04
Jan
EPA Proposes to Clarify Exempt Minimum Risk Pesticide Ingredients
(Beyond Pesticides, January 4, 2013) On December 31, 2012, the U.S. Environmental Protection Agency (EPA) proposed to clarify its labeling requirement for disclosure of all active and inert ingredients in “minimum risk pesticide products,” exempt from registration under Section 25 (b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The rule (77 FR 250) reorganizes the list of eligible active and inert ingredients by adding identifiers that will clarify for the public, and more importantly for federal and state inspectors, which ingredients are permitted in minimum risk pesticide products. The modification would require labels to use common chemical names in the list of ingredients as well as the contact information for the manufacturer.
The lack of clarity on minimum risk pesticide product labels in the past has made it difficult for enforcement officials who must use their own judgment on the applicability of vague descriptors such as cedar leaf oil and cedar wood oil, which are exempt under the current listing of “Cedar Oil” under CFR Section 152.25. While EPA has attempted to improve labeling clarity of minimum risk pesticide products by updating its website, stakeholders have found the measure insufficient.
Regulatory Background
Currently, EPA is empowered under FIFRA 25 (b)(2) to exempt pesticide products that pose a “minimum risk” to humans and the environment, codified in 40 CFR Section 152.25 (g), which was issued in March 1996 (later re-designated as 40 CFR Section 152.25 (f)). Thus, manufacturers of minimum risk pesticide products are not required to register their products with the EPA, pay registration fees, or report to the EPA on their production. In order to receive minimum risk designation, pesticides must meet the following specific criteria:
1. Only specified and approved active and inert ingredients may be used;
2. Those active ingredients must be listed on the label whether their name and weight in the formula;
3. Those inert ingredients must be listed on the label with their name (no weight required);
4. The product may not claim to control or mitigate microorganisms that threaten human health OR claim to control insects or rodents with specific diseases;
5. Finally, the product label may not display false or misleading information as listed in 40 CFR 156.10(a)(5)(i) through (viii), including information on the effectiveness, composition, and value.
The importance of the restrictions to ingredients used in minimum risk pesticide products cannot be understated. Enforcement officers use those ingredients listed under 40 CFR Section 152.25 (f) as a guideline for exemption of minimum risk pesticide products. These inert ingredients are described as “substances for which there is no information to indicate that there is a basis for concern.” While no new active ingredients have been added since the bill was adopted in 1996, several new inert ingredients have been added on to what was historically known as List 4(A) (which has been retained on an interim basis for FIFRA Section 25(b) as well as the National Organic Program). This in turn has obfuscated exactly what inert ingredients are actually eligible for exemption as ingredients in minimum risk pesticide products. Until now EPA has simply responded by updating its website.
The proposal, however, would further specify active ingredients, indicate the common chemical name on the label, name the chemical as determined by the Chemical Abstract Services (CAS), provide specifications if needed. The CAS registry number provides a universal means of identifying chemical substances, providing an easier way to identify designated minimum risk pesticide products. Additionally, EPA is proposing to include information from the United States Pharmacopeia, which sets standards for chemical formulas. The proposal would also codify the existing list of inert ingredients in the CFR reference section.
Inert Ingredients in Context
The 25(b) pesticide product category limits the allowability of inert ingredients to those that are thought to be not hazardous. However, in general, despite their name, “inert” ingredients are neither chemically, biologically or toxicologically inert. In general, inert ingredients are minimally tested, however, many are known to state, federal and international agencies to be hazardous to human health. A 2009 study finds that an inert ingredient in the popular herbicide RoundUp, polyethoxylated tallowamine or POEA, is more deadly to human embryonic, placental and umbilical cord cells than the herbicide itself — a finding the researchers call “astonishing.” POEA is a surfactant, or detergent, derived from animal fat. It is added to Roundup and other herbicides to help them penetrate plants’ surfaces, making the weed killer more effective.
Limited review of inert ingredients in pesticide products has highlighted a primary flaw with the regulatory process for all ingredients in pesticides. Rather than adopt a precautionary principle when it comes to chemicals with unknown toxicity or uncertainties, EPA appears to allow chemicals to remain innocent until proven guilty, and relies on a flawed risk assessment process that does not adequately address exposure and hazard. Once proven guilty, these pesticides, both active ingredients and inerts, have already left a toxic trail on the environment and people’s well-being.
Inerts in Organic Agriculture
In October 2012, the National Organic Standards Board made a landmark decision to require a review of so-called “inert ingredients.” The recommendation contains new regulatory language, a series of steps to use in preparing for inerts review, screening guidelines that the Technical Evaluation Reports (TERs) will address, a tentative list of the proposed groups, and a rough timeline for review and completion. An Inerts Working Group (IWG) consisting of representatives of the NOSB, NOP, and EPA in consultation with the Organic Materials Review Institute (OMRI) and Washington State Dept. of Agriculture (WSDA) developed the process and will continue to fine-tune it. The review of inert ingredients will be performed by the Crops Subcommittee.
The recommendation created a four-year time frame to evaluate inert ingredients currently in use in organic agriculture that are not exempt from pesticide registration under FIFRA section 25(b). This includes former EPA List 4(B) and List 3 inerts in pheromones that were identified through information supplied by the Material Review Organizations OMRI and WSDA. It also will include inert ingredients that have been previously petitioned, and a call for other (inert) ingredients to be identified by manufacturers. This list so far is 126 individual substances. The IWG is working to categorize the substances in the “other” category into additional or existing groups. The full group listing, including the list of chemicals, will be presented at the Spring 2013 NOSB meeting. It is expected that 4-6 groups of chemicals will be evaluated every year during the four year period beginning in 2013. Although this proposal will require a large amount of work, rulemaking is expected to be completed by October 2017.
Take Action
Beyond Pesticides supports the continued effort to clarify the use of inert ingredients in all pesticides, including but not restricted to minimum risk pesticide products exempt under FIFRA. EPA is currently seeking comment on several issues, including: the format of the ingredient lists; the information in the new format of the ingredient lists; the proposed reference to a website that contains a table formatted to include more information on exemptions from the requirement of a tolerance; EPA’s methodology for estimating the costs associated with the proposed label changes; the proposed time frame of two years from the effective date of the final rule for compliance; how the changes will impact state and local agencies; effective methods and venues for communicating these proposed changes to affected entities; and products that would need to be reformulated as a result of the proposed changes.
Submit your comments by going to www.regulation.gov referencing docket number EPA-HQ-OPP-2010-0305 FRL-9339-1, no later than April 1, 2013.
Source: Environmental Expert
All unattributed positions and opinions in this piece are those of Beyond Pesticides.
