By Lisa R. Burchi
On October 7, 2021, U.S. Environmental Protection Agency (EPA) Region 2 announced a settlement with Reckitt Benckiser, LLC (Reckitt Benckiser) regarding alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The specific alleged violations relate to 239 sales and distributions of two rodenticide products in the United States that EPA asserts had misleading advertising claims on the packaging. Reckitt Benckiser has agreed to pay a civil penalty of $458,000 under the settlement to resolve these violations.
Reckitt Benckiser is a supplemental distributor of two rodenticide products that are bait stations registered under FIFRA to kill mice. EPA states that in 2019, it conducted inspections of a Home Depot in South Plainfield, New Jersey, and Reckitt Benckiser’s offices in Parsippany, New Jersey. EPA thereafter determined that Reckitt Benckiser was selling these two rodenticide products in packaging or labeling that made comparative claims as to the effectiveness of the product. Specifically, the packaging stated that the products were “10x Tastier Than Lead Competitor.” The labels EPA approved for the two products did not contain this comparative claim language, and at the time of registration, data associated with the products’ claims were never provided. EPA’s regulations at 40 C.F.R. Section 156.10(a)(5)(iv) provide that statements or representations in the labeling which constitute misbranding include a “false or misleading comparison with other pesticides or devices.” EPA states that because "the comparative claims were not subject to verification, they were ‘false and misleading comparisons’ prohibited under [FIFRA].”
This case serves as another reminder to registrants and supplemental distributors to review all labeling and advertising claims to ensure conformity with EPA-approved labels and avoidance of claims that EPA identifies as false or misleading.
By Lisa M. Campbell, Lisa R. Burchi, and Margaret R. Graham
On September 16, 2016, the U.S. Environmental Protection Agency (EPA) announced it settled an enforcement matter with Syngenta Crop Protection, LLC (Syngenta or Respondent) via a Consent Agreement and Final Order (CAFO) concerning EPA’s allegations that Syngenta violated the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and EPA’s Pesticide Container and Containment Rule (PCCR). The investigation took place over three years, starting in August 2012 and concluding in January 2015. The multi-regional investigation which took place over three years, from August 2012 to January 2015, was conducted by EPA Regions 4, 5, 7, and 8, and found violations in six states: Ohio, Colorado, Iowa, Kansas, Michigan and Missouri.
The CAFO listed the alleged violations in three parts:
- Failure to have repackaging agreements and failure to maintain records concerning the repackaging agreements: In the CAFO, EPA states that it identified numerous and separate occasions when Respondent distributed or sold approximately 19 registered pesticides to approximately 222 refillers “prior to having written repackaging agreements in place with such refillers,” “and/or failed to maintain records of the repackaging agreements with the refillers.” The requirements for such agreements and record keeping are set forth at 40 C.F.R. §§ 165.67(b)(3), 165.67(d), and 165.67(h).
- Distribution and sale of misbranded pesticides: In the CAFO, EPA states that at least seven inspections conducted at different facilities that were refillers of Respondent’s pesticides found pesticides affixed with outdated labels, as well as sales of such products with outdated labels. EPA states that Syngenta was the registrant of all the products at issue and had provided the refillers with the outdated labels for repackaging the pesticide products in refillable containers or bulk tanks on at least 19 separate occasions.
- Failure to maintain data submitted for pesticide registration: In the CAFO, EPA states it conducted an inspection at two laboratories to review compliance with Good Laboratory Practice requirements, and to audit the data for studies submitted by Respondent to EPA to support one of its pesticide registrations. In both cases, Respondent informed EPA that it did not maintain records or raw data associated with the studies and the laboratories confirmed they did not maintain the records at their facilities.
Syngenta neither admits nor denies these allegations, but has agreed to pay a civil penalty of $766,508, as well as to complete an environmental compliance promotion Supplemental Environmental Project (SEP) within four years at a cost of not less than $436,990. Specifically, the SEP will involve a four-year educational awareness training and campaign to educate the regulated community on FIFRA regulatory compliance requirements pertaining to the PCCR. The training will focus on the requirements relevant to bulk pesticide containers, containment, labels, storage, transportation, delivery, clean-out, repackaging agreements, and recordkeeping. The training is intended to increase awareness across a broad array of businesses that handle pesticides, including registrants, refillers, retailers, commercial applicators, and custom blenders of pesticides.
EPA states that the settlement sends “a strong message to pesticide companies to maintain compliance with all federal environmental laws.” Indeed, the breadth of EPA’s investigation and the ultimate size of the penalty signify EPA’s focus on pesticide violations and, particularly, misbranded pesticides. EPA in recent years has focused on labeling violations between registrant and supplemental distributor labels and the issues in this case have some similarities, particularly the need for written contacts between registrants and refillers or supplemental distributors, and also the need to ensure that current pesticide labels are provided before repackaging and relabeling take place.
More information concerning supplemental distributors and repackaging is available in our blog item Registrants Penalized for Actions of Third-Party Pesticide Distributor, our memorandum EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance and in the materials from our webinar EPA's Supplemental Distribution: Enforcement Actions Are Buzzing: How to Avoid Getting Stung.
By Lisa M. Campbell and Lisa R. Burchi
On April 20, 2015, the U.S. Environmental Protection Agency (EPA) announced it had reached settlements with three major pesticide registrants, for the actions of a third-party pesticide distributor, Harrell’s LLC (Harrell’s), a Florida-based lawn and turf care business that was distributing the registrants’ respective products. EPA alleged that Harrell’s sold improperly labeled products that contained the pesticides dithiopyr, chlorantra-niliprole, and imidacloprid.
Without admitting liability, each registrant agreed to pay a penalty with one agreeing, in addition to completing a supplemental environmental project (SEP), to create a $231,000 educational website for the pesticide industry that will feature information on complying with federal pesticide laws.
A 2012 EPA investigation found more than 350 instances of Harrell’s products having been sold without proper pesticide labels -- in some cases, labels were either illegible or were not on the products at all. The products at issue were registered and were sold and distributed by Harrell’s under supplemental distributor relationships. In late 2013, Harrell’s agreed to pay a $1,736,560 civil penalty to EPA, one of the largest ever for a pesticide case.
Under EPA regulations, supplemental distributors like Harrell’s are agents of the registrants, and those registrants are thus responsible and liable for the actions of their supplemental distributors. In its recent National Enforcement Program Managers Guidance (NPMG), EPA’s Office of Enforcement and Compliance Assurance identifies Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) supplemental distribution as a mandatory “focus area.” Specifically, EPA states:
Although required to be consistent with the labels of the basic registered products, distributor product labels frequently deviate substantially from the EPA accepted labels. Such unapproved product labeling can lead to misuse and misapplication as well as pose significant risks to the users who rely on product labels to inform them about proper and safe pesticide use. Due to the potential risk associated with the use of improperly labeled pesticides, it is important that the EPA aggressively pursue compliance for supplemental registrations.
Bergeson & Campbell, P.C. (B&C®) recently issued a memorandum discussing the enforcement actions, the regulatory requirements for supplemental distribution, and what issues companies should address to help avoid such an enforcement action. That memorandum, “EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance,” is available online.
B&C also presented a webinar, “EPA's Supplemental Distribution Enforcement Actions Are Buzzing: How to Avoid Getting Stung,” on July 23, 2014, highlighting the most important steps that both registrants and supplemental distributors can take to ensure compliance and avoid being stung in the current heightened enforcement environment. A recap of the webinar is available online.