A key issue for risk managers to consider is how to proactively assess the use of product-related collateral—material safety data sheets, product inserts on product labels, and warnings—to inform consumers of potential health risks concerning nanomaterials in products. The increasing commercialization of nanomaterials and the rapid introduction of nano-enabled products to the marketplace represent an exciting development in the progression of this emerging technology within the world’s economy.
As with any product, the parties in the chain of distribution of nanomaterials are deemed to possess expertise concerning the safety of their products and the component materials they contain, especially relative to lay consumers. In circumstances where the residual risk of harm from the use of any nanomaterial or nano-enabled product can not be avoided by design or manufacturing improvements, and the level of the residual risk is unreasonable, the law also imposes a duty upon parties in the chain of distribution to provide adequate instructions or warnings that, if read and followed, would serve to alert consumers to the existence of these potential residual risks, so that in using these products or materials the known or reasonably foreseeable risks can be appropriately reduced.
The creation of a proper product label, warning, and/or instruction is a multifaceted process that requires expert consideration of material toxicity data, product use information, the law, and human behavior. This article reviews these aspects of labeling, warning and instruction creation for promotion of nanomaterial safety and product risk management.
I. Nanotechnology Product
Applications and Growth
As the safety of nanomaterials and nanoenhanced products increasingly is being questioned by federal, state, and local governments, and by researchers and the public, the nanotechnology industry will be facing greater scrutiny.
Although nanotechnology may involve the creation of novel nanoscale substances, materials with nanoscale dimensions have been in consumer products for a decade or more (e.g., thin-film wafer technology in semiconductors; nanoscale pigments in coatings, sunscreens, clay fillers, colloidal silver). The past few years, however, have seen sustained growth in new products containing nanotechnology, with over 1,300 products on the market as of March 10, 2011, nearly a 521 percent increase since March 2006,
Among products with identified nanoscale constituents, a predominant number contain nanoscale silver (313 products), followed by carbon (including carbon nanotubes (CNTs), nanofibers, and fullerenes; 91), titanium (including titanium dioxide, TiO2; 59), silica and silicon (43), zinc (including zinc oxide, ZnO; 31), and gold (28). Other nanomaterials (e.g., polymers, clays, quantum dots, organic micelles) are also incorporated in a few products listed in the inventory and by other sources.
Most products in the PEN 2011 inventory are from companies in the United States (587 products) or in countries that heavily export products to the U.S. (367 from Europe and 261 from East Asia). Over 50 percent of the total products listed by category are in health and fitness (738 products), with many fewer in the next largest categories: home and garden (209), automotive (126), and food and beverage (105). Within health and fitness, the largest subcategories are personal care (267), clothing (182), cosmetics (143), and sporting goods (119).
Among personal care products, applications containing nanosilver for its antimicrobial properties include skin and hair care products, wound dressing, oral care, hair styling equipment, towels, and shavers. Nanosilver is also used as an antibacterial agent in clothing. Other products such as skin creams, cosmetics, or dietary aids use nanoscale micelles or liposomes as delivery systems for encapsulated peptides, vitamins, or other nutrients. Fullerenes are used in stabilizing cosmetic formulations, delivery of other ingredients within these products, and antioxidant properties.
Applications of carbon nanotubes in the consumer products inventory are exclusively for structural purposes (bicycles, tennis rackets, golf clubs, shoe cleats, aircraft frames) or in electronics (computer displays, memory chips). Home care products exploit the antibacterial and “self cleaning” properties of nanometal oxides such as silver, titanium, and zinc, in various cleaning solutions and surface coatings.
Most products containing nanotechnology that are currently on the market are likely to be in applications resulting in some form of human contact.
A. Knowledge on Health Risk of Engineered
Nanomaterials in Consumer Products
Despite public concerns regarding the safety of nanotechnology, websites for these products provide little or no objective information on product safety, other than occasional claims of safety without details on underlying safety testing. In most cases, no details are provided on the specific characteristics of the nanoscale ingredients.
In some cases, even the general type of nanomaterial is not stated. Such information may be proprietary; however, it provides little means for a consumer to evaluate the safety of the product.
B. Potential for Exposure
Minimizing exposure to an agent is key to managing potential health risks, particularly for nanomaterials for which toxicity information may be incomplete. Although consumer exposures to nanoparticles in products are likely to be far lower than for manufacturing workers or researchers, consumer exposures may involve a wider variety of conditions, over longer durations, to people who may be more sensitive to health effects. Inhalation and skin contact are the most likely ways consumers may be exposed to nanomaterials in consumer products; although oral intake is also possible for supplements, food contact materials, or implements that are likely or designed to be mouthed (children’s toys, teething rings).
