US Product Labeling Laws and Regulations
The Bayne Law Group LLC attorneys and staff work regularly with our clients to ensure product and label compliance in connection with regulated, potentially hazardous, chemical ingredients. Our firm is familiar with the agencies and departments throughout the United States responsible for ensuring public protection and compliance with toxic and hazardous chemicals laws. The Bayne Law Group LLC works hand-in-hand with our clients to develop compliance programs to manage compliance with state and federal government regulations which require that products be labeled or identified as including ingredients, which if improperly handled, can cause death, injury or other personal or property harm.
Our scope of services for national companies includes:
- Sale of Regulated Products
- State and Federal Labeling Laws
- California Proposition 65
- Federal Hazardous Substances Act
- National Bottle Bill & Recyclable Container Laws
Contact The Bayne Law Group to consult with an experienced attorney concerning your product labeling compliance.
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Our attorneys and staff are prepared to provide the sophisticated representation required by emerging and established businesses from small, mid-market and Fortune 500 companies. Our managing member, Andrew Bayne, has been a practicing commercial attorney for nearly two decades, and has earned an AV Preeminent* rating through Martindale-Hubbell’s peer review standard.
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Our clients come to us from countries throughout the world, including the United States, New Zealand, India, Canada, Australia, China, Europe, the Middle East and South America.
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*AV Preeminent is the certification mark of Reed Elsevier Properties Inc., used in accordance with the Martindale-Hubbell certification procedures, standards and policies. Martindale-Hubbell is the facilitator of a peer review rating process. Ratings reflect the confidential opinions of members of the bar and the judiciary. Martindale-Hubbell ratings fall into two categories: legal ability and general ethical standards.
Legal Counsel to Companies Selling Regulated Products.
Regulated product ingredients include a wide range of naturally occurring and synthetic chemicals that are known to cause cancer or birth defects or other reproductive harm. These chemicals include additives or ingredients in prescription drugs, pesticides, common household products, food, drugs, dyes, or solvents. Regulated chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust.
The Federal Government of the United States tasks several agencies with the protection of the American public from exposure to toxic substances. The agencies which The Bayne Law Group LLC may appear before or interact with on behalf of our client’s include the U.S. Environmental Protection Agency (U.S. EPA), U.S. Food and Drug Administration (U.S. FDA), National Institute for Occupational Safety and Health (U.S. OSHA), National Toxicology Program, and International Agency for Research on Cancer, as well as several state and federal judicial courts.
Most states have departments or agencies responsible for environmental protection before whom The Bayne Law Group LLC also interacts, including New York, New Jersey, Pennsylvania, and California. California alone has two committees dedicated to reducing and preventing exposure to toxic chemicals -the Carcinogen Identification Committee (CIC) and the Developmental and Reproductive Toxicant (DART) Identification Committee are part of the Science Advisory Board of California’s Office of Environmental Health Hazard Assessment (“OEHHA”).
The Bayne Law Group LLC is also engaged in protecting our client’s compliance concerns as monitored by the Consumer Products Safety Commission. The Consumer Products Safety Commission (“CPSC”) is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of types of consumer products under the agency’s jurisdiction. CPSC focusses on protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard resulting in death, injuries, and property damage from various consumer products.
The Bayne Law Group LLC offers Legal Compliance with State and Federal Labeling Laws
Under most state and federal labeling laws, businesses are required to provide a clear and reasonable warning before knowingly and intentionally exposing anyone to a listed chemical. This warning may can be given by a variety of means, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper. Consult an experience attorney with The Bayne Law Group LLC to ensure proper notice and labelling.
By law, a warning must be given for listed chemicals unless exposure is low enough to pose no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm.
Under California’s Proposition 65 (“Prop 65”), for instance, The Bayne Law Group LLC guides businesses in mitigating liability exposure for chemical ingredients which are listed as causing cancer. “No significant risk level” is defined under Prop 65 as the level of exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime. In other words, The Bayne Law Group LLC guides businesses in evaluating adequacy under the law of their Toxicology Risk Assessments which determine whether a person exposed to the chemical at the “no significant risk level” for 70 years would not have more than a “one in 100,000” chance of developing cancer as a result of that exposure.
