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Overview of Records and Administrative Detention Proposed Regulations
Overview of Records and Administrative Detention Proposed Regulations
Background: FDA’s Regulatory Development Timeline
Background: FDA’s Regulatory Development Timeline
Proposed Definitions
Proposed Definitions
Proposed Definitions
Proposed Definitions
Proposed Definitions
Proposed Definitions
Example 1: Common Storage Silo for An Ingredient (e
Example 1: Common Storage Silo for An Ingredient (e
Example 1: Common Storage Silo for An Ingredient (e
Example 1: Common Storage Silo for An Ingredient (e
Example 1: Common Storage Silo for An Ingredient (e
Example 1: Common Storage Silo for An Ingredient (e
Establishment and Maintenance of Records by Non-Transporters
Establishment and Maintenance of Records by Non-Transporters
Establishment and Maintenance of Records by Non-Transporters
Establishment and Maintenance of Records by Non-Transporters
Establishment and Maintenance of Records by Non-Transporters
Establishment and Maintenance of Records by Non-Transporters
Establishment and Maintenance of Records by Non-Transporters
Establishment and Maintenance of Records by Non-Transporters
Example 4: Purple Transportation Company
Example 4: Purple Transportation Company
Example 4: Purple Transportation Company
Example 4: Purple Transportation Company
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Overview of Records and Administrative Detention Proposed Regulations Implementing the Bioterrorism Act

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1Overview of Records and Administrative 40years from date of creation: All other
Detention Proposed Regulations foods, except animal foods.
Implementing the Bioterrorism Act Leslye 41What are the record availability
M. Fraser, Esq. Associate Director for requirements? When FDA has reasonable
Regulations Center for Food Safety and belief that a food is adulterated and
Applied Nutrition. presents a threat of serious adverse
2Purpose of Briefing. Provide an health consequences of death to humans or
overview of proposed regulations animals, records accessible to FDA must be
implementing the Public Health Security available for inspection and copying by
and Bioterrorism Preparedness and Response FDA: Within 4 hours if requested between
Act of 2002 (“the Bioterrorism Act”) (PL 8:00 am and 6:00 pm, Monday-Friday Within
107-188): Section 306: Establishment, 8 hours if requested any other time.
Maintenance, and Availability of Records 42What are the record availability
Section 303: Administrative Detention of requirements (cont.)? If records stored
Food for Human or Animal Consumption. offsite, you must be able to retrieve and
3FDA Regulatory Development: Lead provide them onsite within specified
Personnel. Senior Manager. L. Robert Lake. timeframes Electronic records are
(301) 436-2379. Overall Lead. Leslye M. considered onsite if they can be retrieved
Fraser. (301) 436-2378. Records Lead. Nega from an onsite location.
Beru. (301) 436-1400. Administrative 43What records are excluded? Recipes
Detention Lead. Marquita Steadman. (301) (quantitative formula excluded, but not
827-6733. E-mail: Lloyd.Lake@cfsan.fda.gov individual ingredients) Financial data
Leslye.Fraser@cfsan.fda.gov Pricing data Personnel data Research data
Nega.Beru@cfsan.fda.gov Sales data (other than shipment data
Marquite.Steadman@cfsan.fda.gov. regarding sales).
4Background: FDA’s Regulatory 44What if records aren’t established,
Development Timeline. July – Aug. 2002: maintained, or provided to FDA upon
FDA held six outreach meetings with 36 request? Failure to establish and maintain
Embassies and 52 organizations Until Aug. the required records is a prohibited act
30, 2002: FDA received > 150 comments Failure to make them available to FDA upon
from stakeholders that we considered as we proper request is a prohibited act.
developed the proposed rules. 45When would compliance with the
5Background: FDA’s Regulatory recordkeeping rules be required? After the
Development Timeline. May 9, 2003: FDA final rule is published: Larger businesses
published proposed rules with 60 day (> 500 full time equivalent (FTE)
comment period (ends July 8, 2003) No employees) - within 6 months Small
extensions will be granted given statutory businesses (11-499 FTE employees) - within
deadline May 7, 2003: Public meeting via 12 months Very small businesses (< 10
satellite downlink to domestic and FTE employees) - within 18 months.
