Enforcement actions

The tliird major set of amendments was the Federal Facility Compliance Act of 1992. Tliis aet resoh es the legal question of w hether federal faeilities are subjeet to enforcement actions under RCRA by wai ing the go crnmcnt s so crcign iimnunity from prosecution. As a result, states, USEPA, and the Department of Justice can enforce the pro isions of RCRA against federal facilities, and federal departments and agencies can be subjected to injunctions, administrative orders, and/or pciuiltics for noncomplianec. ... 

When an employer is unable to obtain an MSDS from a supplier or manufacturer, he/shc should submit a written complaint, witli complete background infoniiation, to the nearest OSHA area office. OSHA will tlien, at the same time, call and send a certified letter to he supplier or manufacturer to obtain the needed information. If the supplier or manufacturer still fails to respond within a reasonable time, OSHA will inspect the supplier or manufacturer and take appropriate enforcement action. 

Inspection of facilities and products with follow-up enforcement actions, where necessary ... 

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

The primary goal of enforcement actions is to bring facilities into compliance and ensure future compliance. The enforcement options available under RCRA are... 

The responsibility for the various enforcement actions is divided among different U.S. EPA Headquarters offices, U.S. EPA Regions, and authorized state agencies. Additional information about RCRA enforcement can be found in Refs 15 and 16. 

Both RCRA and CERCLA contain provisions that allow U.S. EPA to require persons contributing to an imminent hazard to take the necessary actions to clean up releases. RCRA s imminent and substantial endangerment provision addresses nonhazardous as well as hazardous solid waste releases. The authority under CERCLA is essentially the same, except that CERCLA s authority to abate an imminent or substantial danger to public health or the environment is limited to hazardous substance releases. In an enforcement action, the RCRA and CERCLA imminent hazard provisions may be used in tandem to ensure adequate protection of human health and the environment. 

GDC applies to all stationary sources (fixed facilities) that handle, produce, process, or store regulated substances or extremely hazardous substances (EHS)47. It obligates facilities to identify and safely manage all hazards, including reactive hazards. Similar to OSHA, EPA can use its GDC enforcement authority to create legally binding requirements or enforce actions for hazards that have not been properly identified or managed. 

Have Such Agreements Continued Following FTC Enforcement Action in this Area ... 

The study was prompted, in part, by the Commission s enforcement actions against alleged anticompetitive agreements that relied on certain Hatch-Waxman provisions." The study was designed to... 

For all generators, copies of all manifests and any records of tests and analyses carried out on the hazardous waste must be kept for at least three years, and for the duration of any enforcement action. 

All generators must keep receipts or manifests of waste shipped, and records of waste analysis for at least three years, or for the duration of any enforcement action by the appropriate State environmental protection agency. 

If the company decided not to use a licenced transporter but would be transporting its own wastes, the company did not need a USEPA-ID number or manifest form. The company must, however, keep a record of the type and quantity, as well as the date, method of transport, and treatment/disposal of its waste(s). The company would need proof of the receipt of the waste by the treatment/disposal facility. The company or its consulting engineer must keep receipts or manifests of waste shipped and records of waste analysis for at least three years, or for the duration of any enforcement action by the Massachusetts DEP. 

In the first few decades of the 1900s FDA brought hundreds of seizure and criminal actions to enforce the FD C Act. Beginning in the 1970s, the formal court enforcement actions have been replaced in two ways. First, FDA has promulgated hundreds of regulations that establish the precise requirements of the law, thus reducing the need for many court enforcement actions. Second, formal court enforcement actions have been replaced by informal administrative enforcement actions such as recalls... 

Legacy Systems The FDA intends to exercise enforcement discretion with respect to all Part 11 requirements for systems that otherwise were operational prior to August 20,1997. Thus they do not intend to take enforcement action to enforce compliance with any Part 11 requirements if all of the following criteria are met for a specific system ... 

In fiscal year 2005, the FDA field office conducted 1437 cGMP inspections, resulting in 15 warning letters, six injunctions, and one seizure. These enforcement actions are discussed later in this chapter. Data for the years 2000-2005 are set forth in Figures 1 and 2. 

A warning letter is distinguishable from a notice of violation, also called an untitled letter. An untitled letter cites violations that do not meet the threshold of regulatory significance for a warning letter, but the FDA has a need nevertheless to communicate. Unlike a warning letter, an untitled letter does not include a warning statement that failure to take prompt correction may result in enforcement action and does not evoke a mandated FDA follow-up. Further, the untitled letter requests (rather than requires) a written response (from the manufacturer) within a reasonable amount of time (e.g., Please respond within 45 days ). 

The FDA is likely to bypass sending a Warning Letter in certain circumstances. According to Chapter 4 of the FDA Regulatory Procedures Manual, the following violations are likely to result in an enforcement action without necessarily issuing a warning letter ... 

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