PROPOSITION 65 PVC Tech Corp Compliance Summary Requirement of a Clear and Reasonable Warning Prior to Exposure

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Patience Fields
6 years ago
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1 PROPOSITION 65 of California Proposition 65, otherwise known as the Safe Drinking Water and Toxic Enforcement Act of 1986 or Prop 65 was a voter initiative passed into law to address public concern over exposure to unsafe and toxic chemicals in the State of California. Proposition 65 states the following: Prohibition on Water Contamination No person in the course of doing business shall knowingly discharge or release a chemical known to the state to cause cancer or reproductive toxicity into water or onto or into land where such chemical passes or probably will pass into any source of drinking water, notwithstanding any other provision or authorization of law except as provided by Section Requirement of a Clear and Reasonable Warning Prior to Exposure No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual, except as provided by Section So what does that mean? It means two main things. One is that we have to be sure that in conducting our business no chemicals included in the Proposition 65 Chemical List are intentionally released to any sources of drinking water. This extends to requesting our manufacturers for certification to assure that our film content complies with Prop 65. And two, that we post physical warnings that legibly and reasonably forewarn individuals within the vicinity of any potential exposure to any restricted chemicals on the Prop 65 list. Are all PROP 65 listed chemicals banned? And does this mean I need to test all the substances on the list? PROP 65 does not ban any chemicals, though this is a common misperception. Instead PROP 65 lists substances and provides Safe Harbor Numbers where available. It also changes as substances are listed and de- listed. PROP 65 relies on industry and their know- how to identify the listed substances relevant to their product. For instance, the PROP 65 list includes salted fish as a substance. It would not be likely for most products to contain that. While testing may be performed to determine substance content and exposures, the regulation itself does not specify any test methods nor does it mandate that testing be performed. It is up to companies in the process of complying to decide if testing would be required to achieve the necessary information critical to determining compliance. 1

2 What are Safe Harbor Numbers? PROPOSITION 65 PVC Tech Corp Compliance Summary The NSRL (No Significant Risk Level) for carcinogens and MADL (Maximum Allowable Dose Levels) for reproductive toxicants are called Safe Harbor Numbers. These numbers express in µg per day what the assigned No Risk or Allowable Dosage exposure levels are for each chemical. The Safe Harbor Number was designed to be a trigger. If the Safe Harbor Number is exceeded then a warning or disclosure is automatically required. It is the OEHHA s goal to have the entire Chemical List designated with safe harbor numbers but the process takes time. As of early 2015, only 310 of the 900 plus substances on the PROP 65 list had Safe Harbor Numbers assigned to them. PROPOSITION 65 List of Chemicals Prop 65 Chemical List January 2015 Over 950+ Substances/Items 310 approximate number of substances with Safe Harbor Numbers Note: access via So if the chemicals I find in my product DON T have a Safe Harbor Number, then I don t need to post warnings or disclose this information? The absence of an assigned Safe Harbor number does not change the requirement to disclose, especially as the chemicals on PROP 65 have been specifically listed for their propensity to cause cancer or reproductive toxicity if leached. The prohibition on water contamination (Part ) relies on what chemicals are knowingly discharged or released in the course of doing business. In fact, guidance on Proposition 65 states that If there is no safe harbor level for a chemical, businesses that knowingly expose individuals to that chemical would generally be required to provide a Proposition 65 warning, unless the business could show that the risks of cancer or reproductive harm resulting from the exposure would be below levels specified in Proposition 65 and its accompanying regulations. 2

3 I noticed some really hazardous chemicals like DEHP don t have a safe harbor number (exposure limit) but I ve seen that labs will test this to a content limit I don t find on the PROP 65 list, where does that content limit come from? In the absence of a safe harbor number or exposure level, or where the exposure level is not reasonable or applicable for the product or item being reviewed, the certain substances then default to referencing an interim content limit derived from the most recent judgment on products of similar use. If another more recent judgment presents a more stringent limit applicable to the same category of product that would then be used. Here s a theoretical example: You have a PVC binder made with a combination of flexible materials and you want to have it tested for DEHP. But you re not sure what limit to meet and test to. The last California court case judgment on a PVC soft folder similar to your product was found to be in violation of PROP 65 for lack of a warning and was then settled with a requirement for that manufacturer to reformulate the product to contain less than 1000 ppm total content of DEHP. Since DEHP does not have a safe harbor number, by default, laboratories will use the most related judgment (the case above) to derive the interim limit. This is what is called a confluence between exposure limits and content limits. This occurs due to gaps in substance limit information, the inevitable variances in end use product exposure testing and as part of the process of how PROP 65 is enforced. While it s widely recognized that this is less than ideal, it has become the norm in industries to monitor frequently litigated PROP 65 listed substances that may be found in their products in order to prevent being subject to enforcement actions. Exposure Limits vs. Content Limits under PROP 65. It s important to note that Safe harbor numbers are exposure levels, which require determination based on use. Many component materials cannot be measured for end use exposures since components represent only one part of the final product. While PROP 65 also requires warnings in California workplaces and domiciled companies can ascertain exposures of dangerous chemicals to workers and their environment, most PROP 65 enforcement focuses on final products distributed through markets, or public environments (including workplaces) where substance exposures can be detrimental. Where final products are concerned, most supplying component manufacturers have defaulted to controlling substances based on content level even though there are no standardized correlations between content levels and exposure. In fact, the PROP 65 list makes no mention of any content restrictions. Final goods manufacturers must therefore consider critical substance content information as well as the normal and foreseeable use of their product in calculating exposures. What does being PROP 65 compliant actually mean? A company or entity is compliant with PROP 65 either by ensuring their products do not expose the public to PROP 65 listed substances, OR failing that, by placing clear and reasonable warnings to notify the public of those exposures. 3

