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What is Subpart GGG?

Subpart GGG, which includes 40 CFR 63.1250 through 63.1261, is known as the National Emission Standard for Pharmaceuticals Production. It is referred to as the Pharmaceutical MACT standard in this program. The Pharmaceutical MACT regulates HAP emissions from processes at pharmaceutical manufacturing operations (PMO).

See Also:

What is the PMO? What is a pharmaceutical product? What is an active ingredient? What is a precursor? What is an isolated intermediate? What is a PMPU? What is a Process?

What is the purpose of the Rule Assistant?

The Phamaceuticals MACT Rule Assistant will provide you with options for compliance with the Pharmaceuticals MACT standard. You will be asked certain questions or asked to select certain options that describe processes or configurations of your facility. The Rule Assistant acts like a smart system to lead you to the specific parts of the rule that apply to your operation. The Rule Assistant also provides explanations of certain parts of the rule to help you choose selections and answer the questions. In many cases, examples and more detailed explanations of difficult parts of the rule can be found by clicking on the question mark symbols found throughout the program. When you finish you should have a good understanding of how you will comply with the rule.

Are there other guidance materials I can use?

This program was created to be used along with the Companion Compliance Assistance Tool developed by the U.S. EPA Office of Enforcement and Compliance Assurance (OECA). The program provides hyperlinks to explanatory information, definitions, frequently asked questions and answers and relevant examples which relate to some of the difficult concepts of the rule. Much of which is taken directly from the OECA Companion Compliance Assistance Tool and is referenced as such. You can access this guidance information by clicking on the question icon whenever it appears througout the program. In addition, a download link to the full text of the OECA guidance tool is provided at the bottom of each screen. The user may find it useful to download the OECA document so that these two products can be referenced together.

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