Overview of Records and

Overview of Records and Administrative Detention Proposed

Regulations Implementing the Bioterrorism Act

Leslye M. Fraser, Esq.Associate Director for Regulations

Center for Food Safety and Applied Nutrition

Purpose of BriefingPurpose of Briefing

Provide an overview of proposed regulations implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act”) (PL 107-188):

– Section 306: Establishment, Maintenance, and Availability of Records

– Section 303: Administrative Detention of Food for Human or Animal Consumption

FDA Regulatory Development:FDA Regulatory Development:Lead PersonnelLead Personnel

E-mail:[email protected]@[email protected]@cfsan.fda.gov

Senior Manager L. Robert Lake (301) 436-2379

Overall Lead Leslye M. Fraser (301) 436-2378

Records Lead Nega Beru (301) 436-1400

Administrative Detention Lead

Marquita Steadman (301) 827-6733

Background: FDA’s Regulatory Background: FDA’s Regulatory Development TimelineDevelopment Timeline

July – Aug. 2002: FDA held six outreach meetings with 36 Embassies and 52 organizations

Until Aug. 30, 2002: FDA received > 150 comments from stakeholders that we considered as we developed the proposed rules

Background: FDA’s Regulatory Background: FDA’s Regulatory Development TimelineDevelopment Timeline May 9, 2003: FDA published proposed rules with

60 day comment period (ends July 8, 2003)– No extensions will be granted given statutory deadline

May 7, 2003: Public meeting via satellite downlink to domestic and international sites– Transcripts available in English, French & Spanish

By Dec. 12, 2003: FDA plans to issue final rules

Proposed Recordkeeping Proposed Recordkeeping RequirementsRequirements

68 FR 25188 (May 9, 2003)68 FR 25188 (May 9, 2003)

Statutory Deadline: December 12, 2003

Who Would Be Required To Who Would Be Required To Establish And Maintain Records?Establish And Maintain Records?

Domestic Domestic personspersons that manufacture, process, pack, that manufacture, process, pack, transport, distribute, receive, hold or import food transport, distribute, receive, hold or import food intended for human or animal consumption in the U. intended for human or animal consumption in the U. S.S.

Persons Persons includesincludes individuals, partnerships, corporations, cooperatives, associations, and government entities.

Foreign Foreign facilitiesfacilities that manufacture, process, pack that manufacture, process, pack or hold food intended for human or animal or hold food intended for human or animal consumption in the U.S., unless excludedconsumption in the U.S., unless excluded

Excluded From All Requirements:Farms

Restaurants

Firms regulated exclusively by the US Department of Agriculture (USDA)

Whom Does The Proposed Rule Whom Does The Proposed Rule Exclude?Exclude?

Excluded From All Requirements: Foreign facilities, if food is further

manufactured/processed (including packaging) by another facility outside the US

Exclusion does not apply if the activities of the subsequent facility are limited to a de minimis activity


Partial Exclusions*Fishing vessels not engaged in processing

Pet food entities that are exempt from FDA’s BSE rule (21 CFR 589.2000)

*No exclusion from the records access provisions


Partial Exclusions for Retail* All retail facilities are excluded from keeping

records of immediate subsequent recipients

Retail facilities employing < 10 full time equivalent employees selling unprocessed food from its farm or a neighboring farm (with respect to records for that unprocessed food)

*No exclusion from records access provisions


Facilities Engaged in Multiple Facilities Engaged in Multiple ActivitiesActivities

Records must be established and maintained for all covered activities

Example: growing oranges and processing them into orange juice for sale to a distributor– Growing—excluded as farm– Processing—records required

What Foods Does the Proposed What Foods Does the Proposed Rule Cover?Rule Cover?

Applies to all foods under FDA’s jurisdiction

Definition in sec. 201 (f) of the Federal Food, Drug, and Cosmetic Act applies:– i.e., “(1) articles used for food or drink for man

or other animals, (2) chewing gum, and (3) articles used for components of any such article.

Examples of FDA-Regulated FoodExamples of FDA-Regulated Food

– Food and food additives for man or animals– Dietary supplements and dietary ingredients– Infant formula– Pet food– Beverages (including alcoholic beverages and

bottled water)– Fruits and vegetablesFruits and vegetables


– Fish and seafoodFish and seafood– Dairy products and shell eggsDairy products and shell eggs– Raw agricultural commodities for use as food Raw agricultural commodities for use as food

or components of foodor components of food– Canned foodsCanned foods– Live food animalsLive food animals– Bakery goods, snack food, and candyBakery goods, snack food, and candy

What Foods Does FDA Not Regulate?What Foods Does FDA Not Regulate?