Elevated exposures to free airborne nanoparticles during handling of raw materials have been shown to be possible in workplace or laboratory settings, although exposures tend to be brief and limited by particle agglomeration and settling.
Investigation of potential effects via skin contact has focused on dermal penetration, for which relatively inert nanomaterials (e.g., TiO2 and ZnO in sunscreens) and even fullerenes have shown little penetration to viable layers of intact skin, except possibly for areas of flexion or skin compromised by sunburn or abrasion, and with uncertainties for age-related sensitivities.
Dermal penetration may be possible and is even advertised for some products with coatings or micronized micelle technology using biologically compatible substances (e.g., phospholipids, amino acids, peptides, fatty acids or esters) to deliver these substances or other nutrients or emollients to the skin. Product advertisements are unclear on whether such skin penetration reaches the underlying vascularized layers and thereby enters systemic circulation to travel to other parts of the body.
Similar micelle technology is being exploited for oral nutritional supplements or oral pharmaceuticals to enhance delivery and absorption of substances that might otherwise be less available. A concern for other products with potential oral contact is the extent to which free nanoparticles may be released, which because of their smaller size may be more efficiently absorbed in the gastrointestinal tract.
Characterization of the material properties of the product is of key importance in assessing exposure. Manufacturers of nanomaterial-containing products should consider the many ways in which the product may be used, misused, abused, or weathered, and the extent to which free nanoparticles may be released from the product under such conditions.
The Environmental Protection Agency recently announced the award of a grant to evaluate whether nanomaterials can leach out of consumer products such as paints, plastics, and fabrics during use and disposal, and whether such exposures could cause toxic effects in humans or the environment.
C. Available Toxicity Information
In addition to the material properties of the product, full characterization of the type of nanomaterial used in the product versus that used in any toxicity testing is an important distinction. For example, the form of TiO2 used in toxicity testing is often an uncoated, more reactive crystal type than the coated and less reactive crystal type used as a pigment in paints. Uses of TiO2 that exploit its more reactive properties (e.g., self-cleaning films), however, are to likely to involve the more reactive crystal type. Fullerenes used in cosmetics and skin creams appear to be the water-soluble, derivatized fullerol form with covalently bonded functional groups that make them more biocompatible with antioxidant and antimicrobial properties.
The major types of metals listed as being used in consumer products are of relatively low toxicity to humans (e.g., silver, TiO2, ZnO).
Other than exposing naked cells or tissues to nanoparticles in vitro, most of the toxicity research on nanomaterials has focused on the inhalation pathway.
Specific concerns about the hazards of nanotechnology have intensified since 2008, when toxicity studies in animals compared the short-term effects of multi-walled carbon nanotubes (MWCNTs) and asbestos.
Toxicity is thus highly related to structure and other properties. Functionalization or attachment of other molecules on carbon nanotubes greatly affects their toxicity, as illustrated by research into medical uses of carbon nanotubes for drug delivery. Pristine carbon nanotubes injected into mice were retained within organs.
Reports on the toxicological similarities of carbon nanotubes to asbestos, however, probably precipitated EPA’s first action to identify a specific new “nano” chemical under the Toxic Substances Control Act (TSCA). On Oct. 31, 2008, carbon nanotubes were identified by EPA as distinct from other carbon forms in the TSCA inventory and new chemicals under TSCA Section 5, thus requiring a pre-manufacture notice for manufacturers or importers (73 Fed. Reg. 212, pp. 64946–64947).
The TSCA Interagency Testing Committee has also recommended to EPA that a number of nanomaterials in commerce need additional research on worker exposures and mammalian toxicology.
D. Potential for Health Risk
Health risks of nanomaterials currently in consumer products under typical uses are likely to be low for consumers. The major types of nanomaterials being used are of low toxicity or are encapsulated or incorporated within components, resulting in low human exposures under most circumstances. However, exposure and toxicity information on many nanomaterials is still considered incomplete, and current regulations do not require any special safety assessments of these products. As new engineered nanoscale materials are produced, their health risk in products will need to be assessed.
Knowledge of the material properties of the nanomaterials and interaction within the product matrix is essential to understanding exposure under normal or abnormal product uses and disposal. During the interim period between development and complete characterization and satisfactory safety testing, the prospects for manufacturers of products that include nanomaterials to warn consumers about potential risks of harm due to exposure raises both business and legal considerations. Written product labels and/or product warnings are one way to inform consumers prior to or at the time of purchase. A manufacturer’s assessment of the need for, and type of, product warning or label, will not be possible without first understanding the potential risks of its product.
