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U.S. Department of Health and Human Services

Food

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Elemental Analysis Manual: Section 1.2 Regulatory Operations

Version 1.1 (September 2010)
Author: Stephen G. Capar

Table of Contents

1.2.1 REGULATORY PROCEDURES MANUAL

1.2.2 COMPLIANCE POLICY GUIDES MANUAL

1.2.3 COMPLIANCE PROGRAM GUIDANCE MANUAL

1.2.4 ORA LABORATORY MANUAL

GLOSSARY


1.2.1 Regulatory Procedures Manual 

The Regulatory Procedures Manual is a reference manual that provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.

1.2.2 Compliance Policy Guides Manual 

The purpose of the Compliance Policy Guides (CPG) Manual is to provide a convenient and organized system for statements of FDA compliance policy, including those statements that contain regulatory action guidance information. The statements made in the CPG are not intended to create or confer any rights, privileges, or benefits on or for any private person, but are intended for internal guidance.

Example of CPGs related to elements:

§540.600 Fish, Shellfish, Crustaceans and Other Aquatic Animals - Fresh, Frozen or Processed - Methyl Mercury (CPG 7108.07)

§545.400 Pottery (Ceramics); Imported and Domestic - Cadmium Contamination (CPG 7117.06)

§545.450 Pottery (Ceramics); Imported and Domestic - Lead Contamination (CPG 7117.07)

§545.500 Silver-Plated Hollowware - Lead Contamination (CPG 7117.05)

1.2.3 Compliance Program Guidance Manual 

Compliance programs and program circulars (program plans and instructions) directed to field personnel for project implementation. See "Food and Cosmetics" through the following link for Current Food Compliance Programs.

1.2.4 ORA Laboratory Manual 

The Office of Regulatory Affairs (ORA) Laboratory Manual (LM) contains definitive regulatory and science guidance on primary functions of field laboratories. The LM contents cover all ISO 17025 elements and operations such as research, court testimony, analysts on inspections, private laboratory reviews, and training. The LM also contains Intranet links to the ORA Quality Manual, the Division of Field Science master list of procedures and work instructions, and the master lists of each ORA laboratory.