Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Recommendations for Collecting 
Representative Samples for Food Testing 
Used as Evidence for Release of Certain 
Fish and Fishery Products Subject to 
Detention Without Physical Examination 
(DWPE) and Removal of a Foreign 
Manufacturers Goods from DWPE: 
Guidance for Industry 
 
Draft Guidance
 
This guidance is being distributed for comment purposes only. 
 
 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that the agency considers your comment on this draft guidance before it begins work 
on the final version of the guidance, submit either electronic or written comments on the draft 
guidance within 60 days of publication in the Federal Register of the notice announcing the 
availability of the draft guidance.  Submit electronic comments to 
http://www.regulations.gov.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.  All comments should be identified with the docket number listed in the notice of 
availability that publishes in the Federal Register.  
 
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN), Office of Food Safety/Division of Seafood Safety, at 240-402-2300. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
February 2024    Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Table of Contents 
 
 
I. Introduction ....................................................................................... 1
   
II. Background ..................................................................................... 2
   
III. Discussion ........................................................................................ 4
   
A.  Recommendations for Collecting Representative Samples for Food Testing Used as 
Evidence for Release of Articles Subject to DWPE ................................................................... 4 
B.  Recommended Analytical Methods ..................................................................................... 7 
C.  Recommended Evidence for Requests for Removal from DWPE Under an Import 
Alert ................................................................................................................................................ 8 
IV. Conclusion ..................................................................................... 10
   
V. References ..................................................................................... 11
   
VI. Appendices .................................................................................... 11
   
Appendix A  Sampling Schedule Recommendations ............................................................. 12 
Appendix B  Amount of Product Recommended Per Sample Unit ..................................... 15 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Recommendations for Collecting 
Representative Samples for Food Testing 
Used as Evidence for Release of Certain 
Fish and Fishery Products Subject to 
Detention Without Physical Examination 
(DWPE) and Removal of a Foreign 
Manufacturers Goods from DWPE: 
1
Guidance for Industry  
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or we) 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 listed on the title page. 
 
I.  Introduction  
 
This guidance is intended to provide recommendations for collecting a representative sample for 
testing when fish and fishery products2 are subject to detention without physical examination 
(DWPE) due to the appearance of adulteration caused by pathogens, unlawful animal drugs, 
scombrotoxin (histamine), and/or decomposition.3  This guidance is also intended to help foreign 
manufacturers and other processors of fish and fishery products subject to DWPE under an 
import alert (IA) to introduce evidence to FDA to support a request to have products removed 
from DWPE.  This guidance does not apply to seafood-related import alerts when sampling and 
testing is not relevant to securing release of individual shipments or removal from DWPE. 
 
 
1 This guidance has been prepared by the Office of Food Safety/Divisions of Seafood Safety and Seafood Science 
and Technology in consultation with the Office of Compliance and the Office of Regulations and Policy, all in the 
Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 
2 Effective March 1, 2016, the United States Department of Agricultures Food Safety Inspection Service assumed 
responsibility for the regulation of domestic and imported Siluriformes fish, and fish products.  Siluriformes include 
fish commonly known as catfish, tra, swai, and basa.  This guidance is not applicable to these fish. 
3 The recommendations regarding sampling and testing may also be relevant when fish and fishery products are 
subject to other types of enforcement action, such as seizure and/or administrative detention.  However, because of 
the volume of questions FDA receives regarding sampling and testing when seafood products are subject to DWPE, 
the guidance focuses on shipments subject to DWPE. 
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In this guidance, we address the following issues regarding seafood products subject to DWPE 
due to pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition: 
 
  Recommendations for the number of sample units (e.g., subsample as used by FDA) to 
be collected and tested from an article of fish and fishery products subject to DWPE to 
ensure statistical confidence and a representative sample; 
  A description of a sample unit and other characteristics of an article to help identify 
the amount of product and product groups or portions within the affected article to be 
sampled; 
  References for analytical methods that may be used to analyze the samples collected; 
  Recommendations for evidence to include in a submission requesting FDA to release an 
article detained under DWPE; 
  Recommendations for types of production-related evidence that may be useful for FDA 
to assess the efforts instituted by the processor(s) to prevent adulteration; and 
  Recommendations for the types of evidence that may be useful when requesting removal 
of a fish and fishery product or manufacturer from DWPE. 
 
If you have questions about whether the guidance is relevant to your situation, you may contact 
CFSAN, Office of Food Safety, Division of Seafood Safety at 240-402-2300. 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe our 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 FDA guidances means that something is suggested or recommended, but not 
required. 
 
II.  Background  
 
Under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
381(a)(3)), an article4 of food imported or offered for import into the United States is subject to 
refusal of admission if it appears from the examination of such samples or otherwise to be 
adulterated. 
 
