Contents

SUBCHAPTER 750 - DETENTION ACTIVITIES

750 - OBJECTIVES

The objective of the detention is to protect the consumer by preventing the presence of or to provide for removal from commerce of meat, poultry, egg products, or devices, which are adulterated or misbranded. The various Acts described in this sub section provide certain detention powers for FDA. Pertinent sections of the Meat Inspection Act (MIA), Poultry Products Inspection Act (PPIA), Egg Products Inspection Acts (EPIA), and the Food, Drug, and Cosmetic Act (FD&C Act), and its Regulations pertaining to detentions, are printed on the reverse of page 1 of the FDA 2289, Detention Notice (IOM Exhibit 750-A).

750.01 - Federal Meat Inspection Act

See IOM 311.03 for information.

750.02 - Poultry Products Inspection Act

See IOM 311.03 for information.

750.03 - Egg Products Inspection Act

See IOM 311.03 for information.

750.04 - Food Drug and Cosmetic Act

See FD&C Act section 304(g) [21 U.S.C. 334 (g)].

Section 304(g) of the Federal Food, Drug, and Cosmetic Act provides FDA with authority to detain a device believed to be adulterated or misbranded. You should become familiar with this section and the regulations implementing it. See 21 CFR 800.55. At the present time, these regulations apply only to devices intended for human use.

750.05 - Definitions

Meat Products and Poultry Products - For FDA purposes, Meat Products & Poultry Products are defined as the carcasses of cattle, sheep, swine, goats, horses, mules, other equines, or domesticated birds, parts of such carcasses, and products made wholly or in part from such carcasses, except products exempted by U.S.D.A. because they contain a relatively small amount of meat or poultry products (e.g.; meat flavored sauces, pork & beans, etc.). Examine labels for USDA Shield or coding information to help determine if it is a USDA product.

Egg and Egg Products - The term "egg" means the shell egg of the domesticated chicken, turkey, duck, goose, or guinea.

The term "Egg Products" means any dried, frozen, or liquid eggs, with or without added ingredients, excepting products which contain eggs only in relatively small proportion or historically have not been, in the judgement of the Secretary, considered by consumers as products of the egg food industry, and which may be exempted by the Secretary under such conditions as he may prescribe to assure the egg ingredients are not adulterated and such products are not represented as egg products. This would be done on a case by case basis by USDA.

Device - Section 201(h) of the FD&C Act [21 U.S.C. 321 (h)] defines a device as follows: "The term "device" *** means an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any primary intended purposes."

751 - INSPECTIONAL PROCEDURE

Direct attention to meat, poultry, or egg products only when found during your regular operations; when so instructed in a C/P; following up on complaints; or, on other assignments as directed by your supervisor.

Placing Detention - Consider detention when so instructed by your supervisor, and only when in your judgement it appears the product will not be held voluntarily and arrangements cannot be made for local, state, or USDA authorities to take control.

751.01 - Criteria for Detention

The criteria listed are for your guidance in judging whether or not the product or products should be detained. Detention may be made when all of the requirements listed for the particular items are met.

For products subject to the Meat Inspection Act or the Poultry Products Inspection Act the requirements are:

1. The article meets the jurisdictional requirements of section 304 of the FD&C Act and is in commercial channels.
2. The article is located in an establishment which does not have USDA meat or poultry inspection service.
3. The article is intended for human food channels or could be readily diverted into such channels.
4. The article appears to be adulterated or misbranded under the FD&C Act.

NOTE: For any contemplated detentions based on misbranding or adulteration under section 402(b) of the FD&C Act [21 U.S.C. 342 (b)], check with your supervisor. These must be cleared with the Center for Food Safety and Applied Nutrition.

For products subject to the Egg Products Inspection Act the requirements are:

1. The article, whether or not in interstate commerce, is located in an establishment which does not have USDA Egg Products Inspection Service.
2. The article is intended for human food channels or could be readily diverted into such channels.
3. There is reason to believe the article is in violation of the Egg Products Inspection Act.

For Devices the requirements are:

1. You have reason to believe the device is adulterated or misbranded.
2. There is no reasonable assurance the device will not be used, moved, altered, or tampered with in any manner before the FDA can take appropriate legal action.
3. The device is intended for human use.