Foods that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the:– Federal Meat Inspection Act (21U.S.C. 601 et

seq.)– Poultry Products Inspection Act (21 U.S.C. 451

et seq.), or – Egg Products Inspection Act (21 U.S.C. 1031 et

seq.)

Proposed DefinitionsProposed Definitions

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

aquaculture facilities

Proposed Farm DefinitionProposed Farm Definition(cont.)(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; 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

Proposed Definitions (cont.)Proposed Definitions (cont.)

Manufacturing/processing– Making a food from one or more ingredients– Synthesizing, preparing, treating, modifying, or

manipulating food, including food crops or ingredients

E.g., cutting, peeling, trimming, washing, waxing, bottling, labeling, or packaging


Pet food – food for non-food producing animals

Perishable food - food that is not heat-treated, not frozen, and not otherwise preserved in a manner so as to prevent the quality of the food from being adversely affected if held longer than 7 days under normal shipping and storage conditions


Restaurant – a facility that prepares and sells food directly to consumers for immediate consumption– e.g., cafeterias, and hospital, nursing home, or day care

kitchens [and by analogy, pet shelters, kennels and veterinary facilities that provide food directly to animals]

– Facilities that provide food to interstate conveyances (e.g., trains, planes) are not restaurants

Proposed Definitions (cont.)Proposed Definitions (cont.) Retail facility: A facility that sells food products

directly to consumers only

Transporter - person who has possession, custody, or control of an article of food for the sole purpose of transporting the food

Non-transporter - a person who owns food or who holds, processes, packs, imports, receives, or distributes food for purposes other than transportation

RecordsRecords Non-transporters Non-transporters Have To Establish Have To Establish And Maintain to Identify the And Maintain to Identify the Immediate Immediate

Previous Source (IPS)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, including responsible individual and contact information (domestic or foreign)

Description of type of food received, including brand name and specific variety

RecordsRecords Non-transporters Non-transporters Have To Establish Have To Establish And Maintain to Identify the And Maintain to Identify the IPSIPS (cont) (cont)

Date food was received

Lot number or other identifier, if available

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

Name, responsible individual, and contact information of the transporters who brought the food to you

Non-transporters’Non-transporters’ Records Records Regarding the IPSRegarding the IPS

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

– What is reasonably available may vary from case to case

Example 1: Common Storage Silo for Example 1: Common Storage Silo for An Ingredient (e.g., Flour)An Ingredient (e.g., Flour)

Information reasonably available is the identity of all potential sources of the flour for each finished product

SourceA

SourceB

SourceC

Common Storage Silo

Manufacturing Plant

Cookies

Example 2: Dedicated Storage Silos Example 2: Dedicated Storage Silos for Each Ingredient Sourcefor Each Ingredient Source

Information reasonably available is the identity of the specific source of the flour for each finished product

SourceA

SourceB

SourceC

ManufacturingPlant Cookies

RecordsRecords Non-transporters Non-transporters Have To Have To Establish And Maintain to Identify the Establish And Maintain to Identify the Immediate Subsequent Recipient (ISR)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 that include:

Firm name, including responsible individual and contact information of ISR (domestic or foreign)

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

What Information Must What Information Must Non-Transporters Non-Transporters Keep in RecordsKeep in Records to Identify the to Identify the ISR ISR (cont)?(cont)?

Date food was releasedLot number or other identifier, if

availableQuantity and how the food is packaged

(e.g., 25 lb cartons) Name, responsible individual, and contact

information of the transporters who transferred the food from you

Establishment and Maintenance of Establishment and Maintenance of Records by Records by Non-TransportersNon-Transporters

Non-transporters (e.g. manufacturers) must establish and maintain records that identify both the transporter and non-transporter IPS and ISR (indicated with solid red arrows above)

Company A Company B Company CManufacturer

Retail Store

RecordsRecords Transporters Transporters Have To Establish Have To Establish And Maintain to Identify the And Maintain to Identify the IPR and ISRIPR and ISR

For each food you transport . . . Firm name, including responsible individual and

contact information (domestic or foreign) of:– Person who had the food immediately before you; and– Person who had the food immediately after you

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

What RecordsWhat Records Would Would TransportersTransporters Have To Establish And Maintain?Have To Establish And Maintain?

