# Presentation: 128065

## 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

**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 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:Lead Personnel

| 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 |

- E-mail:
- _[Lloyd.Lake@cfsan.fda.gov](mailto:Lloyd.Lake@cfsan.fda.gov)_
- _[Leslye.Fraser@cfsan.fda.gov](mailto:Leslye.Fraser@cfsan.fda.gov)_
- _[Nega.Beru@cfsan.fda.gov](mailto:Nega.Beru@cfsan.fda.gov)_
- _[Marquita.Steadman@cfsan.fda.gov](mailto:Marquita.Steadman@cfsan.fda.gov)_

## Background:  FDA’s Regulatory Development 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 Development 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 Requirements68 FR 25188  (May 9, 2003)

***Statutory Deadline:  December 12, 2003***

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

**Domestic *****persons***** that manufacture, process, pack, transport, distribute, receive, hold or import food intended for human or animal consumption in the U. S.**
***Persons ***includes*** ***individuals, partnerships, corporations, cooperatives, associations, and government entities.
**Foreign *****facilities***** that manufacture, process, pack or hold food intended for human or animal consumption in the U.S., unless excluded**

## Excluded From All Requirements:
Farms

Restaurants 

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

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

**Whom Does The Proposed Rule 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

**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**

**Whom Does The Proposed Rule Exclude?**

## 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

**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**

**Whom Does The Proposed Rule Exclude?**

## 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

**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**

**Whom Does The Proposed Rule Exclude?**

## Facilities Engaged in Multiple Activities

**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 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 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 vegetables**

## Examples of FDA-Regulated Food

**Fish and seafood**
**Dairy products and shell eggs**
**Raw agricultural commodities for use as food or components of food**
**Canned foods**
**Live food animals**
**Bakery goods, snack food, and candy**

## 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 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 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****; 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.)

**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**

## Proposed Definitions (cont.)

**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**

## Proposed Definitions (cont.)

**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.)

**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**

## 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, including responsible individual**** ****and contact information (domestic or foreign)**
**Description of type of food**** received, including brand name and specific variety**

## Records Non-transporters Have To Establish And Maintain to Identify the IPS (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’ Records Regarding 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 An Ingredient (e.g., Flour)

**Source**
**A**

**Source**
**B**

**Source**
**C**

**Common Storage **
**Silo**

**Manufacturing Plant**

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

**Cookies**

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

**Source**
**A**

**Source**
**B**

**Source**
**C**

**Manufacturing**
**Plant**

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

**Cookies**

## 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 *****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 Non-Transporters Keep in Records to Identify the ISR (cont)?

**Date**** food was released**
**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 transferred the food *****from***** you**

## Establishment and Maintenance of Records by Non-Transporters

**  ****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 IPS and ISR (indicated with solid red arrows above)**

## Records Transporters Have To Establish And Maintain to Identify the IPR 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 Records Would Transporters 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 Companies

**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 Company

**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 . . .

## Do other recordkeeping requirements 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 records?

**Records must be created *****at the time the activity occurs ***

## 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 and 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 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 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 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?

**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, maintained, or provided to FDA upon 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 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  Specifically 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 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 Detention Requirements68 FR 25242 (May 9, 2003)

***Statutory Deadline:  None***
***FDA Publication Goal:  December 12, 2003***

## What are the criteria for detaining 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 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 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**

## Examples of FDA-Regulated Food

**Beverages (including alcoholic beverages and bottled water)**
**Fruits and vegetables**
**Fish and seafood**
**Dairy products and shell eggs**
**Raw agricultural commodities for use as food or components of food**
**Canned foods**
**Live food animals**
**Bakery goods, snack food, and candy**

## What Food is Not Subject to 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 

**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 Detained 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 Detained Perishable Foods (cont.)

**If 4****th**** calendar day is not a working day****, FDA will advise DOJ on last working day before the 4****th**** 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:Proposed 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 Administrative Detention Order?

**Detention order number**
**The date and hour of the order**
**Identification of the detained food**
**The detention period**
**A statement that the article of food identified in the order is detained for the period shown**

## What Information Must Be Included in An 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 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 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 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 Right 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**

## Appeals

**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 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 | within 2 days of receipt of detention order |
| File appeal without a request for an informal hearing | within 10 days of receipt of detention order
 | within 2 days of receipt of detention order
 |

## 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 in 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.)

**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 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.)

**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 Proposed Rules?

**http://www.fda.gov/oc/bioterrorism/bioact.html**
**Or write to:**
**	****Dockets Management Branch ****(HFA-305)**
**	****Food and Drug Administration**
**	****5630 Fishers Lane, Room 1061**
**	****Rockville, MD USA 20852**

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

**Submit written comments to:**
**	**** ****Dockets Management Branch (HFA-305) **
**	**** ****Food and Drug Administration**
**5630 Fishers Lane, rm. 1061**
**Rockville, MD USA 20852**
**Submit electronic comments to:  **** **_**[http://www.fda.gov/dockets/ecomments](http://www.fda.gov/dockets/ecomments)**_
**YOU MUST INCLUDE THE DOCKET NUMBER:**
**02N-0277:  Records; 02N-0275:  Detention **

## For Further Information . . .

**For current information on FDA’s efforts under the Bioterrorism Act or to obtain an electronic copy of these slides: **
- 	_[http://](http://www.fda.gov/oc/)__[www.fda.gov/oc/](http://www.fda.gov/oc/)__[bioterrorism/bioact.html](http://www.fda.gov/oc/bioterrorism/bioact.html)_