What is Carestream Health doing about the new REACH regulation in the EU?
Carestream Health’s global Environmental, Health, and Safety (EHS) team has analyzed the applicability of REACH to Carestream Health chemical preparations and articles, and continues to manage requirements of this regulation.
For specific REACH questions, please contact the Carestream Health European Union (EU) REACH specialist at firstname.lastname@example.org.
Since Carestream Health imports less than 1 tonne per year of chemical preparations into the EU, we are considered by the REACH regulation to be a “downstream user”, and there are no chemical substances at this time that our company has obligations to register.
Carestream Health has communicated with EU suppliers of chemical preparations and has received assurance that all pre-registration and registration obligations are being met, to ensure an uninterrupted supply chain. Safety Data Sheets which meet the requirements of the REACH regulation are available on our company website for all chemical preparations used by our employees and customers at http://www.carestreamhealth.com/environmental-health-safety.html
An article is defined in the REACH Regulation as “an object which during production is given a special shape, surface or design which determines it function to a greater degree than does its chemical composition”. Examples of Carestream Health products considered to be articles are film, equipment, screens, cassettes, and dental packets.
The Candidate List for REACH Annex XIV issued by the European Chemicals Agency (ECHA) includes certain substances which may be found in products considered to be articles. These substances include such items as di(2-ethylhexyl) phthalate (DEHP) and dibutyl phthalate (DBP).
Carestream Health has a materials composition declaration process with suppliers and based on information received to date, there are no Candidate List substances present in articles at concentrations above 0.1% by weight.
The EHS REACH team will continue to review as future additions are made to the Candidate List. A complete list of current Candidate List substances can be found on the website of the European Chemicals Agency at http://echa.europa.eu/
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Is there mercury in Carestream Health products?
Carestream Health films (including medical x-ray films, dental x-ray films and nondestructive testing films) do not contain any mercury. Like other electronic equipment, display back-lights, scanner lamps, and erase lamps may contain low amounts of mercury. Carestream Health will continue to look for ways to reduce or eliminate these uses of mercury. Carestream Health is in compliance with worldwide regulations regarding mercury in equipment components.
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Should I recover silver from the waste solutions generated by my radiographic imaging processor?
Silver is a valuable resource, and can easily and cost-effectively be recovered and reused. If you are discharging silver bearing waste solutions (e.g., fixer) to the sewer for biological treatment, you will almost certainly have to recover silver to keep within the discharge limits imposed by your local sewer authority.Silver recovery, the process used to harvest the silver from processing solutions, can be done in several ways, depending on the size of your operation, the concentration of silver in your effluent, and the silver discharge limits in your local area. Not only does silver recovery allow facilities to maintain compliance with discharge regulations, but promotes the sustainability of non-renewable natural resources.
If the size of your processing operation makes on-site recovery impractical, then silver-containing solutions can be collected and shipped to an off-site recovery facility. There are many waste management companies that specialize in silver recovery. You will be responsible for collecting and storing the waste safely, and for telling the waste management company about its hazards (if any) so that they can transport and treat it safely.
After silver recovery, how do I measure the silver content of my effluent before discharging to the municipal sewer system?
A number of techniques are available to measure silver in processing effluent, but only precise analytical results from a certified analytical laboratory, with personnel trained to perform silver analysis, should be used to demonstrate regulatory compliance. All samples should be collected in clean, unused containers, properly labeled, and sent immediately to the chosen laboratory. You may need to request analyses for Total Recoverable Silver or Total Dissolved Silver, depending on the requirements of your local discharge regulation.
What types of on-site silver recovery technologies are available?
There are a variety of on-site silver recovery technologies available. Understanding the size of your x-ray film processing operation, amount of effluent, and the silver discharge limit in your local area, will help you to determine the correct technology for your operation. For small volume users, silver recovery using metallic replacement is recommended. These cartridges are simple to use and maintain. Used cartridges must be sent to a silver refiner for further treatment and recovery of metallic silver. Electrolytic silver recovery is the most efficient technique for removing silver from silver-rich waste solutions. The type of electrolytic recovery unit chosen depends on the solutions being treated and the daily volumes requiring treatment.
