WARNING: By Jonathan R. Cooper and Arun J. Kottha Conflicting Issues Regarding Warning Labels May Be Hazardous to Your Company’s Health

Until recently, a properly crafted nal words and message panels and apply based labels alone. See id. NEMA members them on a case-by-case basis; or maintain developed the now-­famous pictorial im- safety warning seldom inter- one set of American National Standards age, “Mr. Ouch,” and they ex- Institute-­style warnings for the US mar- tensively tested it with PRODUCTfered LIABILITY with the salability of a ket and another set of pictograms for the children of several eth- European market. None of these solutions nicities aged 2.5–6.5 product. The 2006 European is attractive. All are potentially costly. years. The Mr. Ouch im- But, this is not merely a financial deci- age ranked the highest in Union Machinery Directive (EUMD), sion. The different warning schemes put to- “every major category relative to depicting which was ratified by the European Union’s gether by the American National Standards a threat and inducing a safe response.” Id. member countries last year, will likely Institute on the one hand and the Interna- The beauty of Mr. Ouch was that it greatly interfere with salability. Many U.S. tional Organization for Standardization on worked. The testing demonstrated that manufacturers sell products in both the the other are both designed to promote and people, including children, recognized the United States and the European Union. to enhance the safety of products. These symbol and understood the information Most of those products are festooned with schemes premise is that uniform formats necessary to avoid harm. From a prod- warning labels both to prevent accidents will enhance readability, and hence, compli- uct liability standpoint, manufacturers and to avoid liability. Warning labels are ance. See ISO 3864-2:2004 & ANSI Z535.4- could prove that they had used effective expensive. They must be designed, manu- 2007, §2.2. Instituting new requirements warnings. This not only improved safety, factured, and applied. They are made from may interfere with that overarching goal. it also improved a manufacturer’s ability special plastic that will withstand harsh to defend its products. Mr. Ouch was the environments. Manufacturers must take A Brief History of the Standard first standard pictorial warning adopted care to affix them to products properly and Pictorial Warning Label by an industry. in the right places. The story of standardizing modern pic- Manufacturers have been able to design torial warning labels begins with the Na- ANSI product warnings for products bound for tional Electrical Manufacturers Association Short of a survey, manufacturers typically both the United States and the European (NEMA). Confronted with rising levels of rely on compliance with “consensus” stand- Union that have harmoniously met US “failure to warn” allegations involving elec- ards promulgated by bodies that draw their standards and EU standards. The EUMD trical equipment in the early 1980s, NEMA’s standards committees from more than one threatens that ability. If the EUMD is fol- members set out to develop a warning label. sector of society. In the United States that lowed to the letter, every warning on every Kenneth Ross, The Story of ‘MR OUCH’, Cre- has often meant standards promulgated by product destined for an EU state must con- ation of a Warning Label, Product Liability the relevant committee of the American sist of a pictogram, or if a product contains Int’l, October 1983 at 152–54. Although National Standards Institute (ANSI). ANSI written warnings, warnings translated into their electrical equipment was generally oversees the creation, promulgation, and the official language of the country for locked, tampering by vandals led to serious use of thousands of norms and guidelines which a product is bound. This leaves a injuries when children explored the interior that directly impact businesses in nearly manufacturer with four choices: ignore US of equipment. Id. To combat failure to warn every sector of the U.S. economy. Amer- warning standards and risk liability for claims, manufacturers needed to develop ican National Standards Institute, About insufficient warnings; ignore the EUMD warning labels effective for young children ANSI Overview, http://www.ansi.org/about_ and risk product rejection in the European who either could not read or who could not ansi/overview/overview.aspx?menuid=1 (last vis- Union; draft multiple translations of all sig- grasp the severity of danger from language-­ ited Feb. 13, 2011).

