Review of Enrollment Break Last Run Executing the Bioterrorism Demonstration (68 FR 58894, Oct. 10, 2003) Leslye M. Fras.


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Transcripts accessible in English, French & Spanish. Outreach materials will be accessible ... procedures, packs, or holds nourishment for human or creature utilization ...
Transcripts
Slide 1

Diagram of Registration Interim Final Rule Implementing the Bioterrorism Act (68 FR 58894, Oct. 10, 2003) Leslye M. Fraser, Esq. Partner Director for Regulations Center for Food Safety and Applied Nutrition

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FDA Lead Personnel L. Robert Lake – Senior Manager (301) 436-2379 or Lloyd.Lake@cfsan.fda.gov Leslye M. Fraser – Lead (301) 436-2378 or Leslye.Fraser@cfsan.fda.gov HELP DESK Phone: 800-216-7331 or 301-575-0156 E-mail: furls@fda.gov Fax: 301-210-0247

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Background: FDA\'s Regulatory Development Timeline Feb. 3, 2003: FDA and Customs and Border Protection (CBP) distributed proposed standard with a 60 day remark period FDA got more than 350 remarks Oct. 10, 2003 : FDA and CBP distributed between time last administer (enlistment framework operational on Oct. 16, 2003)

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Background: FDA\'s Regulatory Development Timeline Oct. 28, 2003: Public meeting by means of satellite downlink to household and worldwide destinations Transcripts accessible in English, French & Spanish Outreach materials will be accessible on FDA\'s site in Arabic , Chinese, French, Hindi, Japanese, Malay, Portuguese, and Spanish: http://www.fda.gov/oc/bioterrorism/bioact.html Dec. 12, 2003: Interim last manage produces results Dec. 24, 2003: Comments due on break last control (remark period will revive in March 2004)

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Regulatory Development Timeline (cont.) FDA likewise is creating two extra principles: Section 306 : Establishment and Maintenance of Records Section 303 : Administrative Detention Goal: by December 12, 2003 , distribute last guidelines actualizing these two arrangements and hold satellite downlink meeting not long after

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What Is An Interim Final Rule (IFR)? An IFR is a last decide that has the full constrain and impact of law ; in this way, influenced parties have a commitment to agree to its prerequisites An IFR permits partners to submit remarks amid general society remark period on the territories asked for then last decide that the organization will consider before choosing whether to issue a modified last lead or affirm the between time last manage as last

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Who Must Register? Proprietors, administrators, or specialists responsible for household or outside offices that assembling/process, pack, or hold nourishment (subject to FDA\'s locale) for human or creature utilization in the U.S. Local offices are required to enroll regardless of whether sustenance from the office enters interstate business

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Who Must Register? (cont.) Owners, administrators, or operators in control may approve a person to enlist in the interest of the office The necessity applies to each secured office , not to firms or organizations all in all E.g., organization with 10 offices must enlist every one independently

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U.S. Operator Foreign offices are required to have a U.S. operator U.S. Operator can be any "individual" that lives or keeps up a position of business in the U.S. also, is physically present in the U.S. "Person" is characterized as an individual, organization, company, or affiliation

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U.S. Operator (cont.) The U.S. specialist goes about as an interchanges join amongst FDA and the office for both routine and crisis correspondences , unless the office selects to assign an alternate crisis contact Having one U.S. operator for enrollment purposes does not block an outside office from having various specialists for different purposes (E.g., deals)

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What Food is Subject to FDA\'s Jurisdiction? Definition in sec. 201 (f) of the Federal Food, Drug, and Cosmetic Act applies: i.e., "(1) articles utilized for sustenance or beverage for man or different creatures, (2) biting gum, and (3) articles utilized for segments of any such article."

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What Food is Subject to FDA\'s Jurisdiction (cont)? But the accompanying are not "sustenance" for reasons for the principle: Food contact substances, as characterized in § 409(h)(6) of the FD&C Act Pesticides controlled by EPA, as characterized in 7 U.S.C. § 136(u)

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Examples of FDA-managed Food Within Scope of the Rule Dietary supplements and dietary fixings Infant recipe Beverages (counting mixed drinks and filtered water) Fruits and vegetables Fish and fish Dairy items and shell eggs

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Examples of FDA-controlled Food Within Scope of the Rule (cont.) Raw horticultural products for use as sustenance or parts of nourishment Canned and solidified sustenances Live sustenance creatures Bakery merchandise, nibble sustenance, sweet, and biting gum Animal encourages and pet sustenance

