containers, which increases your costs.

Hospitals and medical clinics produce large quantities of sharps waste, and therefore need large containers. Smaller containers may be enough for homes and businesses that generate small quantities of sharps waste. You may also choose portable models, which work well for travelling and medical outreach programs.

3. How Durable Is It?

You want a sharps disposal container that is sturdy and resistant to puncture throughout its life (for obvious reasons). Some are made of types of plastic that become soft at certain temperatures. Other types of plastic can become hard and brittle during hot weather, and can break when dropped.

Only use sharps waste containers made from tough, leak-proof material so fluids will not seep out and contaminate the workplace or environment.

4. Will it Allow Me to Clearly See the Contents of the Container?

Once sharps disposal containers are filled to the “full line” they must be closed and disposed of. They are not designed to be filled to the top. Overfilled containers can result in punctures to workers. Avoid this by selecting sharps waste containers that allow staff to see the contents accurately. Some models have a narrow translucent strip, while others are made entirely of clear plastic.

5. Does it Have an Effective Closure Mechanism?

Sharps disposal containers must have a means of permanent closure. This protects workers by preventing waste from being released during handling, hauling and transport. Only select containers that have secure, permanent and strong closure mechanisms.

6. Is it Easy to Use?

It pays to select a user-friendly sharps disposal container. Make sure it is also highly visible in the workplace as employees are more likely to use it if it is conspicuous. Mounting options, such as brackets, can be used to secure the container, providing additional safety.

In addition, make sure you choose a sharps disposal container that is compatible with safety engineering in your workplace. For example, select a tall waste container to accommodate long sharps, or pick a model with an opening for broken or disposed glassware if that is a common waste type in your workplace. Wheeled models are also available for added mobility, which are useful in large institutions.

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HCS & GHS Frequently Asked Questions

What is Hazcom?

Hazcom, better known as the Hazard Communication Standard (HCS), requires employers to disclose hazardous and toxic chemicals in workplaces. HCS is designed to improve the awareness and safety of all workers, especially those who are working in occupations that involve multiple hazardous chemicals.

The HCS is intended to address the issue of classifying the hazards of chemicals, communicate information of such hazards and appropriate protective measures to workers. [1910.1200(a)(2)]

More things to know about HCS…

The HCS is composed of several elements. The HCS includes, but is not limited to, a written hazard communication program, lists of hazardous chemicals in the workplace, labeling of chemical containers and preparation and distribution of safety data sheets to employees and employers, and employee training programs. [1910.1200(a)(2)]

Is the HCS required in all businesses?

The Office of Safety and Health Administration (OSHA) does not specifically state that all businesses should have a Hazcom. However, OSHA mandates that institutions that have any known hazardous chemical in the workplace present in a manner that puts employees in risk of exposure under normal conditions of use or in an emergency to comply with HCS. [1910.1200(b)(2)]

What about GHS? Is it similar to HCS?

GHS stands for Globally Harmonized System of Classification and Labelling of Chemicals. It also defines hazards of chemicals (more details below). GHS is the internationalized version of HCS, and both share a similar goal. GHS is inline with several local chemical safety standards in many other countries. The HCS is the standard used in the United States, and is now part of the GHS.

Is HCS applicable to chemicals that will be moved out of the workplace?

OSHA specifically states that chemicals that are transported in and out the workplace must be covered by the HCS. All chemical containers, including those that will be transported out of the workplace, must have proper labels that are not defaced or damaged. Transported containers must have their own safety data sheets. [1910.1200(b)(3)(i)] [1910.1200(b)(3)(ii)] [1910.1200(b)(3)(iv)] [1910.1200(b)(4)(i)]

Who classifies the hazards of chemicals in the workplace?

Manufacturers, distributors and importers determine and classify the hazards of chemicals. They have to provide the hazard class and associated hazard category to labels of hazardous containers. They also ensure each hazardous container is labeled, tagged or marked. [1910.1200(d)(3)(i)] [1910.1200(f)(1)]

Who maintains the written hazard communication program?

Employers must develop, implement and maintain a written hazard communication program at the workplace. Employers must inform employees about the hazards of non-routine tasks and chemicals used in work areas.

In workplaces with multiple employers, like construction sites, employers must ensure that hazard communication programs like safety data sheets, teaching of precautionary measures and labeling systems are available for easy access by ALL employees on-site. [1910.1200(e)(1)] [1910.1200(e)(2)]

What are the instructions for labels on shipped containers?

Chemical manufacturers, importers and distributors are required to provide the following information on containers of hazardous chemicals:

  • Product identifier
  • Signal word
  • Hazard statement(s)
  • Pictogram(s)
  • Precautionary statement(s)
  • Name, address, and telephone number of the chemical manufacturer, importer or other responsible party

[1910.1200(f)(1)]

Can anyone change the information on the labels of hazardous chemicals?

Aby changing information on labels of hazardous chemicals must be only performed when necessary. For example, the employer shall not remove or deface existing labels on incoming containers of hazardous chemicals, unless the container is immediately marked with the required information.