FDA issues import alerts to inform its field staff about products that appear to be in violation of 
FDAs laws and regulations and thus may be detained without physical examination.  We may 
subject future shipments of fish or fishery products to DWPE when there is information that 
causes future shipments of a product or products to appear violative within the meaning of 
section 801(a) of the FD&C Act.  Such information may exist based on the violative history of a 
product, manufacturer, shipper, grower, importer, geographic area, or country.5 
 
To carry out the provisions of section 801(a) of the FD&C Act when we detain an article that 
appears violative, we provide notice to the owner or consignee (referred to as the owner or 
 
4 As used in this guidance, the term article refers to the quantity of food within a shipment offered for entry that is 
subject to DWPE. 
5 For more information about import alerts, see https://www.fda.gov/industry/actions-enforcement/import-alerts. 
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you) of the nature of the violation and the right to present testimony regarding the 
admissibility of the article (21 CFR 1.94).  In other words, you can submit evidence to 
demonstrate the admissibility of the article that is subject to DWPE.  Frequently, owners or 
consignees submit analytical test results based on samples taken from the article subject to 
DWPE.  FDA then determines if the testimony (analytical package, information, or other 
evidence) is sufficient.  If the evidence is adequate to overcome the appearance of the 
violation(s), FDA will allow the article to proceed for entry into the United States.  If the 
evidence is not adequate to remove the appearance of the violation(s), the entry will be refused 
admission into the United States. 
 
In addition, interested parties may request that their products be removed from DWPE.  FDA 
decisions to remove a product, manufacturer, or other entity from DWPE are based on evidence 
establishing that the conditions that gave rise to the appearance of a violation have been resolved 
and we have confidence that future shipments of the product to the United States will be in 
compliance with the FD&C Act.  FDA may consider analytical results from consecutive tests as 
part of evidence to support removal from DWPE. 
 
When food testing is used as evidence in these scenarios (i.e., in support of admission of an 
article or to support removal from an import alert for consecutive testing), the food testing is 
covered by the Laboratory Accreditation for Analyses of Foods (LAAF) Rule (21 CFR 
1.1107(a)(4) and (5)). 6  The LAAF Rule includes certain specific requirements for food testing 
and analytical results that must be submitted to FDA.  This guidance provides recommendations 
to help owners, consignees, and other interested parties collect representative samples for food 
testing used to secure the release of fish and fishery products when FDA has identified the 
appearance of adulteration linked to a pathogen, unlawful animal drug, scombrotoxin 
(histamine), and/or decomposition and the appearance of these adulterants serve as the basis for 
DWPE.  This guidance also provides recommendations to help foreign manufacturers and other 
processors of fish and fishery products subject to DWPE under an import alert introduce 
evidence to FDA to support a request to have products removed from DWPE. 
 
 
 
 
6 Under the LAAF Rule, owners and consignees are required to use a LAAF-accredited laboratory for food testing in 
certain circumstances, including to support admission of an imported food detained at the border because it is or 
appears to be in violation of the FD&C Act and to support removal from an import alert through successful 
consecutive testing.  The LAAF Rule includes certain requirements for sampling, analysis of samples, methods of 
analysis, and the notifications, results, reports, and studies that LAAF-accredited laboratories must submit to FDA 
(see 21 CFR 1.1149, 1.1150, 1.1151, 1.1152, and 1.1153).  FDA is taking a stepwise approach to implementation of 
the LAAF program based on laboratory capacity.  When there is sufficient LAAF-accredited laboratory capacity for 
the food testing covered by the final rule, we will publish one or more documents in the Federal Register giving 
owners and consignees 6 months notice that they will be required to use a LAAF-accredited laboratory for such 
food testing.  For more information, see FDAs LAAF Rule website, available at https://www.fda.gov/food/food-
safety-modernization-act-fsma/fsma-final-rule-laboratory-accreditation-analyses-foods-laaf.  At the time of 
publication of this draft guidance, owners and consignees are not yet required to ensure that food testing is 
conducted in accordance with the LAAF rule due to current insufficient laboratory capacity.  However, that will 
change if FDA publishes an applicable document in the Federal Register giving owners and consignees notice about 
the requirement to use a LAAF-accredited laboratory. 
3 
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III.  Discussion 
 
A.  Recommendations for Collecting Representative Samples for Food Testing Used as 
Evidence for Release of Articles Subject to DWPE 
 
When a product is subject to DWPE due to the appearance of adulteration linked to a pathogen, 
unlawful animal drug, scombrotoxin (histamine), and/or decomposition, we recommend that you 
develop a statistically robust representative sample consisting of sample units collected 
proportionately from the affected article in order to support the admissibility of the product.  The 
term sample unit refers to the smallest discrete intact component in the article or portions of 
the article (e.g., whole fish, fish fillet, shrimp, can, tub, bag, etc.).  Appendix A provides 
sampling schedule recommendations for the number of sample units to collect and test.7  
Appendix B provides the minimum amount of product recommended for collection to represent 
each sample unit.  The recommended sampling schedules consist of three groupings based on the 
risk to health that the adulteration generally represents to consumers, with more sampling and 
testing warranted when the risk is expected to be greater.  While we generally recommend you 
follow the sampling schedules in Appendix A, we recognize that there may be circumstances 
where another sampling plan could be justified.  If you believe that another sampling plan is 
justified, you may propose such a plan to us before collecting the sample, and we will consider 
whether your plan is appropriate. 
 