Often, metallic replacement cartridges need to be used as a secondary (tailing) recovery method subsequent to the electrolytic recovery equipment to ensure compliance with local sewer discharge limits. Electrolytic units are more costly than simple metallic replacement cartridges and more complex to set up and operate effectively.The removal of silver from wash waters requires still more sophisticated technology such as ion exchange, nanofiltration or reverse osmosis. These techniques are usually only justified in order to meet strict local regulations. Whatever the technique is used for silver recovery, it can provide an economic benefit and enable compliance with local discharge regulations. If on-site silver recovery is not performed, the owner/operator must send silver-rich solutions off site for proper management.
Does all radiographic film contain silver?
All unused and exposed x-ray film contains recoverable silver. The amount of silver in film will vary based on the product type, whether or not it has been processed, and the density of the image.
What do I need to know before I begin working with radiographic film processing chemicals?
Radiographic film processing chemicals are safe to use when potential hazards have been identified, and the solutions are handled in a safe manner. Safe handling of chemicals require that you recognize and avoid the potential hazards. Safe handling practices include wearing personal protective equipment, following procedures that minimize chemical contact, and following the instructions on chemical labels.
Learning more about processing chemicals reduces the possibility of illness or injury. Carestream Health provides this information in our Safety Data Sheet (SDS) for each chemical product. These sheets provide detailed information on the product's composition, together with the precautions that need to be taken to ensure safe storage, handling, use and disposal. Before working with any chemical for the first time, employers should use the information provided in the SDS to assess the risks that employees may face when using the product in their workplace, and make sure that these risks are properly controlled.
What kinds of chemicals am I exposed to when using radiographic film processing solutions, and how do I minimize exposure?
Radiographic film processing solutions are aqueous, and may be either acidic or basic in nature. Carestream Health provides warnings and precautionary statements on product labels, instruction sheets, and packaged products to assure safe use and reduced exposure to the chemicals. You can minimize exposure to any chemical by following the instructions on the labels and Safety Data Sheet (SDS). These SDS not only display the chemical names of the solutions, but also specify potential hazards associated with their use. The warning and precautionary statements also assure safe use and reduced exposure to chemicals. Proper ventilation is also important to assure safe and comfortable indoor air environment for processing areas.
How can I keep myself safe from spills and splashes?
Always use caution when mixing and pouring chemical solutions into processing tanks. Also, use care when moving open containers from one location to another. An important aspect of your facility's health and safety program is a risk assessment to determine if any chemical risks are likely to be present. Such an evaluation results in a determination of the proper personal protective equipment (PPE) necessary for your lab.
In general, the PPE required for handling photographic processing chemicals includes: neoprene or nitrile gloves, safety goggles, and vinyl or rubber apron or lab coat. Check PPE often to make sure it is in good working condition, clean, and works and fits properly. Train employees on the use, limitations, and maintenance, and how to wear PPE. In the event of a spill or chemical splash, you may refer to the Safety Data Sheet (SDS) for recommendations for immediate first-aid treatment. Do not administer first aid to others unless you are trained to do so.
How do I obtain a Safety Data Sheet (SDS)?
Carestream Health provides Safety Data Sheets (SDS) by mail at the time of initial purchase of a product and at subsequent product orders when SDS have been significantly revised. Current SDS can be obtained from our website at www.carestream.com\msds. Radiographic Films - Carestream Health x-ray films do not require a Safety Data Sheet (SDS), which are only required for chemical products. Under normal conditions of use x-ray films do not pose a physical hazard or health risk.
How should I store my radiographic film processing chemicals?
To ensure safe storage of chemicals:
Keep containers easily accessible - Store chemical containers in designated areas, preferably away from heavy traffic, where they are easily accessible and the contents readily identifiable and inventoried. Store the heaviest and most hazardous chemicals at the lower level. Keep out of reach of children.
What can you tell me about the toxicity characteristics of Carestream Health radiographic films?
Representative X-ray films, both processed and unprocessed, were tested based on U.S. EPA's Toxicity Characteristic Leaching Procedure (TCLP). These representative samples did not exhibit the Toxicity Characteristic (TC). In addition, these films do not exhibit the other hazardous waste characteristics of ignitability, corrosivity, or reactivity. As a result, Carestream Health radiographic films are not considered hazardous wastes based on U.S. EPA regulations and can be disposed of safely in a municipal or industrial landfill. This conclusion, however, does not preempt state or local laws and programs.
