U.S. Food and Drug Administration Import Refusal Reports for OASIS :U.S. Food and Drug Administration Import Refusal Reports for OASIS http://www.fda.gov/ora/oasis/ora_oasis_ref.html Import Refusal Reports option 1: INTRODUCTION View Import Refusal by option 2: COUNTRY option 3: PRODUCT Translate Reason code option 1: VIOLATION CODE TRANSLATIONS


View OASIS Refusals by Country or Region :View OASIS Refusals by Country or Region January 2009 December 2008 November 2008 October 2008 September 2008 August 2008 July 2008 June 2008 May 2008 April 2008 March 2008 February 2008


OASIS Entry – Oct 2008 :OASIS Entry – Oct 2008 Manufacturer FEI: Manufacturer Name: Manufacturer address: Product code: 24AEE05 Importers product description: SAMPLE/CANNED FAVA BEANS/24 CANS IN A BOX Refusal date: 20-OCT-2008 FDA District: LOS-DO Entry/doc/line/sfx: Carrier: Bill of Lading: FDA sample analysis: No FDA record of private lab sample analysis: No Charge(s): NEEDS FCE NO PROCESS


Charges :Charges NEEDS FCE 402(a)(4), 801(a)(3); It appears the manufacturer is ADULTERATION not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1). NO PROCESS 402(a)(4), 801(a)(3); It appears that the ADULTERATION manufacturer has not filed information on its scheduled process as required by 21 CFR 108.25(c)(2) or 108.35(c)(2).


Process Registration Low Acid Canned Foods :Process Registration Low Acid Canned Foods


Topics :Topics Why are we regulating this? What are the key regulations? What food products are covered? What food products are not covered? How do I register? Summary


Why? :Why? Spores capable of germinating under anaerobic conditions in canned foods Formation of deadly botulism toxin HACCP-like preventive controls can prevent toxin formation pH below 4.6 aw less than 0.85 Time/temperature combination sufficient to kill Clostridium botulinum spores Clostridium botulinum!


Regulations :Regulations 21 CFR 108 - Emergency Permit Control 21 CFR 113 - Low-Acid Canned Foods 21 CFR 114 - Acidified Foods


21 CFR Part 108 :21 CFR Part 108 Covers procedures to prevent violative LACF or acidified manufacturers from shipping to the U.S. Requires operators of thermal processing equipment, packaging systems and container closure inspectors be under the supervision of a person who has attended a school approved by FDA.


21 CFR Part 108 :21 CFR Part 108 Requires processors of low acid canned foods and acidified foods to register their establishments with FDA Requires processors of low acid canned foods and acidified foods to file their processes with FDA


21 CFR 113 and 114 :21 CFR 113 and 114 Designed to ensure that low acid (21 CFR 113) and acidified (21 CFR 114) canned foods are not contaminated with Clostridium botulinum or its toxin. Covers preparation, equipment, processing, deviations and record keeping


General Requirements :General Requirements Manufacturers of acidified and/or low-acid canned foods engaged in interstate commerce (includes imports) are required to: REGISTER with the FDA FILE scheduled processing information for their products Apply the scheduled process to their products Maintain required records


Foods Not Covered :Foods Not Covered Acid Foods Formulated Acid Foods Fermented Foods Foods Containing Meat and Poultry Low Water Activity (aw) Foods Not Thermally Processed Certain Jams, Jellies, and Preserves Alcoholic Beverages Carbonated Beverages Foods Requiring Refrigeration


Acronyms / Definitions :Acronyms / Definitions LACF Low-Acid Canned Foods FCE Food Canning Establishment


Definitions Low - Acid Canned Food :Definitions Low - Acid Canned Food Any food (other than an alcoholic beverage) Equilibrium pH higher than 4.6 Thermally processed Comes in a hermetically sealed container aw value higher than 0.85


What Are Acid Foods? :What Are Acid Foods? Any food that has a normal equilibrium pH that is 4.6 or lower.


EXAMPLES of Acid Foods :EXAMPLES of Acid Foods Lemon juice Tomato and tomato products Mandarin oranges Apple sauce


Definition ofAcidified Food :Definition ofAcidified Food Any food that has a normal equilibrium pH that is higher than 4.6, has an acid added to it that causes the finished or equilibrium pH to be reduced to a value that is 4.6 or lower, and has an aw value higher than 0.85.


What Are Formulated Acid Foods? :What Are Formulated Acid Foods? A food product where the predominant ingredients are acid foods containing insignificant low-acid ingredients where the equilibrium pH is not significantly changed.


EXAMPLES of Formulated Acid Foods :EXAMPLES of Formulated Acid Foods Some hot sauces Spaghetti sauces Mustards Marinades


What Are Fermented Foods? :What Are Fermented Foods? A food where the pH has been lowered to a value that is 4.6 or lower through the metabolism of carbohydrates by microorganisms that produce acid.


EXAMPLES of Fermented Foods :EXAMPLES of Fermented Foods Some olive products Sauerkrauts Some pickles


FDA Regulates Foods Containing Small Amounts of Meat or Poultry :FDA Regulates Foods Containing Small Amounts of Meat or Poultry Containing less than 3% raw meat (red meat) and/or raw poultry, or containing less than 2% cooked meat (red meat) and/or cooked poultry in the formulation. Products containing more meat come under the jurisdiction of the USDA Food Safety and Inspection Service.