■■ Jonathan R. Cooper is a partner and Arun J. Kottha is an associate in the Cleveland office of Tucker Ellis & West LLP. Mr. Cooper is a trial lawyer whose practice focuses on the defense of product manufacturers in- cluding the national and regional defense of manufacturers of material handling, automation, and electri- cal products. Mr. Kottha focuses his practice on business litigation and mass tort and product liability. Prior to becoming an attorney, he was a licensed ISO auditor, and audited a variety of manufacturing facilities in the Midwest and Eastern Seaboard for compliance with the ISO 9001:2000 quality management standard.

36 n In-House Defense Quarterly n Spring 2011 © 2011 DRI. All rights reserved. In the case of warnings, the relevant Complying with ANSI Z535 also offers (2) a red circle with slash, which signals a standard since 1991 has been ANSI Z535. a manufacturer an advantage in litigation. prohibition; or (3) a blue The ANSI Z535 standards were designed to Complying with ANSI Z535 allows a man- circle, which signals a create something that worked as Mr. Ouch ufacturer to argue that it fulfilled its duty mandatory action. had worked. The mantra of the ANSI warn- to warn by following the relevant consen- ISO 3864-2:2004, §6.2. ing system is threefold: (1) alert a user to sus standard. Inside each type of sign the danger, (2) inform the user of the sever- a pictogram depicts a ity of the danger, and (3) instruct the user ISO hazard, an action, or an instruction. The how to avoid the danger. This is accom- While the ANSI committees were honing most familiar example is the no smoking plished by combining symbols, colors, and the ANSI Z535 standards, the International “prohibition” sign. The ISO 3864-2 system mandatory warning language. Organization for Standardization (ISO), uses three basic colors as signals for the The stated purposes of ANSI Z535 are based in Geneva, Switzerland, was devel- severity of harm a person would encoun- (1) to establish a uniform and consistent oping its own standard, using different ter: red for high, orange for medium, and visual layout for safety signs and labels concepts. While the ANSI standards were yellow for low. Id. at §4.3. So-called “sig- applied to a wide variety of products; (2) to based on safety symbols, signal words, and nal words” can be associated with each minimize the proliferation of designs for message panels, the ISO created a symbol-­ level of severity: “danger,” “warning,” and product safety signs and labels; and (3) to based system. “caution,” respectively. Id. at §5.3. Each of establish a national uniform system for the ISO is the world’s largest developer and the three levels of severity has an equilat- recognition of potential personal injury publisher of International Standards. A eral triangle surrounding an exclamation hazards for those persons using products. non-­governmental organization, ISO is a ANSI Z535.4-2007, §2.2. network of the national standards insti- Table 1—Official European There are four levels of severity denoted tutes of 161 countries, with a Central Sec- Union Languages by capitalized “signal words” that have cor- retariat in Geneva coordinating the system. Austria — German responding colors: “DANGER,” in white International Organization for Standard- Belgium — Dutch, French, German http://www.iso.org/iso/ letters with a red back- ization, Discover ISO, Bulgaria — Bulgarian about/­discover-iso_how-the-iso-system-is-man- ground; “WARNING,” Cyprus — English, Greek aged.htm in black letters with an . A host of information about ISO Czech Republic — Czech www.ISO.org orange background; can be found on its website, , Denmark — Danish “CAUTION,” in black and copies of all referenced ISO stand- Estonia — Estonian letters with a yellow ards can be purchased online as well. Finland — Finnish, Swedish background; or “NOTICE,” in white letters ANSI is the official US representative to France — French with a blue background. Id. at §§5.1, 7.2. A the ISO. American National Standards Germany — German http://www. “safety symbol,” an equilateral triangle Institute, Introduction to ANSI, Greece — Greek ansi.org/about_ansi/­introduction/­introduction. surrounding an exclamation point, accom- Hungary — Hungarian aspx?menuid=1 panies all of these signal words. . According to ISO 3864-2, Iceland — Icelandic A product safety sign or label consists which establishes principles for design- Ireland — English, Irish of a signal word panel, noted above, plus a ing product safety labels, the purpose of a Italy — Italian mandatory “message panel,” which com- product safety label is to alert persons to Latvia — Latvian municates the type