Contact your state and local governments to determine if any additional disposal requirements apply. Even though Carestream Health radiographic films can be disposed of safely in a municipal or industrial landfill, you may want to consider a more environmentally sound option. Film reclamation and recycling is the preferred end of life management method versus landfill disposal. Contact your film distributor or check your local yellow pages to identify the film reclamation/recycling options available to you. Regardless of which end of life management method is selected, you should always ensure that image confidentially concerns are addressed.Outside the U.S., contact your local or regional solid waste authorities for proper recycling and disposal guidance.
Is it safe for me to use and mix processing chemicals while I am pregnant?
Carestream Health is aware of no substantiated reports of adverse effects among people in general working in the industry. You may wish to obtain the Safety Data Sheets for each of the processing chemicals that you work with and discuss this subject with your personal physician.
What personal protective equipment (PPE) is necessary for working with film processing chemicals?
Protecting employees from potential harm when using equipment or in certain work situations is an important part of providing a safe workplace. While a radiographic film processing operation is typically considered a low hazard activity, there are certain operations where employees need to be protected from potential hazards. An understanding of the potential sources and measures to protect employees from the hazards is an important element in the health and safety program at your facility.
The use of personal protective equipment (PPE) is important whenever the possibility of contact with chemicals exists. When handling chemical products, Carestream Health always recommends that users wear safety glasses with side shields, impervious gloves (neoprene or nitrile), and wearing an apron or other protective clothing that is impervious to chemicals, which will protect the eyes, prevent contact with the skin and chemicals from coming in contact with your clothing. Dust or vapor masks are not normally necessary, though exceptions may occur. The product Safety Data Sheets (SDS) will alert users to the possible need for this extra protection. Check PPE often to make sure it is in good working condition, clean, and works and fits properly. Train employees on the use, limitations, maintenance, and how to wear PPE.
What type of plumbing is suitable for radiographic film processing effluent?
The plumbing or pipework used in a conventional medical facility should be made from chemically-resistant materials such as polyvinyl chloride (PVC) or fiberglass reinforced plastic (FRP). Heavy duty cast iron pipe or other cast drain materials are also satisfactory. We do not recommend copper plumbing.
How do I know if I have adequate ventilation in my facility?
Effective ventilation systems are an important tool that helps minimize employee exposure to film processing chemicals. While such processing operations are typically considered to be a low hazard activity, indoor air quality environments can be improved if well-engineered ventilation systems are installed. Potential air contaminants associated with x-ray film processing operations will be determined by the specific process chemistry in use and the operating conditions of the equipment.
Processing solutions may release small amounts of vapors such as acetic acid or gases such as ammonia or sulfur dioxide. Depending on the concentration in the air, these chemicals could be irritating to the eyes and respiratory tract or create odors. Although odor does not indicate safe versus unsafe conditions, strong odors or the presence of eye and/or respiratory irritation can indicate that there is not sufficient general dilution ventilation or that the local exhaust systems may not be capturing the air contaminants effectively at their source. If such conditions become apparent contact your facility environmental support personnel to review your specific ventilation situation.
Do I need a Safety Data Sheet (SDS) for film or equipment?
Carestream Health radiographic films and equipment do not require a Safety Data Sheet (SDS), which are only required for chemical products. Under normal conditions films and equipment do not pose a physical hazard or health risk.
How can I assess the risks of working with radiographic film processing chemicals?
You don't have to be an expert to make a simple assessment of risk, but you will have to know when expert help is needed. First, make sure you have a good understanding of the hazards of the products you use. Prepare a complete list of all the processing chemicals used in the workplace, and ensure you have up-to-date for each one. This list must be updated each time you receive a new chemical product, and you may find it useful to give a named individual the responsibility for maintaining these important records.
Then read the Safety Data Sheets carefully. These sheets follow a standard format, and describe the product and its properties in detail, including specific advice on how to store use and dispose of it safely. Remember that the most important information is also summarized on the product labels, which will also carry an internationally recognized symbol (pictogram) identifying the principal hazard (if any). Second, look at how you are going to use the products in your own workplace. Consider how you or your employees might be exposed to or come into contact with the chemicals from the moment you receive them, through storage, mixing and use, to recovery or final disposal. Look at the possibilities for contact (getting the chemical on the skin and the eyes), ingestion (swallowing the chemical, perhaps as a contaminant of food or drink) and inhalation (breathing in mists or gases).
