Source: https://www.federalregister.gov/articles/2013/01/22/2013-01157/agency-information-collection-activities-proposed-collection-comment-request-registration-of-food
Timestamp: 2015-07-03 11:06:28
Document Index: 22078943

Matched Legal Cases: ['§ 1', '§ 1', '§ 1', '§ 1', '§ 1', '§ 1']

Federal Register | Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Dates: Submit either electronic or written comments on the collection of information by March 25, 2013.
-4417 (4 pages)
Shorter URL: https://federalregister.gov/a/2013-01157 Regulations.gov Docket Info
Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002—21 CFR 1.230-1.235 (OMB Control Number 0910-0502)—Extension Back to Top
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188) added section 415 to the Federal Food, Drug, and Cosmetic Act (the FD Act) (21 U.S.C. 350d), which requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. Sections 1.230-1.235 of FDA's regulations (21 CFR 1.230-1.235) set forth the procedures for registration of food facilities. Information provided to FDA under these regulations helps the Agency to notify quickly the facilities that might be affected by a deliberate or accidental contamination of the food supply. In addition, data collected through registration is used to support FDA enforcement activities and to screen imported food shipments. Advance notice of imported food allows FDA, with the support of the Bureau of Customs and Border Protection, to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies. If a facility is not registered or the registration for a facility is not updated when necessary, FDA may not be able to contact the facility and may not be able to target import inspections effectively in case of a known or potential threat to the food supply or other food-related emergency, putting consumers at risk of consuming hazardous food products that could cause serious adverse health consequences or death.
FDA's regulations require that each facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States register with FDA using Form FDA 3537 (§ 1.231). The term “Form FDA 3537” refers to both the paper version of the form and the electronic system known as the Food Facility Registration Module, which is available at http://www.access.fda.gov. Domestic facilities are required to register whether or not food from the facility enters interstate commerce. Foreign facilities that manufacture, process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.
In addition to registering, a facility is required to submit timely updates within 60 days of a change to any required information on its registration form, using Form FDA 3537 (§ 1.234), and to cancel its registration when the facility ceases to operate or is sold to new owners or ceases to manufacture, process, pack, or hold food for consumption in the United States, using Form FDA 3537a (§ 1.235).
The FDA Food Safety Modernization Act (FSMA) (Public Law 111-353), enacted on January 4, 2011, amended section 415 of the FD Act in relevant part to require registrants for food facilities to submit additional registration information to FDA, and to require facilities required to register with FDA to renew such registrations biennially. Section 415(a)(2) of the FD Act (21 U.S.C. 350d(a)(2)), as amended by FSMA, also provides that, when determined necessary by FDA “through guidance,” a food facility is required to submit to FDA information about the general food category of a food manufactured, processed, packed or held at such facility, as determined appropriate by FDA, including by guidance. These amendments took effect October 1, 2012. To comply with this statutory deadline, FDA initially obtained OMB approval of the following additional collection of information requirements under the emergency processing provisions of the PRA:
Modification of food facility registration forms to include the following mandatory fields: The email address for the contact person of a domestic facility and the email address of the U.S. agent for a foreign facility, an assurance that FDA will be permitted to inspect the facility, and specific food categories as identified in the guidance document entitled, “Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories” (77 FR 64999, October 24, 2012) (section 415(a)(2) of the FD Act); and
The requirement that registered facilities submit registration renewals to FDA biennially (section 415(a)(3) of the FD Act (21 U.S.C. 350d(a)(3)).
2The term “Form FDA 3537” refers to both the paper version of the form and the electronic system known as the Food Facility Registration Module, which is available at http://www.access.fda.gov.
§ 1.230-1.233 and section 415 of the FD&C Act
FDA 35372
FDA 3537
New Facility Registration Subtotal
Updates under § 1.234 and section 415 of the FD&C Act
Cancellations under § 1.235
FDA 3537a
Biennial renewal of registration required by section 415 of the FD&C Act
0.5 (30 mins.)
Updates, Cancellations or Biennial Renewals Subtotal