Dates food was received and delivered Lot number or other identifier, if available Quantity and how the food is packaged (e.g., 25

lb cartons) Identification of each and every mode of

transportation and responsible individual(s) throughout transport

Example 3: Various Transportation Example 3: Various Transportation CompaniesCompanies

Trucks and planes are owned by different companies. The proposed rule would require each company to keep records only of transactions to which it is a party (i.e., from whom it received the food and to whom it released the food).

Company A Company B Company C Manufacturer

Retail Store

Example 4: Purple Transportation Example 4: Purple Transportation CompanyCompany

All trucks and planes are owned by Company A (Purple Transportation Co.) The proposed rule would require the company to keep records of when the food was put on each vehicle and who was responsible for the food during each leg of the trip.

Manufacturer

Retail Store

Frequently Asked Questions . . .Frequently Asked Questions . . .

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

Yes - you still must comply with all other statutes and regulations that apply to you

E.g., recordkeeping requirements for infant formula, low acid canned food, animal feed, bottled water, color additives

When do I have to create the When do I have to create the records?records?

Records must be created at the time the activity occurs

Can I Use Existing Records?Can I Use Existing Records?

Yes – if they contain all the information required by the proposed rule

You are responsible for supplementing existing records, if necessary, to ensure all required information is established and maintained

In what format must I establish In what format must I establish and maintain these recordsand maintain these records??

In any format, paper or electronic

Must contain all the required information

Proposed rule exempts records from 21 CFR Part 11, which specifies criteria for acceptance by FDA of certain electronic records

NOTE: No exemption if the records are kept for some other statutory or regulatory purpose

How long must the records be How long must the records be retained? retained?

1 Year from date of creation:– Perishable foods not intended for processing

into non-perishable foods– All required records for animal food, including

pet food

2 years from date of creation:– All other foods, except animal foods

What are the record availability What are the record availability requirements? requirements?

When FDA has reasonable belief that a food is adulterated and presents a threat of serious adverse health consequences of death to humans or animals, records accessible to FDA must be available for inspection and copying by FDA:

– Within 4 hours if requested between 8:00 am and 6:00 pm, Monday-Friday

– Within 8 hours if requested any other time

What are the record availability What are the record availability requirements (cont.)? requirements (cont.)?

If records stored offsite, you must be able to retrieve and provide them onsite within specified timeframes

Electronic records are considered onsite if they can be retrieved from an onsite location

What records are excluded?What records are excluded?

Recipes (quantitative formula excluded, but not individual ingredients)

Financial data Pricing data Personnel data Research data Sales data (other than shipment data regarding

sales)

What if records aren’t established, What if records aren’t established, maintained, or provided to FDA upon maintained, or provided to FDA upon

request?request?Failure to establish and maintain the

required records is a prohibited act

Failure to make them available to FDA upon proper request is a prohibited act

When would compliance with the When would compliance with the recordkeeping rules be required?recordkeeping rules be required?

After the final rule is published: – Larger businesses (> 500 full time equivalent

(FTE) employees) - within 6 months– Small businesses (11-499 FTE employees) -

within 12 months– Very small businesses (< 10 FTE employees) -

within 18 months

Some Significant Areas For Which FDA Some Significant Areas For Which FDA Specifically Is Seeking CommentSpecifically Is Seeking Comment

Statutory ambiguity/FDA interpretation that we are required by the Statute to promulgate regulations

Intrastate coverage authority Limiting foreign coverage to those subject to

Registration rule Outer food packaging exclusion Fishing vessels not engaged in processing

exclusion Retail facility/Roadside stand exclusion

Some Significant Areas For Which FDA Some Significant Areas For Which FDA Specifically Is Seeking Comment (cont.)Specifically Is Seeking Comment (cont.)

Perishable food definition and record retention criteria

Pet food partial exclusion Criteria for determining scope of pet food

coverage Non-transporter requirement to keep records on

both transporters and non-transporters Inclusion of a Model Form in the final rule

Proposed Administrative Proposed Administrative Detention RequirementsDetention Requirements

68 FR 25242 (May 9, 2003)68 FR 25242 (May 9, 2003)

Statutory Deadline: NoneFDA Publication Goal: December 12, 2003

What are the criteria for detaining What are the criteria for detaining food?food?

