KimYoungKFBHayConfer ence2007

Slide1: 

Kim R. Young Deputy Director, Division of Compliance Center for Veterinary Medicine

Slide2: 

New FDA Rules Implementing the Bioterrorism Act of 2002 Overview of Registration and Record Keeping

Public Health Security and Bioterrorism Preparedness and Response Act of 2002: 

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 The Bioterrorism Act is divided into five titles: Title I -- National Preparedness for Bioterrorism and Other Public Health Emergencies Title II -- Enhancing Controls on Dangerous Biological Agents and Toxins Title III -- Protecting Safety and Security of Food and Drug Supply Title IV -- Drinking Water Security and Safety Title V -- Additional Provisions

Public Health Security and Bioterrorism Preparedness and Response Act of 2002: 

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Title III (Safety of Food and Drug Supply):    Subtitle A (Food Supply Protection)       Section 303 (Detention)       Section 305 (Registration)       Section 306 (Records Maintenance)       Section 307 (Prior Notice)                 Subtitle B (Drug Supply Protection)       Section 321 (Foreign Registration)       Section 322 (Import for Export)              

Slide5: 

Registration of Food Facilities

Who Must Register? : 

Who Must Register? Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food (subject to FDA’s jurisdiction) for human or animal consumption in the U.S. Domestic facilities are required to register whether or not food from the facility enters interstate commerce

Who Must Register?(cont.): 

Who Must Register? (cont.) The requirement applies to each covered facility, not to firms or companies as a whole E.g., company with 10 facilities must register each one separately

What Facilities Are Exempt?: 

What Facilities Are Exempt? Non-profit establishments Retailers Farms Restaurants Fishing vessels, except those that engage in processing as defined in FDA’s seafood HACCP regulations (21 CFR 123.3(k))

Definitions: 

Definitions Farm: a facility in one general physical location devoted to the growing and harvesting of crops for food and/or the raising of animals for food (including seafood) E.g., apple orchards, dairy farms, feedlots, and aquaculture facilities

Farm Definition(cont.): 

Farm Definition (cont.) Farm includes a facility that . . . Packs or holds food if all food is grown or raised on that farm or consumed on that farm or another farm under the same ownership; or Manufactures/processes food, if all of the food used in such activities is consumed on that farm or another farm under the same ownership

Definitions : 

Definitions Restaurant – a facility that prepares and sells food directly to consumers for immediate consumption E.g., cafeterias, cafes, fast food establishments and hospital, nursing home, or day care kitchens; and, by analogy, pet shelters, kennels, and veterinary facilities that provide food directly to animals Note: “Consumers” does not include businesses

“Mixed-Type” Facilities: 

“Mixed-Type” Facilities If an establishment is a combination of a facility subject to the rule and an exempt facility, the facility is required to register E.g., a farm that grows oranges and manufactures/ processes the oranges into juice for sale to a distributor must register because the manufacturing/processing activity is subject to the rule

“Mixed-Type” Facilities (cont): 

“Mixed-Type” Facilities (cont) A facility is exempt from registering only if all of its activities are included in one or more exemptions E.g., a farm that sells the orange juice it produces to consumers as its primary function would be exempt under the farm exemption and the retail exemption

Slide14: 

Record Keeping

Definitions: 

Definitions Farm: a facility in one general physical location devoted to the growing and harvesting of crops for food and/or the raising of animals for food (including seafood) E.g., apple orchards, dairy farms, feedlots, and aquaculture facilities

Definitions: 

Definitions Farm includes a facility that . . . Packs or holds food, if all food is grown, raised, or consumed on that farm or another farm under the same ownership; and Manufactures/processes food, if all of the food used in such activities is consumed on that farm or another farm under the same ownership

Who is excluded from all of the regulations in this subpart?: 

Who is excluded from all of the regulations in this subpart? Farms Foreign persons, except for foreign persons who transport food in the United States Restaurants

Who is excluded from all of the regulations in this subpart? (cont.): 