of hazard, the conse- a specific hazard and to identify how they Liechtenstein — German quence of failing to avoid the hazard, and can avoid the hazard. ISO 3864-2:2004, Lithuania — Lithuanian how to avoid the hazard. Id. at Annex B. Graphical Symbols—Safety Colours and Luxembourg — French, German ANSI-style warning standards have a num- Safety Signs—Part 2: Design Principles for Malta — English, Maltese http://www.iso.org/ ber of specific instructions regarding font, Product Safety Labels, The Netherlands — Dutch iso/iso_catalogue/­catalogue_tc/­catalogue_detail. alignment, and other physical character- Norway — Norwegian htm?csnumber=31020 istics of the language used on a message . In short, the ISO and Poland — Polish panel, in addition to grammatical instruc- the ANSI have similar goals—to establish Portugal — Portuguese tions, such as avoiding passive voice and uniform systems so that users and oth- Romania — Romanian prepositional phrases. Id. ers have information about hazards, their Slovakia — Slovak The idea is that any person could, with a severity, and how to avoid them. The major Slovenia — Slovenian quick look, know what sort of trouble was difference is the method that each system Spain — Spanish ahead, what might happen, and how to avoid uses to attempt to achieve its goals. Sweden — Swedish the trouble. Manufacturers in the United To comply with the ISO regulations, Switzerland — French, German, Italian States have now spent a little over a gener- businesses must use at least one of three Turkey — Turkish ation teaching users and consumers to rec- types of “safety signs”: (1) an equilateral United Kingdom — English ognize and interpret ANSI-style warnings. yellow triangle, which signals a warning;

In-House Defense Quarterly n Spring 2011 n 37 point in the appropriate color, and together, ing safety labels to specific situations than It is possible to harmonize the ISO and they form a “hazard severity panel.” Using the ANSI system. In contrast, the ANSI the ANSI standards into a single “hybrid” signal words or a hazard severity panel is system is more concerned with standard- label. An ISO-­ANSI-­hybrid warning label not mandatory, however. Id. at §5.1 (“If ization. ANSI’s theory is that although a would have an ISO image accompanied by the level of hazard severity is to be indi- manufacture may not adapt a warning may an ANSI-­compliant message panel and sig- cated…”). Stated differently, each label to each unique situation, workers will be nal word. This would ostensibly satisfy the “shall be comprised of one or more safety safer because they become conditioned to visual ISO requirements and supply the signs,” and can be “accompanied by a haz- respond to the same signal words and warn- required text of the ANSI requirements. ard severity panel.” Id. at §6.1. Finally, This solution is not perfect. The ISO sys- a manufacturer has the option of add- n tem doesn’t require language at all in either ing “supplementary safety information a “hazard severity panel” or “supplemen- PRODUCTtext,” LIABILITY which can include warnings such as, Manufacturers in the United tary safety information text,” and if a man- “ELECTRICAL HAZARD—Contact with ufacturer does choose to exercise such Water Can Cause Electrical Shock.” Id. at States have now spent a little an option, the ISO standards do not offer §§3.15, 6.1. Using these language-­based guidance on the language a manufacturer warnings, as with signal words, is volun- over a generation teaching should use. Moreover, the colors and color tary. Id. at §6.1. schemes of the ISO and the ANSI standards users and consumers to differ slightly. For example, including an How Do ISO and ANSI ANSI-­compliant message panel for a par- Standards Differ? recognize and interpret ticular risk severity would not adhere to the The ISO warning standards rely more ISO color standard. However, the “hybrid heavily on images than the ANSI warning ANSI-style warnings. label” described above very nearly would standards. In fact, an ISO warning can be comply with both standards. exclusively visual, without words at all. In n contrast, the ANSI standard mandates both Enter the New European Requirements a “signal word” and a “message panel” that ing style so that they heed warnings when Harmonizing ISO and ANSI warnings may provides necessary information to a user they are exposed to them year after year. be for naught due to the European Union of a product. Neither the ANSI nor the ISO There is a great deal of debate in the scien- Machinery Directive (EUMD). A manufac- warning schemes has the force of law. The tific community about whether warnings turer selling a product in Europe will