|April 15, 2011|
Previously published on April 12, 2011
To the consternation of many manufacturers, distributors, and retailers, states increasingly are taking steps to regulate chemicals contained in consumer and personal care products. The consumer and personal care products industry has made it known that it would prefer consistent, comprehensive federal regulation, rather than having to comply with a mixed-bag of varying state and local requirements. However, according to Healthy States, a November 2010 report prepared by the advocacy group Safer States, in the last decade both the number of states adopting chemical regulation laws, and the number of laws they have adopted, have tripled. MIKE BELLIVEAU, SAFER STATES, HEALTHY STATES: PROTECTING FAMILIES FROM TOXIC CHEMICALS WHILE CONGRESS LAGS BEHIND 6 (2010) [hereinafter HEALTHY STATES], available at http://www.saferstates.com. According to the study, 18 states passed 71 new chemical safety laws during that period. Id. All indications are that this trend will continue.
Federal Regulation of Chemicals
Several federal agencies regulate chemicals used in consumer and personal care products, but historically, such regulation has been limited. Although the U.S. Environmental Protection Agency (EPA) has initiated several chemical regulatory initiatives over the past year, historically, it has made limited use of its primary statute regulating chemicals, the Toxic Substances Control Act (TSCA), 15 U.S.C. §§ 2601, et seq., (2010).
The EPA TSCA Inventory has over 80,000 chemicals, but few have been adequately tested, limiting the agency’s ability to act. HEALTHY STATES at 10. Congress last year indicated an interest in updating TSCA, which has not been amended since its enactment in 1976, but no action was taken. The willingness of the new, Republican-dominated Congress to take up TSCA reform is not clear. Id. at 10-11.
In an effort to encourage and facilitate TSCA reform, EPA has published six “Essential Principles for Reform of Chemicals Management Legislation.” See EPA, ESSENTIAL PRINCIPLES FOR REFORM OF CHEMICALS MANAGEMENT LEGISLATION (9/29/09), available at http://www.epa.gov/opptintr/existingchemicals/pubs/principles.html.
In an effort to take more concrete action, since December 2009 EPA has issued “Action Plans” for eight chemicals. See EPA, CHEMICAL ACTION PLANS, www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html (last updated 11/10/10).
These Action Plans summarize the available hazard, exposure, and use information for the chemical, outline the chemical’s known risks, and describe the regulatory measures EPA is considering. Id. EPA also has announced plans to tap into never-used authority under TSCA to compile and maintain a list of chemicals of concern, which presumably will become a basis for regulation. See Press Release, “EPA Announces Actions to Address Chemicals of Concern (12/30/09),” available at http://yosemite.epa.gov/opa/admpress.nsf.
Certain personal care products, such as cosmetics and fragrances, are exempt from TSCA and EPA regulation. Regulated instead by the Food and Drug Administration, these products historically have been evaluated and regulated based upon human health and safety concerns, with little consideration of their environmental impacts. This historic failure to address environmental concerns has left these manufacturers open to criticism as environmental groups and consumer advocates, as well as the growing body of state and local chemical laws and regulations, have forced them to focus on environmental issues. Whether these products ultimately are formally subjected to federal TSCA regulation, or the manufacturers voluntarily submit certain of these products to environmental review, it seems clear that these members of the personal care products industry no longer will be able to use the TSCA exemption as cover to ignore the environmental impacts of their products. Environmental regulation of those products, in some form, seems inevitable.
Another source of federal chemical regulatory authority is the Consumer Products Safety Commission (CPSC). CPSC’s authority in this area, however, as well as its historic exercise of that authority, has been limited. The CPSC’s authority to regulate certain chemicals was expanded in 2008, when Congress enacted the Consumer Product Safety Improvements Act (CPSIA). As of February 10, 2009, the CPSIA prohibited the manufacture, sale, distribution, and importation of any “children’s toy” or “childcare” article if it contained any of six phthalates above specified concentrations.
Other federal agencies are tangentially involved in chemical regulation, including even the Drug Enforcement Administration. Other federal legislation, such as the Pollution Prevention Act of 1990, 42 U.S.C. §§ 13101-13109 (2010), while not focused on regulation, has been facilitating federally funded research into toxics reduction and other such initiatives.