international sites Transcripts available 46Some Significant Areas For Which FDA
in English, French & Spanish By Dec. Specifically Is Seeking Comment. Statutory
12, 2003: FDA plans to issue final rules. ambiguity/FDA interpretation that we are
6Proposed Recordkeeping Requirements 68 required by the Statute to promulgate
FR 25188 (May 9, 2003). Statutory regulations Intrastate coverage authority
Deadline: December 12, 2003. Limiting foreign coverage to those subject
7Who Would Be Required To Establish And to Registration rule Outer food packaging
Maintain Records? Domestic persons that exclusion Fishing vessels not engaged in
manufacture, process, pack, transport, processing exclusion Retail
distribute, receive, hold or import food facility/Roadside stand exclusion.
intended for human or animal consumption 47Some Significant Areas For Which FDA
in the U. S. Persons includes individuals, Specifically Is Seeking Comment (cont.).
partnerships, corporations, cooperatives, Perishable food definition and record
associations, and government entities. retention criteria Pet food partial
Foreign facilities that manufacture, exclusion Criteria for determining scope
process, pack or hold food intended for of pet food coverage Non-transporter
human or animal consumption in the U.S., requirement to keep records on both
unless excluded. transporters and non-transporters
8Whom Does The Proposed Rule Exclude? Inclusion of a Model Form in the final
Excluded From All Requirements: Farms rule.
Restaurants Firms regulated exclusively by 48Proposed Administrative Detention
the US Department of Agriculture (USDA). Requirements 68 FR 25242 (May 9, 2003).
9Whom Does The Proposed Rule Exclude? Statutory Deadline: None FDA Publication
Excluded From All Requirements: Foreign Goal: December 12, 2003.
facilities, if food is further 49What are the criteria for detaining
manufactured/processed (including food? An officer or qualified employee of
packaging) by another facility outside the FDA may order detention of food if
US Exclusion does not apply if the credible evidence or information that the
activities of the subsequent facility are food presents a threat of serious adverse
limited to a de minimis activity. health consequence or death to humans or
10Partial Exclusions* Fishing vessels animals (SAHCODHA) Applies to both
not engaged in processing Pet food domestic and imported foods.
entities that are exempt from FDA’s BSE 50Administrative Detention. Detention
rule (21 CFR 589.2000) *No exclusion from must be approved at district director
the records access provisions. Whom Does level or higher, as designated by the
The Proposed Rule Exclude? Secretary Detention period < 20 days,
11Whom Does The Proposed Rule Exclude? unless Secretary needs more time (< 30
Partial Exclusions for Retail* All retail days total) to pursue seizure or
facilities are excluded from keeping injunction FDA can direct the movement of
records of immediate subsequent recipients the food to a secure facility, as
Retail facilities employing < 10 full appropriate Prohibited act to transfer an
time equivalent employees selling article in violation of a detention order
unprocessed food from its farm or a or remove/alter any required mark or
neighboring farm (with respect to records label.
for that unprocessed food) *No exclusion 51What Food is Subject to FDA’s
from records access provisions. Jurisdiction? Definition in sec. 201 (f)
12Facilities Engaged in Multiple of the Federal Food, Drug, and Cosmetic
Activities. Records must be established Act applies: i.e., “(1) articles used for
and maintained for all covered activities food or drink for man or other animals,
Example: growing oranges and processing (2) chewing gum, and (3) articles used for
them into orange juice for sale to a components of any such article.” Examples
distributor Growing—excluded as farm of FDA-regulated food: Food and food
Processing—records required. additives for man or animals Dietary
13What Foods Does the Proposed Rule supplements and dietary ingredients Infant
Cover? Applies to all foods under FDA’s formula Pet food.
jurisdiction Definition in sec. 201 (f) of 52Examples of FDA-Regulated Food.
the Federal Food, Drug, and Cosmetic Act Beverages (including alcoholic beverages
applies: i.e., “(1) articles used for food and bottled water) Fruits and vegetables
or drink for man or other animals, (2) Fish and seafood Dairy products and shell
chewing gum, and (3) articles used for eggs Raw agricultural commodities for use
components of any such article. as food or components of food Canned foods
14Examples of FDA-Regulated Food. Food Live food animals Bakery goods, snack
and food additives for man or animals food, and candy.