now inconsistency between the two systems can are effective in changing behavior. That de- need to comply with this new law, which create potential litigation problems and pos- bate extends to whether the ANSI and the introduces yet a third set of requirements sible safety issues. If a manufacturer, adher- ISO formats increase user safety compli- for approved warnings, unless the EUMD ing to the ISO standard, exports its products ance. A recent study found that the ANSI is modified. to the United States, it risks liability based and the ISO formats did not result in sig- The EU Parliament has power to legislate upon failure to warn. The liability stems nificantly greater safety compliance than “directives” and “regulations.” Both have from failing to produce warnings adher- messages that did not follow a particular the force and effect of law. Regulations are ing to the relevant US standards. format. Eric F. Shaver, et al., Comparison of self-­executing, and they are effective and In addition, the goals of the two systems, ISO and ANSI Standard Formats on People’s binding on the member states automati- while similar, are not exactly the same. The Response to Product Warnings, Proceedings cally and immediately. Individual member ISO’s goal is “to alert persons to a specific of the Human Factors and Ergonomics So- states do not ratify them on a country-­by-­ hazard and to identify how the hazard can ciety at 2197–2201 (2006), http://www.hfes. country basis although they are sovereign be avoided.” ISO 3864-2:2004, http://www. org/publications/ProductDetail.aspx?ProductId=79, nations. Once the EU Parliament approves iso.org/iso/iso_catalogue/catalogue_tc/catalogue_ accessed 1/19/2011. Reading the study did or “ratifies” a directive, each member state detail.htm?csnumber=31020. The ANSI’s goals show that US residents were more likely must still enact country-­specific legislation. are “(1) to establish a uniform and consis- to comply with an ANSI-­formatted warn- Each member state may tailor a directive to tent visual layout for safety signs and labels ing than an ISO-­formatted warning even its particular needs as long as its version applied to a wide variety of products; (2) to though the ISO warnings contained a sig- remains aligned with the spirit of the direc- minimize the proliferation of designs for nal word and a message panel. Id. at 2199. tive. And directives generally set forth a product safety signs and labels; and (3) to Using ISO-style warnings in the United series of goals and assign a date by which establish a national uniform system for the States or ANSI-style warnings in Europe each member state must enact legislation recognition of potential personal injury would probably have safety consequences. If to its effect. For example, the EU Parlia- hazards for those persons using products.” the goal of each warning system is to provide ment enacted EUMD in 2006 and estab- ANSI Z535.4-2007, §2.2. a uniform system to provide readily under- lished that individual member states would The ISO system is less concerned with standable access to safety information, using enact country-­specific legislation by June variation and more concerned with adapt- a different system would seem contradictory. 29, 2008, which would take effect Decem-

38 n In-House Defense Quarterly n Spring 2011 ber 29, 2009, at the latest. 2006/42/EC, Art. community languages of each EU member product, a warning label in all of the com- 26, ¶1, http://eur-lex.europa.eu/LexUriServ/site/ state. So to comply with the EUMD and with munity languages, which is extremely dif- en/oj/2006/l_157/l_15720060609en00240086. the ANSI and ISO standards now requires ficult. Moreover, the EUMD requires that a pdf (last visited Jan. 18, 2011). Each Euro- translating signal words and the message warning “accompany” a product. 2006/42/ pean Union member state has now enacted panels into multiple languages. EC, Annex I, §1.74. It is not clear that EUMD country-­specific legislation. directing a buyer or user to a website would The EUMD is applicable to (1) ma- Harmonizing US and European satisfy that requirement. chinery; (2) interchangeable equipment; Requirements: What Do We Do? A third possibility is to use an entirely (3) safety components; (4) lifting accessories; After ratification of the EUMD, designing pictorial ISO warning in the United States (5) chains, ropes, and webbing; (6) remov- one warning label that would pass mus- and the European Union. However, such able mechanical transmission devices; and ter in both America and Europe may be a plan creates risk if someone using a (7) partly completed machinery. 