FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Human and Animal Food Operations

Office of Regulatory Sciences

Document Number:

DIR-000078

Revision #: 03

Revised:

04 May 2020

Title: 

FMD-147: Communicating Laboratory Analytical Findings for Food Products 

and Environmental Samples Directive

Page 1 of 10

For the most current and official copy, check QMiS.

Sections in This Document

1. Purpose ....................................................................................................................................1

2. Scope .......................................................................................................................................1

3. Background...............................................................................................................................2

4. Responsibility............................................................................................................................3

5. Procedure-Communications to Responsible Party ...................................................................4

6. References ...............................................................................................................................6

7. Glossary/Definitions..................................................................................................................6

8. Records ....................................................................................................................................8

9. Supporting Documents .............................................................................................................8

10. Document History .....................................................................................................................9

11. Change History.........................................................................................................................9

12. Attachments............................................................................................................................10

1. Purpose

This Field Management Directive (FMD) provides criteria to the Office of 

Regulatory Affairs (ORA) divisions and laboratories for the release of 

preliminary and completed laboratory analytical findings for human and animal 

food product and environmental samples to the responsible party (e.g. the 

owner, operator, or agent in charge of the establishment from which certain 

samples are collected.

2. Scope

This FMD provides criteria for the communication of preliminary and completed 

original analytical findings of human and/or animal food product and 

environmental samples collected during FDA Office of Human and Animal 

Food Operations (OHAFO) and Office of Enforcement and Imports Operations

(OEIO) Import inspections and analyzed in ORA laboratories. 

Communications are consistent with the Release of ORA Laboratory Analytical 

Results to the Responsible Party: Guidance for Food and Drug Administration 

Staff.

This FMD applies to the following types of samples:
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Human and Animal Food Operations

Office of Regulatory Sciences

Document Number:

DIR-000078

Revision #: 03

Revised:

04 May 2020

Title: 

FMD-147: Communicating Laboratory Analytical Findings for Food Products 

and Environmental Samples Directive

Page 2 of 10

For the most current and official copy, check QMiS.

A. Finished product samples of human and animal food subject to 21 USC 

Section 374(d) for 704(d) samples under the Federal Food, Drug and 

Cosmetic Act (FFDCA).

B. Samples of human and animal food including raw materials, in-process 

samples, and finished products where the collection establishment or 

dealer is voluntarily holding product pending receipt of analytical 

findings (Dealer Voluntary Hold).

C. Environmental samples collected at an establishment where human 

and/or animal food is manufactured, processed, or packed.

D. For samples when FDA determines the release/non-release of 

preliminary or final laboratory findings is in the interest of public health 

as described in the Guidance document, Release of ORA Laboratory 

Analytical Results to the Responsible Party

This FMD cannot and does not cover all forms of communication that may 

occur related to any particular assignment, investigation or sample collected. It 

does not preclude other forms of communications as required by assignment 

or in cases where there is risk to public health from an adulterated product. For 

example, there may be internal FDA telephone calls concerning sample results 

during an outbreak investigation or there may also be telephone calls with 

firms to alert them to sample results in cases where there is a risk to public 

health. As such, other internal or external communications are not prohibited 

by this FMD.

3. Background

FDA provides results from analytical testing of human and animal food and 

environmental samples without requiring the responsible party to submit a 

Freedom of Information Act (FOIA) request in following instances:

A. 704(d) Samples

1. 21 USC Section 374(d) “Analysis of samples furnished owner” of the

FFDCA requires that, “Whenever in the course of any such 

inspection of a factory or other establishment where food is 

manufactured, processed, or packed, the officer or employee 

making the inspection obtains a sample of any such food, and an 

analysis is made of such sample for the purpose of ascertaining 

whether such food consists in whole or in part of any filthy, putrid, or 

decomposed substance, or is otherwise unfit for food, a copy of the 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Human and Animal Food Operations

Office of Regulatory Sciences

Document Number:

DIR-000078

Revision #: 03

Revised:

04 May 2020

Title: 

FMD-147: Communicating Laboratory Analytical Findings for Food Products 

and Environmental Samples Directive

Page 3 of 10

For the most current and official copy, check QMiS.

results of such analysis shall be furnished promptly to the owner, 

operator, or agent in charge.”

2 . “Unfit for food” has been used to describe human and animal foods

that have an abnormal odor, abnormal color, are contained in

abnormal containers (swollen cans), contaminated with pathogens,

contains an undeclared allergen, etc. It has also been used for fish 

infested with copepods or other parasites. Any human and animal 

food product that may be rejected by the consumer may also be

considered unfit for human and/or animal food.

