FDA's Final Rule on Recordkeeping Under the Bioterrorism Act (Full Summary)

According to the FDA, such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food.

Effective Date and Various Compliance Dates of Final Rule

Although this final rule is effective February 7, 2005, the final rule and FDA sources state that the compliance date for Subpart J is December 9, 2005, except for small businesses (i.e. fewer than 500 but more than 10 full-time equivalent (FTE) employees) the compliance date is June 9, 2006, and except for very small businesses (i.e. 10 or fewer FTE employees) the compliance date is December 11, 2006.

(FDA sources state that a notice correcting the compliance dates in the final rule for small businesses (the final rule erroneously states that the compliance date is June 9, 2005 or June 9, 2004) is expected to be issued in the next several weeks. Other corrections are also expected to be included.)

Entities Subject to Subpart J Recordkeeping Requirements

New 21 CFR 1.326(a) states that the following (unless excluded) are subject to the new recordkeeping requirements of Subpart J:

Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the U.S. are subject to the regulations in Subpart J, unless they qualify for one of the exclusions in 21 CFR 1.327. If a person conducts more than one type of activity at a location, they are required to keep records with respect to those activities covered by Subpart J, but are not required by this subpart to keep records with respect to activities that fall within one of the exclusions in 21 CFR 1.327.

New 21 CFR 1.326(b) adds that persons who are subject to the regulations in Subpart J must keep records whether or not the food is being offered for or enters interstate commerce.

Entities Excluded (in whole or part) from Subpart J Recordkeeping Requirements

New 21 CFR 1.327 lists those persons and entities that are excluded from all or part of the regulations in Subpart J. These full and partial exclusions include (partial list):

Meat, poultry, or egg products subject to exclusive USDA jurisdiction. Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the U.S. that is within the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act are excluded from all of the requirements in Subpart J with respect to that food while it is under the exclusive jurisdiction of the USDA.

Certain foreign persons. Foreign persons, except for foreign persons who transport food in the U.S., are excluded from all of the requirements of Subpart J.

Packaging. Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food are subject to 21 CFR 1.361 (record availability requirements) and 1.363 (consequences of failing to establish/maintain records or make them available to FDA as required by Subpart J) with respect to its packaging (the outer packaging of food that bears the label and does not contact the food).

All other persons who manufacture, process, pack, transport, distribute, receive, hold, or import packaging are excluded from all of the requirements of Subpart J.

Food contact substances (other than finished containers that directly contact food). Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food contact substances other than the finished container that directly contacts food are excluded from all of the requirements of this subpart, except 21 CFR 1.361 and 1.363.

Finished containers that directly contact food. Persons who place food directly in contact with its finished container are subject to all of the requirements of Subpart J as to the finished container that directly contacts that food. All other persons who manufacture, process, pack, transport, distribute, receive, hold, or import the finished container that directly contacts the food are excluded from the requirements of this subpart as to the finished container, except 21 CFR 1.361 and 1.363.

Food for personal consumption. Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food for personal consumption are excluded from all the requirements of Subpart J.

(See 21 CFR 1.327 for additional full and partial exclusions, including farms; restaurants; certain fishing vessels; etc.)

Use of Existing Records to Satisfy the Requirements of Subpart J

New 21 CFR 1.330 states that the regulations in Subpart J do not require duplication of existing records if those records contain all of the information required by this subpart. If a covered person keeps records of all of the information as required by this subpart to comply with other Federal, State, or local regulations, or for any other reason, then those records may be used to meet these requirements.

Moreover, FDA states that persons do not have to keep all of the information required by this final rule in one set of records. If they have records containing some of the required information, they may keep those existing records and keep, either separately or in a combined form, any new information required by this final rule.

1. CFR 1.330 further provides that there is no obligation to create an entirely new record or compilation of records containing both existing and new information, even if the records containing some of the required information were not created at the time the food was received or released.

Regulations of Subpart J are in Addition to Existing Recordkeeping Regulations

New 21 CFR 1.329(a) provides that in addition to the regulations in Subpart J, persons must comply with all other applicable statutory provisions and regulations related to the establishment and maintenance of records for foods except as described in 21 CFR 1.329(b) (see below). For example, the regulations in Subpart J are in addition to existing recordkeeping regulations for low acid canned foods, juice, seafood, infant formula, color additives, bottled water, animal feed, and medicated animal feed.

New 21 CFR 1.329(b) states that records established or maintained to satisfy the requirements of Subpart J that meet the definition of electronic records in 21 CFR 11.3(b)(6) are exempt from the requirements of 21 CFR Part 11. Records that satisfy the requirements of this subpart but that are also required under other applicable statutory provisions or regulations remain subject to 21 CFR Part 11.

