Federal Agencies Issue "Good Importer Practices" Draft Product Safety Guidance
The Food and Drug Administration has issued a press release announcing that the Departments of Health and Human Services, Agriculture, Commerce, Homeland Security, and Transportation, and the Consumer Product Safety Commission, the Environmental Protection Agency, and the Office of the U.S. Trade Representative have issued a draft product safety guidance for industry titled "Good Importer Practices."
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Comments on this draft guidance are due by April 12, 2009.
Draft Importer Guidance on Product Safety and Security Requirements
This guidance document provides general recommendations to importers on possible practices and procedures they may follow to increase the likelihood the products they import are in compliance with applicable U.S. safety and security requirements.
For example, at various points in a product's life cycle - growing, harvesting, designing, manufacturing, processing, packing, receiving, storing, transporting, importing, and distributing - it may be appropriate for companies to consider implementing preventive controls to decrease the risk of the product causing harm to people, animals, and/or the environment.
Recommendations to Help Assess Imported Product's Life Cycle
The recommendations provided in the draft guidance are intended to promote and facilitate an assessment by importers of the product's life cycle, so the importer may make sound decisions about how best to address the product's potential to cause harm and to facilitate compliance with U.S. requirements.
Although this guidance relates to requirements and practices pertaining to product safety, importers should also take steps to help ensure that the products they bring into the United States comply with other applicable legal requirements.
Recommendations Designed to Anticipate Sources of Product Hazards
The guidance is designed to provide importers with steps they can take to help ensure imported products are in compliance with applicable U.S. statutes and regulations. Recommendations in the draft guidance are designed to anticipate potential sources of product hazards, offer preventive controls firms can implement to mitigate such hazards, and help ensure imported products are safe and are compliant with U.S. requirements.
"Good Importer Practices" Guidance Was Recommended in Import Safety Action Plan
The agencies are issuing the draft guidance to implement recommendations outlined in the "Action Plan for Import Safety: A Roadmap for Continual Improvement," issued by the Interagency Working Group on Import Safety, and to help foster a consistent approach by federal agencies and importers in ensuring the safety of products brought into the U.S.
"Good Importer Practices" Organized into 4 Guiding Principles
The draft "Good Importer Practices" are broadly organized under four guiding principles:
- Establishing a product safety management program
- Knowing the product and applicable U.S. requirements
- Verifying product and company compliance with U.S. requirements throughout the supply chain and product life cycle
- Taking corrective and preventive action when the imported product is not in compliance with U.S. requirements
Draft Guidance Recommends Practices to Identify and Minimize Risk of Imports
The draft guidance recommends that importers consider instituting practices to identify and minimize risks associated with imported products. The draft guidance recommends that, in general:
importers should know the producer of the foreign products they purchase and any other manufacturers with which they do business, such as consolidators, trading companies, and distributors;
understand the products that they import and the vulnerabilities associated with these products;
understand the hazards that may arise during the product life cycle, including all stages of production; and
ensure proper control and monitoring of these hazards.
(The draft guidance document would not establish legally enforceable rights or responsibilities. Instead, the guidance document, when finalized, would describe the current thinking of U.S. federal departments and agencies on a topic, and readers should view it only as recommendations, unless the document cites specific regulatory or statutory requirements. Nothing in the document is intended to affect the importer's responsibility to comply with all applicable requirements found in U.S. statutes and regulations.)
(See ITT's Online Archives or 05/28/08 news, 08052800, for BP summary of an FDA official's discussion of an upcoming "good importer practices" document.
See ITT's Online Archives or 11/09/07 news, 07110910, for BP summary of the Import Safety Action Plan's long term recommendations, including the development of good importer practices.)
- comments due by 04/12/09
FDA contact - Jeffrey Shuren (301) 796-4840
FDA press release (dated 01/12/09) available at http://www.fda.gov/bbs/topics/NEWS/2009/NEW01941.html.
Draft guidance (dated 01/09) available at http://www.fda.gov/oc/guidance/goodimportpractice.html.
Federal Register notice announcing the availability of the draft guidance (FR Pub 01/13/09) available at http://edocket.access.gpo.gov/2009/pdf/E9-453.pdf.