II. Legal Implications for Product Liability
All parties in the chain of manufacture, importation, distribution and sale of nanomaterials and nano-enabled products in the United States are under duties imposed by law to produce and sell products that are free of defects in design and manufacture, and that are reasonably safe for the ordinary purposes for which the nanomaterials are used. Yet, sometimes the best possible design and manufacturing processes still result in a product with an unreasonable level of residual risk of harm. In these circumstances, a legal duty exists in the United States to provide adequate instructions and/or warnings, so that if they were read and followed, known or reasonably foreseeable risks associated with use or consumption of the product may be reduced or avoided.
A. Restatement of the Law—Torts:
Product Liability: Duty to Warn Generally
A product “is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the instructions or warnings renders the product not reasonably safe.” Restatement 3d of Torts: Products Liability §2(c) (1998) (the “Restatement”).
The Restatement, as black letter law, presents a reasonableness test for judging the adequacy of product warnings: A product is defective (i.e., not reasonably safe) because of inadequate instructions or warnings if it poses a foreseeable risk of harm that could be reduced or avoided by reasonable instructions or warnings. The editors’ comments to §2(c) of the Restatement suggest that “[w]arnings also may be needed to inform users and consumers of nonobvious and not generally known risks that unavoidably inhere in using or consuming the product. Such warnings allow the user or consumer to avoid the risk warned against by making an informed decision not to purchase or use the product at all and hence not to encounter the risk.” Restatement 3d of Torts: Products Liability §2 cmt. i.
The warnings are necessary for products with inherent risks that reasonably foreseeing users would deem material or significant in deciding whether to use the product. Id. This is most often seen in the area of pharmaceuticals, in which “courts have recognized a distinctive need to provide risk information so that recipients of the information can decide whether they wish to purchase or utilize the product.” Id.
B. Key State Law Nuances on Duty
To Warn for Nanotechnology
A nationwide survey of product warning and labeling law is beyond the scope of this article, but examination of pertinent legal precedent from three of the top four states noted for nanomaterial research, development and commercialization is illustrative.
As such, there still exists some variety among jurisdictions in the application of the Restatement’s principles. This article will address briefly the law of three very representative nanotechnology jurisdictions across the United States: Massachusetts, California, and New York.
1. Massachusetts: Negligence and Breach
of Implied Warranty of Merchantability
Prior to the publication of the Restatement, Massachusetts implied warranty of merchantability law presumed “that a manufacturer was fully informed of all risks associated with the product at issue, regardless of the state of the art at the time of the sale, and amounts to strict liability for failure to warn of these risks.” Vassallo v. Baxter Healthcare Corp., 428 Mass. 1, 20 (1998) (citing Simmons v. Monarch Mach. Tool Co., 413 Mass. 205, 207-08 n.3 (1992), and Hayes v. Ariens Co., 391 Mass. 407, 413 (1984)).
In Vassallo, the Massachusetts Supreme Judicial Court contemplated the law as set out in the Restatement, noting that the majority of states require the seller “ ‘to give warning against [a danger], if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the … danger,’ ” and acknowledged comment m to §2 of the Restatement (“An overwhelming majority of jurisdictions supports the proposition that a manufacturer has a duty to warn only of risks that were known or should have been known to a reasonable person”). Id. at 20-21. The court also noted that three jurisdictions that had previously adhered to the same standard as Massachusetts had recently converted to an objective knowledge standard, including New Jersey. Id. at 21. The reversal of New Jersey strict liability doctrine for breach of warranty for failure to warn was of particular importance to the court, as it had “relied in part on New Jersey law [as set forth in Feldman v. Lederle Lab, 97 N.J. 429, 455 (1984) rev’d 125. N.J. 117 (1991); modified 132 N.J. 339 (1993)] in formulating the strict liability standard expressed in the Hayes decision.” Id.
The court therefore held that:
In recognition of the clear judicial trend regarding the duty to warn in products liability cases, and the principles stated in Restatement (Third) of Torts: Products Liability, supra at §2(c) and comment m, we hereby revise our law to state that a defendant will not be held liable under an implied warranty of merchantability for failure to warn or provide instructions about risks that were not reasonably foreseeable at the time of sale or could not have been discovered by way of reasonable testing prior to marketing the product. A manufacturer will be held to the standard of knowledge of an expert in the appropriate field, and will remain subject to a continuing duty to warn (at least purchasers) of risks discovered following the sale of the product at issue.
Id. at 22-23.Massachusetts thus adopted the approach as set forth in the Restatement, using an “expert-in-the-field” objective knowledge standard to determine a breach of the implied warranty of merchantability for failure to warn. Massachusetts already had in place an objective knowledge standard in negligence actions based on an alleged failure to warn. Mitchell v. Sky Climber Inc., 396 Mass. 629, 631 (1986). (Finding that in an action for negligence, “[a] manufacturer of a product has a duty to warn foreseeable users of dangers in the use of that product of which he knows or should have known.”); see also Morin v. Autozone Northeast Inc., 79 Mass. App. Ct. 39, 51 (App. Ct. 2011).
