Packaging requirements for household cleaners.
THE VARIETY of cleaning products found in U.S. homes has greatly increased in recent years. New markets have emerged for non-toxic, petrochemical-free, "green" and hypoallergenic hy·po·al·ler·gen·ic
Having a decreased tendency to provoke an allergic reaction.
adj products, as well as other innovative formulations. Amid the exciting growth in today's household cleaning industry, we find that companies face hard challenges navigating safety labeling and packaging rules. Federal rules dictate an array of particulars that must appear in safety labeling and packaging. This column serves as a primer on safety labeling and packaging requirements.
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 PPPA Printing Presses and Publications Act (Malaysia)
PPPA People, Pay and Pensions Agency (UK MoD)
PPPA Poison Prevention Packaging Act of 1970 (US) ") and the Federal Hazardous Substances Act ("FHSA FHSA Federal Hazardous Substances Act
FHSA Family Health Service Authority
FHSA Family History Society of Arizona "). Failure to meet the labeling requirements of the FHSA or the packaging requirements of the PPA PPA 1. Palpation, Percussion & Ausculation 2. Pittsburgh pneumonia agent 3. Postpartum amenorrhea 4. Price per accession 5. Pure pulmonary atresia , results in a product being deemed "misbranded mis·brand
tr.v. mis·brand·ed, mis·brand·ing, mis·brands
To brand or label misleadingly or fraudulently.
Adj. 1. ." 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 fumes
odorous gases and other volatile materials; inhalation of irritating fumes causes coughing and, if sufficiently severe, irreversible pulmonary edema. or ingestion ingestion /in·ges·tion/ (-chun) the taking of food, drugs, etc., into the body by mouth.
1. The act of taking food and drink into the body by the mouth.
2. 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 turpentine, yellow to brown semifluid oleoresin exuded from the sapwood of pines, firs, and other conifers. It is made up of two principal components, an essential oil and a type of resin that is called rosin. and petroleum distillate dis·til·late
A liquid condensed from vapor in distillation.
a product of distillation. 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 o·ver·am·bi·tious
Ambitious to an excessive degree.
over·am·bi 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 noncompliance
failure of the owner to follow instructions, particularly in administering medication as prescribed; a cause of a less than expected response to treatment.
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 pre·emp·tive or pre-emp·tive
1. Of, relating to, or characteristic of preemption.
2. Having or granted by the right of preemption.
a. 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.
When a person begins a civil lawsuit, the person enters into a process called litigation. .
GEORGIA C. RAVITZ, Esq. is a partner and Jeff Weinstein, Esq. is an associate of Arent Fox PLLC PLLC Professional Limited Liability Company
PLLC Polk Life and Learning Center (Bartow, FL)
PLLC Partners of Limited Liability Corporation , a general practice law firm based in Washington, DC. Ms. Ravitz' practice specializes in FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. and FTC FTC
See Federal Trade Commission (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.