Release of ORA Laboratory Analytical Results to the Responsible Party: Guidance for Food and Drug Administration Staff

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Release of ORA Laboratory Analytical
Results to the Responsible Party:
Guidance for Food and Drug
Administration Staff
You may submit written comments regarding this guidance at any time. Submit electronic
comments to http://www.regulations.gov. Submit written comments to the Dockets Management
Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
All comments should be identified with the docket number FDA-2019-D-1163.
For questions regarding this guidance or additional copies, contact the Office of Regulatory
Affairs (ORA) Office of Strategic Planning and Operational Policy (OSPOP) at
ORAPolicyStaffs@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs
Center for Devices and Radiological Health
Center for Food Safety and Applied Nutrition
Center for Tobacco Products
Center for Veterinary Medicine
March 2019

Contains Nonbinding Recommendations
Release of ORA Laboratory Analytical
Results to the Responsible Party:
Guidance for Food and Drug
Administration Staff1
I. 	Introduction
This document provides guidance for FDA staff regarding the release of final and, in some
circumstances, preliminary Office of Regulatory Affairs (ORA) laboratory analytical results to
the responsible party.2 This policy applies to samples collected during FDA regulatory activities
and analyzed in ORA laboratories. It applies to FDA personnel assigned to deliver and discuss
ORA laboratory analytical results with the responsible party. The policy does not require the
responsible party to file a Freedom of Information Act (FOIA) request for the records.3
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidance means that something is suggested or
recommended, but not required.
II. 	Background
Sample collection and analysis (which may include finished product and environmental samples)
are important tools the FDA uses to assess regulatory compliance of FDA-regulated products and
ensure public health protection. In general, the FDA does not release the results of any
regulatory testing it conducts until its ORA laboratory analytical results are final and the report is
completed, accepted by the responsible FDA official, and any protected information is
1 This guidance has been prepared by the Office of Strategic Planning and Operational Policy, in the Office of
Regulatory Affairs, in cooperation with the Center for Devices and Radiological Health, the Center for Veterinary
Medicine, the Center for Tobacco Products, and the Center for Food Safety and Applied Nutrition at the U.S. Food
and Drug Administration.
2 For purposes of this guidance, the term responsible party may include an owner, operator or agent in charge of the
site where the regulatory sample is collected, or who may otherwise be responsible for the safety of the product
sampled. In some circumstances, more than one responsible party may need to be contacted.
3 FDA may also share records, including ORA laboratory analytical results, with other entities including state and
local governments and other federal agencies in accordance with 21 C.F.R. Part 20, Subpart E.
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
responsible for this guidance as listed on the title page.

Contains Nonbinding Recommendations
appropriately redacted.4 The FDA has processes in place for the release of final ORA laboratory
data and analytical results to the responsible party from which the samples are collected.5,6
However, because certain laboratory tests performed in ORA laboratories may take several
weeks to complete, it can be necessary for the Agency to share preliminary results with the
responsible party before the final results are confirmed.
This guidance provides a standardized policy on the release of final ORA laboratory analytical
results for FDA samples. The FDA will generally release such results when doing so would
advance public health goals. This guidance clarifies when and how such results could be
released. This document also describes the FDA’s policy to orally share, under some
circumstances, certain preliminary ORA laboratory analytical results (internally referred to as
“Cannot Rule Out” (CRO) results) with the responsible party.7 A CRO result is a preliminary
indication that the sample may yield a final result that could present a public health hazard or
threat. A CRO result indicates that the laboratory analytical testing is ongoing, and final results
have not yet been determined.
Communicating a CRO result before the FDA confirms the final result is intended to provide the
responsible party with information to make informed decisions about potential hazards and
products on the market, as well as to consider initiating or preparing to initiate appropriate
mitigating strategies to address a potential hazard.
III. 	Policy
A. Proactive release of CRO ORA laboratory analytical results
1. 	In general, FDA should not share CRO results until testing is completed.
2. 	However, FDA may orally release CRO results to the responsible party after
clearance in accordance with ORA laboratory procedures if the FDA determines that
such release is in the interest of public health. FDA’s assessment and consideration
of when to release CRO results should include, but not be limited to:
a. 	The potential consequences of the injury or illness that could be caused by the
regulated product, if it is ultimately confirmed to contain a poisonous or
deleterious substance(s) or other hazardous substance, or otherwise deemed to
represent a public health threat;
b. 	Any background information on the danger associated with the poisonous or
deleterious substance(s) or other hazardous substance/situation related to the
sample under analysis;
4 See 21 C.F.R. §§ 20.20(a), 20.105; 21 C.F.R. Part 20, Subpart D.
5 See ORA-LAB,5.10 Reporting Laboratory Data,
https://www.fda.gov/downloads/ScienceResearch/FieldScience/LaboratoryManual/UCM092171.pdf
6 For the release of ORA food and food-related environmental laboratory analytical samples, see FMD 147
Communication of Sample Analysis Results for Food Products and Environmental Samples,
https://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectives/UCM449001.pdf
7 Pursuant to 21 C.F.R.§§ 20.21, 20.105(c), when FDA discloses CRO results to the responsible party, the
information is immediately available for public disclosure to any member of the public who requests it.

