(A) Severity is demonstrated by the seriousness of the violation and the degree of noncompliance. Violations demonstrating severity may include, but are not limited to, risks to public or animal health and safety; involvement of drugs, food additives, harmful substances, unapproved ingredients, or any other substance in an amount specified as being unsafe; risk of consumer or competitive harm; or non-cooperation of the violator, such as failure to accept responsibility for assuring compliance, failure to cease noncompliant actions despite awareness of requirements, failure to implement requested corrections, failure to participate in requested meetings, or failure to provide requested records.

(B) Intent is demonstrated by the degree to which the violator failed to prevent noncompliance. Violations demonstrating intent may include, but are not limited to, events that did not occur accidentally, involuntarily, or in a manner beyond the control of the violator; voluntary or knowing concealment, misrepresentation, or fraud, such as refusing to provide production records or other evidence, providing false or conflicting records or statements, or refusing to correct a violation that financially benefits the violator; or negligence in attempting to prevent a violation, such as failure to implement requested corrections, failure to develop standard operating procedures or quality assurance plans, failure to maintain documentation showing procedures and plans are followed, or failure to create and maintain production records.

(C) Recurrence is demonstrated by repeated violations. Violations demonstrating recurrence may include, but are not limited to, multiple violations of the same code section within twelve months.