Make an estimate of how likely this is based on your actual day-to-day work practices, and don't forget to take into account the possibility of an accidental exposure occurring as a result of predictable carelessness or accident. Your employees are the experts in this area: don't be afraid to involve them in the process! Use this assessment, together with your knowledge of the hazards of the chemicals, to consider whether there may be a risk of injury or ill-health (it is good practice to write down a short summary of this risk assessment, and you should of course repeat the process whenever you change the chemicals or the way in which you use them). If you see a risk of chemical exposure, but can't measure that exposure accurately, then you may now need expert help. This situation is most likely to arise where there is some risk of breathing in chemical dusts or vapors. A suitably qualified expert such as an Industrial or Occupational Hygienist will be able to make the measurements needed, and compare them with any exposure standards set by your local authorities.
How can I minimize and control the risks of working with radiographic film processing chemicals?
The risks of exposure to chemicals can be controlled in two main ways: by preventing release at the source, or by protecting the employee. The first is usually the best. The risks of contact may be reduced by careful design of mixing and handling operations and by the use of mechanical aids and barriers to avoid spills and splashes. Ingestion can be avoided by following good hygiene principles. Never eat, drink, smoke or take food or drink into areas where chemicals are used, handled or stored. Always wash hands thoroughly after handling chemicals and before eating or drinking.
Never store chemicals in food containers, and never keep food in containers, which have been used to hold chemicals. Never store food in containers, cupboards or fridge's that are meant for chemical storage. Making sure that chemicals cannot get into the air of the workplace can prevent inhalation. Lids should always be fitted to chemical storage containers, and local exhaust ventilation can be used to remove mists or vapors if released, for example, during chemical mixing. Good general room ventilation will also make sure that the small quantity of volatile chemicals that may be released during the processing operation are diluted and removed in safety. If these simple precautions are followed, the need for personal protective equipment (PPE) can be kept to a minimum.
As it is not usually possible to avoid all risks of skin and eye contact, Carestream Health always recommends that users wear impervious gloves, simple protective clothing, and eye protection when handling its chemical products. Dust or vapor masks are not normally necessary, though exceptions may occur. The product Safety Data Sheets will alert users to the possible need for this extra protection. All control measures, including PPE, must be regularly inspected and maintained to make sure they continue to do their job properly. Employees must be told of the need for any controls to reduce the risks of exposure, and given training to make sure they use the controls correctly.
Can I put radiographic film processing solution down the drain?
Radiographic film processing effluents (tank overflows) contain chemicals that are biodegradable. They are, therefore, compatible with aerobic (with oxygen) biological treatment systems and are effectively treated when sent to an efficient sanitary sewage treatment facility. Permission from the local treatment authority may be needed (a written consent or permit is usually needed and limits what can and can not be discharge). Contact your local authorities to see if you need consent and to determine local discharge limits.Carestream Health strongly recommends that you never pour silver-bearing effluents such as used fixers down the drain. Rather you should practice on-site recovery techniques or manage the silver-rich fixer off-site using a reputable waste management company.
Can I dispose of radiographic film processing solutions to my septic system?
Carestream Health films are not considered hazardous wastes based on U.S. EPA regulations and can be disposed of safely in a municipal or industrial landfill. This does not preempt state or local laws and programs. Contact your state and local governments to determine if any additional disposal requirements apply.
Representative Carestream Health films, both processed and unprocessed, were tested using the U.S. EPA's Toxicity Characteristic Leaching Procedure (TCLP). These representative samples did not exhibit the Toxicity Characteristic (TC) of hazardous materials. In addition, these x-ray films do not exhibit the other hazardous waste characteristics of ignitability, corrosivity, or reactivity as outlined in 40 CFR Part 261.
Even though Carestream Health radiographic films can be disposed of safely in a municipal or industrial landfill, we recommend that consider a more environmentally sound option. Film reclamation and recycling is a preferred end of life management method versus landfill disposal. Contact your film distributor or check your local yellow pages to identify the film reclamation/recycling options available to you.
Regardless of which end of life management method is selected, you should always ensure that image confidentially concerns are addressed.Outside the U.S., contact your local or regional solid waste authorities for proper recycling and disposal guidance.
My plumber recommends the use of Limestone pits or Neutralization tanks. Do I need one?
We are often asked about the need to discharge x-ray film processing wastes to "limestone pits" or neutralization tanks before sending to a sewer. These devices may be required by local plumbing or sewer discharge codes in an attempt to protect the waste systems from acidic chemicals. In the case of film processing effluent for Carestream Health processing chemicals, not only is the neutralization function unnecessary, the limestone pit or neutralization tank often becomes fouled, and eventually a maintenance problem. In addition to dissolved chemical salts there is usually a small amount of gelatin present.
