Enforcement Programs

The FDA s approval and enforcement programs are adrninistered by five centers organized along product lines. Although ah five centers must fohow the general provisions of the Act, each center is governed by its own unique and distinctive set of laws and regulations. The five centers are as fohow. 

There are three essential elements to RCRA s enforcement program compliance monitoring, enforcement actions, and compliance assistance and incentives. 

The FDA should accept, where legally permissible, the equivalent standards, compliance activities, and enforcement programs of other countries, provided that the FDA is satisfied that such standards, activities, and programs meet the FDA s level of public health protection. 

An Introductory Forensic Science Course in a Law Enforcement Program... 

The Superfund law made cleanup the responsibility of anyone who had dumped toxic wastes, even if the disposal had occurred decades earlier. The federal government prepared a National Priority List that catalogued the worst sites and set up an enforcement program to ensure that sites on the list were taken care of. When no one could be found to pay for the remedy, the government used a pool of money—the Superfund—collected from a new tax on oil and chemical companies.43... 

The FDA s reputation for fairness and impartiality was dented in 1989 by scandal, corruption, and fraud. The pharmaceutical industry, particularly that part concerned with the manufacture of generic products, was also tainted. The FDA s backlash has been to move away from systems of trust toward strict enforcement of compliance. The linchpin of the FDA s new attitude has been preapproval inspection, incorporated into formal enforcement programs on October 1, 1990. 

The EPA has had a very active enforcement program for PCB violations. It also actively enforces the PCB regulations through civil penalty proceedings. 

A state that is administering its own occupational safety and health enforcement program pursuant to Section 18 of the Act must have provisions as effective as those of Section 11(c) to protect employees from discharge or discrimination. The OSHA, however, retains its Section 11(c) authority in all states regardless of the existence of an OSHA-approved state occupational safety and health program. 

Safety professionals should be aware of the new Severe Violator Enforcement Program established in 2010, which is intended to focus OSHA enforcement resources on recalcitrant employers who endanger workers by demonstrating indifference to their responsibilities under the law. Additionally, safety professionals should be aware that it is proposed to increase the monetary penalties. The current maximum penalty for a serious violation, one capable of causing death or serious physical harm, is only 7,000 and the maximum penalty for a willful violation is... 

Subject Severe Violator Enforcement Program (SVEP)... 

This Instruction establishes enforcement policies and procedures for OSHA s Severe Violator Enforcement Program (SVEP), which concentrates resources on inspecting employers who have demonstrated indifference to their OSH Act obligations by willful, repeated, or failure-to-abate violations. This Instruction replaces OSHA s Enhanced Enforcement Program (EEP). 

OSHA Instruction CPL 02-00-145, Enhanced Enforcement Program (EEP), January 1,2008. 

B. The Assistant Secretary by this Instruction determines that the specific inspections nnder the Nationwide Inspections of Related Workplaces/ Worksites process are critical inspections for the pnrpose of 29 CFR 1908.7(b)(2)(iv) and delegates to the Director of the Directorate of Enforcement Programs the authority to determine site selections of those related workplaces/worksites. See paragraph XV.B.7.b. (p. 16). 

D. When a case meets the severe violator enforcement case criteria, the Area Director will notify the Regional Administrator, who in turn will notify the Directorate of Enforcement Programs (DEP). 

If there is a compelling reason not to conduct a follow-up inspection, the reason must be documented in the file. The Region shall also report these cases monthly to the Director of Enforcement Programs, along with the reason a follow-up was not initiated. 

The Directorate of Enforcement programs will serve as the National Office point of contact for all SVEP nationwide referrals. Any questions should be addressed to the Director or Deputy Director in DEP. All Regional Administrators will name a SVEP Coordinator. 

At the request of the Director of the Directorate of Enforcement Programs, the Regional Administrator, or the Regional Coordinator, OSA will assist in identifying similar and other related worksites nationwide (including in State Plan States) of the same employer. 

The Directorate of Enforcement Programs (DEP) will compile an End of the Fiscal Year Report of each Region s SVEP activity, which will be sent to the Assistant Secretary. 

Enclosed you will find a copy of a Citation and Notification of Penalties for violations of the Occupational Safety and Health Act of 1970, which were issued to [establishment name, located in city, state]. This case has been identified as a severe violator enforcement case under the Occupational Safety and Health Administration s (OSHA) Severe Violator Enforcement Program (SVEP). 

Potential Incidents of Noncompliance, BSEE at http //www.bsee.gov/Inspection-and-Enforcement/ Enforcement-Programs/Potential-Incident-of-Noncompliance—PINC.aspx... 

The CVSA is a not-for-profit organization that was created to keep the roadways safe from commercial motor vehicle accidents and incidents. Its devotion to safety is demonstrated in its current mission statement which reads Our mission is to promote commercial motor vehicle safety and security by providing leadership to enforcement, industry, and policy makers. This is accomplished by establishing effective transportation safety standards for motor carriers, drivers, vehicles, and inspectors through compliance, education, training, and enforcement programs. ... 

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