Wild Bird Feeding Industry
Members Records
BT Act Section 306, Establishment and Maintenance of Records


Food for both humans and animals that is consumed anywhere in the US requires record keeping. The purpose of the Maintenance of Records regulations is to allow the FDA to identify the sources of food when the 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 (FDA refers this to as SAHCODHA).

WHO IS REQUIRED TO KEEP RECORDS


WBFI Members in the following membership categories are required by these regulations to keep records:

· Packer

· Distributor

· Processor

· Feeder/Accessories – if you also sell seed products

· Retailer

· Associate – if you are a packaging supplier whose product comes in contact with the food in the package


Businesses that are not required to register their facilities may be required to keep records under these regulations. Examples of WBFI Members who must keep records but are not required to register their facilities include:

·Packaging suppliers - The food contact substances, i.e., the package portion that contacts the food, is not exempt - it is considered food. Therefore, packaging suppliers must keep records.

. Transporters (truck, rail, plane, vessel) – Transportation providers are required to keep records of previous source and delivery destination (one up, one down).

. Retail facilities – Retail stores, including wild bird specialty stores, must keep records on their immediate previous source (suppliers) but not the consumers they sell to. Business sales require record keeping; not consumer sales.

. Retailers with 10 or less FTE’s (Full Time Equivalency) are exempt from record keeping but are subject to record access and prohibited act provision.

WHAT ARE THE RECORD KEEPING REQUIREMENTS


The requirements for Non-Transporters are different from those for Transporters.


COMPLIANCE DATES


Based on total number of full time employees (FTE) in the entire business, not each individual location or establishment. A full time employee counts as one FTE. Two part-time employees, each working half time, count as one FTE.

. Large Businesses (>500 FTE’s per 12 months) must be in a position to comply with the regulations by December 9, 2005

· Small Businesses (11 - 499 FTE’s per 12 months) have 18 months, or until June 9, 2006, to be in a position to comply.

. Very Small Businesses (<10 FTE’s per 12 months) have 24 months, or until December 9, 2006 to comply.


WHAT ARE THE GENERAL RECORD RETENTION REQUIREMENTS?


. Required records must be created when the 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


Non-compliance to keep records as required under the BT Act is a prohibited act.

Other record keeping requirements in statutes and regulations still apply.

Existing records can satisfy this requirement as long as all the information required exists.

WHAT RECORDS ARE EXCLUDED FROM BT ACT RECORDS ACCESS?

· Recipes for food (not the ingredients the quantity of each ingredient)

· Financial data

· Pricing data

· Personnel data

· Research data

· Sales data (other than shipment data regarding sales)

HOW WILL FDA MAKE A REQUEST?


An investigator or other FDA personnel upon presentation of credentials will submit a written notice, FDA 482 – Notice of Inspection, to the owner, operator, or agent in charge, and inform that person of the records requested and FDA’s legal authority to obtain these records.

Note: FDA may request additional records related to the implicated food article at a later time under the same authority.

Once a 482 is issued, the clock starts to provide records: ASAP not to exceed 24 hours.

COOL: Country Of Origin Labeling is currently a CBP requirement; now the FDA is considering adding this as a BT Act requirement.

LINKS TO ADDITIONAL INFORMATION


http://www.cfsan.fda.gov/~dms/fsbtact.html#records

From this FDA site, you can select a number of different information pieces on Records Maintenance.

http://www.cfsan.fda.gov/~acrobat/fsbtrec.pdf

What you Need to Know about Establishment and Maintenance of Records

This booklet is available in pdf. It is 8 pages long. This guide is intended to be of assistance to small businesses (11 – 499 FTE’s).

http://www.cfsan.fda.gov/~dms/fsbtac23.html

Fact Sheet from FDA on the Establishment and Maintenance of Records regulations.

RECORDS NON-TRANSPORTERS HAVE TO ESTABLISH AND MAINTAIN TO IDENTIFY THE IMMEDIATE PREVIOUS SOURCE (IPS)



Non-transporters have to establish and maintain records to identify the non-transporter and transporter IPS of all food you receive that include:

· Firm name; address; telephone number; fax number, and e-mail address, if available of the non-transporters IPS (domestic and foreign)

· Description of type of food received, including brand name and specific variety. For imported product, the bag’s marks must be recorded.

· Date food was received

· For persons who manufacture, process or pack food, the lot or code number or other identifier (to the extent the information exists)

· Quantity and how the food is packaged (e.g. 25 lb. cartons)

· Firm name; address; telephone number; fax number; and e-mail address, if available of the transporter IPS who brought the food to you

RECORDS NON-TRANSPORTERS HAVE TO ESTABLISH AND MAINTAIN TO IDENTIFY THE IMMEDIATE SUBSEQUENT RECIPIENT (ISR)


Non-transporters have to establish and maintain records to identify the non-transporter and transporter ISR of all food you release. Records must include:

· Firm name and contact information of the non-transporter’s ISR (domestic and foreign)

· Description of type of food released, including brand name and specific variety

· Date food was released

· For persons who manufacture, process or pack food, the lot or code number or other identifier (to the extent the information exists)

· Quantity and how the food is packaged (e.g. 25 lb. cartons)

· Firm name and contact information of the transporter ISR who transported the food from you.

Note: Blind shipments or CPU (customer pick up) is not allowed.

· Records must include all information reasonably available to you to identify the specific source of each ingredient that was used to make every lot of finished product (note: what is reasonably available may vary from case to case)

Example 1: Common storage silo for an ingredient such as flour that is combined from three sources, the information reasonably available is the identity of all potential sources of the flour for each finished product.

Example 2: Dedicated storage silo for each ingredient source, information reasonably available is the identity of the specific source of the flour for each finished product.

REQUIREMENTS FOR TRANSPORTERS TO ESTABLISH AND MAINTAIN RECORDS

(Transporters have 5 options for meeting these requirements in the regulations)


(1) Establish and maintain the following records themselves:

Names of transporter’s IPS and transporter’s ISR
Origin and destination points
Date shipment received and released
Number of packages
Description of freight
Route of movement during the time food transported when various transportation companies are involved, e.g. truck to plane to another truck for delivery.
Transfer point(s) through which shipment moved
(2) Department of Transportation’s Federal Motor Carrier Safety Administration of roadway interstate transporters (bill of lading)

(3) Department of Transportation’s Surface Transportation Board of rail and water interstate transporters (bill of lading)

(4) Warsaw Convention of international air transporters (airway bill)

(5) Entering into a written agreement with the non-transporters IPS and ISR located in the United States to establish and maintain the required information.

NOTE: there are specific requirements for agreements between non-transporters and transporters.