The RFR requires a responsible party to file a report through an FDA internet portal when there is reason to believe that an adulterated food (other than infant formula) will cause serious adverse health consequences or death to humans or animals. "Responsible party" is defined as the person who submits the registration information to FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. Federal, state, and local government officials may also use the portal to report information that may come to them about such foods.
Submit electronic comments on the draft guidance to http://www.regulations.gov/.
Find out what are its implecations and loopholes click the link below