October 11, 2002
and Records Integrity Branch (PIRIB)
Re: Methodology for Determining the Data Needed and the Types of Assessments Necessary to Make FDCA Section 408 Safety Determinations for Lower Toxicity Pesticide Chemicals
The Northwest Coalition for Alternatives to Pesticides, the World Wildlife Fund, Beyond Pesticides and the Natural Resources Defense Council submit the following comments regarding the guidance document "Methodology for determining the data needed and the types of assessments necessary to make FFDCA section 408 safety determinations for lower toxicity pesticide chemicals."
1. The proposed methodology fails to implement the Food Quality Protection Act's mandates for EPA to develop and implement an estrogenic substances screening program and take action based on this screening "as is necessary to ensure the protection of public health." [FFDCA Sec. 408(p)]
The Food Quality Protection Act requires EPA to screen pesticide ingredients and determine their ability to disrupt endocrine systems. EPA is also required to take action to protect public health from those chemicals found to have endocrine effects. The proposed methodology makes it virtually impossible for EPA to carry out this mandate. The proposal exempts most "inert" and other "lower toxicity" pesticide chemicals from additional data requirements. Because few chemicals have existing data demonstrating whether or not they affect endocrine systems, EPA will be left with no means to acquire the information necessary to carry out this mandate.
We are particularly concerned about the family of chemicals containing nonyl phenol, octyl phenol, nonylphenol ethoxylates, and their chemical relatives. The World Health Organization's International Programme on Chemical Safety has just issued a report ("Global Assessment of the State-of-the-Science of Endocrine Disruptors") that states that "numerous studies have demonstrated the ability of NPEO's [nonylphenol ethoxylates] to disrupt the normal function of the endocrine systems of various organisms." As further evidence, we have attached to these comments a list of examples of published research documenting these endocrine disrupting effects, and studies that have been done to document the widespread environmental contamination by these chemicals.
Many of this family of compounds, however, have already been classified by EPA as List 4B inerts (for example, p- nonylphenol, ethoxylated; nonylphenol, ethoxylated, monoether with sulfuric acid; nonylphenol, ethoxylated, monoether with sulfuric acid, sodium salt; nonylphenol, ethoxylated, monoether with sulfuric acid, triethanolamine salt; nonylphenol, ethoxylated, phosphate ester; 4-nonylphenol, ethoxylated, phosphate ester; and nonylphenol, ethoxylated, phosphate ester, sodium salt). Following the logic outlined in the guidance document, an FFDCA Sec. 408 safety determination for these ingredients will be made, and they will be exempted from the requirement of a tolerance, all with little or no assessment of their endocrine disrupting potential.
Numerous other compounds in this chemical family are currently classified by EPA as List 3 inerts, but also seem likely under the proposed methodology to be given an exemption from a tolerance and a List 4 classification without complete consideration of their potential endocrine disrupting effects (for example, phenol, nonyl-, phosphite (3:1); polyethylene glycol branched-nonylphenol ether phosphate; polyethylene glycol branched-nonylphenol ether phosphate potassium salt; polyethylene glycol branched- nonylphenol ether sulfate ammonium salt; polyoxyethylene branched-C9-alkylphenol; nonylphenol ether with (C2H4))9 phosphate 3; nonylphenol, ethoxylated, monoether with sulfuric acid, ammonium salt; p- nonylphenol, ethoxylated, phosphated, calcium salt;, p- nonylphenol, ethoxylated, phosphated, dipotassium salt; p- nonylphenol, polymer with propylene oxide and formaldehyde; nonylphenolpolyoxyethylene sulfosuccinate; octylphenol; para- octylphenol; tert- octylphenol, ethoxylated and phosphated).
2. The proposed methodology fails to ensure that pesticide products will not cause "unreasonable adverse effects on the environment" [FIFRA Sec. 3(c)(5)] and are not "misbranded" [FIFRA Sec. 2, 12] because the proposed methodology's reduced toxicology data requirements are not accompanied by requirements for increased ingredient disclosure.
The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires EPA to regulate pesticide use "to the extent necessary to prevent unreasonable adverse effects on the environment." FIFRA also prohibits the sale of misbranded pesticides, those whose labels are false or misleading. In the agency's regulations, EPA has specifically identified "a false or misleading statement concerning the composition of the product" as an example of misbranding.
Minimal toxicological data requirements have been part of EPA's efforts to meet this FIFRA requirement since the agency published its inert ingredients policy statement in 1987. The proposed guidance document, however, states that "the 1987 base set of data is no longer appropriate." This action destroys the balancing act that has existed since 1987 between ingredient disclosure and toxicology data requirements. Consumers are given neither the protection of toxicology testing, or the information they need (ingredient disclosure) to conduct their own hazard assessment. When EPA's Inert Disclosure Stakeholder Workgroup surveyed how other agencies treat ingredient disclosure in other kinds of consumer products, the Workgroup found that, in general, disclosure requirements were imposed when toxicological data were not required. For example, "while cosmetic producers are required to disclose every ingredient of the cosmetic products they sell, they are not subject to required toxicology studies or FDA review that would delay their entrance to the market. In contrast, pesticide producers must make a significant investment in toxicology and product chemistry and wait for EPA approval before they can begin to produce a revenue stream from a new end-use pesticide product." ["Final report of the Pesticide Program Dialog Committee on the Activities of the Inert Disclosure Stakeholder Workgroup," April 2002.] The proposed guidance document reduces data requirements for inert ingredients yet fails to improve labeling requirements.
It is worth noting that the guidance document compares the agency's recommendation for reducing data requirements for inert ingredients with the reduced data requirements for biopesticides and antimicrobial pesticides. ("since biopesticides generally tend to pose lower risks to humans than conventional pesticides, the Agency generally requires much less data..."; "the data requirements for each antimicrobial use category are commensurate with the potential exposure and risks associated with that use pattern...") However, in both of these cases (biopesticides and antimicrobials) the ingredients that are the subject of the data requirements are identified on product labels.
In conclusion, we request that EPA include all inert ingredients in the prioritization process for the Endocrine Disruptor Screening Program. Regulatory action to restrict or eliminate toxic "inert" chemicals should not be delayed pending this endocrine disruptor testing. We also request that inert ingredients be identified on labels to the full extent possible under current law.
We look forward to hearing how our comments will be incorporated into the final guidance document.Sincerely,