State Regulation of Chemicals
Notwithstanding the federal framework for regulating chemicals, and recent efforts by EPA and CPSC to regulate more aggressively, environmental advocacy groups, many consumer groups, and state and local politicians have become increasingly concerned about the presence of toxic chemicals in everyday consumer goods, their prevalence in the environment generally, and the adverse health impacts of such chemicals, particularly on children and other vulnerable populations. These parties have grown increasingly frustrated with the lack of federal effort to regulate chemicals, and the slow pace and limited scope of those efforts when they are undertaken, resulting in increasing use of state law to regulate these chemicals.
As these state initiatives have grown over the last decade, the worst fears of the consumer and personal care products industry are being realized. Available indices of these laws indicate that there are currently over 1,000 state and local chemical laws and regulations on the books. Each of these laws is unique in one or more respects, imposing state-by-state, and even municipality-by-municipality, compliance challenges on what is otherwise an international industry.
State regulation of chemicals in consumer and personal care products has taken many forms. The more significant forms include green chemistry laws, bans and other limitations on specific chemicals, and child product safety laws. State laws, however, also regulate chemical notifications, chemical labeling, product packaging, waste minimization, lifecycle controls, and purchasing prohibitions and incentives. Interestingly, states have not copied one of the first, and most high-profile, state chemical regulation efforts, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, or Proposition 65 (codified as amended in scattered sections of CAL. HEALTH & SAFETY CODE ch. 6.6, div. 20). Proposition 65 requires California to maintain a list of chemicals known to cause cancer or reproductive toxicity, and requires manufacturers of products containing those chemicals to place specified warnings on product packaging. Proposition 65 is enforced by private attorney generals bringing suit against alleged violators. While notification and labeling requirements are common in the newer state laws, Proposition 65’s focus and enforcement mechanisms remain unique.
As noted, many advocacy and other groups are encouraging and supporting state chemical regulation efforts. A relatively new support group, unique in that it was formed by the states, is the Interstate Chemicals Clearinghouse (IC2). THE INTERSTATE CHEMICALS CLEARINGHOUSE, www.newmoa.org/prevention/ic2/index.cfm (last updated 2/15/11).
Founded in the summer of 2008, IC2 currently has 10 members: California, Connecticut, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, Washington, and the Portland, Oregon, Metro Regional Government. Although economic and other factors have slowed the growth of IC2, it has held a number of meetings and informational sessions and has provided financial and other assistance to member states. IC2 also has promulgated six fundamental operating functions and goals, including supporting states with development and implementation of programs to promote the use of safer chemicals and products, developing methods of identifying safer alternatives to toxic chemicals, sharing data and information, helping states meet the information needs of business and the public, sharing strategies for chemical prioritization initiatives, and helping to build the capacity of state agencies to regulate chemicals. Although not labeled as such, IC2 appears dedicated primarily to helping states develop green chemistry programs.
Green Chemistry Laws
The most publicized and innovative state chemical regulatory initiatives are the green chemistry laws. The green chemistry program recently proposed by California is the most aggressive and well known. As defined by California, green chemistry is “the innovation, design, and manufacture of chemical products and processes intended to reduce or eliminate the creation and use of materials hazardous to human health and the environment.” CALIFORNIA DEPARTMENT OF TOXIC SUBSTANCES CONTROL [DTSC], California Green Chemistry Initiative, www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/index.cfm (last visited 3/31/11).
While this may sound relatively benign, the potential real-world consequences of green chemistry can be anything but. In practice, these programs involve identification by the state of one or more “priority chemicals,” and require manufacturers of products containing those priority chemicals to study and evaluate those chemicals and products, to study and identify less toxic alternatives, and, depending on the chemical, the product, and the findings, to substitute less toxic alternatives for the priority chemicals in the products. As these programs develop, they will have a significant impact on manufacturers, products, and consumers.
California attempted to implement its green chemistry program at the end of 2010, but following some last minute changes, both industry and environmental groups raised objections. This, and the transition from Governor Schwarzenegger to Governor Brown, delayed and effectively put the program on hold. It is our understanding that nothing will happen with California’s green chemistry program until the new Governor appoints a new head of DTSC, and even then it is uncertain whether and how the program will be implemented.
In the last few years, several states have adopted green chemistry laws, although they are narrower, more focused, and less ambitious then California’s. Maine’s Toxic Chemicals in Children’s Products Law, for example, adopted in 2008, required the state to adopt a list of Chemicals of High Concern by January 1, 2010, and then, by regulation, to begin identifying and regulating priority chemicals. See ME. REV. STAT., tit. 38, §§ 1691 - 1699- B. Maine’s Chemicals of High Concern list initially had approximately 1,700 chemicals and, to date, two priority chemicals have been designated for regulation. See MAINE DEPARTMENT OF ENVIRONMENTAL PROTECTION [DEP], CHEMICALS OF HIGH CONCERN LIST (Jul. 17, 2009), available at www.maine.gov/dep/oc/safechem/highconcern/.