751.02 - Detention Procedure

Immediate Action - After assuring yourself the criteria for detention are met, immediately advise your supervisor of the situation. The information you must furnish should consist of that requested in blocks numbered 2, 4, 5, 7, 8, 10, 11, 13, 15, 17, 18, 19, 20, 22 and 24 on the Detention Notice, FDA 2289. See IOM 751.03. For devices mark #22 and #24 N/A.

If your supervisor instructs you to detain the article, proceed as in IOM 751.03, and 751.04.

Executing The Detention - When you have been authorized by your supervisor to place a detention proceed as follows:

1. If the product is not currently stored under proper conditions to maintain its integrity, or if devices are stored in such a way as to interfere with the firm's operation, arrange for proper storage as follows:
   1. Maintain surveillance on in-transit products and detain after products are placed in storage if possible.
   2. Arrange for the custodian (dealer) to place the product in proper storage if custodian will agree.
   3. If neither (a) nor (b) is possible, place product under detention and, except for devices, remove it to proper storage facility. Notify the custodian of the place of storage (block 16 on the FDA 2289) and advise your supervisor of the necessity for including this information in the letter to the owner.
      After a device is detained, it may not be moved unless specific procedures are followed. Consult your supervisor for guidance.
2. Personally inform the immediate custodian, at the highest management level, that the article is under U.S. detention, and if a device, that record keeping requirements of 21 CFR 800.55(k) are in force.
3. Prepare the "Notice of Detention, FDA-2289", as instructed in IOM 751.03 and issue page 1, the original, to the custodian named. If the product is a device, point out the appeal rights of the owner, which are listed on the back of Page 1 of the FDA-2289.
4. Affix a sufficient number of "Detention Tag, FDA-2290", to the article in a manner to assure visibility.

751.03 - Detention Notice FDA 2289

The Detention Notice, FDA 2289, is a pre-numbered five-part snap-out form, constructed and arranged to serve as a Notice of Detention and as a report of the action.

Preparation of Detention Notice - Print or type the information in the appropriate blocks. The first page blocks to be filled in are those numbered 1 through 12, 15 and 16. Once page 1 is completed, signed and issued to the custodian, it becomes an official document and the detention period begins.

You must immediately complete the additional pages of the Notice of Detention (2 through 5) and submit them to your supervisor, for processing the action. Blocks to be typed on these pages are items 13, 14 and 17 through 26. See IOM Exhibit 750-A.

Preparation of Page 1.

1. DISTRICT ADDRESS, PHONE NUMBER, NAME OF DISTRICT DIRECTOR - This may be typed in advance.
2. NAME OF CUSTODIAN - Obtain the name of the highest-ranking official of the firm at the place of detention, and issue to him. Page 1 of the FDA 2289 is to be issued to the person named in this block.
3. DETENTION NOTICE NUMBER - This is pre-stamped on each form. Any correspondence or subsequent actions should reference this number.
4. TITLE OF CUSTODIAN - Insert proper official title such as president, warehouse manager, etc. Do not use courtesy titles.
5. TELEPHONE NO. - Insert the office telephone number including, area code.
6. DATE AND HOUR DETAINED - Insert actual date and time you hand the original to the custodian. The period of detention begins when you issue the original to that person.
7. FIRM NAME - Enter the legal name of the custodial firm.
8. ADDRESS - Use complete street name, city, state and Zip Code of custodial firm.
9. MAXIMUM DETENTION ______ DAYS - Enter "20" unless devices are involved. For devices enter either "20" or "30", as instructed by your supervisor.
10. NAME OF DETAINED ARTICLE - Use the actual name of the actual product e.g., "Beef Pot Pies with mushrooms" not just "Pies". "Dr. Z's Tongue Depressors", not just "device".
11. SIZE OF DETAINED LOT" - Indicate number of cases or other type container or article and subordinate containers, e.g., 2000 cases/24/#2 cans. 250 half sides pork carcasses, 500/fore quarters veal, 95 crates/50 lbs. whole fryers, 25/30 lb. cans frozen eggs, etc.
12. DETAINED ARTICLE LABELED - Quote enough labeling so the article can be positively identified. Include product numbers, lot numbers, serial numbers, control codes, grade marks, etc.
13. APPROXIMATE VALUE OF LOT - This is the wholesale or invoice value of the merchandise. Estimate if there is no documentary reference you can quote.
14. SAMPLE NUMBER(S) - List numbers of any samples taken in connection with the detention.
15. REASON FOR DETENTION - Describe the apparent violation and briefly list evidence available to substantiate it. If the product is a device, always state not only the section of the FD&C Act the device is believed to violate, but the particulars of the violation as well. Discuss the reasons for detention with your supervisor when you obtain the permission to detain a device. See Page 4 of IOM Exhibit 750-A.
16. DETAINED ARTICLE STORED AT - In most instances this will be the same as the custodial firm indicated in blocks 7 and 8. However, if the product has been moved to another location, enter the name and address of the firm and location where it finally comes to rest and will stay until the detention is terminated. Once the product is detained, it is unlawful to move it without direct authority from FDA except that devices may be moved and processed under 21 CFR 800.55 (h)(2) pursuant to section 304(g)(2)(B) of the FD&C Act [21 U.S.C. 334 (g)(2)(B)].
    