Who is excluded from all of the regulations in this subpart? (cont.) Restaurant/Retail facility if sales of food it prepares and sells to consumers for immediate consumption are > 90% of its total food sales Persons performing covered activities with food regulated exclusively by the USDA

Establishment and Maintenance of Records by Non-Transporters: 

Company A Company B Company C Manufacturer Establishment and Maintenance of Records by Non-Transporters Retail Store Non-transporters (e.g. manufacturers) must establish and maintain records that identify both the transporter and non-transporter [Immediate Previous Source and Immediate Subsequent Recipient (indicated with solid red arrows above)

Example 1: Common Storage Warehouse for An Ingredient (e.g., Hay): 

Example 1: Common Storage Warehouse for An Ingredient (e.g., Hay) Farm A Farm B Farm C Common Storage Manufacturing Plant Information reasonably available is the identity of all potential sources of the flour for each finished product Animal Feed

Example 2: Dedicated Storage for Each Ingredient Source: 

Example 2: Dedicated Storage for Each Ingredient Source Farm A Farm B Farm C Manufacturing Plant Information reasonably available is the identity of the specific source of the flour for each finished product Animal Feed

Record Retention Periods: 

Record Retention Periods

What are the record retention requirements? : 

What are the record retention requirements? General: Required records must be created when food is received and released, except to the extent that the information is contained in existing records Records must be retained at the establishment where the covered activities occurred (onsite) or at a reasonably accessible location The maintenance of electronic records is acceptable

Do other recordkeeping requirements in statutes and regulations still apply?: 

Do other recordkeeping requirements in statutes and regulations still apply? Yes - covered persons must still comply with all other statutes and regulations related to the establishment and maintenance of records for foods E.g., recordkeeping requirements for infant formula, juice, seafood, low acid canned food, animal feed, bottled water, color additives

Can Existing Records Satisfy the Requirements of this Subpart?: 

Can Existing Records Satisfy the Requirements of this Subpart? Yes – to the extent they contain information required by this subpart Covered persons are responsible for supplementing existing records, if necessary, to ensure all required information is established and maintained Information required by this rule does not have to be kept in one set of records

What are the record availability requirements?: 

What are the record availability requirements? When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals . . . . . . Any records and other information accessible to FDA under section 414 or 704(a) of the act must be made readily available for inspection and photocopying or other means of reproduction as soon as possible, not to exceed 24 hours from the time of receipt of the official request.

What records are excluded from BT Act records access?: 

What records are excluded from BT Act records access? Recipes for food (as defined in the rule) Financial data Pricing data Personnel data Research data Sales data (other than shipment data regarding sales)

Questions and Answers RegardingEstablishment and Maintenance of Records (Edition 4): 

Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4) Who is Excluded From All or Part of the Regulations? (Section 1.327) http://www.cfsan.fda.gov/~dms/recguid4.html

Question 4.1: 

Question 4.1 Company A cools, holds in cold storage, markets and sells a raw agricultural commodity (RAC) [Hay] grown on a farm land which is owned by company B and farmed by company C. The RAC [Hay] is harvested by a contractor company D that places the RAC grown on the farm land leased and farmed by company C directly into unlined corrugated boxes [Hay Bales]. The boxes are marked as a product of company A and the box [Hay Bales] serves as the primary container for the RAC [Hay] during distribution and wholesaling. Which companies and activities qualify for the farm exemption?

Answer 4.1: 

Answer 4.1 Company A Records Company C No Records Company D No Records Company B No Records

Question 4.2 : 

Question 4.2 A farm grows, dries, and chops alfalfa before releasing it to another person for use as animal feed. Is the farm still exempt from this regulation?

