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RAC

Recombinant DNA Advisory Committee

Raw Agricultural Commodity

Any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing [Ref: Sec. 201. [21 U.S.C. 321]  Chapter Ii—Definitions 1]

Receipt Acknowledgement

Correspondence (e.g. email, letter) or a Portal on-screen notice provided to a Reporter that notes receipt of their information.

Recombinant DNA Molecules

Under the current NIH Guidelines, these are molecules constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or molecules that result from their replication.

Regulatory Authority

The Federal agency that regulates businesses, their products and services, in the public interest.

Report Type

Any of a specific type of Safety Report, (e.g., marketed drug adverse-event report, cosmetic product problem, report of an over-the-counter drug product-use error). Depending on the product and the reporter’s issue (i.e., the situation), different data need to be requested by the Portal application software, in order to be captured in the report. \"Reporting situations\" generally correspond with their respective Government form.

Reporter

The person that submits the safety report—and for an organization, is authorized to provide information on its behalf.

Responsible Party

The Reporter for a \"1005 Mandatory Reportable Food Report\"; or, a person that submits the registration under Section 415(a) for a food facility that is required to register under Section 415(a), at which the article of food is manufactured, processed, packed, or held; or, the person or agent that submits the registration number for a facility that manufactures, packs, processes or holds a human or animal food product.



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