An officer or qualified employee of FDA may order detention of food if credible evidence or information that the food presents a threat of serious adverse health consequence or death to humans or animals (SAHCODHA)

Applies to both domestic and imported foods

Administrative DetentionAdministrative Detention Detention must be approved at district director level or

higher, as designated by the Secretary

Detention period < 20 days, unless Secretary needs more time (< 30 days total) to pursue seizure or injunction

FDA can direct the movement of the food to a secure facility, as appropriate

Prohibited act to transfer an article in violation of a detention order or remove/alter any required mark or label

What Food is Subject to FDA’s What Food is Subject to FDA’s Jurisdiction?Jurisdiction?

Definition in sec. 201 (f) of the Federal Food, Drug, and Cosmetic Act applies:– i.e., “(1) articles used for food or drink for man or

other animals, (2) chewing gum, and (3) articles used for components of any such article.”

Examples of FDA-regulated food:– Food and food additives for man or animals– Dietary supplements and dietary ingredients– Infant formula– Pet food


– Beverages (including alcoholic beverages and bottled water)

– Fruits and vegetablesFruits and vegetables– Fish and seafoodFish and seafood– Dairy products and shell eggsDairy products and shell eggs– Raw agricultural commodities for use as food or Raw agricultural commodities for use as food or

components of foodcomponents of food– Canned foodsCanned foods– Live food animalsLive food animals– Bakery goods, snack food, and candyBakery goods, snack food, and candy

What Food is Not Subject to What Food is Not Subject to Administrative Detention?Administrative Detention?

Foods that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the:– Federal Meat Inspection Act (21U.S.C. 601 et

seq.)– Poultry Products Inspection Act (21 U.S.C.

451 et seq.), or – Egg Products Inspection Act (21 U.S.C. 1031

et seq.)

Labeling or Marking of Detained Food Labeling or Marking of Detained Food

Detention may require marking or labeling of detained food, which would include:– Statement food is detained by FDA– Statement food must not be consumed, moved,

altered, or tampered with in any manner without written permission from FDA

– Violation of detention order or removal of tag or label is a prohibited act

– Detention order number, detention period, and name of FDA official who issued the order

Proposed Expedited Procedures for Proposed Expedited Procedures for Detained Perishable FoodsDetained Perishable Foods

If FDA initiates a seizure action against a detained perishable food, FDA will:– send the seizure recommendation to the U.S.

Department of Justice (DOJ) < 4 calendar days after detention order issued, unless extenuating circumstances* exist

*Includes, but not limited to instances when the results of confirmatory testing or other evidential development requires > 4 working days to complete

Proposed Expedited Procedures for Proposed Expedited Procedures for Detained Perishable Foods (cont.)Detained Perishable Foods (cont.)

– If 4th calendar day is not a working day, FDA will advise DOJ on last working day before the 4th day of our plans to recommend seizure action and send recommendation as soon as possible on first working day that follows

FDA’S Administrative Detention:FDA’S Administrative Detention:Proposed DefinitionsProposed Definitions

Perishable foods –Food that is not heat-treated, not frozen, and not otherwise preserved in a manner as to prevent the quality of the food from being adversely affected if held longer than 7 days under normal shipping and storage conditions

Calendar Day – every day shown on the calendar

What Information Must Be Included in An What Information Must Be Included in An Administrative Detention Order?Administrative Detention Order?

Detention order numberThe date and hour of the orderIdentification of the detained foodThe detention periodA statement that the article of food

identified in the order is detained for the period shown

What Information Must Be Included in An What Information Must Be Included in An Administrative Detention Order (cont.)?Administrative Detention Order (cont.)?

A brief, general statement of the reasons for the detention

The address and location where the article of food is to be detained and appropriate storage conditions

Any applicable conditions of transportation Statement that the food is not to be

consumed, moved, altered, or tampered with in any manner during the detention period (unless subject to a conditional release)

What Information Must Be Included in An What Information Must Be Included in An Administrative Detention Order (cont.)?Administrative Detention Order (cont.)?

Information regarding the appeal process

Name and contact information of the District Director in whose district the food is located

Statement indicating how the approval of the detention order was obtained (orally or in writing)

Who would receive a copy of the Who would receive a copy of the detention order?detention order?