2. California: Strict Product Liability, Negligence,
and Breach of Implied Warranty of Merchantability
Unlike Massachusetts, California had adopted the requirement of objective knowledge of the relative scientific community similar to that stated in the Restatement several years prior to its publication for strict liability in tort. In Anderson v. Owens-Corning Fiberglas Corp.
In so holding, California “expressly applied to manufacturers of all products the same rule of strict liability for failure to warn of known or reasonably scientifically knowable risks that we previously applied specifically to manufacturers of prescription drugs.” Id. at 1009 (citing Anderson, 53 Cal. 3d at 1000). The publication of the Restatement, therefore, did not affect California law’s use of an objective knowledge standard on duty to warn in product liability cases.
California law also uses an objective knowledge standard in duty to warn cases based on the theory of implied warranty of merchantability. Harris v. Belton,
3. New York: Strict Product Liability, Negligence,
and Breach of Implied Warranty of Merchantability
The standard for a manufacturer’s duty to warn after the Restatement in New York is not as clear-cut as that of Massachusetts and California. Prior to the publication of the Restatement, the New York Court of Appeals stated that “a plaintiff may recover in strict products liability or negligence when a manufacturer fails to provide adequate warnings regarding the use of its product. A manufacturer has a duty to warn against latent dangers resulting from foreseeable uses of its products of which it knew or should have known.” Rastelli v. Goodyear Tire & Rubber Co., 79 N.Y. 2d 289, 297 (1992) (internal citations omitted). The objective knowledge requirement was in line with the recommendations of the Restatement.
Subsequent to the publication of the Restatement, New York confirmed that there was no foreseeability requirement for strict products liability. In 1998, the year of the Restatement’s publication, the New York Court of Appeals held that “[u]nder New York law, it is well settled that a … product may be defective by reason of a manufacturing flaw, an improper design, or a failure to provide adequate warnings for the product’s use … . [T]he manufacturer of a defective product engaged in its normal course of business may also be held strictly liable for injuries caused by a product, regardless of privity, foreseeability or the exercise of due care.” Gebo v. Black Clawson Co., 92 N.Y. 2d 387, 392 (1998) (internal citations omitted). This concept was further endorsed by the New York courts as recently as 2006. Plainview Water Dist. v. Exxon Mobil Corp., No. 009975-01, 2006 N.Y. Misc. LEXIS 3730, at *35 (N.Y. Sup. Ct. Nov. 27, 2006) (citing Sprung v. MTR Ravensburg Inc., 99 N.Y. 2d 468, 473 (2003)) (“[m]anufacturers of defective products may be held strictly liable for injury caused by their products—meaning that they may be liable regardless of privity, foreseeability or reasonable care”); see also Adeyinka v. Yankee Fiber Control Inc.,
New York courts continue to embrace an objective knowledge requirement for liability based on negligence or implied warranty theory. In order to bring a claim for negligence based on failure to warn, a plaintiff “must demonstrate that defendants knew or should have known the harmful character of the product without a warning. Whether the warning was adequate and whether defendants knew of the [product’s] dangerous nature without a warning is a question for the jury.” Bickram v. Case I.H.,
As you can see, the jurisdiction in which a claim arises has implications for the types of claims and the scope of evidence necessary to sustain a claim for failure to warn concerning a nanomaterial risk or hazard. In most cases, the basis for a court to adjudicate the issues of reasonable prudence, objective knowledge of risks, the knowledge of a particular scientific community, or the proof of a legal causal connection between risk and personal injury or property damage, will turn on expert testimony or scientific evidence. The threshold standard for the admissibility of expert scientific evidence is therefore of vital importance to assessing the viability of failure to warn claims.
III. Key State Law Nuances for Nanotechnology on Daubert Evidentiary Admissibility Standard
For approximately 70 years, or until 1993, the standard for the admission of scientific expert evidence was known as the Frye standard, as articulated in Frye v. United States,
When the question involved does not lie within the range of common experience or common knowledge, but requires special experience or special knowledge, then the opinions of witnesses skilled in that particular science, art, or trade to which the question relates are admissible in evidence. Numerous cases are cited in support of this rule. Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs.
The Frye standard thus required courts to determine whether a scientific “principle or discovery” was generally accepted within the relevant scientific community.
In 1993, the United States Supreme Court ruled in Daubert v. Merrell Dow Pharmaceuticals Inc.,
Just as with variations in the legal elements of failure to warn claims between states, not all states have followed the Daubert standard. Our sample nanotechnology jurisdictions are instructive.