Chemical manufacturers, importers, distributors, or employers who become newly aware of any significant information regarding the hazards of a chemical shall revise the labels for the chemical within six months of becoming aware of the new information, and shall ensure that labels on containers of hazardous chemicals shipped after that time contain the new information. If the chemical is not currently produced or imported, the chemical manufacturer, importer, distributor, or employer shall add the information to the label before the chemical is shipped or introduced into the workplace again. [1910.1200(f)(9)] [910.1200(f)(11)]

Who develops safety data sheet for hazardous chemicals?

Manufacturers and importers of hazardous chemicals are responsible for developing or obtaining safety data sheets for each hazardous chemical they produce or import. They must ensure that safety data sheets are in the English language (copies in other languages are allowed). [1910.1200(g)(1)] [1910.1200(g)(2)]

What information should be on a safety data sheet?

Manufacturers, distributors and employers preparing safety data sheets must ensure that the information provided is accurate and has scientific basis. Chemical manufacturers or importers are required to provide information based on the following section numbers and headings. The safety data sheet should contain the following, where applicable:

Section 1      Identification

Section 2      Hazard identification

Section 3      Composition/information on ingredients

Section 4      First-aid measures

Section 5      Fire-fighting measures

Section 6      Accidental release measures

Section 7      Handling and storage

Section 8      Exposure controls and personal protection

Section 9      Physical and chemical properties

Section 10   Stability and reactivity

Section 11   Toxicological information

Section 12   Ecological information

Section 13   Disposal considerations

Section 14   Transport information

Section 15   Regulatory information

Section 16   Other information, including date of preparation or last revision

If no relevant information is found for any sub-heading within a section, the manufacturer, the distributor or employer will mark to indicate that no applicable information was found. [1910.1200(g)(5)] [1910.1200(g)(2)] [1910.1200(g)(3)]

What about safety data sheets for complex mixtures?

For chemical ingredients that are essentially the same, but the exact composition varies from mixture to mixture, the manufacturer, distributor or employer may prepare one safety data sheet for all of these similar mixtures. [1910.1200(g)(4)]

Employers must train employees on hazardous chemicals

Employers must train employees on information and safety training on chemicals in the work area at their initial assignment, and whenever a new chemical hazard is introduced in the workplace. Employees must be informed on how to work with hazardous chemicals in the operation area, and location and availability of written hazard communication programs. Employers have to inform employees about the details of the hazard communication program.

Employers must also train employees on how to detect the presence or release of hazardous substances in work areas, hazards to health of the chemicals and protective measures. [1910.1200(h)(1)]

What about those chemicals considered trade secrets?

Manufacturers, distributors or employers may withhold the identity of chemicals treated as trade secrets provided that:

  • There is supporting evidence that the chemical is a trade secret.
  • The properties and effects of the hazardous chemical must be disclosed.
  • The safety data sheet indicates that the specific chemical identity and/or percentage of composition are being withheld as a trade secret.

Most importantly, trade secret chemicals must be disclosed to medical professionals in case of exposure or in an emergency. In non-emergency situations, the identity of the hazardous chemical should be disclosed to medical professionals, employees or their representatives if:

  • There is a written request.
  • Used to assess hazards of the chemical(s).
  • Used to conduct or assess sampling of the workplace atmosphere to determine exposure levels.
  • Used for medical treatment of exposed employees.
  • Used to design or assess engineering or protective measures for exposed workers.
  • Used to determine exposure levels and treating harmful exposures
  • The request includes a description of procedures to maintain confidentiality of disclosed information.

The persons who will know the identity of chemicals treated as a trade secret must agree in a written confidentiality agreement not to use the trade secret information for any purpose other than the health need and not to release information except to OSHA. [1910.1200(i)]

What is the effective date of revised HCS regulations?

Employers must have trained all employees about the new label elements and safety data sheets by December 1, 2013.

Chemical manufacturers, distributors and employers must comply with all the modified HCS regulations no later than June 1, 2015. [1910.1200(j)]

GHS FAQ

What is GHS?

GHS or the Globally Harmonized System of Classification and Labelling of Chemicals is an international system for standardizing and harmonizing classification and labelling of chemicals in United Nations member countries.

The GHS can be described as the international version of the HCS (Hazard Communication Standard) used in the United States. The HCS is aligned with the terms of the GHS.

However, the GHS is not a regulation or a standard. Rather, it contains the agreed hazard classification and communication provisions, and information on how to apply them.

Does GHS cover all hazardous chemicals?

The GHS covers all hazardous chemicals. The GHS states that ‘all types of chemicals will be covered’ and ‘protection will not be reduced’.

When will the GHS be implemented?

The GHS is not a standard nor a regulation, so therefore it has no implementation schedule. The GHS is designed to tie into different chemical safety regulations in UN countries. All existing systems have to develop strategies to phase into the new GHS requirements.

How is the GHS to be applied?

The GHS is composed of the following programs:

  • GHS classification (identifying intrinsic hazards of chemicals)
  • Hazard communication (safety data sheets and labels)
  • Risk management systems (risk communication and exposure monitoring/control)
  • Safe use of chemicals

What is GHS classification?