Owner, operator or agent in charge of the place where the detained food is located

Owner* of the food if different from those listed above

Shipper of record* and owner and operator of the vehicle/carrier*, if detained food is located in a vehicle or other carrier

* If identities can be readily determined

When does a detention order When does a detention order terminate?terminate?

FDA authorized representative will issue a detention termination notice if FDA terminates a detention order or the detention period expires

Detention order deemed terminated if FDA fails to issue a detention termination notice or detention period expires

Administrative Detention Administrative Detention Right to AppealRight to Appeal

BT Act requires Secretary, after an opportunity for informal hearing, to decide appeals in 5 days

– Appeal decision is subject to judicial review– process terminates if Secretary files for seizure

or injunction– detention order terminates if Secretary does not

comply with appeal requirements

AppealsAppeals Any person who would be a claimant for the food, if

seized under section 304(a) of the Act, can appeal a detention order

Request of an appeal with or without an informal hearing must be addressed to the FDA District Director in whose district the food is located

FDA Regional Food and Drug directors or officials senior to them preside at hearings, who may require hearing to be completed within 1 day

Presiding officer will issue final agency decision

Detention Appeal TimelinesDetention Appeal Timelines

Non-perishable Articles of Food

Perishable Articles of Food

File intent to appeal with a request for an informal hearing

within 4 days of receipt of detention order

not applicable

File appeal with request for an informal hearing

within 10 days of receipt of detention

order


File appeal without a request for an informal hearing

within 10 days of receipt of detention

order


Detention Appeal Timelines (cont.)Detention Appeal Timelines (cont.)

Non-perishable Articles of Food

Perishable Articles of Food

Hold hearing (FDA) within 3 days after an appeal is filed

within 2 days after an appeal is filed

Make decision on appeal (FDA)

within 5 calendar days after an appeal is filed

within 5 calendar days after an appeal is filed

Use of Classified Information Use of Classified Information in Hearingsin Hearings

Some credible evidence or information supporting a detention order may consist of classified national security information

While we are obliged to provide a fair, expeditious, and impartial hearing, release of classified information is restricted

Use of Classified Information (cont.)Use of Classified Information (cont.) If FDA may do so (while safeguarding the

information/source), FDA will provide the general nature of the information and an opportunity to offer opposing evidence or information

If classified information was used to support the detention, then any confirmation of such detention will state whether it is based in whole or in part on that classified information

FDA is considering developing general regulations on handling classified information for all FDA-regulated products

Next StepsNext Steps These are proposed rules; there is no duty to

comply with the rules now, but note:

– The BT Act’s access to records authority is in effect now; however, the Act does not provide a specific time period within which applicable records must be made available to FDA upon an appropriate request (Act says records must be made available at “reasonable times”)

– Administrative detention authority is in effect now. Until final regulations are published and in effect, 21 CFR Part 16 would apply to any detention proceedings.

Next Steps (cont.)Next Steps (cont.)

Comments on the records and detention proposed rules are due no later than July 8, 2003

FDA plans to publish the final rules by Dec. 12, 2003

How Do I Get a Copy of the How Do I Get a Copy of the Proposed Rules?Proposed Rules?

http://www.fda.gov/oc/bioterrorism/bioact.html

• Or write to:Or write to:Dockets Management Branch Dockets Management Branch (HFA-305)Food and Drug AdministrationFood and Drug Administration5630 Fishers Lane, Room 10615630 Fishers Lane, Room 1061Rockville, MD USA 20852Rockville, MD USA 20852



How To CommentHow To Comment(Deadline July 8, 2003)(Deadline July 8, 2003)

Submit written comments to: Dockets Management Branch (HFA-305) Food and Drug Administration5630 Fishers Lane, rm. 1061Rockville, MD USA 20852

Submit electronic comments to: http://www.fda.gov/dockets/ecomments

YOU MUST INCLUDE THE DOCKET NUMBER:– 02N-0277: Records; 02N-0275: Detention

http://www.fda.gov/dockets/ecomments

http://www.fda.gov/dockets/ecomments

For Further Information . . .For Further Information . . .

For current information on FDA’s efforts For current information on FDA’s efforts under the Bioterrorism Act or to obtain an under the Bioterrorism Act or to obtain an electronic copy of these slides: electronic copy of these slides:




Documents

Overview of Records and