Packaging requirements for household cleaners.
The U.S. Consumer Product Safety Commission (the "Commission") is charged with oversight of household and consumer product safety. Commission authority over labeling and packaging for safety derives mainly from two closely tied federal laws, the Poison Prevention Packaging Act ("PPPA") and the Federal Hazardous Substances Act ("FHSA"). Failure to meet the labeling requirements of the FHSA or the packaging requirements of the PPA, results in a product being deemed "misbranded." On encountering a misbranded product, the Commission typically calls for remedial action ranging from placing supplementary stickers on future labeling to immediate recall of the product. Violation of Commission standards can result in recalls, product seizures and civil penalties. Serious flaunting of Commission requirements may result in criminal penalties.
The FHSA requires safety labeling on all products containing hazardous substances. A "hazardous substance" is defined as anything that creates a foreseeable threat of substantial personal injury or illness. It extends over substances that are toxic, corrosive, flammable, combustible, are irritants or strong sensitizers, or contained under dangerous pressure. "Foreseeable" in this context would include abuses such as deliberate inhalation of fumes or ingestion by children. The standard is objective and therefore there need be no determination or regulation declaring your product hazardous before FHSA applies. Labeling requirements under the FHSA vary depending on the category into which your product fits: toxic, highly toxic, flammable, extremely flammable, or combustible. During the past decade, the Commission has, on occasion, deployed its rulemaking and expert resources to clarify the exact status of cleaning ingredients, such as methyl salicylate and methacrylic acid.
Commission rules detail specific safety labeling that must appear on methyl alcohol, turpentine and petroleum distillate products and a variety of other common cleaning ingredients. At a minimum, safety labeling on hazardous substances must:
* Indicate the substance;
* State "DANGER" if the substance is extremely flammable, corrosive and/or highly toxic. "WARNING," or "CAUTION" should appear in the ease of other hazardous substances. "Poison" along with the skull-and-crossbones symbol must also appear on the label of any highly toxic hazardous substance;
* List hazards associated with the product, (e.g., "Highly Irritating Fumes," "Toxic When Ingested");
* Describe precautions to avert the harm and
* List "necessary or appropriate" instructions for first-aid treatment.
Federal labeling rules also specify other particulars regarding the form, size, format and placement of safety messages for household cleaners.
Makers of home cleaning supplies must also be aware of PPPA packaging requirements. The PPPA authorizes the Commission to establish standards for the child resistant packaging ("CR packaging") of any household substance if (1) the degree or nature of the hazard it poses to children is such that special protective packaging is required to avert serious injury or illness, and (2) the special packaging is "technically feasible, practicable and appropriate."
Household cleaners expressly subject to special packaging provisions of the PPPA include methanol and turpentine-based cleaners, solvents for paints and coatings, wood oil cleaners, spot removers, metal cleaners, fluoride treatments, adhesive removers, and general-use household oils. More broadly, however, CR packaging requirements would apply to any substances that would be deemed hazardous under the FHSA.
In implementing the PPPA, the Commission has emphasized the issue of "appropriateness." CR design must balance resistance to small children's efforts to open, or to quickly extract "toxic or harmful" amounts of contents with ease of use concerns for adults. Regulations provide that CR packaging must frustrate small children's efforts to open not less than 85% of the time before an adult demonstrates the proper way, and not less than 85% effectiveness afterward. Under the same constraints, however, adults aged 50-70 years must be capable of successfully opening the packaging with not less than a 90% success rate. This balance largely reflects the Commission's sensitivity to the potential harm caused by overambitious CR requirements: adults fed up with wrestling difficult packaging tend to leave open containers around the house, creating even greater dangers for children. Under this open standards have generated diverse CR packaging for household cleaning products, most featuring cap-and-bottle arrangements that incorporate dispensing valves, or push-in or push-and-turn locking mechanisms.
Having sketched some of the basic issues to consider in safety labeling and packaging, we note that Commission requirements tend to have implications far beyond the Commission itself. First, Commission regulations serve as a template for individual state labeling and packaging requirements. As a consequence, states undertake enforcement actions that are indirectly, if not directly, based on Commission standards. Second, several states regard noncompliance with applicable federal standards as evidence of noncompliance with the standard of care in product liability cases. Conversely, compliance with federal regulations has a preemptive effect on some claims under state law.
When preparing safety labeling and packaging, companies must be mindful of how federal compliance policies can best position them for potential state enforcement action and tort litigation.
GEORGIA C. RAVITZ, Esq. is a partner and Jeff Weinstein, Esq. is an associate of Arent Fox PLLC, a general practice law firm based in Washington, DC. Ms. Ravitz' practice specializes in FDA and FTC regulatory matters and she counsels cosmetic and personal care companies in advertising and regulatory matters.
For additional information, contact: Ravitz.Georgia@arentfox.com or (202) 857-8939.
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|Title Annotation:||Regulatory Issues|
|Author:||Ravitz, Georgia C.; Weinstein, Jeff|
|Publication:||Household & Personal Products Industry|
|Date:||Apr 1, 2005|
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