    NAME OF FDA EMPLOYEE - Print or type.
    SIGNATURE - Sign the form.
    TITLE - Enter your title.

    Preparation of Page 2 through 5 - The blocks on pages 2 through 5 are identical and completion of these constitutes your report on the detention, unless directed otherwise by your supervisor.

17. NAME AND ADDRESS OF ARTICLE OWNER - This will probably be the same as the custodian's. However, they may differ in the case of public warehouses or consigned goods. Enter the name and address including, zip code , of the actual owner.
18. NAME AND ADDRESS OF INITIAL SHIPPER OR SELLER - - Enter name and address of person or firm who first shipped or sold the product.
19. NAME AND ADDRESS OF SUBSEQUENT SHIPPERS OR SELLERS - If products have passed through more than one firm prior to coming to your attention, list these firms.
20. NAME OF CARRIERS - List carrier or carriers involved, starting with the one who first picked up the article.
21. DATE LOT SHIPPED - Use date on a shipping document, not the invoice date.
22. NAME AND ADDRESS OF PACKING PLANT - Enter firm name and address of the plant where products were actually packed, processed, manufactured or assembled. For devices enter "N/A"
23. DATE LOT RECEIVED - Self-explanatory.
24. PACKING PLANT U.S.D.A. NO. - All plants under U.S. Department of Agriculture inspections are numbered. This number is placed on products packed or processed in that particular plant. Enter the complete number. For devices enter "N/A".
25. DESCRIPTION OF SAMPLE - Describe sample collected in connection with the detention operations. This will be the same as on the C/R.
26. REMARKS - Elaborate on items wherever necessary. List any recommendations you made to the custodian for special storage such as refrigerated, frozen, etc.

Distribution of FDA-2289 - The five-part snap-out is distributed as follows:

Page 1, original - Give to custodian. Page 2,3,4 - Turn in to your district immediately using the fastest means possible. Page 5 - Retain in your possession.

751.04 - Detention Tag FDA 2290

This tag is a warning and identification device intended to be affixed to the detained products.

Preparation - As soon as you have issued the Detention Notice, fill out Detention Tags, FDA 2290, following the instructions below. See IOM Exhibit 750-B.

Front of Tag.

"DETENTION DATE AND HOUR" - Copy the date and hour of detention from block #6 of the Detention Notice.

"DETENTION NOTICE NO. DN" - Copy the exact number from block #3 of the Detention Notice.

"MAXIMUM DETENTION _____ DAYS" - Copy the number of days from block #9 of the Detention Notice.

"NAME FDA EMPLOYEE" - Print or type.

"SIGNATURE" - Sign.

"TITLE" - Enter your title.

Reverse of Tag.

"NAME OF DETAINED ARTICLE" - Enter the name exactly as in Block #10 of Detention Notice.

"DETAINED ARTICLE LABELED" - Copy enough from Block #12 of Detention Notice to identify the product.

"SIZE OF DETAINED LOT" - Copy from Block #11 of Detention Notice.

Use of Tag - Complete and affix tags so they are visible on several sides of the lot detained. Use sufficient tags to give adequate warning the lot is under U.S. Detention and must not be used, moved or tampered with, in any manner.

Each tag has a self-locking pin, the point of which should be firmly inserted in an appropriate seam, border, flap, or other area of the container or product, and pulled sharply downward to engage the top curve of the pin. Do not just lay tags on the articles. Secure them to the containers or products. If locking pin cannot be used, tape or tie the tag firmly onto the container or item.