Dietary supplements and dietary 53What Food is Not Subject to
ingredients Infant formula Pet food Administrative Detention? Foods that are
Beverages (including alcoholic beverages subject to the exclusive jurisdiction of
and bottled water) Fruits and vegetables. the U.S. Department of Agriculture (USDA)
15Examples of FDA-Regulated Food. Fish under the: Federal Meat Inspection Act
and seafood Dairy products and shell eggs (21U.S.C. 601 et seq.) Poultry Products
Raw agricultural commodities for use as Inspection Act (21 U.S.C. 451 et seq.), or
food or components of food Canned foods Egg Products Inspection Act (21 U.S.C.
Live food animals Bakery goods, snack 1031 et seq.).
food, and candy. 54Labeling or Marking of Detained Food.
16What Foods Does FDA Not Regulate? Detention may require marking or labeling
Foods that are subject to the exclusive of detained food, which would include:
jurisdiction of the U.S. Department of Statement food is detained by FDA
Agriculture (USDA) under the: Federal Meat Statement food must not be consumed,
Inspection Act (21U.S.C. 601 et seq.) moved, altered, or tampered with in any
Poultry Products Inspection Act (21 U.S.C. manner without written permission from FDA
451 et seq.), or Egg Products Inspection Violation of detention order or removal of
Act (21 U.S.C. 1031 et seq.). tag or label is a prohibited act Detention
17Proposed Definitions. Farm: a facility order number, detention period, and name
in one general physical location devoted of FDA official who issued the order.
to the growing of crops for food and/or 55Proposed Expedited Procedures for
the raising of animals for food (including Detained Perishable Foods. If FDA
seafood) e.g., apple orchards, dairy initiates a seizure action against a
farms, feedlots, and aquaculture detained perishable food, FDA will: send
facilities. the seizure recommendation to the U.S.
18Proposed Farm Definition (cont.). Farm Department of Justice (DOJ) < 4
includes a facility that . . . Packs or calendar days after detention order
holds food if all food is grown or raised issued, unless extenuating circumstances*
on that farm or consumed on that farm; and exist *Includes, but not limited to
Manufactures/processes food, if all of the instances when the results of confirmatory
food used in such activities is consumed testing or other evidential development
on that farm or another farm under the requires > 4 working days to complete.
same ownership. 56Proposed Expedited Procedures for
19Proposed Definitions (cont.). Detained Perishable Foods (cont.). If 4th
Manufacturing/processing Making a food calendar day is not a working day, FDA
from one or more ingredients Synthesizing, will advise DOJ on last working day before
preparing, treating, modifying, or the 4th day of our plans to recommend
manipulating food, including food crops or seizure action and send recommendation as
ingredients E.g., cutting, peeling, soon as possible on first working day that
trimming, washing, waxing, bottling, follows.
labeling, or packaging. 57FDA’S Administrative Detention:
20Proposed Definitions (cont.). Pet food Proposed Definitions. Perishable foods
– food for non-food producing animals –Food that is not heat-treated, not
Perishable food - food that is not frozen, and not otherwise preserved in a
heat-treated, not frozen, and not manner as to prevent the quality of the
otherwise preserved in a manner so as to food from being adversely affected if held
prevent the quality of the food from being longer than 7 days under normal shipping
adversely affected if held longer than 7 and storage conditions Calendar Day –
days under normal shipping and storage every day shown on the calendar.
conditions. 58What Information Must Be Included in
21Proposed Definitions (cont.). An Administrative Detention Order?
Restaurant – a facility that prepares and Detention order number The date and hour
sells food directly to consumers for of the order Identification of the
immediate consumption e.g., cafeterias, detained food The detention period A
and hospital, nursing home, or day care statement that the article of food
kitchens [and by analogy, pet shelters, identified in the order is detained for
kennels and veterinary facilities that the period shown.
provide food directly to animals] 59What Information Must Be Included in
Facilities that provide food to interstate An Administrative Detention Order (cont.)?
conveyances (e.g., trains, planes) are not A brief, general statement of the reasons
restaurants. for the detention The address and location
22Proposed Definitions (cont.). Retail where the article of food is to be
facility: A facility that sells food detained and appropriate storage
products directly to consumers only conditions Any applicable conditions of
Transporter - person who has possession, transportation Statement that the food is
custody, or control of an article of food not to be consumed, moved, altered, or
for the sole purpose of transporting the tampered with in any manner during the
food Non-transporter - a person who owns detention period (unless subject to a
food or who holds, processes, packs, conditional release).
imports, receives, or distributes food for 60What Information Must Be Included in
purposes other than transportation. An Administrative Detention Order (cont.)?