It is the identification of hazards of a chemical or mixture. The GHS uses the following criteria in assigning a category of hazard/danger of a chemical:

  • Physical hazards

o   Explosives

o   Flammable gases

o   Flammable aerosols

o   Oxidizing gases

o   Gases under pressure

o   Flammable liquids

o   Flammable solids

o   Self-reactive substances

o   Pyrophoric liquids

o   Pyrophoric solids

o   Self-heating substances

o   Substances that emit flammable gases upon contact with water

o   Oxidizing liquids

o   Oxidizing solids

o   Organic peroxides

o   Corrosive to metals

  • Health hazards

o   Acute toxicity

o   Skin corrosion/irritation

o   Serious eye damage/eye irritation

o   Respiratory or skin sensitization

o   Germ cell mutagenicity

o   Carcinogenicity

o   Reproductive toxicology

o   Target organ systemic toxicity – single exposure

o   Target organ systemic toxicity – repeated exposure

o   Aspiration toxicity

  • Environmental hazards

o   Hazardous to aquatic environments, acute, chronic or both

What is the GHS approach to mixtures?

The GHS physical hazard criteria also apply in identifying hazards from mixtures, and use the following tier approach to classify mixtures:

Generally, use test data for the mixture, if available

Compare to substance hazard criteria, or use bridging principles if applicable

Estimate hazards based on the known component information

What is a bridging principle?

Bridging principles are used in the GHS to identify hazards of untested mixtures.  When a mixture has not been tested, but there is sufficient data on the components and/or similar tested mixtures, the data can be used in accordance with the following bridging principles:

  • Dilution: If a mixture is diluted with a diluent that has an equivalent or lower toxicity, then the hazards of the new mixture are assumed to be equivalent to the original.
  • Batching: If a batch of a complex substance is produced under a controlled process, then the hazards of the new batch are assumed to be equivalent to the previous batches.
  • Concentration of Highly Toxic Mixtures: If a mixture is severely hazardous, then a concentrated mixture is also assumed to be severely hazardous.
  • Interpolation Within One Toxic Category: Mixtures having component concentrations within a range where the hazards are known are assumed to have those known hazards.
  • Substantially Similar Mixtures: Slight changes in the concentrations of components are not expected to change the hazards of a mixture and substitutions involving toxicologically similar components are not expected to change the hazards of a mixture.
  • Aerosols: An aerosol form of a mixture is assumed to have the same hazards as the tested, non-aerosolized form of the mixture unless the propellant affects the hazards upon spraying.

If bridging principles are not applicable or cannot be used, the hazards should be estimated based on component information.

What are the label elements in GHS?

GHS standardized labels must have the following:

  • Product name or identifier
  • Signal word (‘Warning‘ for less severe hazards, or ‘Danger’ for more severe hazards)
  • Physical, health, environmental hazard statements
  • Supplemental information (non-harmonized information not required or specified by the GHS)
  • Precautionary measures and pictograms (measures to minimize or prevent adverse effects)
  • First-aid statements
  • Name and address of company/supplier
  • Telephone number of supplier

How to describe multiple hazards on GHS labels

Where a substance or mixture presents more than one GHS hazard, there is a GHS precedence scheme for pictograms and signal words. For substances and mixtures covered by the UN Recommendations on the Transport of Dangerous Goods, Model Regulations, the precedence of symbols for physical hazards should follow the rules of UN Model Regulations. For health hazards, the following principles of precedence apply for symbols:

  1. if the skull and crossbones applies, the exclamation mark should not appear;
  2. if the corrosive symbol applies, the exclamation mark should not appear where it is used for skin or eye irritation;
  3. if the health hazard symbol appears for respiratory sensitization, the exclamation mark should not appear where it is used for skin sensitization or for skin or eye irritation.

If the signal word ‘Danger’ applies, the signal word ‘Warning’ should not appear. All assigned hazard statements should appear on the label. The “competent authority” may choose to specify the order in which they appear.

Does the GHS require a label format or layout?

No. The GHS only specifies that there must be hazard pictograms, signal word and hazard statements located on the label.

Can anyone vary the applications of the components of the GHS?

The GHS states that ‘competent authorities’ may vary the application of GHS components according to type of product (industrial, pesticide, consumer, etc.) or industry (workplace, farm, retail store, etc.) or lifecycle of the chemical.

Are chemical containers in the workplace covered by the GHS?

Yes. In addition, products covered by the scope of GHS must carry the GHS label when supplied to the workplace. Employers can also choose to display label information in the work area rather than on individual containers.

Do I have to use the GHS Safety Data Sheet?

If you are already in compliance with the Safety Data Sheet of the HCS, then you do not have to use an additional GHS Safety Data Sheet. Keep in mind that the HCS is part of the GHS.

How does the GHS address trade secrets or confidential business information?

The GHS states that it does not harmonize mechanisms for protection of trade secrets or confidential business information. Refer to the HCS to find out how to address such confidential information.

Do employers have to train workers on GHS regulations?

Yes. Employers have to train workers to recognize and interpret safety data sheets, as well as take appropriate actions to address chemical hazards.