Signs of the Global Times

Coming soon to factory floors, laboratories, and store shelves: new labels for chemical products that will look similar throughout the world. There are standard symbols for properties such as flammability and corrosivity. And there are standardized cautionary statements, some of which differ from the ones used for years in the U.S.

The new labels are part of the Globally Harmonized System (GHS) for the classification and labeling of chemicals. It's designed to protect human health and the environment and to facilitate international trade in chemicals.

GHS had its genesis at the 1992 Earth Summit, held in Rio de Janeiro. In Agenda 21, an Earth Summit agreement intended to steer the world toward sustainable development into the 21st century, governments pledged to come up with GHS for chemicals. The initial goal was for countries to develop such a system and have it in place by 2000.

Governments have been working together over the past decade to flesh out details of GHS. But, as with many other voluntary international efforts, the deadline for implementation has slipped. The new global goal is to have as many nations as possible in compliance with GHS by 2008. Still, many countries are beginning to adopt GHS.

U.S. chemical companies generally are eager for the U.S. to implement this international system because it can drive down the cost of labeling and improve the movement of chemicals internationally. One notable exception is the U.S. agricultural pesticide sector, which doesn't want GHS to apply to pesticides sold domestically.

For the U.S. to implement GHS, four federal agencies must change their regulations: the Department of Transportation's (DOT) Pipeline & Hazardous Materials Safety Administration, the Occupational Safety & Health Administration, the Environmental Protection Agency, and the Consumer Product Safety Commission (CPSC).

Though the agencies are in contact on the issue, they are at widely varying stages of rule-making. No single office coordinates GHS implementation in the U.S. government. Meanwhile, companies can't just voluntarily adopt GHS. If they did, they would violate existing federal regulations.

One of the biggest challenges that GHS will present to U.S. companies that make commercial chemicals or consumer products is use of symbols rather than words to describe hazard and risk. Symbols are widely used to communicate hazard in places such as Europe, where many languages are spoken, or in countries with low literacy rates.

GHS includes a uniform system for classifying chemicals according to the hazards they pose. Each hazard class has a pictogram. The diamond-shaped GHS pictograms for communicating hazards in the workplace or to consumers are black symbols on a white background with a red border.

SYMBOLS USED on the pictograms range from the almost universally recognized emblem of acute toxicity--a skull and crossbones--to new ones that at first can appear confusing. For example, a silhouette of a human head and trunk with a sort of a star imposed over the upper chest warns of chronic toxicity hazards. Types of chronic toxicity flagged by this symbol can range from cancer hazards to reproductive problems.

Pictograms for hazardous materials transportation differ slightly--they contain the same black symbols but on colored backgrounds. These pictograms, developed a decade ago in a United Nations effort on transportation, are already in use in much of the world, including the U.S.

U.S. industry has been resistant to the use of symbols to warn workers and consumers, says Robert J. Kiefer, director of international affairs for the Consumer Specialty Products Association. But companies realize that they will have to embrace pictograms to participate in the global marketplace, he says. And both federal officials and industry representatives note that U.S. workers and consumers alike will need educating about the meaning of the symbols.

Industrialized countries, including the U.S., that already have a chemical regulation system in place face a more difficult task in switching to GHS than will developing nations, says Jennifer C. Silk, deputy director of OSHA's Directorate of Standards & Guidance. Developing countries that have no labeling or material safety data sheet (MSDS) requirements can adopt GHS fairly easily. In the U.S., "we have to retrofit it to a very complicated regulatory structure," she says.

DOT is the part of the federal government that is furthest along in aligning its regulations with GHS. It has made good progress because GHS provisions governing the transportation of hazardous materials are based on the UN Recommendations on the Transport of Dangerous Goods. DOT adopted the UN recommendations into its regulations during the 1990s. Therefore, its current regulations are very similar to GHS standards.

GHS uses the same transportation pictograms as the UN scheme's placards. However, GHS differs from the UN recommendations in its criteria for classifying the physical hazards of toxic materials and flammable liquids. For instance, the flash point for defining what constitutes a flammable liquid differs slightly in the two systems.