Under California’s legislation, by way of example, for chemicals that are listed as causing birth defects or reproductive harm, the “no observable effect level” is determined by identifying the level of exposure that has been shown to not pose any harm to humans or laboratory animals. Proposition 65 then requires this “no observable effect level” to be divided by 1,000 in order to provide an ample margin of safety. Businesses subject to Proposition 65 are required to provide a warning if they cause exposures to chemicals listed as causing birth defects or reproductive harm that exceed 1/1000th of the “no observable effect level.” The Bayne Law Group LLC works with businesses to manage compliance and mitigation of legal risk.
To further assist businesses, some state and federal agencies have developed numerical guidance levels, known as “safe harbor numbers” (described below) for determining whether a warning is necessary or whether discharges of a chemical into drinking water sources are prohibited. After assessing possible exposure concerns, The Bayne Law Group LLC counsels our clients to manage their labeling compliance requirements. We also work with business to assess whether to provide a warning simply based on its knowledge, or assumption, about the presence of a listed chemical without attempting to evaluate the levels of exposure.
The Bayne Law Group LLC assist our clients with understanding the U.S. Federal Hazardous Substances Act
The Federal Hazardous Substances Act (FHSA) requires precautionary labeling on the immediate container of hazardous household products to help consumers safely store and use those products and to give them information about immediate first aid steps to take if an accident happens. The Act also allows the Consumer Product Safety Commission to ban certain products that are so dangerous or the nature of the hazard is such that the labeling the act requires is not adequate to protect consumers.
Contact The Bayne Law Group to consult with an experienced attorney concerning your product FHSA labeling compliance.
The following is a general unofficial summary of the requirements of the Federal Hazardous Substances Act that apply to chemicals and other hazardous substances prepared by CPSC. It does not replace the requirements of the act itself at 15 U.S.C. § 1261, et seq. or the regulations published in 16 C.F.R. Part 1500. This summary does not include all of the details included in those requirements, particularly those involved in testing products to determine whether they require labeling to address specific hazards.(This does not cover the FHSA as it applies to toys and other articles intended for use by children that present thermal, electrical, or mechanical hazards.) For those details, please refer to the regulation, personally consult with competent legal counsel, or contact the CPSC Office of Compliance.
Where can I find the requirements for chemicals and other hazardous substances?
The FHSA is in Title 15 of the United States Code, starting at section 1261. Rules that tell you the requirements of the act, how to determine whether a product requires labeling, what labeling is required for specific products, and what products are banned are published in the Code of Federal Regulations in Title 16, Part 1500. Because the Commission may add new rules from time to time, we recommend that you periodically check for new or revised rules in the Code of Federal Regulations. You can obtain the regulations issued under the Federal Hazardous Substances Act, 16 C.F.R. Part 1500, and any other regulations referenced in this summary from the Commission’s Web Site at: http://www.cpsc.gov.
How do I determine whether a product requires labeling?
First, the FHSA only covers products that, during reasonably foreseeable purchase, storage, or use, may be brought into or around a place where people live. Products used or stored in a garage, shed, carport, or other building that is part of the household are also covered. The Act requires hazardous household products (“hazardous substances”) to bear labeling that alerts consumers to the potential hazards that those products present and that tells them what they need to do to protect themselves and their children from those hazards. Whether a product must be labeled depends on its contents and the likelihood that consumers will be exposed to any hazards it presents. To require labeling, a product must first be toxic, corrosive, flammable or combustible, an irritant, or a strong sensitizer, or it must generate pressure through decomposition, heat, or other means. Second, the product must have the potential to cause substantial personal injury or substantial illness during or as a result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children.
How can I find out whether a product presents one of the hazards listed above?
Each of the hazards above has a specific definition in the FHSA. Where it is appropriate, regulations issued under the Act specify the tests to perform to evaluate a product for a specific hazard. The definitions and citations to the appropriate tests are below. All of the references are available from the Commission’s web site at: http://www.cpsc.gov. under the “Business” icon. In evaluating a product, you should make sure to consider the finished product that consumers will use, rather than its individual ingredients.
(1) A product is toxic if it can produce personal injury or illness to humans when it is inhaled, swallowed, or absorbed through the skin. 16 CFR 1500.3(c)(1) and (2) contain certain tests on animals∗ to determine whether a product can cause immediate injury. In addition, a product is toxic if it can cause long term chronic effects like cancer, birth defects, or neurotoxicity. 16 CFR 1500.3(c)(2)(ii) and 1500.135 tell you how to evaluate products for chronic hazards.
