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May 7, 2013

State FIFRA Issues Research and Evaluation Group Convenes Semi-Annual Full Committee Meetings

Bergeson & Campbell, P.C.

On April 22-23, 2013, the Association of American Pesticide Control Officials (AAPCO)/State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research and Evaluation Group (SFIREG) Pesticide Operations Management (POM) Working Committee (WC) held its semi-annual full committee meeting in U.S. Environmental Protection Agency (EPA) offices in Crystal City, Virginia. Through a cooperative agreement in 1978, EPA and AAPCO created SFIREG, an AAPCO committee with EPA funding, to promote information exchange and cooperation between the states and EPA in the development of pesticide policies and regulations. More information about SFIREG and its committees is available online.

Issues of potential interest discussed during the meeting included the following, each of which is discussed below:

  • Bee Inspection Guidance
  • Insect Repellency Mark Update
  • Pesticide Use/Misuse in Marijuana Production Activities
  • EPA’s Spray Drift Reduction Technology Program
  • NPIC Incident Reporting, Coordination with SLA
  • OSHA HCS GHS Implementation and Effect on FIFRA Labeling
  • SLA Options for Addressing Widespread Use of Unregistered Pesticides
  • OECA Update and Distributor Label Enforcement Efforts
  • Other Topics

Bee Inspection Guidance

Brian Rowe, Michigan Department of Agriculture and Rural Development, discussed the status of bee-kill inspection guidance developed with support from an EPA Regional grant. According to Rowe’s description, the document contains narratives and checklists, and addresses a range of issues, including pre-inspection planning, onsite inspection, interviewing beekeepers, potential pesticide sources, sampling and sample analysis, and bee basics. Rowe stated that the guidance is under final review, though he does not expect many additional changes given a prior review and comment period. Rowe speculated that the guidance will be available soon, and that he expects comments will be solicited on it.

Insect Repellency Mark Update

Rose Kyprianou, EPA Office of Pesticide Programs (OPP) Field and External Affairs Division (FEAD), provided an update on development of a voluntary program for registrants of skin-applied insect repellent products to adopt an EPA-developed graphic to provide standardized information about how long the product repels designated pests (ticks and/or mosquitoes). Kyprianou reported that the voluntary program is expected to launch in Summer 2013, with publication of a new guidance document and website. OPP will maintain a list of products approved for use of the mark on the website.

SFIREG members expressed renewed concern about whether FIFRA Section 25(b) products would be permitted to participate in the program and whether EPA would review the exempt products seeking this approval to confirm compliance with the FIFRA Section 25(b) requirements, including composition and labeling. Kyprianou stated that no final decision has been made in this regard.

Pesticide Use/Misuse in Marijuana Production Activities

Laura Quakenbush, Colorado Department of Agriculture, presented on the enforcement challenges state regulators face regarding pest management for marijuana grown for state-approved uses, given that there are no federally-approved pesticide products. According to Quakenbush, 18 states have approved marijuana for medical use, with others anticipated to do so, and two states (Colorado and Washington) have approved it for recreational use. As long as marijuana remains an illegal substance at the federal level, however, EPA is not expected to approve products for use on this crop, nor approve supplemental labels for use in these states or FIFRA Section 24(c) Special Local Need (SLN) registrations. Quakenbush noted that the situation raises several issues, including:

  • For products with broad approved uses (“all crops”) and tolerance exemptions, is there any basis for a state to enforce against sale/distribution of the product for this use?
  • Whether marijuana is a food crop (as it may be ingested as well as smoked) and whether a tolerance or tolerance exemption would be needed.
  • Whether the Worker Protection Standard applies.

Quakenbush stated that she has received inquiries with risk concerns about pesticide residues for products not assessed for use on marijuana. Following discussion, as EPA is not expected to address this issue as long as marijuana remains illegal at the federal level, the POM WC referred the issue to AAPCO for further consideration.

EPA’s Spray Drift Reduction Technology Program

Jay Ellenberger, Deputy Division Director, FEAD, provided an update on EPA’s spray drift reduction technology program, which OPP expects to launch later in 2013. According to Ellenberger, the purpose of the program is to promote the identification and use of application technologies that reduce pesticide spray drift. Under the voluntary program, application equipment manufacturers would volunteer to test their product(s) according to an EPA-developed protocol and submit the study results. EPA would review the data and assign a Drift Reduction Technology (DRT) rating, depending on the percent drift reduction when compared with the standard. EPA would post the DRT identity and rating online. In their pesticide product registration or amendment applications, registrants could specify use of equipment meeting a certain DRT rating, in which case EPA would consider the DRT efficacy in its risk assessment and risk management decisions. Ellenberger stressed that this is a voluntary program and that, initially, products applied aerially and by ground boom for row and field crops would be eligible to participate.