A. Massachusetts
The Massachusetts Supreme Judicial Court has observed that Daubert set forth “five factors that a judge should consider in determining the reliability of proposed scientific evidence. The five factors are whether the scientific theory or process (1) has been generally accepted in the relevant scientific community; (2) has been, or can be, subjected to testing; (3) has been subjected to peer review and publication; (4) has an unacceptably high known or potential rate of error; and (5) is governed by recognized standards.” Commonwealth v. Powell, 450 Mass. 229, 238 (2007) (citing and explaining Daubert, 509 U.S. at 593-594).
Massachusetts adopted the Daubert standard in part in Commonwealth v. Lanigan, 419 Mass. 15, 24 (1994). However, the court “cautioned that `general acceptance in the relevant … community will continue to be the significant, and often the only, issue.’ ” Commonwealth v. Patterson, 445 Mass. 626, 640 (2005) (citing Lanigan, 419 Mass. at 26). “Lanigan’s progeny makes clear that general acceptance in the relevant community of the theory and process on which an expert’s testimony is based, on its own, continues to be predominant to establish the requisite reliability for admission of expert opinion in Massachusetts courts regardless of other Daubert factors. Where general acceptance is not established by the party offering the expert testimony, a full Daubert analysis provides an alternate method of establishing reliability.” Id. at 640-41 (internal citations omitted). See also Powell, 450 Mass. at 238; Commonwealth v. Sands, 424 Mass. 184, 185-86 (1997) (“a party seeking to introduce scientific evidence may lay a foundation either by showing that the underlying scientific theory is generally accepted within the relevant scientific community, or by showing that the theory is reliable or valid through other means.”).
B. California
California has not adopted the standard set forth in Daubert, using instead the Kelly-Frye or Kelly standard. See
People v. Venegas,
The Kelly-Frye standard is a variation on the Frye standard, and refers to the holding of People v. Kelly,
The court further held that “proof of a technique’s general acceptance in the relevant scientific community would no longer be necessary once a published appellate decision had affirmed a trial court ruling admitting evidence obtained by that scientific technique, `at least until new evidence is presented reflecting a change in the attitude of the scientific community.’ ” Id. at 545 (citing People v. Kelly, 17 Cal. 3d at 32). The Kelly-Frye standard was renamed simply the Kelly test in 1993, when the United States Supreme Court held in Daubert that the Federal Rules of Evidence had superseded Frye. Id.
C. New York
Like California, New York has also not yet adopted the standard set forth in Daubert. However, New York still utilizes the standard set forth in Frye. See Parker v. Mobil Oil Corp., 7 N.Y.3d 434, 447 n.3 (2006) (internal citations omitted) (“Although some amici urge the Court to adopt the federal standard (or some portions of it) as expressed in Daubert v. Merrell Dow Pharmaceuticals Inc. (requiring that scientific testimony be relevant and reliable in order to assist the trier of fact under Federal Rule of Evidence 702), the parties make no such argument and acknowledge that Frye is the current standard in New York.”); see also People v. Wernick, 89 N.Y. 2d 111, 115 (1996) (“[The New York Court of Appeals] has often endorsed and applied the well-recognized rule of Frye v. United States” (
While all federal courts must follow the Daubert standard, our sample nanotechnology jurisdictions demonstrate that there remains some variation in state law treatment of expert scientific evidence in all cases, including those for alleged failure to warn. All parties in the chain of distribution for nanomaterial-enabled products or nanomaterials themselves must be informed on the state of knowledge in the scientific community relevant to the specific nanomaterials they synthesize, handle or incorporate into their products.
An understanding of relevant test methods and data, familiarity with the medical, toxicological, and scientific literature, and the applicability of any governmental regulations or industry standards, will equip manufacturers with the tools that will potentially be used by scientific experts in future product liability litigation on the issues of breach of duty or product defect due to alleged failure to warn, and on the issue of causation between risk/hazard and alleged harm. All this information should be evaluated in assessing whether, when, and to what extent, labels, warnings or instructions should be issued for specific nanomaterials or nanomaterial-enabled products.
IV. Imposition of Duty to Label or Warn
by Statute, Regulation, or Industry Standard
The issue of warning and labeling concerning industrial and consumer products in the context of tort and warranty law has been the subject of much legal debate among jurists, legal commentators, and safety advocates over the last 80 years. It should come as no surprise that a fierce debate would follow the subject of the proposed labeling or warning concerning nanomaterial objects and products containing them. The debate over international labeling guidance for manufactured nano-objects, and products containing manufactured nano-objects, has been in development for the last few years. In 2010, a draft technical standard (DTS) that would offer “guidance” for labeling of manufactured nano-objects and products containing manufactured nano-objects was put up for a vote in early 2011 among member bodies of nanotechnology committees of both the European Committee for Standardization (CEN), CEN TC-352, and the International Organization for Standardization (ISO), ISO TC-229. The labeling guidance document was rejected by the vote, which suggests that much more work needs to be done on the scope and content of a proposed labeling standard or technical standard before it will be fully embraced by the international community.