Answer 4.2: 

Answer 4.2 FDA considers "harvesting" as encompassing those activities traditionally performed during the removing of a crop from the field through the safe storage of the crop. Thus, drying and chopping activities that are an essential part of the harvest process and which are traditional farming operations for a particular crop are activities covered by the "farm" definition. For example, the harvesting of hay typically includes the cutting in the field, drying, baling and storage of the hay. If, however, a farmer were to remove cut hay from storage and chop the hay to make hay cubes to sell, then establishment and maintenance of records would be required as FDA considers this activity manufacturing/processing of the already stored hay. A farm can manufacture/process food and retain its exemption under the rule, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

Question 4.5: 

Question 4.5 I am a hay grower that will bale some of my hay and make ensilage out of the rest. What does FDA consider as "harvesting" as it is used in the definition of "farm"? Does drying my hay naturally in the field versus drying my baled hay artificially with blower fans in my barn prior to storage make a difference in whether I am considered exempt as a farm under the final rule?

Answer 4.5: 

Answer 4.5 FDA interprets harvesting as the activities traditionally performed during the removing of a crop from the field through the safe storage of the crop. The harvesting of hay includes the cutting, drying, baling and storage of the hay. Whether the hay is dried naturally in the field or on racks in front of fans before being placed in storage does not change the status of a "farm" since the harvesting of hay requires proper drying before it can be safely stored. However, if you were to remove the hay from storage and chop the hay to make hay cubes to sell, then establishment and maintenance of records for the hay cubes would be required for this activity (but not the growing and harvesting of the hay) since this activity is considered manufacturing/processing of the already stored hay. Further, the ensiling process of cutting grass off the field and blowing the wet grass into a silo for preservation is a traditional harvesting activity that falls within the farm exemption.

Question 4.6: 

Question 4.6 If I sell hay that I grow on my farm to another farm, am I subject to the establishment and maintenance of records provisions in the final rule?

Answer 4.6: 

Answer 4.6 No, you do not have to establish and maintain records for the hay you grow and sell to another farmer or to a direct consumer such as a person that owns pleasure horses. Harvesting also includes releasing the crop to another person. Thus, activities associated with the selling of the crop, such as transportation of the hay by the farmer either directly or through a third-party transporter to a buyer is included within the farm exemption. A farm that transports its products from the field does not cease to be a "farm" because such transportation is considered incidental to traditional farming activities. However, if you purchase hay from another farm under different ownership to resell, then you have to establish and maintain records related to the hay you receive and release.

Answer 4.6 - Example A: 

Abe No records required Betty No Records Required Charlie (as a farmer) No Records Required Answer 4.6 - Example A

Answer 4.6 - Example B: 

Abe No records required Betty No Records Required Charlie (as a broker) Records Required on Hay Brokered Answer 4.6 - Example B

Question 4.7: 

Question 4.7 Does a farm have to keep records of who transported hay that was bought or sold?

Answer 4.7: 

Answer 4.7 No. If the hay was transported by the farm/seller (Abe in the example in 4.6) or farm/buyer (Betty), no transportation records are needed. Trucks used as part of a farm operation fall within the definition of farm and are exempt from all of the requirements. However, if the hay was transported by a person that does not meet the definition of a farm, such as commercial trucking operation, then the transporter must establish and maintain records.

Question 4.8: 

Question 4.8 I mix my corn and haylage with a commercial protein supplement to feed my cattle. Do I need to keep records?

Answer 4.8: 

Answer 4.8 No. The definition of farm includes "facilities that manufacture/ process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership." Therefore, establishment and maintenance of records is not required for this on-farm mixed feed as long as the mixture is fed to animals on the farm or another farm under the same ownership. However, records would need to be kept if the mixed feed is released to someone other than a farm under the same ownership. Mixing the corn and haylage with a commercial supplement constitutes manufacturing/processing and falls outside the traditional farming activity once the feed is distributed to anyone other than another farm under the same ownership.

Slide43: 

Contact Kim R. Young Deputy Director Division of Compliance (HFV-230) 7519 Standish Place Rockville, Maryland 20855 Phone: 240-276-9207 Fax: 240-276-9241 E-mail: kyoung@cvm.fda.gov