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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.
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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.
Now let’s take a look at 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.
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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 pay.
Also keep in mind that registrations require amending when changes to any of the following elements occur:
(1) Name and address of the company,
(2) The type of ownership (individual, partnership, cooperative association, corporation, or any organized group of persons whether incorporated or not), and/or
(3) 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. Tomorrow we will review reporting requirements and examples of violations resulting in such penalties.