Contains Nonbinding Recommendations
c. 	Susceptibility of the consumers that could be affected;
d. 	The accuracy of the screening method; and
e. 	Whether release of the CRO results would interfere with an investigation or
enforcement proceeding.
3. 	FDA Centers and Offices that should be consulted before orally communicating CRO
results to the responsible party, include but are not limited to:
a. 	For-cause inspections:
i. 	For CRO results for samples collected as part of a for-cause inspection
(e.g., follow-up to a recall, patient death/injury, or consumer
complaint), ORA should collaborate with the respective Center to
coordinate strategy prior to communicating with the responsible party.
b. 	Outbreaks and emergencies:
i. 	For CRO results that are associated with a human or animal food or
cosmetic outbreak being coordinated by the FDA Coordinated
Outbreak Response and Evaluation Network (CORE), ORA should
collaborate with CORE, the respective Center, and Centers for Disease
Control and Prevention (CDC), to coordinate strategy prior to
communicating with the responsible party.8
ii. 	For CRO results associated with other FDA-regulated products related
to a public health emergency, ORA should collaborate with the FDA’s
Office of Emergency Operations and the respective Center to
coordinate strategy prior to communicating with the responsible party.
c. 	Concerns about the sterility of products labeled “sterile:”
i. 	For CRO results associated with sterile injectable, inhalation, topical
or ophthalmic drug products, ORA should collaborate with the
respective Center or, if necessary, the Counter-Terrorism and
Emergency Coordination Staff to coordinate strategy prior to
communicating with the responsible party.
ii. 	For CRO results associated with sterile medical devices, ORA should
coordinate with the respective Center to coordinate strategy prior to
communicating with the responsible party.
d. 	Other situations associated with a public health risk:
i. 	When deemed appropriate by the ORA program director, and in
accordance with a strategy developed in collaboration with the
respective Center, CRO results may be communicated to the
responsible party.
8 State partners should also be included in communications with the responsible party, in accordance with ORA’s
Field Bulletin 61: Inviting State Partners on Calls with Firms to Explain CDC Epidemiological or Laboratory Data
During Outbreak Investigations.

Contains Nonbinding Recommendations
4. 	Any release of CRO results should include the disclaimer statement below. When
results are communicated orally to the responsible party, the FDA official releasing
the CRO results should read the statement to the responsible party and document
doing so.
Disclaimer: “Cannot rule out” sample results are preliminary in
nature. They are being shared at this time for informational purposes only.
Although this information should be considered as one component of a larger
evaluation of product safety, the FDA’s communication of these preliminary
results does not imply that any future action by any government agency or
private party is necessary or appropriate. Final Office of Regulatory Affairs
(ORA) laboratory analytical results will be provided as soon as practicable
after they become available. However, you remain responsible for assuring
the quality and safety of all products you have released to the market. The
FDA is not responsible for the consequences of any private party’s decision to
act, or to not act, on the “cannot rule out” results. More information about
“cannot rule out” ORA laboratory results is available at [Provide link to this
guidance].
B. Release of final ORA laboratory analytical results
Upon request by the responsible party (either received by FDA orally or in writing), the FDA
may, at its discretion or if mandated by law,9 release final ORA laboratory analytical results
for samples that were collected during FDA regulatory activities. The final results may be
provided to the responsible party without the need to file a request that is formally designated
as a FOIA request. Releasing final ORA laboratory analytical results in this manner allows
the responsible party to take appropriate action, and/or resume normal operation based on the
results.
1. 	In situations where a responsible party is voluntarily holding product, or holding
product under the conditions set forth in the import entry bond, pending final ORA
laboratory analytical results, the FDA may orally notify the responsible party of the
final laboratory analytical results. Written notification may follow at FDA’s
discretion or if required by law. FDA personnel should document the details of the
notification discussion, as well as the responsible party’s response.
2. 	In limited cases, FDA may withhold the release of ORA laboratory analytical results,
e.g. if the release is reasonably expected to interfere with an investigation or
enforcement proceeding.
9 See, e.g., section 704(d) of the Federal Food, Drug and Cosmetic Act, which requires that, “[w]henever 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.” (emphasis added).