23Records Non-transporters Have To Information regarding the appeal process
Establish And Maintain to Identify the Name and contact information of the
Immediate Previous Source (IPS). District Director in whose district the
Non-transporters have to establish and food is located Statement indicating how
maintain records to identify the the approval of the detention order was
non-transporter and transporter IPS of all obtained (orally or in writing).
food you receive that include: Firm name, 61Who would receive a copy of the
including responsible individual and detention order? Owner, operator or agent
contact information (domestic or foreign) in charge of the place where the detained
Description of type of food received, food is located Owner* of the food if
including brand name and specific variety. different from those listed above Shipper
24Records Non-transporters Have To of record* and owner and operator of the
Establish And Maintain to Identify the IPS vehicle/carrier*, if detained food is
(cont). Date food was received Lot number located in a vehicle or other carrier * If
or other identifier, if available Quantity identities can be readily determined.
and how the food is packaged (e.g., 25 lb 62When does a detention order terminate?
cartons) Name, responsible individual, and FDA authorized representative will issue a
contact information of the transporters detention termination notice if FDA
who brought the food to you. terminates a detention order or the
25Non-transporters’ Records Regarding detention period expires Detention order
the IPS. Records must include all deemed terminated if FDA fails to issue a
information reasonably available to you to detention termination notice or detention
identify the specific source of each period expires.
ingredient that was used to make every lot 63Administrative Detention Right to
of finished product What is reasonably Appeal. BT Act requires Secretary, after
available may vary from case to case. an opportunity for informal hearing, to
26Example 1: Common Storage Silo for An decide appeals in 5 days Appeal decision
Ingredient (e.g., Flour). Information is subject to judicial review process
reasonably available is the identity of terminates if Secretary files for seizure
all potential sources of the flour for or injunction detention order terminates
each finished product. if Secretary does not comply with appeal
27Example 2: Dedicated Storage Silos for requirements.
Each Ingredient Source. Information 64Appeals. Any person who would be a
reasonably available is the identity of claimant for the food, if seized under
the specific source of the flour for each section 304(a) of the Act, can appeal a
finished product. detention order Request of an appeal with
28Records Non-transporters Have To or without an informal hearing must be
Establish And Maintain to Identify the addressed to the FDA District Director in
Immediate Subsequent Recipient (ISR). whose district the food is located FDA
Non-transporters have to establish and Regional Food and Drug directors or
maintain records to identify the officials senior to them preside at
non-transporter and transporter ISR of all hearings, who may require hearing to be
food you release that include: Firm name, completed within 1 day Presiding officer
including responsible individual and will issue final agency decision.
contact information of ISR (domestic or 65Detention Appeal Timelines.
foreign) Description of type of food Non-perishable Articles of Food.
released, including brand name and Perishable Articles of Food. File intent
specific variety. to appeal with a request for an informal
29What Information Must Non-Transporters hearing. within 4 days of receipt of
Keep in Records to Identify the ISR detention order. not applicable. File
(cont)? Date food was released Lot number appeal with request for an informal
or other identifier, if available Quantity hearing. within 10 days of receipt of
and how the food is packaged (e.g., 25 lb detention order. within 2 days of receipt
cartons) Name, responsible individual, and of detention order. File appeal without a
contact information of the transporters request for an informal hearing. within 10
who transferred the food from you. days of receipt of detention order. within
30Establishment and Maintenance of 2 days of receipt of detention order.
Records by Non-Transporters. 66Detention Appeal Timelines (cont.).
