OAR 603-012-0250: Enforcement Guidelines

(1) The Department may use alternative enforcement actions in addition to, or instead of, assessing a civil penalty. Alternative enforcement actions may include but are not limited to: a letter of advisement; a notice of violation; a stop sale, use or removal; and license/registration revocation, suspension or denial. (2) In addition to any other penalty provided by law, the Director may assess civil penalties for commission of acts prohibited by ORS 596.100. Civil penalties will be assessed in accordance with the magnitude of the violation. Prohibited acts are categorized by magnitude of violation as follows: (a) Category 1: In addition to taking any alternative enforcement action deemed necessary to protect the public interest, the Department will issue a civil penalty for a Category 1 violation. Category 1 violations include: (A) Registering or attempting to register any product using fraudulent or deceptive practices in an effort to evade or attempt to evade the requirement of ORS 596.100 or rules adopted there-under; (B) Submitting false or fraudulent applications, records, invoices or reports; and (C) Making any false or misleading representation in connection with the sale, offer for sale, or distribution of an animal remedy, veterinary biologic or pharmaceutical. (D) Impeding, obstructing, hindering or otherwise preventing or attempting to prevent the Department from performing its duties under ORS 596.100. (b) Category 2: Except for a repeat violation, for which the Department may immediately issue a civil penalty, prior to issuing a civil penalty for a Category 2 violation against a manufacturer, the Department will take written alternative enforcement action and will allow a specified amount of time to take corrective action. Failure to complete the corrective action within the specified time period or repeat violations may result in the immediate issuance of a civil penalty. Category 2 violations include: (A) Selling, offering for sale, or distributing a veterinary product that is not registered with the Department under ORS 596.100; and (B) Failing, refusing, or neglecting to pay registration fees required under ORS 596.100; and (C) Failing, refusing, or neglecting to provide complete product registration information as required under OAR 603-012-0230(1). (3)(a) Maximum civil penalties are not to exceed the following: (A) Category 1 (i) First violation - $500, (ii) Second violation - $1,500, and (iii) Third or subsequent violations - $2,500. (B) Category 2 (i) First violation - $250, (ii) Second violation - $750, and (iii) Third or subsequent violations - $2,500. (b) In determining whether a violation is first, second, or third violation, the Department will focus on the nature of the actions and not the specific product involved, and may consider a subsequent failure to register a product or a subsequent sale of an unregistered product, even if a different product than involved in the earlier violation, a second or third violation. (4) Notwithstanding sections (2) and (3) of this rule, any violation that arises from gross negligence or willful misconduct and results in substantial harm to human health, animal health, or the environment may be subject to a civil penalty of not more than $2,500 for the initial violation or any subsequent violation. In the context of the acts prohibited in this section, “refusing” constitutes willful misconduct that is subject to a civil penalty of not more than $2,500 for the initial violation or any subsequent violation.