Effective July 8, 2011, for example, any manufacturer of children’s products containing nonylphenol or nonylphenolefhoxylates (i.e., household supplies, cosmetics, and personal care products, and consumer home maintenance products) is required to submit specified information to the state, with further regulation assumed. For the second priority chemical, Bisphenol A (BPA), manufacturers of infant formula or baby food sold in plastic containers, jars, or cans will be required to submit specified information. By January 1, 2013, such manufacturers must submit an assessment of safer alternative chemicals to BPA. Also, unless the manufacturer has an approved Compliance Plan, after January 1, 2012, no manufacturer of reusable food or beverage containers can sell or distribute those products in Maine.
Washington State has several green chemistry initiatives. Since 2008, Washington’s Toxic Reduction Advisory Committee has been charged with recommending regulations to help businesses achieve a 50 percent reduction in toxic substance use, developing recommended strategies to encourage waste minimization, and creating opportunities for incentives that reward businesses for toxic chemicals reduction. In its Children’s Safe Products Act (WASH. REV. STAT. §§ 70.240.010 - 70.240.060), on the other hand, the state must develop a list of toxic chemicals that have either been found in children’s products or in human tissue. As in Maine, these are referred to as Chemicals of High Concern. WASH. ADMIN. CODE § 173-334-140. Larger manufacturers will be required to begin reporting use of these chemicals in 2012, with smaller manufacturers phased in over time. As products containing these chemicals are identified, the law requires preparation of reports to address, among other things, identification of regulatory options for dealing with those products.
The Minnesota Toxic Free Kids Act (MINN. STAT. §§ 116.9461 - 116.9407) also requires the state to compile a list of Chemicals of High Concern, and to identify priority chemicals in children’s products by February 1, 2011. This will be followed by studies and reports, which are required to contain recommendations regarding mechanisms to reduce and phase out the use of priority chemicals in children’s products and to promote consumer product design that uses green chemistry principles.
Less regulatory, or restrictive approaches to green chemistry regulation have been adopted in Connecticut, Massachusetts, and Michigan. Connecticut’s Act Concerning Child Product Safety (CONN. GEN. STAT. §§ 21a-335 —21a-346) requires the state to develop lists of chemicals and alternatives, but provides for study and information sharing through a multi-state clearinghouse. Massachusetts’ Toxics Use Reduction Act (MASS. GEN. LAWS ch. 21I) established an institute to assist businesses with reducing, by 50 percent, toxics in products. In Michigan, by Executive Directive No. 2006-6, the Governor established the Michigan Green Chemistry Programs, intended to prevent pollution and increase economic development through green chemistry measures.
As noted, state interest in green chemistry programs appears to be growing. Illinois and Michigan adopted new green chemistry legislation on July 29, 2010, and December 15, 2010, respectively. In Michigan, two companion measures intended to fill out the state’s newly adopted green chemistry program still are being considered by the legislature. Legislation also is known to be under consideration, or is being studied, in Massachusetts, New York, Oregon, Vermont, and Arkansas.
Bans and Limitations on Specific Chemicals
The most common form of state chemical regulation involves bans or limitations on specific chemicals of concern. Chemicals most commonly banned or restricted in the past include lead, mercury, formaldehyde, dioxins, cadmium, and arsenic. These laws often seem to be a reaction to a specific publicized incident or event involving the particular chemical or class of chemicals, and the states’ response often seems to involve some form of “pack mentality,” with a number of states banning or limiting the same chemicals at the same time.
These bans are too numerous and varied to summarize effectively, but it is helpful to get a sense of some of the chemicals of recent concern. For example, a class of chemicals being broadly banned at the state level are persistent, bioacumitative and toxic (PBT) chemicals. New York law encourages PBT-free purchasing, and a number of other states, including Ohio, Washington, and California, have banned or significantly limited use of PBT’s.