Foods That Require Refrigeration :Foods That Require Refrigeration These products are labeled “Product Requires Refrigeration” and refrigerated during storage and distribution. This should not be confused with “Refrigerate After Opening”.


Examples of Foods That Require Refrigeration :Examples of Foods That Require Refrigeration Certain pasteurized crab meat products Raw oysters in jars or cans Non-shelf stable milks


Water Activity (aw) :Water Activity (aw) This refers to the amount of free moisture in a given product. Examples of low water activity products Oyster flavored sauces Honey Sweetened condensed milk Cooking oils (vegetable, olive, canola, etc.)


Registration and Process Filing :Registration and Process Filing Acid foods Formulated acid foods Fermented foods Foods containing large amounts of meat and poultry Foods requiring refrigeration Foods not thermally processed Certain jams, jellies, and preserves Carbonated beverages Low water activity (aw) Alcoholic beverages Exempted Not Exempted Low acid canned foods Acidified low acid canned foods


Emergency Permit Control 21 CFR Part 108 :Emergency Permit Control 21 CFR Part 108 Requires processors of LACF or AF to register. Requires scheduled process filing.


Registration :Registration The identification of a manufacturer of acidified and/or low-acid canned food products.


Process Filing :Process Filing This is the submission of processing information for a manufacturer’s LACF products.


Slide 34:01 15789 01-05-24/004 0300 0407 X X X 70 13 00 250 X 6 0 X Dr. Perez’s Canning Plant, Murcia, Spain My Mother’s Holding Company Anywhere, California I. M. Gettingpaid /S/ 66-2-123-4567 5/24/01 SAMPLE Not a Valid Process 8 2 X 8 2 02 03 70 70 16 00 21 00 245 240 6 0 6 0 8 2 8 2 0300 0300 0407 0407 0407 0407 0407 0300 0300 0300 6 0 6 0 6 0 8 2 8 2 240 245 250 140 140 140 11 00 14 00 19 00 04 05 06 07 08 0603 0603 0700 0700 140 70 250 250 6 0 6 0 17 00 15 00 62 0 62 0 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 0 25 1 1 1 1 1 1 1 1


LACF Online Registration and Filing :LACF Online Registration and Filing Online registration and filing allow the food industry to submit process filings electronically. Allows industry to: Edit registration information View status of process filing Access current and previously submitted filings Submit new filing forms


LACF Online Applications :LACF Online Applications Access to LACF and FURLS Authorized Representatives access to LACF profile FDA Unified Registration and Listing System (FURLS) https://www.access.fda.gov/oaa-lacf Phone 301-436-2441 E-mail lacf@cfsan.fda.gov Authorized Representative info https://info1.cfsan.gov/lacf/client/help/FAQRegistration.htm


FURLS (First Time Access) :FURLS (First Time Access) Log onto https://www.access.fda.gov/oaa-lacf/. Click on “Low Acid Canned Food” button. LACF page will appear with the statement “ Your FURLS cas_____ has been linked to LACF Online. Confirmation page will appear and an email will be sent to user (instructions for access). Open email and go to link. Log into FURLS and click on the “Low Acid Canned Food” button. Log back into FURLS and click on the “Low Acid Canned Food“ button.


Food Manufacturer’s are... :Food Manufacturer’s are... Responsible for ensuring that their food is manufactured in compliance with the FDA regulations.


Government :Government Responsible for auditing processors to determine their compliance with the regulations.


FDA Inspections :FDA Inspections Establishment of a Scheduled Process Delivery of a Scheduled Process Documentation of Process Delivery Container Integrity What are the Four Key Areas?


Establishment of a Scheduled Process :Establishment of a Scheduled Process Has the firm filed processes for all regulated food products? Was the process established by a qualified individual? Were heat penetration and temperature distribution studies conducted?


Delivery of Scheduled Process :Delivery of Scheduled Process Are critical factors including time, temperature, initial temperature, fill weight under control?


Delivery of Scheduled Process :Delivery of Scheduled Process Is the equipment capable of delivering the process?


Documentation of Process Delivery :Documentation of Process Delivery Are accurate records maintained for all critical factors?


Documentation of Process Delivery :Documentation of Process Delivery Are the records reviewed by plant management within one working day of processing? How are process deviations identified, evaluated, and handled?


Container Integrity :Container Integrity Are container closure exams being conducted at the proper frequency? Is the cooling water sanitized where applicable? Are containers handled properly after thermal processing?


Summary :Summary 21 CFR 108, 113 and 114 are the key regulations for canned food Certain products are covered and some are not LACF and AF processors are required to register and file scheduled processes An electronic filing system is available FDA’s canned food inspection program is proactive in that it emphasizes design and delivery to make products safe


Additional Information :Additional Information FDA’s LACF and AF resources page: http://www.cfsan.fda.gov/~comm/lacf-toc.html Low Acid canned and acidified food – the FDA importers guide (available in other languages) http://www.cfsan.fda.gov/~lrd/lacf.html