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Registration Definitions Facility – a foundation or structure(s) under one possession at one general physical area (or on account of a versatile office, heading out to different areas), that makes/procedures, packs, or holds nourishment for human or creature utilization in the U.S. An "office" might be one nourishment handling plant with different structures in one area

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"Office" Definition (cont.) A building that has numerous organizations at the same location would be considered 2 or more offices What is not an office: Transport vehicles in the event that they hold sustenance just in the typical course of business as bearers A private habitation of an individual Non-packaged drinking water gathering and circulation foundations

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Definitions (cont.) Manufacturing/handling Making a sustenance from one or more fixings Synthesizing, get ready, treating, altering, or controlling sustenance, including sustenance yields or fixings E.g., cutting, peeling, trimming, washing, waxing, packaging, naming, or bundling

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Definitions (cont.) Packaging – putting nourishment into a holder that straightforwardly contacts the nourishment that the customer gets Packing – setting nourishment into a compartment other than bundling the sustenance Holding – stockpiling of sustenance E.g., stockrooms, icy storerooms, stockpiling storehouses, grain lifts, fluid stockpiling tanks

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What Facilities Are Exempt? Non-benefit foundations Retailers Farms Restaurants Fishing vessels, aside from those that take part in handling as characterized in FDA\'s fish HACCP controls (21 CFR 123.3(k)) Facilities directed only, all through the whole office, by the U.S. Bureau of Agriculture (USDA) Note: USDA manages meat items, poultry items, and egg items

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Definitions (cont.) Non-benefit foundation A beneficent substance that gets ready or serves nourishment specifically to the buyer or generally gives sustenance or suppers to utilization by people or creatures in the U.S. E.g., sustenance banks, soup kitchens, and philanthropic nourishment conveyance administrations Must meet the terms of area 501 (c)(3) of the U.S. Inside Revenue Code

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Definitions (cont.) Retail foundation : A foundation that offers sustenance items specifically to customers as its essential capacity A foundation that makes/procedures, packs, or holds nourishment if the foundation\'s essential capacity is to offer nourishment, including nourishment that it makes/procedures, or holds, straightforwardly to purchasers

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Definitions (cont.) Note: Businesses are not considered buyers Primary capacity is measured by yearly deals to shoppers, which must be more noteworthy than yearly deals to non-buyers

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Definitions (cont.) Restaurant – an office that gets ready and offers nourishment straightforwardly to buyers for prompt utilization E.g., cafeterias, bistros, fast food foundations and doctor\'s facility, nursing home, or day care kitchens; and, by similarity, pet havens, pet hotels, and veterinary offices that give nourishment specifically to creatures Facilities that give nourishment to interstate movements (E.g., trains, planes) are not eateries

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Definitions (cont.) Farm : an office in one general physical area gave to the developing and collecting of yields for sustenance and/or the raising of creatures for sustenance (counting fish) Washing, trimming external leaves, and cooling produce are considered some portion of gathering when done on a ranch E.g., apple plantations, dairy homesteads, feedlots, and aquaculture offices

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Farm Definition (cont.) Farm incorporates an office that . . . Packs or holds sustenance on the off chance that all nourishment is developed or raised on that ranch or expended on that homestead or another homestead under the same possession ; or Manufactures/forms nourishment, in the event that the greater part of the sustenance utilized as a part of such exercises is devoured on that ranch or another homestead under the same proprietorship

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Additional Exemption for Some Foreign Facilities Foreign offices that assembling/process, pack, or hold nourishment are excluded if a resulting outside office further makes/forms (counting bundles) the nourishment, with the exception of if the consequent office performs marking or any comparable action of a de minimis nature, both remote offices must enroll

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Foreign Facilities—Register or Exempt? Register: Manufacturing/preparing a completed sustenance item Packing or holding a nourishment item or sustenance fixing Exempt: Manufacturing/handling a nourishment fixing that is along these lines further made/handled outside the U.S.

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"Blended Type" Facilities If a foundation is a mix of an office subject to the standard and an absolved office, the office is required to enroll E.g., a ranch that develops oranges and fabricates/forms the oranges into juice available to be purchased to a wholesaler must enlist in light of the fact that the assembling/preparing movement is liable to the tenet

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"Blended Type" Facilities (cont) An office is excluded from enrolling just in the event that the greater part of its exercises are incorporated into one or more exclusions E.g., a homestead that offers the squeezed orange it produces to buyers as its essential capacity would be excluded under the ranch exclusion and the retail exception

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Two Types of Information: Mandatory and Optional All compulsory fields in an enrollment must be finished, with the exception of: Facilities that select "most/all" for sustenance pr

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