NPIC Incident Reporting, Coordination with SLA

Emily Selia, FEAD, presented on Pesticide Registration Improvement Extension Act (PRIA)-funded efforts by Oregon State University (OSU) and EPA to expand the services offered through the National Pesticide Information Center (NPIC). According to Selia, NPIC provides science-based information about pesticides and pesticide-related topics to the public, including homeowners, schools, and the medical community, through its website, telephone hotline, outreach materials, and training assistance. Selia stated that OSU/NPIC is interested in communicating and collaborating with SFIREG and state lead agencies (SLA).

One opportunity is use of NPIC to collect incident and other information through its vet portal, designed for reporting by veterinarians, and its new eco portal, for public reporting of environmental incidents. SFIREG POM WC members expressed concerns about access to incident data received this way. Selia stated that NPIC currently encourages callers to contact SLAs as well; SFIREG POM WC members suggested that perhaps NPIC could ask callers whether they would be willing to have NPIC join an SLA contact on the call, particularly for situations with enforcement implications. SFIREG POM WC members also inquired about NPIC’s process for assessing the quality of data received through the portals. Selia agreed to coordinate follow-up between NPIC and SFIREG POM WC.

OSHA HCS GHS Implementation and Effect on FIFRA Labeling

Kristen Hendricks, FEAD, provided an overview of EPA Pesticide Registration Notice (PRN) 2012-1 and the implications of Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS) Globally Harmonized System (GHS) amendments on FIFRA labeling. Following a discussion of GHS’ history and efforts by OSHA and the Department of Transportation (DOT), Hendricks addressed the potential for inconsistencies between GHS and FIFRA requirements. As Hendricks explained, FIFRA labels are excluded from GHS requirements, but product Safety Data Sheets (SDS) are subject to OSHA HCS GHS requirements and also may be considered FIFRA labeling if distributed with the product. Among the opportunity for inconsistency, GHS has fewer signal words (no Caution) and assigns signal words according to different metrics than under FIFRA. Hendricks stated that PRN 2012-1 directs registrants to explain any inconsistencies on the SDS in Section 15, Other Regulatory Information, to avoid misleading labeling that could be considered misbranding.

SLA Options for Addressing Widespread Use of Unregistered Pesticides

Rose Kachadoorian, Oregon Department of Agriculture (ODA), presented options for SLAs in situations of widespread use of unregistered pesticides, particularly dual-use products that are sold for non-pesticide purposes. As one example, Kachadoorian stated that molten sulfur, often distributed with a burner, is used widely as a fungicide in greenhouse applications and that some Universities/Agricultural Extensions recommend doing so but that there are no sulfur products registered that describe this practice on their labels. Kachadoorian stated that she had wondered if such an application method might be covered by FIFRA Section 2(ee) but had had conversations with EPA registration staff who disagreed with this interpretation. Moreover, labels for certain sulfur registered products state “Do not expose to heat.” Kachadoorian expressed concern about worker exposure, particularly as restricted entry interval (REI) information in the literature distributed with some of these products is much less than the REI for registered agricultural uses.

As a second example, Kachadoorian stated that sulfur dioxide is used widely in the wine industry to sanitize wine barrels and corks. Based on discussions with industry representatives, Kachadoorian stated that the industry does not appreciate that this is an EPA-regulated use, noting that the Food and Drug Administration allows addition of sulfur dioxide to the wine itself to prevent oxidation and inhibit yeast growth.

In both cases, Kachadoorian expressed concern about worker exposure and also the non-compliance with state requirements for applicator certification. According to the discussion, in at least one case, a company distributing sulfur with a burner was cited for sale and distribution of an unregistered pesticide, as the burner supported the intent finding. As it is not a FIFRA violation to use an unregistered pesticide, however, Kachadoorian solicited ideas for how to address this issue. Dave Stangel, EPA Office of Enforcement and Compliance Assurance (OECA), suggested approaching existing sulfur or sulfur dioxide registrants to add these uses to their labels. Kachadoorian stated there may be other recourse under state laws; in Oregon, for example, it is a violation to apply a pesticide in an unsafe manner, according to Kachadoorian. That and educating Agricultural Extension Specialists were the extent of the solutions raised during discussion.