B. Dealer Voluntary Hold 

1. When samples of human and/or animal food (including raw 

materials, in-process and finished products) are collected during an 

inspection of a human and/or animal food manufacturer, processor 

or packer, the FDA investigator determines the manufacturer’s intent 

with respect to holding or distributing products associated with the 

collected samples while FDA performs analytical testing. FDA 

desires to promptly provide analytical results to those firms holding 

products pending FDA results without requiring the firm to submit a 

FOIA request. Providing analytical results in this manner allows the 

firm to take appropriate action. The firm is also notified in the event 

no analysis is to be performed.

C. Environmental Samples

1. When FDA collects environmental samples within a facility where 

human and/or animal food is manufactured, processed, or packed, 

the FDA investigator also determines whether the manufacturer 

intends to hold processed products pending the outcome of the FDA 

analytical testing. FDA has determined that analytical results of

environmental samples collected in human and/or animal food

manufacturing establishments for analysis should be promptly

conveyed to the firm inspected without requiring the firm to submit a

FOIA request. Providing analytical results in this manner allows the 

firm to take appropriate action.

4. Responsibility

A. ORA Laboratories 

1. Receive and analyze the sample. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Human and Animal Food Operations

Office of Regulatory Sciences

Document Number:

DIR-000078

Revision #: 03

Revised:

04 May 2020

Title: 

FMD-147: Communicating Laboratory Analytical Findings for Food Products 

and Environmental Samples Directive

Page 4 of 10

For the most current and official copy, check QMiS.

2. Communicate sample analytical findings, per procedure, to the 

appropriate compliance units and other FDA Stakeholders identified 

in the assignment/program. 

3. Prepare and send completed original analytical findings to the 

responsible party named in Collection Remarks on the Report of 

Sample Analysis form (Form FDA 1551).

B. ORA Compliance Branch (CB) Divisions 

1. Orally communicate preliminary laboratory analytical findings to the 

responsible party such as “Cannot Rule Out (CRO)” results and if a 

sample is not tested when the dealer is voluntary holding product.

5. Procedure-Communications to Responsible Party

A. Laboratory Communication of Preliminary Results:

1. In certain instances, the Office or Regulatory Science (ORS)

internally communicates preliminary analytical findings. 

2. ORS communicates the preliminary interim /CRO information of the 

sample to the applicable Agency compliance unit and 

assignment/program designees. 

a. CRO results; when ongoing laboratory analysis is being 

conducted but such results may present a public health hazard 

and prompt notification is necessary.

b. The lab communicates to ORA’s Division’s CB and investigation 

branch (IB) when it is determined not to analyze the sample.

B. Laboratory Communication of Final Sample Analytical Findings: 

1. Upon completion of analysis, the laboratory documents and 

communicates final analytical findings to the applicable Agency 

compliance unit and assignment/program in accordance with the 

ORA Laboratory Manual. 

2. Issue original lab final results to the firm by completing Form FDA 

1551 in accordance with the ORA Laboratory Manual. 

C. ORA Division Compliance Branch Communication of Preliminary 

Results:
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Human and Animal Food Operations

Office of Regulatory Sciences

Document Number:

DIR-000078

Revision #: 03

Revised:

04 May 2020

Title: 

FMD-147: Communicating Laboratory Analytical Findings for Food Products 

and Environmental Samples Directive

Page 5 of 10

For the most current and official copy, check QMiS.

1. When preliminary findings/CRO results are received, the Division 

CB:

a. Shares findings with the responsible party when dealers are 

voluntarily holding product. 

b. When necessary for public health protection, shares CRO 

preliminary laboratory analytical findings with the responsible 

party before the completed original analytical findings are 

confirmed based on the specific case.

c. Center Offices of Compliance are consulted/included as 

appropriate.

2. When adverse findings sample results are provided by the analyzing 

laboratory the Division CB contacts the responsible person at the

firm for the product and informs them of the results. 

a. Center Offices of Compliance are consulted/included as 

appropriate.

b. State partners, Federal partners, and any other stakeholders 

receive a summary of what was communicated by the 

compliance unit to the responsible party after this action takes 

place as appropriate. 