Most recently, ISO released a new Technical Report, Nanotechnologies: Nanotechnology Risk Evaluation, ISO/TR 13121:2011. It sets forth a procedure “for identifying, evaluating, addressing, making decisions about, and communicating the potential risks of developing and using manufactured nanomaterials, in order to protect the health and safety of the public, consumers, workers and the environment.” The Technical Report is not an ISO Standard representing international consensus, or even a Technical Specification, which represents a particular technical committee’s consensus. A Technical Report is an informative document as opposed to a normative one, but it may be an important due diligence reference for all manufacturers of nanomaterial-enabled products or nanomaterials. Although the United States has thus far been hesitant to support sweeping international standards regulating the use, labeling, and warning of engineered nanomaterials in consumer products, should such a measure eventually pass muster in the international community, U.S. companies would be forced to comply if they wish to transact business overseas. As was the case with ISO 9000, complying with international standards is the cost of doing international business for many U.S. companies, even when those standards are much more onerous than those adopted here.
While some would argue that international standards are “voluntary” in terms of compliance, there can be no argument that U.S. law or federal regulations make compliance compulsory for regulated products manufactured, imported, distributed, or sold in the United States. As an example, a new federal bill seeks to reform and amend aspects of the Food, Drug, and Cosmetic Act of 1938 to require much greater regulation of cosmetic products manufactured, imported, distributed, and sold in the United States. The bill would require the detailed disclosure of ingredients, including nanomaterial ingredients and even contaminants from the manufacturing process or packaging at specified levels, that can be found in the final cosmetic products used by consumers. The disclosure would be required both on product packaging and by publication, and applies to in-store, professional salon and internet retail sales of cosmetics.
The Safe Cosmetics Act of 2011 (H.R. 2359) was recently introduced in the House of Representatives by Rep. Janice Schakowsky (D-Ill.) and several co-sponsors. The act includes a detailed scheme to require the Food and Drug Administration to obtain what may have traditionally been proprietary information from cosmetic manufacturers concerning the chemical ingredients and certain contaminants present in their products, and assess them for safety. The act contains a process for phasing out the use of substances that are either known to be or proven to be toxic, and making all product ingredient and contaminant information more available and transparent to consumers.
Although a comprehensive summary of the act’s provisions is beyond the scope of this paper, Section 613 is remarkable as it requires “that the label on each package of cosmetics … bears a declaration of the name of each ingredient in such cosmetic in descending order of prominence.” The act requires rulemaking by the FDA to establish requirements for listing ingredients on labels, how such labels are to be made for products that are too small in size to contain the required label or are sold on the Internet, and for public disclosure of the ingredients. The act specifically authorizes regulations by FDA for requiring nanomaterials labeling concerning “minerals or other particulate ingredients” as “nano-scale” on a cosmetic label if more than 1 percent of the ingredients in the cosmetic “are 100 nanometers or smaller in not less than 1 dimension,” or if such ingredients “possess scale-specific hazard properties.”
Any ingredient required by the act to be listed on a label would not be treated as a trade secret, and only “[t]he concentration of cosmetic ingredients used in a finished cosmetic shall be considered confidential business information and may not be made available to the public … .” These labeling requirements would become effective within 18 months of enactment of the bill, and would apply to all cosmetics available for retail sale, and to all manufacturers, distributers, and internet vendors of such cosmetics.
The act suggests that lawmakers may themselves be monitoring the international scientific data and policy debates concerning the presence of nanomaterials in certain types of products. All product manufacturers, importers, distributors, and retailers should monitor all legislative and regulatory activity in their respective industries as part of their ongoing due diligence and product risk assessment processes.
V. Warnings Development Process
Warnings can come in a variety of formats. From a safety perspective, the broadest definition of a warning is information about a negative consequence that has the potential to change the behavior of the exposed individual or organization that is capable of reducing exposure and preventing the warned-against behavior. Warning information should be developed utilizing a risk- and effectiveness-based analysis where the potential hazards and the ability to avoid those hazards are considered when determining if information should be contained in the warning. Today, there is often a secondary reason for the inclusion of warnings information, which unfortunately is not always based on a scientific analysis, but rather is an attempt to reduce legal exposure from failure to warn claims. This secondary motivation is even more compelling when the true risks of a product are yet unknown, or there is a lack of agreement in the scientific community as to the type and level of risks present with a product. This paper is an early attempt to authoritatively describe some of the forces driving the development of product warnings or labels for products incorporating nanomaterials, and to revisit an approach to the development of warnings or labels for nanomaterial products that is based primarily on a scientific process.
