Petition process

Individuals and companies often use the formal eitizen petition process to raise issues regarding the safety and efficacy of pharmaceuticals. Brand-name companies, for example, have petitioned the FDA on issues relating to bioequivalence for partieular generic dmgs. 

The evaluation of the safety of a new excipient as a food additive could be accomplished by the submission of a food additive petition to the United Nations expert panel operating under the auspices of the FAO and the World Health Organization known as the JECFA. A JECFA review could serve as a separate independent safety review to support the new excipient for potential use in drug products. Alternatively, the safety of a new excipient could be evaluated through the food additive petition processes, as currently in practice both in the United States and the EU, assuming that the new excipient can be demonstrated to have a technological function as a food additive. 

In the past, petitioners filed petitions with FDA to review the GRAS status of a substance and affirm the substance as GRAS. In 1997, FDA proposed to replace this GRAS affirmation petition process with a proposed voluntary notification procedure where any interested party may notify FDA of the determination that a substance is... 

New dosage forms submitted through the ANDA suitability petition process... 

If a candidate substance is to be used directly in/on food, and is not already covered under prior sanction or GRAS categorization, and is not bioengineered nor a dietary supplement, then it is most likely a bona fide food additive/ingredient and stringent premarket (i.e., FDA approval before marketing) approval is mandated by a petition process. If... 

Currently, the United States neither imports nor exports PCBs. Section 6(e)(3)(A) of TSCA (Pub. L. 94-969, 90 stat. 2003,15 USC 2601 et. seq.) prohibited all manufacture and importation of PCBs after January 1, 1979. On January 2, 1979, however, EPA announced that companies that had filed petitions for exemptions from the PCB manufactuiing/importation ban could continue manufacturing or import activity until EPA acted on the application petition. As of July 7,1997, the U.S. Court of Appeals for the Ninth Circuit overturned the Import for Disposal Rule. EPA can now only allow imports of PCBs by issuing exemptions to importers via the petition process under Section 6(e) of TSCA. See the... 

This petition process is intended to expedite, not delay, resolution of interstate pollution conflicts. Thus, it should not be viewed as an administrative remedy which must be exhausted prior to bringing suit under Section 304 of the Act. Rather, the committee intends to create a second and entirely alternative method and basis for preventing and abating pollution. 22/... 

In Canada and the United States, the food additive petition processes are similar and require premarket review and approval. In the United States, under the proposed GRAS Notification rule, a manufacturer can declare that a substance is GRAS if there is scientific consensus among qualified experts about its safety under the conditions of intended use. The manufacturer then notifies FDA, and if the agency has no questions, a letter of no objection is issued. 

Infant formulas are regulated as food. If a manufacturer wishes to add a new ingredient to an infant formula, it must follow one of three routes it may determine a substance is GRAS without formally notifying FDA, it may file a GRAS Notification with FDA, or it may file a Food Additive Petition (see Box 4-1 for the definition of a food additive) with FDA. The GRAS Notification and the Food Additive Petition processes are described below. 

The Federal Food and Drug Administration (FDA) regulates the use of food colors and food contact colors in the United States. Food colors must be approved in an extensive petition process with the FDA. There are two methods by which food contact colors can be used. First there is the traditional food additive petition for use of a food contact substance. If successful, this process leads to listing in the Code of Federal Regulations (CFR) as a new color available for various substrates. Restrictions may be applied to the use of listed colors. The CFR should be consulted and... 

CFR 68, Protection of the environment chemical accident prevention provisions. Includes a hst of regulated substances and thresholds, the petition process for adding or deleting substances to/from the hst of r ulated substances, the requirements for owners or operators of stationary sources concerning the prevention of accidental releases, and approved state accidental release prevention programs. 

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