D. Laboratory communicates instances when analysis cannot be 

completed: 

1. During the course of the inspection the Consumer Safety Officer 

(CSO) requests the responsible party who, if voluntarily holding 

product, to notify the appropriate FDA Division of any subsequent 

change in the decisions to hold or distribute the product in question.

2. For these rare situations when the CSO learns that a sample will not 

be analyzed by the ORA lab, the CSO notifies the responsible 

individual at the firm. 

3. For other “no test” situations, the laboratory notifies the ORA 

Division’s CB and IB to determine the course of action moving 

forward.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Human and Animal Food Operations

Office of Regulatory Sciences

Document Number:

DIR-000078

Revision #: 03

Revised:

04 May 2020

Title: 

FMD-147: Communicating Laboratory Analytical Findings for Food Products 

and Environmental Samples Directive

Page 6 of 10

For the most current and official copy, check QMiS.

6. References

A. Compliance Program Guidance Manual (CPGM) 7303.836, Chapter 03 

– Foodborne Biological Hazards

B. FD&C Act 21 USC Section 374(d) for 704 (d) samples

C. Outbreak Investigations

D. Investigations Operations Manual (IOM): Chapter 4 – Sampling

1. 4.1.1.4 – Report of Analysis

2. 4.1.6 – Investigational Samples

3. 4.3.7.7– Environmental Samples

4. 4.4.10.1.3. – Dealer Voluntarily Holding

5. 4.4.10.1.5 – Factory Food Sample

6. 4.4.10.3.9 – Collection Remarks

7. 4.4.10.3.64 – 704(d) Samples

E. ORA Laboratory Procedure, ORA–LAB.5.10, Reporting Laboratory Data

F. Release of ORA Laboratory Analytical Results to the Responsible 

Party: Guidance for Food and Drug Administration

7. Glossary/Definitions

A. Acronyms

1. CB: Compliance Branch

2. CRO: Cannot Rule Out

3. FDA: Food and Drug Administration

4. FFDCA: Federal Food, Drug and Cosmetic Act

5. FMD: Field Management Directive

6. FOIA: Freedom of Information Act

7. IB: Investigations Branch

8. OEIO: Office of Enforcement and Imports Operations

9. OHAFO: Office of Human and Animal Food Operations

10.ORA: Office of Regulatory Affairs
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Human and Animal Food Operations

Office of Regulatory Sciences

Document Number:

DIR-000078

Revision #: 03

Revised:

04 May 2020

Title: 

FMD-147: Communicating Laboratory Analytical Findings for Food Products 

and Environmental Samples Directive

Page 7 of 10

For the most current and official copy, check QMiS.

11.ORS: Office of Regulatory Science

B. Definitions

1. 704(d) Sample: A 704(d) sample is a commonly used term that 

references 21 USC Section 374(d) “Analysis of samples furnished 

owner” of the FFDCA requires that, “Whenever in the course of any 

such inspection of a factory or other establishment where food is 

manufactured, processed, or packed, the officer or employee 

making the inspection obtains a sample of any such food, and an 

analysis is made of such sample for the purpose of ascertaining 

whether such food consists in whole or in part of any filthy, putrid, or 

decomposed substance, or is otherwise unfit for food, a copy of the 

results of such analysis shall be furnished promptly to the owner, 

operator, or agent in charge.”

2. Cannot Rule Out (CRO): A preliminary indication that the sample 

may yield a final result that could present a public health hazard or 

threat. A CRO finding indicates that the laboratory analytical testing 

is ongoing, and final results have not yet been determined. A CRO 

indication may ultimately be determined to be negative or positive in 

its final result. 

3. Completion of Sample Analysis: The date of the laboratory

management’s completion of the FACTS Sample Summary. 

4. Dealer Voluntary Hold: The responsible party is refraining from or 

restricting product distribution when samples of human and/or animal 

food (including raw materials, in-process and finished products) are

collected during an inspection of a manufacturer, processor or

packer pending analytical results. See IOM 4.4.10.1.3.

5. Environmental Sample: A sample consisting of various items 

including, but not limited to: swabs, process or agricultural water, 

animal scat, soil, and/or other items found in and/or around a farm, 

food processor, packing house, vehicle, conveyance or other 

location where food is exposed to environmental or processing 

conditions that could result in adulteration with microbiological or 

other contamination. 