Given the projected growth of the nanomaterial industry and the wide-ranging applications, it is useful to separate the types of products into consumer and industrial classifications. When designing warnings, instructions, and labeling, it is important to consider who the likely users of the product will be, and the environment where the product will be used. In the case of an industrial product, a manufacturer can reasonably believe and contend the information in a properly designed and supplied material safety data sheet (MSDS) will be utilized in a proper HAZCOM program, and that the industrial employer will utilize this material and comply with other local, state, and federal regulations dealing with employee training, safety monitoring, and safety enforcement.
However, the same case cannot be made for the manufacture and sale of consumer products. When dealing with consumer products, a manufacturer must assume, especially for novel and new products, that the primary source of information a user may receive about unique hazards associated with its product will come from the manufacturer or from written materials provided by manufacturers of similar products. Given the wide disparity between environments, training, and supervision of the use of products containing nanomaterials in occupational and consumer products settings, the issues for each will be considered separately in the following sections.
A. Consumer Products
One of the most difficult issues facing producers of consumer products that include nanomaterials appears to be the general public’s lack of knowledge about what nanotechnology really is. Historically, human factors research dealing with risk perception has reliably demonstrated that a lack of knowledge or understanding of a technology has been shown to drive a fear-based assessment of risk in people, in effect driving the perception of risk to a higher level than that which is actually present. With nanotechnology, however, the public has favorable perceptions (Simons et al., 2009; Cobb and Macoubrie 2004; Bainbridge 2002), especially in the United States (Burri and Bellucci 2007; Priest 2006), and the general public anticipates that the benefits of nanotechnology will outweigh the associated risks (Priest 2006; Bainbridge 2002).
While perceptions of nanotechnology are generally positive, it has been noted that “because Americans lack specific information about nanotechnology, their opinions about it should be also sensitive to new information” (Cobb 2005, p. 223). The public’s perception of nanotechnology could become negative if news of risks becomes available (Simons et al., 2009; Priest 2006). Slovic (1987) reported that hazards that were not understood seemed more serious, and further, hazards that appeared to be out of the control of the user were rated as more severe. Regardless of whether the public’s perception of nanotechnology is positively or negatively biased, it is important that an objective scientific approach to warnings development be utilized to minimize the likelihood of fear-based risk assessment for nanomaterials.
From a human factors perspective, providing ambiguous information or information that cannot be utilized by the exposed individuals to reduce their risks will not increase the overall safety of the product, and, therefore, should not be included in on-product labeling. McCarthy et al. (1995) describes the risk-based approach to the development of consumer products warnings on labels. In the case of nanomaterials, or nanomaterial products, the approach that is utilized should not be any different just because the technology appears to be new and the potential hazards may be unique.
Given that it is currently accepted that encapsulated nanoparticles do not present a health risk, a product manufacturer should attempt to determine if the reasonably foreseeable uses and misuses of a product are unlikely to expose the user to free nanoparticles. If this is the case, then there would be insufficient scientific reason to warn a user concerning the presence of encapsulated nanoparticles. However, if a manufacturer has a reasonable expectation that a product will be either misused or that its normal use will expose a user to free nanoparticles, then the process would move to the next phase of evaluation. This would be the scientific determination of risk of injury due to the use of the product or the reasonably foreseeable misuse of the product. If it is determined that there is/are situation(s) that can create hazards associated with nanomaterials, then those hazards should be evaluated in comparison to the entire population of hazards associated with the product’s use and misuse.
It is well accepted that it is impossible to foresee every potential misuse or abuse of a product, and it is often not feasible or practical to attempt to warn about all known or foreseeable hazards. A process that has been described fully by McCarthy et al. (1995) recommends that the decision of when to warn needs to be based on consideration of both effectiveness and impact of candidate warning messages. That is, how likely is it that the presentation of the information in the warning will alter the safety-critical behavior and improve overall product safety? Products utilizing nanomaterials should not be given any different consideration when considering the use of product safety information.
Additionally, the nanomaterial-related warning information or labeling needs to be considered within the context of other hazards associated with the product. Care should be taken not to elevate nanomaterial-related warnings simply because they are novel. A reasonable process for a consumer product manufacturer to follow when developing safety-related warning or labeling information for their product would be:
- Determine what information is necessary to comply with any applicable regulatory guidelines,
- Identify residual hazards with the highest risk of injury,
- Determine which hazards or exposure modes contribute the greatest risk for the product, and
- Beginning with the highest-risk hazards, consider possible candidate or labeling warnings messages, keeping in mind the likely effectiveness of the candidate message to deter hazardous behavior or alleviate exposure to risk.