Highlights of Definitions Added by New Subpart J

The following are a selection of the definitions that are applicable to this final rule and found in 21 CFR 1.328 (partial list):

Food. Food has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (Act). Examples of food include, but are not limited to fruits; vegetables; fish; dairy products; eggs; raw agricultural commodities for use as food or as components of food; animal feed, including pet food; food and feed ingredients and additives, including substances that migrate into food from the finished container and other articles that contact food; dietary supplements and dietary ingredients; infant formula; beverages, including alcoholic beverages and bottled water; live food animals; bakery goods; snack foods; candy; and canned foods.

Holding. Holding means storage of food. Holding facilities include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.

Nontransporter. Nontransporter means a person who owns food or who holds, manufactures, processes, packs, imports, receives, or distributes food for purposes other than transportation.

Packaging. Packaging means the outer packaging of food that bears the label and does not contact the food. Packaging does not include food contact substances as they are defined in section 409(h)(6) of the Act (21 U.S.C. 348(h)(6)).

Transporter. Transporter means a person who has possession, custody, or control of an article of food in the U.S. for the sole purpose of transporting the food, whether by road, rail, water, or air. Transporter also includes a foreign person that transports food in the U.S., regardless of whether that foreign person has possession, custody, or control of that food for the sole purpose of transporting that food.

FDA Final Rule Provides Five Recordkeeping Options for Transporters

The FDA states that transporters must establish and maintain the following records for each food they transport in the U.S. This requirement may be fulfilled by either:

Option 1 - Establishing and maintaining certain records. Under new 21 CFR 1.352(a), transporters may establish and maintain the following records:

Names of the transporter's immediate previous source and transporter's immediate subsequent recipient;

Origin and destination points;

Date shipment received and date released;

Number of packages;

Description of freight;

Route of movement during the time the transporter transported the food; and

Transfer point(s) through which shipment moved; or

Option 2 - Establishing and maintaining records required by FMCSA (roadway Interstate Transporters). New 21 CFR 1.352(b) states that transporters may establish and maintain records containing the following information currently required of roadway interstate transporters by the Department of Transportation's Federal Motor Carrier Safety Administration (FMCSA) under 49 CFR 373.101 and 373.103 as of December 9, 2004:

Names of consignor and consignee;

Origin and destination points;

Date of shipment;

Number of packages;

Description of freight;

Route of movement and name of each carrier participating in the transportation; and

Transfer points through which shipment moved; or

Option 3 - Establishing and maintaining records required by Surface Transportation Board (rail and water interstate transporters). New 21 CFR 1.352(c) states that transporters may establish and maintain records containing the following information currently required by the Department of Transportation's Surface Transportation Board of rail and water interstate transporters under 49 CFR 1035.1 and 1035.2 as of December 9, 2004:

Date received;

Received from;

Consigned to;

Destination;

State of;

County of;

Route;

Delivering carrier;

Car initial;

Car no;

Trailer initials/number;

Container initials/number;

No. packages; and

Description of articles; or

Option 4 - Establishing and maintaining records required by Warsaw Convention (international air carriers). New 21 CFR 1.352(d) states that transporters have the option of establishing and maintaining records containing the following information currently required by the Warsaw Convention of international air transporters on air waybills:

Shipper's name and address;

Consignee's name and address;

Customs reference/status;

Airport of departure and destination;

First carrier; and

Description of goods; or

Option 5 - Recordkeeping agreements with certain nontransporters. New 21 CFR 1.352(e) states that a transporter may enter into an agreement with the nontransporter immediate previous source located in the U.S. and/or the nontransporter immediate subsequent recipient located in the U.S. to establish, maintain, or establish and maintain, the information in 21 CFR 1.352(a), (b), (c), or (d). The agreement must contain the following elements:

Effective date;

Printed names and signatures of authorized officials;

Description of the records to be established and/or maintained;

Provision for the records to be maintained in compliance with 21 CFR 1.360, if the agreement provides for maintenance of records;

Provision for the records to be available to FDA as required by 21 CFR 1.361, if the agreement provides for maintenance of records;

Acknowledgement that the nontransporter assumes legal responsibility under 21 CFR 1.363 for establishing and/or maintaining the records as required by this subpart; and

Provision that if the agreement is terminated in writing by either party, responsibility for compliance with the applicable establishment, maintenance, and access provisions of Subpart J reverts to the transporter as of the date of termination.

Nontransporter Must Identify Immediate Previous Sources of Food

Under new 21 CFR 1.337, nontransporters must establish and maintain the following records for all food they receive:

The name of the firm, address, telephone number and, if available, the fax number and e-mail address of the nontransporter immediate previous source, whether domestic or foreign;

An adequate description of the type of food received, to include brand name and specific variety (e.g., brand x cheddar cheese, not just cheese; or romaine lettuce, not just lettuce);

The date the food was received;

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

The quantity and how the food is packaged (e.g., 6 count bunches, 25 pound (lb) carton, 12 ounce (oz) bottle, 100 gallon (gal) tank); and

The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter immediate previous source (the transporter who transported the food to you).