Non-transporters (e.g. manufacturers) must Non-perishable Articles of Food.
establish and maintain records that Perishable Articles of Food. Hold hearing
identify both the transporter and (FDA). within 3 days after an appeal is
non-transporter IPS and ISR (indicated filed. within 2 days after an appeal is
with solid red arrows above). filed. Make decision on appeal (FDA).
31Records Transporters Have To Establish within 5 calendar days after an appeal is
And Maintain to Identify the IPR and ISR. filed. within 5 calendar days after an
For each food you transport . . . Firm appeal is filed.
name, including responsible individual and 67Use of Classified Information in
contact information (domestic or foreign) Hearings. Some credible evidence or
of: Person who had the food immediately information supporting a detention order
before you; and Person who had the food may consist of classified national
immediately after you Description of type security information While we are obliged
of food, including brand name and specific to provide a fair, expeditious, and
variety. impartial hearing, release of classified
32What Records Would Transporters Have information is restricted.
To Establish And Maintain? Dates food was 68Use of Classified Information (cont.).
received and delivered Lot number or other If FDA may do so (while safeguarding the
identifier, if available Quantity and how information/source), FDA will provide the
the food is packaged (e.g., 25 lb cartons) general nature of the information and an
Identification of each and every mode of opportunity to offer opposing evidence or
transportation and responsible information If classified information was
individual(s) throughout transport. used to support the detention, then any
33Example 3: Various Transportation confirmation of such detention will state
Companies. Trucks and planes are owned by whether it is based in whole or in part on
different companies. The proposed rule that classified information FDA is
would require each company to keep records considering developing general regulations
only of transactions to which it is a on handling classified information for all
party (i.e., from whom it received the FDA-regulated products.
food and to whom it released the food). 69Next Steps. These are proposed rules;
34Example 4: Purple Transportation there is no duty to comply with the rules
Company. All trucks and planes are owned now, but note: The BT Act’s access to
by Company A (Purple Transportation Co.) records authority is in effect now;
The proposed rule would require the however, the Act does not provide a
company to keep records of when the food specific time period within which
was put on each vehicle and who was applicable records must be made available
responsible for the food during each leg to FDA upon an appropriate request (Act
of the trip. says records must be made available at
35Frequently Asked Questions . . . “reasonable times”) Administrative
36Do other recordkeeping requirements in detention authority is in effect now.
statutes and regulations still apply? Yes Until final regulations are published and
- you still must comply with all other in effect, 21 CFR Part 16 would apply to
statutes and regulations that apply to you any detention proceedings.
E.g., recordkeeping requirements for 70Next Steps (cont.). Comments on the
infant formula, low acid canned food, records and detention proposed rules are
animal feed, bottled water, color due no later than July 8, 2003 FDA plans
additives. to publish the final rules by Dec. 12,
37When do I have to create the records? 2003.
Records must be created at the time the 71How Do I Get a Copy of the Proposed
activity occurs. Rules?
38Can I Use Existing Records? Yes – if http://www.fda.gov/oc/bioterrorism/bioact.
they contain all the information required tml Or write to: Dockets Management Branch
by the proposed rule You are responsible (HFA-305) Food and Drug Administration
for supplementing existing records, if 5630 Fishers Lane, Room 1061 Rockville, MD
necessary, to ensure all required USA 20852.
information is established and maintained. 72How To Comment (Deadline July 8,
39In what format must I establish and 2003). Submit written comments to: Dockets
maintain these records? In any format, Management Branch (HFA-305) Food and Drug
paper or electronic Must contain all the Administration 5630 Fishers Lane, rm. 1061
required information Proposed rule exempts Rockville, MD USA 20852 Submit electronic
records from 21 CFR Part 11, which comments to:
specifies criteria for acceptance by FDA http://www.fda.gov/dockets/ecomments YOU
of certain electronic records NOTE: No MUST INCLUDE THE DOCKET NUMBER: 02N-0277:
exemption if the records are kept for some Records; 02N-0275: Detention.
other statutory or regulatory purpose. 73For Further Information . . . For
40How long must the records be retained? current information on FDA’s efforts under
1 Year from date of creation: Perishable the Bioterrorism Act or to obtain an
foods not intended for processing into electronic copy of these slides:
non-perishable foods All required records http://www.fda.gov/oc/bioterrorism/bioact.
for animal food, including pet food 2 tml.
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