Two of the most-often cited violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) are also the first two aspects of the regulation: registration and reporting.

Over and over again, FIFRA-regulated pesticide facilities are being cited and penalized for failure to register according to state and/or federal requirements. Often these violations are just the tip of the iceberg since failure to register results in failure to meet annual reporting requirements and even failure to provide proper labeling information as provided by the Environmental Protection Agency (EPA). This snowball effect should be cause for pesticide and device producers to step up and follow the rules, especially considering pesticides are on the EPA’s list of ongoing Enforcement Initiatives.

According to 40 CFR Part 167(1) “Any establishment where a pesticidal product is produced must be registered with the Agency.” The term “produce” means the manufacture, preparation, propagation, compounding, or processing of any pesticide, active ingredient or device, or to package, repackage, label, relabel, or otherwise change the container of a pesticide or device including:

  • Establishments where a substance is produced and intended to be an active ingredient in a pesticide or the producer has active or constructive knowledge that an active ingredient will be used as such,
  • Domestic establishments producing a pesticide product for export,
  • Any unregistered pesticide,
  • Foreign establishments producing a pesticidal product for import into the United States,
  • Foreign or domestic establishments producing a pesticidal product for use under a FIFRA section 5 Experimental Use Permit, FIFRA section 18 Emergency Exemption or section 24(c) Special Local Needs registration.

Not included under this part are custom blenders of pesticides who mix pesticidal products to meet specific customer specifications and that meet the six-part definition provided in part 167.3.

Registering a pesticide establishment is a one-time requirement and must be completed prior to any actual production of pesticide products or devices. Registration provides the company with an EPA Company Number which is required to obtain an Establishment Number (using EPA Form 3540-8). Establishment Numbers are required to be provided on every label or immediate container of each pesticide, active ingredient or device the establishment produces.

Two related violations and penalties cited by EPA at different facilities in 2013

  • In December 2013, one of the largest penalties ever handed down by FIFRA enforcement – $1,736,560 – was in part the result of lack of registration compliance. The case involved a Florida-based company with multiple sites in several states that was inspected in 2012 and found to have produced large amounts of pesticides over several years at a facility in Alabama that was not registered with the EPA. The company was also cited for more than 350 events of illegal sales and distribution of pesticides without labels or with illegible labels, as well as violating a Stop Sale, Use or Removal Order (SSURO) issued by EPA in 2012 by continuing to sell and distribute pesticides.
  • Another similar FIFRA enforcement action settlement was announced in early 2013 with a Massachusetts-based company for production of pesticide products in an unregistered establishment and sales and distribution of unregistered pesticide cleaning products. The action came on the heels of an SSURO issued by EPA and culminated in a $10,000 penalty that was based upon the company’s ability to pay.

Also keep in mind that registrations require amending when changes to any of the following elements occur:

  • Name and address of the company,
  • The type of ownership (individual, partnership, cooperative association, corporation, or any organized group of persons whether incorporated or not), and/or
  • The name and address of each producing establishment for which registration was obtained.

Each registration will remain in effect as long as timely annual pesticide reports are submitted, but may be terminated for failure to submit reports resulting civil and/or criminal penalties.

40 CFR Part 167.85 provides the most basic reporting information under FIFRA for pesticide producers. To begin, all establishments covered under FIFRA are required to first register as pesticide producers and then report on each pesticidal product, including pesticides, active ingredients of pesticidal products or devices produced. For newly registered establishments, the first report must be submitted initially within 30 days of the registration. After that, reports must be submitted annually on or before March 1 of each following year for the previous calendar year. As with FIFRA registration, custom blenders of pesticide products are not required to report.

This reporting requirement provides the EPA with information necessary to oversee not only what pesticidal products are being produced, but where they are produced, in what quantity, for what ultimate use, and how they are to be applied. The EPA also uses the reported information to assess inspection priorities and risk reduction activities related to the products.

For example, EPA can use the information to notify certain producers of changes to required labeling information, locate and contact producers when a pesticide is found to be altered or cancelled due to impacts on human health or the environment, or to notify pesticide producers in preparation for or response to natural disasters.

To enable this oversight, pesticide reports include the following:

  • Name and address of the establishment;
  • Amount of each pesticidal product/device:
    Produced during the past year;
    Sold or distributed during the past year;
    Estimated to be produced during the current year.

Registered establishments should report on only those pesticidal products actually produced at the reporting establishment. Foreign-producing establishments should report on only those pesticidal products exported to the United States. All reporters are responsible for obtaining, completing and submitting the reports on the required forms by the appropriate date and EPA does not grant extensions for these submissions.

One notable area of concern is that of “supplemental distribution” where a registered product is actually sold and/or distributed under another entity’s name and address, instead of or in addition to the registrants. In this case, the distributer is considered an agent of the registrant and as such, may be held liable for violations related to the distributed product. Supplemental distribution is only allowed after notifying the EPA and when certain other requirements are met including packaging and labeling requirements defined in 40 CFR 152.132.

As simple and straight forward as these requirements are, they are also repeatedly violated, often in addition to other violations relating to mislabeled products.

One such case was announced in March of 2013 against a Connecticut company that failed to report annual production and sales data, as well as notices of FIFRA imports, and was cited for distributing or selling misbranded pesticides or devices, and distributing and selling pesticides for unauthorized uses. The EPA issued a Stop Sale Order and a settlement was reached with a civil penalty of $50,000 and certification of compliance with all relevant FIFRA regulations.

In addition, four New England companies agreed to pay fines for not submitting annual reporting requirements while six more agreed to close down their pesticide producing operations in lieu of paying penalties for failure to submit annual reports. These companies cannot produce pesticides or re-register as pesticide producers for five years in accordance with the settlements.

For more information contact Ralph Carito at Total Environmental & Safety, LLC (Total) at 908-442-8599 or rcarito@TotalEnviron.com.