2006/42/ impossible. The main problem is the lan- product in the United States is injured. If EC, Art. 1, ¶1. There are a number of items guage requirement of the EUMD, which someone is injured, that person’s attorney excepted from the EUMD: site hoists; weap- requires translating all text in warning will argue that the manufacturer failed ons; devices for lifting personnel; consumer labels into over 20 languages. It appears to effectively warn because the manu- products; certain farm tractors; electri- that the only clear way to comply with facturer failed to comply with the ANSI cal equipment, including a variety of items the directive’s language requirements is standards’ text requirement. All of these from consumer electronics to high-­voltage to use no language at all! However, that options might potentially address the reg- switchgear; certain safety devices; vehicles warning would then fail to comply with ulatory structure anomalies, but they all for transport of persons and cargo, land, sea, ANSI Z535.4, and its effects on safety are have drawbacks. and air; machinery for “nuclear purposes”; unknown. The overarching concern with these military equipment; and a variety of highly Manufacturers have limited options to warning standards is worker safety. Attor- specialized machines. Id. at Annex I, §1.7. solve this problem, and none is ideal. The neys can advise clients of the best way Section 1.7 to annex I, entitled “informa- first option is to simply issue different to prevail in a lawsuit, but it is far better tion,” deals with warnings and accompany- warnings: use ANSI standards for the US- to avoid lawsuits in the first place and to ing instructions. The Machinery Directive bound products and wordless, ISO-based promote safety as a company policy. The explicitly states a preference for pictorial-­ warning labels for products sold in Europe. premise of the ANSI and the ISO warn- based warnings, presumably due to the di- This possibility precludes using a universal ing systems is to present information to versity of languages spoken in the European warning label and increases costs because a user quickly: a worker reads the word Community. In fact, a manufacturer will need to design and “Danger,” in a certain recognizable format written or verbal information and warn- implement two warnings regimes, engage that he or she has seen hundreds of times ings must be expressed in an official workers to install the warnings, and engage because the same scheme is used on every Community language or languages, inspectors to ensure that labelers use the product. That worker knows that injury or which may be determined in accordance proper warnings. Another possibility is to death can result from failing to follow the with the Treaty by the Member State in use an ANSI-­compliant warning for a prod- label instructions. While the research on which the machinery is placed on the uct for distribution across continents and the effectiveness of ISO and ANSI warn- market and/or put into service and may offer a subsequent European purchaser a ings shows that neither truly effectively be accompanied, on request, by versions way to obtain language translations, per- changes user behavior when compared to in any other official Community lan- haps through an automated website that user behavior when they confront nonstan- guage or languages understood by the would send translated warnings to any- dard labels, adding a third scheme without operators. one who provides a serial number. This a scientific basis certainly will not advance 2006/42/EC, Annex I, §1.7. methodology, though, does not solve the the cause of safety. Shaver, n.23, supra. In short, a manufacturer must translate problem by permitting a manufacturer to If the EUMD precipitously changes how warning label text into the official language retain one universal warning label, and in workers comply with label warnings com- or languages, if more than one, of the mem- fact, it requires maintaining warning labels pared to how they complied with the labels ber state in which a manufacturer places it. in myriad languages at increased cost. In that manufacturers have used for 30 years, If a manufacturer sells a product to an entity addition, it underscores the main problem labels that they have used to teach work- near a border, the languages can multiply. with the Machinery Directive: to comply ers about safety for those past 30 years, Table 1, Official European Union Coun- with the strict letter of the EUMD, a man- shouldn’t the EUMD have included some try Languages, on page 37, lists the official ufacturer must keep on hand, or affix to a effort to advance safety?

In-House Defense Quarterly n Spring 2011 n 39