This combination results in a nutrient-rich effluent in which bacteria flourish. This will foul the limestone media, and in effect, the limestone pit becomes a mini-waste treatment plant. This can produce odors and will eventually require maintenance and cleaning. Because the total effluent pH is well within sewer codes we question the need and strongly recommend against the use of these treatment methods for x-ray film processing effluent.
Do I need consent to discharge my radiographic film processing effluent?
Your need for a written consent (e.g., discharge permit) depends on
If your drains discharge directly to the environment, e.g. to a lake, stream, river, or septic system, you need a permit. If you discharge to a local sanitary sewer system that directs the process effluent to a treatment facility with secondary biological treatment, check with your local treatment authority to see if you need a discharge permit. Whatever your mode of discharge, we recommend silver recovery for the silver-rich waste solutions.
How do I find out what my local discharge limits/sewer codes and requirements are?
To determine what the discharge limits established by your local treatment authority are, you will need to contact them directly. Your x-ray processing effluents should generally be within discharge limit requirements, once silver recovery has taken place. Do not discharge your waste fixer solution (fixer tank overflow) without first employing silver recovery because the silver content will most likely exceed discharge limits for silver.
How should I dispose of radiographic film processing wastes?
First, make sure you have done everything possible to minimize the amount of waste you generate from your processing operation. This is not just environmentally responsible, but can be cost-effective too. Some processing units can be configured to use as little wash water as possible. Check regularly to see that you are not over-replenishing your process, and remember that keeping the process in control helps avoid the need to discard out-of-specification solutions. Chemical losses are greatly affected by the volume of solution carried over from one tank to another, and into the wash water. Keep these losses to a minimum by making sure that efficient squeegees are fitted, and checked and maintained regularly. When making adjustments to the processing units always ensure that image quality is not being impacted.
In principle, there are a number of ways to dispose of processing waste safely and with little environmental effect. In practice though, the "best" option will usually depend on the waste management and treatment processes actually available to you.
Radiographic film processing wastes and wash waters contain chemicals that are biodegradable. They can therefore be treated effectively when discharged to sanitary sewer systems leading to efficient biological treatment facilities, such as those operated by most municipal treatment authorities. These authorities set sewer codes or discharge limits to limit the quantity and type of chemicals received at the treatment works, and may - within these limits - be prepared to accept some or all waste from photo processing. Check with your local authorities to find out their rules and guidelines. Most will insist as a minimum requirement that your waste is treated before discharge to recover silver, and you may have to monitor your waste regularly to make sure you don't exceed any discharge limits.
Carestream Health does not recommend that processing wastes be discharged to simple septic sewage treatment systems. They do not have the capacity to treat the waste, and their efficiency is likely to be impaired as a result. It should go without saying that processing wastes should never be discharged directly to natural waters without full and proper treatment.
If you don't have access to efficient biological treatment, if local rules prevent the discharge of some or all of your processing wastes, or if the scale of your operation makes sewer discharge impracticable, you will have to arrange to have it collected and taken off-site. Many waste management companies now specialize in treating this type of waste and recovering silver. You will still be responsible for collecting and storing the waste safely, and for telling the waste management company about its hazards (if any) so that they can transport and treat it in safety.
Are there any special restrictions affecting the management of waste radiographic film in the EU?
Waste x-ray film is not listed as hazardous under the EU Hazardous Waste Directive, and no special controls should be necessary for storage and handling. The rules controlling the transport of waste is complex, and depends on whether or not the material is to be shipped from one country to another. Recent decisions by international conventions have classified film waste as non-hazardous, though some controls may still be applied in the short term to those materials containing silver. Contact your country or regional solid waste authorities for proper recycling and disposal guidance.
How can I be sure that Carestream Health equipment products are safe to use?
Carestream Health equipment products are designed to conform to all applicable health and safety legislation and standards. The CE mark is placed on the product or equipment by the manufacturer for sale or installation in the EU. It is a manufacturer's self declaration/certification that the product or equipment complies with all applicable EU Directives. It also indicates that the manufacturer has the technical information to substantiate compliance with all the applicable standards and directives. All products bearing the CE mark must have a Declaration of Conformity (DoC).Make sure you read the instructions for the safe use of equipment that Carestream health provides. This information is to be found in the user manual, and may be repeated on labels and packaging as appropriate.
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