6. Food Sample: A sample consisting of raw materials, in-process

and/or finished products that an FDA investigator collects during an

inspection or investigation at a human and/or animal food grower, 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Human and Animal Food Operations

Office of Regulatory Sciences

Document Number:

DIR-000078

Revision #: 03

Revised:

04 May 2020

Title: 

FMD-147: Communicating Laboratory Analytical Findings for Food Products 

and Environmental Samples Directive

Page 8 of 10

For the most current and official copy, check QMiS.

processor, or manufacturer. This includes medicated and nonmedicated feeds.

7. Home Division: The division is the programmatic organizational unit 

most likely to pursue action if required as identified on the CR as

“Original CR & Records To” and in which the firm or individual 

responsible is physically located.

8. Home District: The home district is the district in whose territory the 

sample was collected, or in whose territory the firm or individual 

responsible is physically located.

9. Laboratory Finding: Consists of Cannot Rule Out (CRO) and original 

laboratory findings and does not include additional analysis nor 

further speciation of pathogens.

8. Records

A. Report of Sample Analysis (Form FDA 1551)

9. Supporting Documents

None 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Human and Animal Food Operations

Office of Regulatory Sciences

Document Number:

DIR-000078

Revision #: 03

Revised:

04 May 2020

Title: 

FMD-147: Communicating Laboratory Analytical Findings for Food Products 

and Environmental Samples Directive

Page 9 of 10

For the most current and official copy, check QMiS.

10. Document History

Revision

#

Status*

(D, I, R)

Date Author Name and Title Approving Official Name 

and Title

1.0 I 3/1/2011 Operations Management

2.0 D 8/22/2014 Donald A. Bennett

Quality System Manager Ellen Morrison

2.0 R 5/20/2015 Donald A. Bennett

Quality System Manager Ellen Morrison

03 R

See Date 

in Header

Bruce Ross

Senior Advisor, OHAFO

Michael Rogers, Assistant 

Commissioner for Human 

and Animal Food 

Operations

Paul Norris, Director of 

Office of Regulatory 

Sciences

* - D: Draft, I: Initial, R: Revision

11. Change History

Revision 

#

Change

03 • Broadened applicability to cover official and environmental samples collected by 

ORA investigators as part of inspections under section 704(d) of the FFDCA that 

are either analyzed by an ORA laboratory or a center laboratory.

• Added Cannot Rule Out (CRO) notifications into communication process.

• Clarified ORA/Division Compliance Branch will be responsible for orally 

communicating both potentially violative (Lab Class 3) and/or CRO sample 

findings to the responsible party in real time, in consultation with the center, and 

other stakeholders (i.e. CORE, CDC) as appropriate.

• Specified and clarified roles/responsibilities for the actions needed

Developed a process map of the “lifecycle of a collected sample” and include 

“predictable time frame targets” for pathogen analysis.

• More clearly identified what parts of the Agency need to be informed about analytical 

findings (especially when they are positive).

• Renumbered as a directive in QMiS and released in the PCC Vault
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Human and Animal Food Operations

Office of Regulatory Sciences

Document Number:

DIR-000078

Revision #: 03

Revised:

04 May 2020

Title: 

FMD-147: Communicating Laboratory Analytical Findings for Food Products 

and Environmental Samples Directive

Page 10 of 10

For the most current and official copy, check QMiS.

2.0

• Title changed from “704(d) Letters” to reflect communication of analytical findings 

for a variety of sample types.

• Standardized Lab use of Form FDA 1551 for communication of results.

• Standardized Lab as transmitter of Form FDA 1551 to Firm/Dealer in all cases.

• Standardized information Lab is to include in notification emails to districts

(sample number, product and classification).

• Clarified when results will be communicated to districts via established email

process:

o 704(d) Samples when Class 3 or Class 5.

o Dealer Voluntary Hold in all cases.

o Environmental Samples in all cases.

• Clarified that when called for (as above), the results will be transmitted to the

division BEFORE the Form FDA 1551 is sent to the Firm/Dealer.

• Specified results to be sent to the responsible person in charge of the firm in all 

cases. This is an effort to standardize routing of communications and facilitate 

automation for future communications.

• Specified collection of email addresses on the Collection Report for use in

transmitting analytical results from the lab to the firm.

• Added timeframe for notification of results to districts under special conditions (3., A.,

2.) “When required per the procedures identified below, communicate sample

results to collecting districts within 24 hours of completing sample analysis and in

advance of sending the FDA Form 1551, Report of Sample Analysis, to the collection

or dealer firms.”

• Document Number: FMD.147 

• Title: Communication of Sample Analysis Results for Food Products and 

Environmental Samples (FMD-147)

1.0 • New

12. Attachments

None