Date: Feb 10, 2005
"Harmonization" is the term commonly used to define government efforts to replace divergent international regulatory policies with uniform global standards. Webster's Dictionary defines the term, in part, as a "pleasing combination of elements in a whole." At bottom, businesses that ship product to multiple jurisdictions benefit from the harmonization of international chemical laws. It is unclear, however, whether industry or EPA will significantly benefit, or find a "pleasing combination," in the application to pesticides of the "Globally Harmonized System of Classification and Labeling of Chemicals" (GHS), a scheme that would require significant changes to the labels of registered pesticide products.
What is the GHS?
The GHS classifies chemicals according to their hazard and creates a labeling system that largely communicates hazards through pictograms. The GHS, developed by the United Nations Economic and Social Council Subcommittee, is a voluntary system that does not impose binding treaty obligations on countries. However, EPA has expressed plans to implement the GHS for all pesticide products by 2008. 69 Fed. Reg. 52262 (August 25, 2004). OSHA, DOT and the CPSC also are considering how to implement the system. Significantly, for EPA to implement the GHS, it must undertake the rulemaking process and revise its pesticide labeling rules at 40 C.F.R. part 156.
How Will the GHS Impact Pesticides?
GHS implementation affects pesticide regulation in two primary areas: First, it changes labeling by requiring (1) new pictograms illustrating the hazards of a pesticide (e.g., skull and crossbones in a red diamond); (2) more conservative precautionary statements and signal words; and (3) the listing of certain inert ingredients that contribute to the hazard of the product. Second, the GHS will change EPA's existing hazard classification categories. For example, for acute toxicity hazards, the GHS imposes new LD50 thresholds and toxicity categories.
The GHS addresses physical hazards (e.g., flammability, explosivity, oxidizers, and metal corrosives), health hazards, and aquatic toxicity. Health hazards include acute toxicity, skin corrosion/irritation, serious eye damage/eye irritation and sensitization. Although the GHS addresses chronic hazards (mutagenicity, carcinogenicity, reproductive toxicity), EPA does not plan to adopt this part, as existing pesticide labels do not address these hazards.
The addition of new pictograms is significant. GHS pictograms are composed of a symbol surrounded by a red diamond-shaped border. Symbols include skull and crossbones for certain acute hazards, a dead fish and tree symbol representing aquatic toxicity, and a variety of symbols illustrating physical hazards such as explosivity (an exploding bomb), flammability (a flame), and corrosion (a corroded surface and hand underneath a beaker). It will take time for consumers and users to understand these new pictograms; further, the symbols are multi-colored, and therefore more expensive to print.
With respect to health hazards, the GHS specifies five acute toxicity categories (as opposed to four under FIFRA), but uses the same classification criteria (LD50 or LC50 values). Generally, the GHS criteria are more conservative. For example, EPA uses the "Danger" signal word and skull and crossbones symbol for chemicals in Categories I and II (e.g., oral LD50 of up to 50 mg/kg) while the GHS uses the "Danger" signal word and skull and crossbones symbol for chemicals in Categories 1-3 (e.g, oral LD50 of up to 300 mg/kg.). Notably, the GHS eliminates the use of the signal word "Caution," instead requiring "Warning" or "Danger."
With respect to inert ingredients, the GHS requires disclosure on the label of ingredients that contribute to hazard classification, but provides that national rules governing disclosure of Confidential Business Information (CBI) take precedence over ingredient disclosure provisions. Although FIFRA section 10 protects registrants from disclosing inert ingredients that are trade secret, those ingredients that have not been protected from previous disclosure (e.g, ingredients on an MSDS) and that contribute to hazard classification must be listed on the front panel of the label.
EPA Must Use the GHS to Simplify Pesticide Labels
Are these changes worth making for pesticide products? Of concern, unlike transportation or worker exposure laws, pesticides - as a general rule throughout the world - require pre-market review and approval before sale. Accordingly, harmonized labeling will not be as beneficial as a harmonized registration process. That is, regardless of labeling, a pesticide registrant must still satisfy potentially unique criteria and data requirements to lawfully sell in a foreign jurisdiction.
Further, the GHS must serve to streamline pesticide labels, rather than adding additional language to overwhelmingly cluttered labels. As made clear by the Consumer Labeling Initiative, a joint industry/government project, EPA-registered pesticide labels are too wordy and difficult for consumers to understand. Thus, to make the GHS worthwhile, the EPA and industry must use the opportunity to streamline pesticide labels, and they must push for greater harmonization of international registration processes - beyond that currently provided by the OECD. If both of these objectives are met, and the burden of revising labels is not too great (on industry or EPA), the end result may be a "pleasing combination" for industry, EPA and consumers.
If you have any questions on EPA's implementation of the GHS, please contact Mike Novak at firstname.lastname@example.org or 202-434-4485.