Higher-ups at DOT forbade officials working on GHS to speak on the record with C&EN. However, the department's website notes that the Pipeline & Hazardous Materials Safety Administration plans to adopt parts of GHS that are different from current regulations based on the UN recommendations, including the criteria for classifying hazards. DOT hopes to have these changes in place by Jan. 1, 2007, according to the website. The department says it plans to allow a one-year transition period for industry to comply with the new rule.

The other three federal agencies with responsibility for implementing GHS have much larger challenges than DOT, and whether they will be able to meet the 2008 target remains to be seen. OSHA, EPA, and CPSC are aiming for 2008, but, unlike DOT, they are not committed to firm deadlines.

OSHA's task is to revise its hazard communication standard. This will be "a major rule-making," Silk says, and will have its biggest impact on chemical manufacturers.

The hazard communication standard, which was issued in 1983, is aimed at ensuring chemical safety in the workplace and sets requirements for makers and users of hazardous substances. It covers about 650,000 products found in more than 3 million U.S. workplaces.

The standard requires chemical manufacturers and importers to evaluate the hazards of their products and then prepare labels and MSDSs to convey these hazards to downstream customers. Employers with hazardous substances in their workplaces must train workers to handle these chemicals appropriately. Employers must provide exposed workers with labels and material safety data.

THE CRITERIA for evaluating hazards are different under the OSHA standard than under GHS, Silk says. For instance, a chemical either meets the definition of a carcinogen under the OSHA hazard communication standard or it doesn't, she explains. GHS, instead, differentiates between chemicals classified as carcinogens based on evidence in humans versus those classified based on data from laboratory animals. When the U.S. implements the global system, chemical makers will have to reevaluate their products in light of GHS criteria and craft new labels and MSDSs, she says.

OSHA has never required symbols to communicate to workers the hazards of chemicals, Silk says. Companies that make chemicals as well as businesses that use them will have to teach their employees what GHS pictograms mean, Silk says.

EPA also faces a large regulatory effort to implement GHS. The agency believes implementation of GHS means that companies will have to change labels on all 22,000 currently registered pesticides, says Mary Frances Lowe, senior program adviser at EPA's Office of Pesticide Programs. The simplest alteration a company might make is changing the current black border around the skull-and-crossbones symbol to red on a pesticide's label, she says. Other changes may include rewording the label.

In some cases, EPA's regulations require the same phrase that GHS requires, such as "causes skin irritation." But EPA's current "causes substantial but temporary eye injury" would become "causes severe eye irritation" in the new system. Lowe says, "It conveys the same thing in words that people will understand."

The challenge is that EPA must approve any change to any pesticide labels. So the agency is working with industry to devise a plan to minimize the expenditure of resources by companies and EPA to implement GHS, Lowe says.

In 2004, the agency issued a white paper describing how it might implement GHS, and it is now examining the public comments it received. Lowe says the agency is planning to hold a public meeting later this year to discuss with stakeholders--primarily the agricultural pesticide industry--the various options for adopting the global system.

One option is to require companies to switch to GHS whenever they request a label change for a pesticide, Lowe says. Companies regularly update pesticide labels with revised first-aid information or worker protection statements. Moving to GHS during these periodic label changes might minimize the impact on EPA and companies of implementing the new system. This would stagger the effect of implementation, she says.

Some companies, however, are concerned about this option, Lowe says. They fear that if they change a product's label to a more stringent GHS warning than the current system, and if a competitor does not alter its labels, they'll be at a disadvantage.

Another option is for a separate approval process for switching pesticide labels to GHS, with a deadline, Lowe says.

The agency expects there to be a transition period when both the current labeling system and GHS will be in use, she adds. There may need to be a date after which all new production of pesticides must carry GHS labels.

Lowe stresses that EPA is not contemplating product recalls or requiring new stickers to be placed on labels as part of GHS implementation. Furthermore, the agency does not intend to require pesticide makers to label products for chronic effects but rather will stick with its current scheme of warnings about acute effects, she says.

The U.S. agricultural pesticide industry recently decided to oppose GHS implementation by EPA for pesticide labeling.