Advise the custodian that Detention Tags have been affixed, the reason for the detention and, in the case of devices, advise the custodian the lot may not be moved without written permission of the Agency. In-process devices may be completed without permission. See 21 CFR 800.55(h)(2) for instructions.

751.05 - Termination of Detention

When final action has been taken on the detention, you will be authorized to terminate the detention. This will occur when one of the following conditions has been met.

1. The article has been brought into compliance, denatured or destroyed under appropriate supervision.
2. For USDA products the USDA, state, county, or local authorities have accepted jurisdiction and control of the article.
3. For USDA products, it has been determined there is no significant violation of the FD&C Act, or of the Egg Products Inspection Act, whichever is applicable, and the USDA has been notified that FDA intends to terminate the detention.
4. Twenty consecutive days have expired (or 20 or 30 days, for devices), counting from the day and hour of detention of the product.
5. Seizure or other legal action has been accomplished.
6. The District Director or the Regional Food and Drug Director orders the termination.

Removal of Detention Tags - As soon as you are authorized to terminate the detention, proceed to where the detained material is stored, personally remove and completely destroy all detention tags. Do not merely throw them in the trash.

Issuance of Detention Termination Notice FDA 2291 - As soon as you have removed all detention tags, tell the custodian the article is no longer under detention. Immediately prepare a Detention Termination Notice by filling out blocks 1 through 10, 12, 13, and the bottom of the form to include name, title and signature. Give the original, (page 1), to the custodian. This terminates the detention.

Complete the remaining blocks on page 2. Use the "Remarks" section to elaborate on pertinent information such as supervision, reconditioning, destruction accomplished, etc. The Detention Termination Notice, FDA 2291 together with Detention Notice, FDA 2289 will, unless instructed otherwise, constitute the complete report on the detention. See IOM Exhibit 750-C.

752 - SAMPLING

Official samples of articles involved in this type operation are collected, prepared, and submitted, in the same manner as any other regulatory samples.

753 - SUPERVISION OF RECONDITIONING, DENATURING, OR DESTRUCTION

Methods and procedures for reconditioning, denaturing, or destruction, will be proposed to the district by the owner of the merchandise. Do not take any action on this unless you are authorized by your supervisor. The district officials will determine the adequacy of the proposed method. If satisfactory, you will be advised of the procedure and authorized to monitor the action.

When the operation is satisfactorily completed, and when authorized, terminate the detention as indicated in IOM 751.05.

The results of the reconditioning, denaturing or destruction may be described in the "Remarks" section on the Detention Termination Notice, FDA 2291, if desired. See IOM Exhibit 750-C.

759 - REPORTING

Except in unusual situations. or unless instructed otherwise by your supervisor, the Detention Notice, FDA 2289, the Detention Notice Termination, FDA 2291, and the FACTS Collection Record, are designed to provide all information required to report the action from detention to termination.

SUBCHAPTER 760 - DENATURING

760 - OBJECTIVE

The basic purpose of denaturing is to prevent salvage or diversion of violative materials for human consumption.

761 - DIVERSION TO ANIMAL FEED

Carefully consider any situation before agreeing to diversion of contaminated foods to animal feed. The indiscriminate use of contaminated food for livestock may constitute a hazard to such livestock, as well as humans.

When denaturing human foods for animal feed purposes, contact the Center for Veterinary Medicine, Division of Compliance (HFV-236) to determine if the product may be converted safely to animal feed.

Rodent or Bird Contaminated Foods - Diversion of rodent or bird contaminated foods for animal feed is authorized only when the contaminated product is treated by heat to destroy Salmonella organisms. In the case of wheat and other grains containing rodent excreta, a suitable heat process may be used or the product is examined bacteriologically and shown not to contain Salmonella.

Moldy Food - If processors insist on salvage of moldy grain or foods for animal feed use, it must be done under proper supervision, and provide for:

1. treatment by dry heating to destroy viable spoilage microorganisms (generally, this will result in grain having a toasted color and odor), and
2. evidence it does not contain mycotoxins, and
3. evidence, by animal feeding studies, the product is safe for animal use.

Pesticide Contamination - Foods contaminated by pesticides residues should not be diverted to animal food use unless a determination is made which assures illegal residues will not result in the food animal or their food products, e.g., meat, milk, eggs.

762 - DECHARACTERIZATION FOR NON-FOOD OR FEED PURPOSES

The choice of methods, should be made by considering the type of the denaturant, the physical properties of the diverted material, and the ultimate use of the article.