As this process applies to nanomaterials and consumer products, steps 2 and 3 rely on the underlying knowledge of health risks discussed earlier in this article. The risk-based prioritization of the hazards can be used to guide manufacturers as to which hazards they should warn or label about. Based on sound scientific principles, the process of determining warnings or labels for nanomaterial-related hazards should NOT be any different than warnings developed for other hazards.
B. General ANSI Standards Related
to Warning and Labeling
American Standards
In a products liability context, lawsuits alleging failure to warn or inadequate warnings are predominant in the United States. It is therefore increasingly important for manufacturers and workplace owners to comply with the current standards in product safety communications. The ANSI Z535 series of voluntary consensus standards provide guidance to manufacturers on the standardization of formatting of on-product labels, environmental safety signs, and collateral materials. This series of standards does not provide information about the content of safety-related messages or any criteria for when safety-related information is required. Additionally, manufacturers should not make the erroneous assumption that simply complying with the ANSI Z535 standards will guarantee user compliance, reduce risks, or improve product safety.
Although compliance with ANSI standards, including those regarding product warnings and labeling, is technically voluntary, in order to satisfy the legal duty to warn as a practical matter, manufacturers must meet or exceed industry standards. However, manufacturers must first ensure compliance with mandatory standards, which must take precedence over voluntary standards. Litigants and the courts often use the ANSI standards as a benchmark to determine whether a manufacturer has fulfilled its legal duty to warn. Therefore, after mandatory compliance considerations, manufacturers may wish to seek compliance with applicable ANSI standards to reduce the risks of potential litigation.
C. General International Standards
Related to Warning and Labeling
ISO Standards
While the voluntary ANSI standards are often a basis of the legal standard in the United States, for products being used abroad, manufacturers must comply with mandatory international requirements and safety label formats. The myriad languages used in international commerce, and the requirements to produce labeling text in the native language where the product will be sold, have led to attempts to utilize symbol-only safety labels for use on exported products. Similarly, the safety requirements for workplace owners in Europe and elsewhere also differ from Occupational Safety and Health Administration rules and other U.S. standards. It is therefore critical to meet current international safety label requirements, through ISO-formatted and harmonized safety labels. ISO 3864-2 sets forth the requirements for the design and coloring of safety labels and signs in the international arena so as to alert product users as to a specific hazard and to identify how it can be avoided.
Europe, in particular, requires compliant safety labeling in order to meet CE (“Conformité Européene”) marking requirements and pass inspection. When dealing with products or workplaces in both the United States as well as abroad, there is no single solution for these labeling requirements. Generally speaking, graphic-only, ISO-style labels do not comply with the recommendations in the ANSI Z535 standards. There are currently efforts being undertaken attempting to harmonize ANSI and ISO standards, but as of this writing, there is no single labeling guideline that will satisfy both ANSI and ISO universally.
D. General Industrial or Occupational
Warning Compliance and Assessment
If a company determines that there is a need to engage in voluntary compliance audits concerning workplace and product safety, they should be conducted periodically by a designated audit team that has a thorough knowledge of both health and safety statutes, regulations, industry standards, and company policies and procedures. The audit team members can change depending upon the operations being audited, and it should be staffed by individuals who will provide the team as a whole with expertise in the manufacturing and production processes, hazard monitoring and control procedures, and personal protective equipment. To the extent possible, the audit should simulate an actual OSHA inspection and include record review, facility walk-through, and employee interviews.
To ensure that the maximum benefits of an audit program accrue to an employer, it must be committed to immediately evaluating the audit findings and developing an action plan to address the findings. To the extent that it is feasible to take immediate action with respect to all hazards that are discovered, employers should do so and should document the remedial steps taken.
Where resources limit the ability to address all issues at once, the employer must establish priorities and should do so in the action plan. In determining priorities, the employer should consider hazard severity and frequency of exposure. The action plan should also include follow-up procedures to verify and evaluate the effectiveness of the corrective measures taken. Use of the self audit will permit employers to determine the state of their compliance and evaluate the safety of their workplace, the safety of their workers, and their financial risk of fines arising from citations and claims from compensable injuries to workers from unsafe conditions before it is too late.
VII. Conclusion
Regardless of the nature of the nanomaterials to be considered, prudence dictates that while the development of nanomaterial toxicity data concerning human health and the environment is an ongoing and dynamic process, all parties in the chain of nanomaterial product and nanomaterial distribution should undertake serial risk analysis and cradle-to-grave product risk assessment in order to decide whether the unique circumstances surrounding their products, at any given time, compel the development of safety instructions, labels, or product warnings as a means of promoting both consumer safety and risk management. The development of proper warnings and/or labeling is a multidisciplinary process that should include careful input from risk managers, engineers, industrial hygienists, toxicologists, and qualified legal counsel.
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