(A) Grain whole; or
(B) Oilseed whole.
(vii) Sifting, separating, or sizing:
(C) Grain or oilseed byproducts; or
(D) Other plants or plant byproducts.
(g) Subpart C of this part does not apply to facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing.
(h) Subpart B of this part does not apply to the holding or transportation of one or more raw agricultural commodities as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act.
SEC 507.7 Requirements that apply to a qualified facility.
(a) A qualified facility is exempt from subpart C of this part provided that for the calendar year in which it is to be considered a qualified facility, the facility has submitted to FDA documentation that:
(1) Demonstrates the facility is a qualified facility as defined in SEC 507.3. For the purpose of determining whether a facility satisfies the definition of qualified facility, the baseline year for calculating the adjustment for inflation is 2011; and
(2)(i) Demonstrates the owner, operator, or agent in charge of the facility has identified the potential hazards associated with the animal food being manufactured, processed, packed, or held at the facility, is implementing preventive controls to address the hazards, and is monitoring the performance of the preventive controls to ensure that such controls are effective; or
(ii) Demonstrates the facility is in compliance with state, local, county, or other applicable non-Federal food safety law. This documentation may include inspection reports, certification by an appropriate agency (such as a State department of agriculture), or other documentation deemed appropriate by FDA.
(b) The documentation required by paragraph (a) of this section must be submitted to FDA by any one of the following means:
(1) To submit electronically, go to http://www.access.fda.gov and follow the instructions. This Web site is available from wherever the Internet is accessible, including libraries, copy centers, schools, and Internet cafes. FDA encourages electronic submission.
(2) To submit documents in a paper format or in an electronic format on a CD-ROM, mail these to the
(c) The documentation required by paragraph (a) of this section must be:
(1) Submitted to FDA initially within 90 days of the applicable compliance date of this part; and
(2) Resubmitted at least every 2 years, or whenever there is a material change to the information described in paragraph (a) of this section. For the purpose of this section, a material change is one that changes whether or not a facility is a "qualified facility".
(d) A qualified facility that does not submit documentation under paragraph (a)(2)(i) of this section must provide notification to consumers as to the name and complete business address (the street address, city, state, and ZIP code for domestic facilities, and comparable full address information for foreign facilities) of the facility where the animal food was manufactured or processed as follows:
Most Popular Stories
- Updates on Everglades' Stranded Pilot Whales
- Hezbollah Chief's Assassination Claimed by Sunni Group
- Stolen Cobalt-60 Recovered in Mexico
- Wind Power and Wildlife Can Coexist
- Ford Mustang Still Packs Power
- NSA Tracks 5 Billion Cellphone Records a Day
- Allstate Seeks to Invest in Minority Firms
- Sarmiento to Handle Greeley Latin Ops
- First-time Jobless Claims Drop Below 300,000
- White House Pushes to Extend Unemployment Benefits