(2) A product is corrosive if it destroys living tissue such as skin or eyes by chemical action. Tests* for corrosivity are at 16 CFR 1500.41.
(3) A product is an irritant if it is not corrosive and causes a substantial injury to the area of the body that it comes in contact with. Irritation can occur after immediate, prolonged, or repeated contact. Tests* for skin and eye irritation are at 16 CFR 1500.41 and 1500.42, respectively.
(4) A strong sensitizer is a product that the Commission declares by regulation has a significant potential to cause hypersensitivity. That hypersensitivity does not happen when a person first comes in contact with the product, and only becomes evident after the person has been exposed to the product for a second time. 16 CFR 1500.13 lists the products that the Commission has classified as strong sensitizers.
(5) The flammability of a product depends on the results of testing. 16 CFR 1500.3(c)(6) defines the terms “extremely flammable”, “flammable”, and “combustible” as they apply to liquids, solids, and the contents of self-pressurized containers like aerosol cans. For example, a flammable liquid can be:
a. Extremely flammable if, when tested, it has a flash point at of below 20° Fahrenheit (F.),
b. Flammable if it has a flash point above 20° F. and below 100°F., or
c. Combustible if it has a flash point at or above 100° F. up to and including 150° F.
Please consult 16 CFR 1500.3(c)(6) for exceptions to these limits. Solid and self-pressurized products can be either extremely flammable or flammable. Please refer to 16 CFR 1500.3(c)(6(v)-(vii) for these definitions. 16 CFR 1500.43 and 43(a) contain the basic tests for the flammability of liquids and similar products. The procedure for testing solid materials appears in 16 CFR 1500.44, while 16 CFR 1500.45 and 46 specify the procedures to use to test the contents of self-pressurized containers.
(6) Products that generate pressure, through decomposition, heat, or other means include aerosols, fireworks that contain explosive powder, and certain pool chemicals that, when their containers are heated by sunlight, for example, start to react and generate pressure in the containers. The FHSA does not have any tests to determine the amount of pressure that these types of products might generate.
Are there any guidelines that I can use to evaluate exposure to a product and the risk of injury it may present?
There are no formal guidelines. However, among the things to consider are:
(1) How the contents and form of the product might cause an injury,
(2) the product’s intended handling, use, and storage, and
(3) any accidents that might foreseeably happen during handling, use, or storage that could hurt the purchaser, user or others, including young children who might get into the package of the product.
What information must I put on the package of a product that is hazardous?
The label on the immediate package of a hazardous product, and any outer wrapping or container that might cover up the label on the package, must have the following information in English:
(1) The name and business address of the manufacturer, packer, distributor, or seller;
(2) The common or usual or chemical name of each hazardous ingredient;
(3) The signal word “Danger” for products that are corrosive, extremely flammable, or highly toxic;
(4) The signal word “Caution” or “Warning” for all other hazardous products;
(5) An affirmative statement of the principal hazard or hazards that the product presents, for example, “Flammable”, “Harmful if Swallowed”, “Causes Burns”, “Vapor Harmful”, etc.;
(6) Precautionary statements telling users what they must do or what actions they must avoid to protect themselves;
(7) Where it is appropriate, instructions for first aid treatment to perform in the event that the product injures someone;
(8) The word “Poison” for a product that is highly toxic, in addition to the signal word “Danger”;
(9) If a product requires special care in handling or storage, instructions for consumers to follow to protect themselves; and
(10) The statement “Keep out of the reach of children”. If a hazardous product such as a plant does not have a package, it still must have a hang tag that contains the required precautionary information. That information must also be printed in any literature that accompanies the product and that contains instructions for use.
Are there any guidelines describing how to make sure that the label of a hazardous product is conspicuous?
Yes. The FHSA requires that all of the safety information about hazardous products must be located prominently on the label and must be in conspicuous and legible type in contrast by typography, layout or color with the other printed information on the label. The regulation at 16 CFR 1500.121 contains guidelines to use to make sure that the information the act requires appears prominently and conspicuously on the label of a hazardous substance. For example, the signal word and statement of hazard must appear on the surface of the immediate container of the product that has the labeling designed to be most prominently shown to or examined by consumers when they shop at retail. The remainder of the labeling may appear elsewhere on the package, as specified in the regulation. The regulation also covers a variety of other topics such as type size and style, color contrast, and special rules for tubes, unpackaged hazardous products, and accompanying literature. Please consult the regulation for details. Other regulations (16 C.F.R.1500.122 – .134) cover topics such as condensing information on the label, how to label products with multiple hazards, the deceptive use of disclaimers on a label, the use of the signal word “Poison” on certain corrosive products, the Commission’s policy that first aid instructions should not recommend inducing vomiting by using a solution of salt water, and labeling for literature that accompanies a hazardous substance. These regulations also contain examples of the appropriate labels for self-pressurized containers and extremely flammable contact adhesives.