"EPA has not made a case for GHS for the regulation of pesticides," says Ray S. McAllister, regulatory policy leader for the industry group CropLife America. Unlike commodity chemicals or consumer products, pesticides bear labels that are highly specific to the country in which they are used, he explains. This is in part because of differences in crops, farming methods, and climate.

"We're not going to get a trade benefit, and we're not going to get a health benefit" from switching pesticides labeled for U.S. use to GHS, McAllister says, adding that a changeover would be "significant and expensive."

In addition, GHS standards may force U.S. pesticide labels now bearing the word "caution" to use the term "warning," which indicates greater risk, he says. This could hurt sales of products that have been used safely for years because some local governments and school systems have a policy of not purchasing pesticides that bear "warning" on their label, McAllister says. Alternatively, companies would have to conduct additional tests on existing products--studies not required by EPA regulations--to show that the pesticides deserve the "caution" designation.

"We need to keep talking," Lowe says.

Makers of nonagricultural pesticides, including EPA-registered antimicrobials such as sanitizers and disinfectants, are supporting the switch to GHS. Lowe notes that these products, such as toilet bowl cleaners, generally involve the same terms of use regardless of what country they're used in. Thus, their labels show less variation than those used on agricultural pesticides shipped around the world.

Kiefer of the Consumer Specialty Products Association notes that Canada, Mexico, and the U.S. are working under the aegis of the North American Free Trade Agreement to coordinate their application of GHS to nonagricultural pesticides.

CPSC'S PLANS for implementing the global system are not clear. Repeated phone calls over a week's time from C&EN to the agency about GHS went unanswered. In contrast to DOT, EPA, and OSHA, the agency's website contains no information on the global system.

Kiefer says CPSC seems to lack the staff and other resources needed to adopt GHS, adding that industry hasn't heard much from the agency.

But several trade groups are eager to work with CPSC on the global labeling scheme. Richard I. Sedlak, the Soap & Detergent Association's senior vice president for technical and international affairs, says industry wants the U.S. to retain its unique regulatory approach for consumer products, which is based on risk.

Under GHS, countries can choose to label consumer products using either a hazard- or a risk-based system.

Retaining CPSC's risk-based scheme is important not just for the U.S. market, Sedlak and Kiefer say, but to show other countries how they, too, can adopt risk-based labeling for consumer goods. Thus, companies wouldn't have to come up with both risk- and hazard-based labels under GHS. Industry opposes hazard-based labeling because manufacturers ultimately could be placing so many warnings on products that consumers may not be able to differentiate the degrees of hazard posed by the chemicals, Kiefer says.

In addition, Kiefer and Sedlak say they want the U.S. to be a world leader in implementing GHS for consumer goods. "Canada is the one out in front right now" on this issue, Kiefer says.

Except for agricultural pesticide producers, most of the U.S. chemical sector is pushing for a domestic switch to GHS. Michael P. Walls, managing director of health, products, and science policy at the American Chemistry Council, says U.S. implementation of GHS "is something we really want." Because the U.S. is a major player in the global chemical market, ACC wants to ensure that the U.S. regulatory system conforms as much as possible to that of other countries. "It's critical that the U.S. not be left behind" in global adoption of GHS, Walls says.

"Obviously there are advantages to doing this, tremendous advantages," Kiefer notes. "There will be some short-term costs, because every label will need to be changed," he acknowledges. But the benefits will far outweigh the costs, he says.

Sedlak says large companies that sell across national boundaries are looking for a harmonized labeling system. They want to be able to use the same label on their products in all their markets, differing perhaps only in what language its words are in.

Industry groups are worried about how U.S. agencies are progressing on adopting GHS, which is not required by statute or court order.

The agencies working on GHS need an overarching plan to meet the 2008 deadline, Walls says. Kiefer says industry organizations are working together to ask the Bush Administration to coordinate GHS implementation among the four agencies. About a dozen U.S. trade groups are drafting a formal request to the President's Council on Environmental Quality to spearhead that coordination.

"They need to be synchronized," Kiefer says, or else business "could have disruption in the market."