As suggested above, many states have banned or limited the use of phthalates, particularly in toys and child-care products. Phthalates make plastics softer and more flexible and durable, and are used in baby bottles, baby food containers, and toys, as well as in modeling clay, medical devices, and home products. Because of their toxicity and persistence in the environment, phthalates have received both state and federal regulatory attention. California, in 2007, was one of the first to ban phthalates, followed by many others, including Vermont, Washington, and Minnesota. One of EPA’s new Action Plans is directed at phthalates. See EPA, PHTHALATES ACTION PLAN SUMMARY, www.epa.gov/opptintr/existingchemicals/pubs/actionplans/phthalates.html (last updated 6/25/10).
Another chemical of recent concern, as noted above for Maine, is BPA. This chemical generally is used to strengthen plastics in food and beverage containers, children’s toys, child care items, medical devices, and personal care and household items. A number of states in addition to Maine, including Minnesota and Connecticut, have banned or limited BPA in the last few years, and legislation is pending in a number of other states.
Most recently, 3, 4- methylenedioxy-N-methylcathinone, also known as Methylone, which is present in bath salts, room deodorizers, and plant food, has become a significant state concern. As found in these products, Methylone has been shown to be a powerful euphoric and hallucinogen. Louisiana’s Governor recently banned Methylone and, in January 2011, Florida’s Attorney General issued an emergency regulation designating Methylone as a controlled substance. Other states, including North Dakota and Kentucky, have passed or are considering bans. It is said that IC2 was formed largely in response to concerns about Methylone.
Child Product Safety Laws
Many of the laws adopted by the states, whether green chemistry, bans on specific chemicals, or notice, labeling, or packaging laws, are focused on child safety. This focus is consistent with state regulators’ concerns about the health effects of chemicals on vulnerable populations. This regulatory focus has been driven in part by recent significant product recalls, including over 17 million toys in 2007 that violated lead paint standards, high cadmium levels in over 55,000 units of children’s costume jewelry in January 2010, and elevated cadmium in 12 million promotional drinking glasses last year from McDonalds.
The consumer and personal care products industry is facing a significant regulatory and compliance challenge as federal, state, and local governments adopt myriad rules and regulations governing chemicals in its products. For an international industry, state-by-state regulation is a legitimate concern and a significant regulatory challenge. State and local chemical regulation is growing, and ignoring it or passively watching it happen only allows its continued unfettered growth. The industry should manage this phenomenon and the challenges it presents aggressively and intelligently, with the twin goals of addressing the legitimate concerns of the public and lawmakers regarding the potential health effects of toxics, and protecting their products, companies, and industry from possible reactive, ill-considered, duplicative, inconsistent, and unnecessary efforts to regulate. Possible suggestions for accomplishing this include:
Develop programs for tracking state legislative efforts and, where appropriate, intervene to attempt to influence legislation to eliminate provisions that are unduly burdensome or that impose unusual or unnecessary obligations that differ from those in other states. The goal is to encourage consistency. A concerted effort to ensure that new state laws are consistent with those in other states will help to limit compliance challenges. It may be prudent, for example, to take the lead in some cases and to propose and encourage the use of model laws to address certain state law issues, particularly in the developing green chemistry area.
Develop programs for tracking development of chemicals of concern lists, designation of priority chemicals, study and reporting requirements, development of safer alternatives lists, and evaluation of regulatory alternatives in existing state programs, primarily to minimize burdensome requirements and to ensure consistency and eliminate unnecessary differences among the states. As states develop lists of chemicals of concern and priority chemicals, particularly as the programs mature and the lists expand beyond the obvious “bad actors,” it also will be important to make sure that the listing of any chemicals complies with the requirements of state law. The industry must ensure that any decisions are based on science. Any state or federal chemical listings, any evaluation of alternatives, and any regulatory determinations, including substitutions or reformulations, must provide an opportunity for due process.
The most likely approach for preempting state chemical laws is for Congress to adopt a comprehensive federal chemical regulatory program that expressly preempts those laws. It seems appropriate for the consumer and personal care products industry to actively support such legislation. It is unlikely, however, that the industry’s support of comprehensive federal legislation will succeed if the focus is upon limiting or avoiding chemical regulation. Green chemistry, particularly its emphasis on evaluating alternatives and product reformulation, has caught the public’s imagination and overt industry efforts to reverse or scale back these programs are not likely to be well received. While it is critical that the industry fight to make sure that the regulatory processes and procedures are fair and reasonable, that legislative and regulatory agency decisions are scientifically supported and defensible, and that, in addition to due process, the alternatives analyses and reformulation decisions account for and incorporate rational health, economic, financial, and market considerations, the substance of the current state law initiatives must be addressed and included in any federal regulation that will hope to preempt comparable state laws.