Will the Commission design a label for my product?
No. That is the responsibility of the person who manufactures or sells a product for household use. However, the Commission will provide you with informal comment on a label that you propose to use as long as you provide:
(1) the complete or proposed label,
(2) complete quantitative formula.
(3) adequate pharmacological, toxicological, physical, and chemical data that may be relevant to the possible hazards that the product may present, and
(4) any additional information that would assist us in evaluating the proposed label. This could include complaints of injury, information about how consumers may use the product, and recommendations obtained from poison control centers or physicians about the appropriate first aid treatment to administer if the products is swallowed or otherwise involved in an incident.
Are there any chemical products that are so dangerous that they are banned from sale?
Yes. The FHSA allows the Commission to ban a hazardous substance if the Commission determines that the product is so hazardous that the cautionary labeling required by the act is not adequate to protect the public. The Commission has banned the following products:
(1) Extremely flammable water repellents for use on masonry walls and floors inside homes;
(2) Carbon tetrachloride and mixtures containing it;
(3) a. Aerial fireworks devices that create an audible effect through a charge of more than 2 grains of pyrotechnic material;
b. firecrackers that produce an audible effect through a charge or more than 50 mg. (.772 grains) of pyrotechnic material; and
c. other fireworks devices that do not meet the general performance requirements of 16 C.F.R. 1507. Kits and components used to produce the banned fireworks are also included in the ban. Pest control devices are not.
(4) Liquid drain cleaners that contain 10% or more by weight of sodium or potassium hydroxide and that are not packaged in child-resistant packaging. See 16 C.F.R. 1700 for the child-resistant packaging requirements;
(5) Products containing soluble cyanide salts;
(6) General- use garments containing asbestos;
(7) Self-pressurized products that contain vinyl chloride monomer as an ingredient or in the propellant;
(8) Reloadable tube aerial shell fireworks devices that use shells wider than 1.75 inches. Please refer to 16 C.F.R. 1500.17 for the details of and exceptions to each specific ban.
Are there any other products that are banned?
Yes. Any toy or other article that is intended for use by children and that contains a substance that presents one of the hazards discussed above is also banned under the FHSA if a child can gain access to the substance. 16 C.F.R. 1500.85 contains a number of exceptions to this general banning provision.
Are there any other regulations covering hazardous chemical products that I should know of?
Yes, 16 C.F.R. 1500.14 has special labeling requirements for ethylene glycol, diethylene glycol, benzene, toluene, xylene, petroleum distillates, turpentine, methyl alcohol, charcoal, fireworks devices, and art materials that present a risk of chronic toxicity.
In addition, under the Consumer Product Safety Act, the Commission has banned:
(1) Certain extremely flammable contact adhesives (16 C.F.R. 1302);
(2) Paint and other surface coatings containing more than .06% lead, and furniture, toys, and other articles intended for use by children that are coated with such paint (16 C.F.R. 1303); and
(3) Consumer patching compounds and artificial ashes and embers used in fireplaces containing free-form asbestos that can be inhaled (16 C.F. R. 1304 and 1305).
The Commission has also issued labeling requirements for aerosol products that contain chlorofluorocarbons warning that the substance may harm health and the environment by reducing the ozone in the upper atmosphere (16 C.F.R. 1401).
The above is a general unofficial summary of the requirements of the Federal Hazardous Substances Act that apply to chemicals and other hazardous substances prepared by CPSC. It does not replace the requirements of the act itself at 15 U.S.C. § 1261, et seq. or the regulations published in 16 C.F.R. Part 1500. This summary does not include all of the details included in those requirements, particularly those involved in testing products to determine whether they require labeling to address specific hazards.(This does not cover the FHSA as it applies to toys and other articles intended for use by children that present thermal, electrical, or mechanical hazards.) For those details, please refer to the regulation, personally consult with competent legal counsel, or contact the CPSC Office of Compliance.
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