4 So there are two levels of compliance, one on the Substance Level and another on the Labeling or Notification Level. The phrase PROP 65 compliant may therefore indicate that this product does not present exposures to substances or that warnings have been placed. It s important to know the difference when speaking to your component suppliers. My business is not based in California, but my products do find their way there, do I still need to worry about PROP 65? Yes, you do. PROP 65 is a California law that imposes its requirements on any products and processes that enter its markets regardless of source or origin. Exemptions to PROP 65 do not relate to the geography of the product source. As a non- resident business, you would not need to worry about occupational warnings required under PROP 65. PROP 65 Warnings Title 27 Article of the California Code of Regulations provides information regards clear and reasonable warnings. This discusses warnings for certain categories of products such as consumer products, food, alcoholic beverages, prescription drugs, medical and/or dental procedures as well as occupational warnings. None of these warnings are industry specific. In January 2015, the OEHHA (The Office of Environmental Health Hazard Assessment) formally proposed changes to how warnings are written, graphically depicted and placed. These proposed changes are pending approval. If adopted this would replace current warning methodologies and present additional requirements for business and CA workplaces. To Warn or Not to Warn: when warning may negatively impact sales of your product While PROP 65 issues two seemingly simple requirements, the regulation often presents a conundrum for many businesses in evaluating how to comply and how warnings would impact sales. For companies marketing products sensitive to negative perceptions of potential environmental hazards, the decision not to warn often leads back to the drawing board. Redesign and reformulation to improved safer products and materials is in fact, one of the goals behind the creation of PROP 65. Enforcement is rampant under PROP 65 and avoiding warnings is only possible if products are remade to where substance exposure requirements are satisfied, or if the same product is not sold in California at all. If redesign is the most viable path for you, identifying the substance composition of your product will be critical to successful compliance. 4

5 PROP 65 and Other Chemical Regulations PROPOSITION 65 PVC Tech Corp Compliance Summary Many of the substances and chemicals listed under PROP 65 are also found in other regulations such as the US CPSIA for lead and phthalates, the US CONEG for heavy metals, different chemical acts by state and various European regulations such as RoHS for lead and flame retardants, and REACH for Substances of Very High Concern. PROP 65 is not derived from any other regulation. While proposed chemical listings may use data gathered for use in other regulations, a chemical can only be successfully listed through one of four mechanisms: Via the State Qualified Experts (SQE) Mechanism Via the Authoritative Bodies (AB) Mechanism Via the Formally Required Mechanism Via the Labor Code Section 6382 (b)(1) or (d) Mechanism While trends in other regulations may provide additional impetus for the OEHHA to list a substance, changes in the PROP 65 list can only be made through the methods identified above. Subsequently, compliance to any other regulation does not translate to compliance to PROP 65, nor can certification under other regulations be submitted for PROP 65. PROP 65 lab testing may use content testing methodologies identified for use under other regulations such as the CPSIA phthalates test, or REACH but final compliance on end use or final products must address the matrix of both content and exposure levels specific to PROP 65. PVC Tech Corp and PROP 65 As a California business PVC Tech Corp complies with the requirements of Prop 65 in the workplace and in our products. For substance compliant products: We develop films designed with substance content restrictions relevant to the most recent PROP 65 list. We monitor changes to the list that may affect this substance compliance and advise our customers accordingly. If you are interested in a film that can help your final product comply with PROP 65, please contact us. For substance non- compliant products: Where we have films that contain substances that can present exposures, the appropriate warnings are placed. We provide any available certifications for compliant materials or disclosures for films non- compliant due to substance content, all of which are traceable to our manufacturers. 5

ContiTech North America

ContiTech North America Dear Customer: Certain products now contain the following warning language about certain chemicals or compounds that may be found in Continental ContiTech s products or component