Nontransporter Must Identify Immediate Subsequent Recipients of Food

New 21 CFR 1.345 provides that nontransporters must also establish and maintain the following records for food they release:

The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the nontransporter immediate subsequent recipient, whether domestic or foreign;

An adequate description of the type of food released, to include brand name and specific variety (e.g., brand x cheddar cheese, not just cheese; or romaine lettuce, not just lettuce);

The date the food was released;

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

The quantity and how the food is packaged (e.g., 6 count bunches, 25 lb carton, 12 oz bottle, 100 gal tank); and

The name of the firm, address, telephone number, and, if available, the fax number and e-mail address of the transporter immediate subsequent recipient (the transporter who transported the food from the nontransporter).

The final rule also requires that nontransporters' records include information reasonably available to them to identify the specific source of each ingredient used to make every lot of finished product.

Records Required to be Retained Under Subpart J

New 21 CFR 1.360(a) states that persons subject to Subpart J must create the required records when they receive and release food, except to the extent that the information is contained in existing records. The regulations contained in new 21 CFR 1.360 further provide:

Record retention requirements for nontransporters. Under new 21 CFR 1.360(b), nontransporters must retain for 6 months after the dates they receive and release the food all required records for any food having a significant risk of spoilage, loss of value, or loss of palatability within 60 days after the date they receive or release the food.

In addition, new 21 CFR 1.360(c) states that nontransporters must retain for 1 year after the dates they receive and release the food all required records for any food for which a significant risk of spoilage, loss of value, or loss of palatability occurs only after a minimum of 60 days, but within 6 months, after the date they receive or release the food.

New 21 CFR 1.360(d) states that nontransporters must retain for 2 years after the dates they receive and release the food all required records for any food for which a significant risk of spoilage, loss of value, or loss of palatability does not occur sooner than 6 months after the date they receive or release the food, including foods preserved by freezing, dehydrating, or being placed in a hermetically sealed container.

In addition, new 21 CFR 1.360(e) provides that nontransporters must retain for 1 year after the dates they receive and release the food all required records for animal food, including pet food.

Requirements for records retained by transporters, or nontransporters on behalf of a transporter. Under new 21 CFR 1.360(f), transporters, or nontransporters retaining records on behalf of a transporter, must retain for 6 months after the dates they receive and release the food all required records for any food having a significant risk of spoilage, loss of value, or loss of palatability within 60 days after the date the transporter receives or releases the food.

Furthermore, transporters, or nontransporters retaining records on behalf of a transporter, must retain for 1 year after the dates they receive and release the food, all required records for any food for which a significant risk of spoilage, loss of value, or loss of palatability occurs only after a minimum of 60 days after the date the transporter receives or releases the food.

Location of records. New 21 CFR 1.360(g) states that subject persons must retain all records at the establishment where the covered activities described in the records occurred (onsite) or at a reasonably accessible location.

Electronic records. New 21 CFR 1.360(h) provides that the maintenance of electronic records is acceptable, and states that electronic records are considered to be onsite if they are accessible from an onsite location.

Final Rule's Record Availability Requirementsunder Subpart J

According to new 21 CFR 1.361, 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 Federal Food, Drug, and Cosmetic Act (Act), 21 USC 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction.

Such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice.

Records Excluded from Subpart J

New 21 CFR 1.361 explains that the establishment and maintenance of records as required by Subpart J does not extend to recipes for food as defined in 21 CFR 1.328; financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales).

Consequences for Failing to Establish Records Required by Subpart J

New 21 CFR 1.363(a) states that the failure to establish or maintain records as required by section 414(b) of the Act and this final rule or the refusal to permit access to or verification or copying of any such required record is a prohibited act under section 301 of the Act.

In addition, under 21 CFR 1.363(b), the failure of a nontransporter immediate previous source or a nontransporter immediate subsequent recipient who enters an agreement under 21 CFR 1.352(c) to establish, maintain, or establish and maintain, records required under 21 CFR 1.352(a) or (b), or the refusal to permit access to or verification or copying of any such required record, is a prohibited act under section 301 of the Act.

It is also provided at new 21 CFR 1.363(c) that the failure of any person to make records or other information available to FDA as required by section 414 or 704(a) of the Act and this regulation is a prohibited act under section 301 of the Act.

(See ITT's Online Archives or 05/13/03 news, 03051305, for BP summary of the FDA's proposed rule on recordkeeping.)

FDA Contact - Nega Beru (301) 436-1400

FDA Final Rule (D/N 2002N-0277, FR Pub 12/09/04) available at http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-26929.pdf