OECA Update and Distributor Label Enforcement Efforts

Stangel, OECA, provided an overview of the findings from the recently concluded Office of Civil Enforcement (OCE) distributor label enforcement pilot program. According to Stangel, one lesson learned is the need to clarify the amount of data that must be collected during a site inspection such that it is proportional to the scope of the violation and sufficient to identify and support enforcement needs, but not excessive given resource constraints. Stangel stated that prospectively, OCE plans to begin analyzing physical samples of distributor products. Stangel also stated that in its review of annual production reports, OCE discovered continued production of a distributor’s product even though the corresponding primary product has been cancelled. This may be due to failed communication between the registrant and its toll manufacturers, according to Stangel, and is an issue on which OCE will give closer attention.

Separately, Stangel stated the OECA Inspection Manual is in its final stage of revisions and should be available soon. Stangel also stated that OECA is continuing to develop the concept of “Next Generation Compliance,” which involves greater reliance on electronic methods for determining compliance, given diminished resources. A discussion ensued regarding the accountability of EPA Regions to SLAs for updates regarding enforcement referrals.

Other Topics

  • OPP Update: Jim Roelofs, FEAD, reported on various OPP activities. Roelofs stated he had developed a label training presentation intended for science reviewers, rather than label drafters/reviewers, and would be pleased to share with states if interested. He also described a break-out session discussion at the recent CropLife America/Responsible Industry for a Sound Environment annual Sprint Meeting regarding submission of labels with extensively bracketed optional language and the challenges such a submission raises for label reviewers. Finally, Roelofs stated that OPP is continuing to work on the two SFIREG issues papers, concerning methomyl misuse and contaminated compost, and is committed to providing SFIREG with a response.
  • FIFRA Section 25(b) Proposed Rule: Cary Giguere, Vermont Agency of Agriculture, Food and Markets and POM WC Chair, stated that the comment period for the proposed rule, which addresses more specific identification of eligible active and inert ingredients and changes to applicable labeling requirements, has just closed. According to the ensuing discussion, EPA is just beginning to review comments and no specific timeline yet exists for issuing the rule in final.
  • Biocides for Fracking Fluid: Jennifer McLain, Deputy Director, Antimicrobials Division, and Jeff Comstock, Vermont Agency of Agriculture, Food and Markets, raised an issue for discussion regarding biocides registered for oil and gas uses, particularly hydraulic fracturing (commonly referred to as fracking). Of the 30 or so active ingredients registered for these uses, only one is a restricted-use pesticide subject to federal requirements for certified applicators. Many states, however, require applicator certification for general use pesticides. According to the presentation, fracking and other oil and gas biocide uses are use patterns unfamiliar to many states and for which these states do not have applicator certification programs. Following discussion, the SFIREG POM WC agreed to refer the issue to the AAPCO Certification and Training Assessment Group (CTAG).
  • Web-Distributed Labeling Enforcement: Jim Gray, North Dakota Department of Agriculture, noted the need for a process for tracking and sorting out errors and violations as web-distributed labeling (WDL) begins. Gray posed whether the SLAs have thought through how WDL may affect label review during inspections and how SLAs will assess whether the label in the channels of trade is consistent with the approved label. During discussion, options for addressing issues were identified, including contacting the EPA Regional Office, using the State Label Issues Tracking System (SLITS), or calling the EPA registration Product Manager (PM). After discussion, it appears most SLA representatives would first call the PM.
  • FIFRA Section 25(b) Working Group Update: Robert McNally, Division Director, FEAD, stated that OPP proposes to address issues raised previously by the Working Group by developing a Questions and Answers (Q&A) document that could be posted on the OPP website. McNally solicited input from the SLAs on the proposed list of questions/issues. In the ensuing discussion, several SFIREG POM WC participants stated their primary concern is the lack of EPA follow-up to SLA enforcement referrals for products that claim FIFRA Section 25(b) status but that appear ineligible.
  • Cooperation with States and Tribal Co-Regulator Cooperation: Dan Helfgott, Chief, Government International Services Branch, FEAD, stated a committee has been formed and efforts are underway to leverage state expertise and improve communication to support tribal enforcement efforts. Helfgott solicited comments from SFIREG POM WC members. During the ensuing discussion, the need for coordination between states and tribes in support of FIFRA Section 24(c) SLN registrations was identified. Clarification of applicable applicator certification requirements and related coordination was another area identified for focus.
  • FIFRA Section 24(c) Guidance Working Group: Kachadoorian, ODA, stated that a new working group recently has been established to revise and update the FIFRA Section 24(c) guidance document for states and EPA.