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The action was intended to reduce the registration and registration review burdens shouldered by businesses and the EPA, respectively, and encourage the development of low-risk methods of pest control. But implementation of the provision, called the minimum risk exemption (40 CFR 152.25(f)), has been problematic. In December 2012, the EPA proposed revisions to improve the clarity of the exemptions and eliminate the unintended complications and unnecessary work they were creating.
Name Game
The problem is rooted in how the exempted ingredients are identified in the regulations. Since the exemptions were promulgated, businesses, the EPA, and state regulatory agencies have all learned that the exempted substances can go under a variety of names. Ingredients may be listed on the label with one of numerous chemical, common, or Latin names. Determining whether an ingredient on a pesticide product label is the same substance on the regulatory lists of exempted active and inert substances is a time-consuming task. This has made inspections cumbersome, particularly for state inspectors, who must sometimes contact the EPA to find out if an ingredient claimed by a company as exempt is in fact the same or close enough to the ingredient listed at 152.25(f).
“For example,” says the EPA, “the way active ingredients are currently listed in the exemption is vague, and inspectors are confronted with the need to determine whether certain product ingredients as they are listed on product labels, such as cedar leaf oil or cedar wood oil, are exempt under the more general terminology used in 40 CFR 152.25(f), which lists only ‘cedar oil.’”
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State Inspections
The EPA notes that 37 states and the District of Columbia require registration of pesticide ingredients that are exempted from registration by the EPA. The combination of federal and state requirements places a significant burden on state inspectors even without the confusion posed by the exemptions. The EPA attempted to provide clarity by updating its website explaining minimum risk pesticide products; however, feedback from stakeholders indicated this was not sufficient to solve the problem. The Agency quotes the state of California:
“Although well intended, rather than relieving the States of ever-increasing regulatory workload, the proliferation of minimum risk pesticides now available in the marketplace has resulted in the opposite effect. In California, recent data indicates that approximately 20 percent of the routine marketplace inspections include some type of additional follow up having to be performed to determine compliance status for minimum risk pesticides.”
The lack of clarity surrounding how ingredients are permitted in minimum risk pesticide products has also made it difficult for companies to determine whether a specific formulation is within the exemption. According to the EPA, this has encouraged a “proliferation of illegal products, or products that do not meet the federal exemption criteria for ingredients, labeling or other conditions.”
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Proposed Revisions
The proposal would attempt to improve the situation in two ways.
- •First, the active ingredients list under 152.25(f)(1) would be modified to contain four column headings:
- -Label display name. This is the common chemical name that would be required to be used on labels of products that contain these ingredients.
- -Chemical name, as determined by the Chemical Abstract Services (CAS).
- -Specifications. This column would generally be empty, but some substances listed in the exemption had specifications associated with them in the text of the exemption as published in 1996.
- -CAS registry number (CAS No.). A CAS No. is a unique numerical identifier that provides one of the most distinct, readily available, and universally accepted means of identifying chemical substances.
- •Second, a new inert ingredients list under 152.25(f)(2) would be codified with three column headings: Label display name; chemical name; and CAS No.
Labels
As indicated above, the proposed changes will also address labels. Specifically, the EPA is seeking to revise 40 CFR 152.25(f)(3) to include the requirement that labels of exempt products use the label display name in the ingredient lists when a label display name is specified in the exemption.
The proposed changes to the FIFRA minimum risk exemption were published in the December 31, 2012, FR.