In addition to the total number of sample units collected being statistically robust based on the 
total weight of the article, the adequacy of the evidence depends on ensuring that the sampling is 
representative of every portion of the affected article.  If the sampling is not representative and 
statistically robust, there will generally be insufficient evidence supporting the admissibility of 
the article.  To ensure that the sampling is representative across different product portions, we 
recommend using commercial documentation, such as invoices, packing lists, and 
manufacturers or shippers lists of production codes, to identify discrete portions making up 
the article. 
 
The owner or consignee of an article subject to DWPE may identify discrete portions making 
up the article on the basis of: 
 
1.  Line - Product within the article that can be grouped by attributes or characteristics, such 
as uniform type (e.g., species), size (e.g., size of product portions/pieces, count, package 
weight), and market form (e.g., head on/off, tail on/off, peeled, deveined, butterflied, 
cooked, raw, skin on/off, filleted, headed and gutted, breaded, ingredient 
formulation/treatments), that often appears as a single line item in the shipment manifest, 
invoice, or packing list.  When sampling based on a product line, the individual collecting 
the sample (sampler) should ensure cross-representation of production codes (see 2 
below) within each line; or 
 
 
7 For more information about the basis for FDAs recommendations in Appendix A, see Derivation of Sampling 
Recommendations Related to Recommendations for Collecting Representative Samples for Food Testing Used as 
Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination 
(DWPE) and Removal of a Foreign Manufacturers Goods from DWPE: Guidance for Industry (Ref. 1). 
4 
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2.  Production Code - Product within the article associated with the same history of 
exposures, e.g., product originating from a specific farm, harvest area, or harvester and 
processed and packed under uniform conditions in a specific period of time (e.g., day or 
shift) at a specific packing facility and production line, or the same sequence of facilities 
and lines, culminating in coding the packed product with the same manufacturers 
production code.  Coding is frequently specific to product attributes or lines such as those 
described in 1 above, but if the coding is a production date code only, then the sampler 
should ensure cross-representation of product attributes or lines within each production 
code-based sample. 
Owners may propose different attributes as a basis for separating the article into different 
portions.  Documents such as invoices, packing lists, and manufacturers or shippers listing of 
production codes and photographs may be helpful to demonstrate that the proposed sample is 
representative. 
 
When the article subject to DWPE consists of two or more discrete portions, the recommended 
number of sample units should be collected proportionately from each portion making up the 
article (i.e., the percentage of sample units from each portion should correlate to the volume (net 
weight) of product that the specific portion represents in the article).  For example, a 40,000-
pound article of tilapia fillets subject to DWPE due to the appearance of unlawful animal drugs 
should result in a total sample size of 150 units per the recommended sampling Table in 
Appendix A.  A portion of the 40,000-pound article consisting of 6,360 pounds of product should 
result in the collection of 24 of the 150 units collected from that 6,360-pound portion, i.e., 6,360 
 40,000 = 0.159 (or 15.9%) and 0.159 x 150 units rounds off to 24 (see Line 001/003 in the 
illustration below). 
Example:  An importer has an article of frozen tilapia fillets subject to DWPE due to 
the appearance of unlawful animal drug residues.  The article consists of seven line 
items delineated by the size or weight of the fillets.  A suggested sampling scheme is 
as follows: 
 
Number of 
  Net Wt.  Sample Units 
Line Description 
Line   (lbs)  to Collect & 
Test 
001/001  Tilapia fillets, 6-8 oz  16,800  63 
001/002  Tilapia fillets, 4-6 oz  8,580  32 
001/003  Tilapia fillets, 8-10 oz  6,360  24 
001/004  Tilapia fillets, 10-12 oz  4,150  16 
001/005  Tilapia fillets, 12-14 oz  2,810  10 
001/006  Tilapia fillets, < 4 oz  980  4 
001/007  Tilapia fillets, > 14 oz  320  1 
  Total  40,000  150 
   
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In this example, the 150 sample units recommended in the sampling Table in 
Appendix A for unlawful animal drugs are collected proportionately by the volume of 
product in the lines.  In addition, consistent with the recommendations above for 
sampling by lines, assurances should be made that a cross representation of 
production codes are included within the group of sample units collected from each 
line as may be applicable to that line. 
 
To the extent possible within the sampling scheme, sample units should be collected randomly to 
give the broadest representation of each portion (i.e., one subsample per carton/tote/container 
randomly selected from the portion to be sampled).  Random sampling within each portion 
means that every unit of fish or fishery product within the portion sampled should have an equal 
chance to be selected.  For example, any package, from any carton, from any layer on any pallet 
within the portion, has an equal chance to be selected.  The selection of sample units should not 
be restricted to only some pallets or some layers on the pallets that are conveniently accessible.  
It may be appropriate to add additional sample units to those randomly selected if some 
important attribute of the portion was completely missed in the random draw (e.g., a particular 
prominent production code may have been missed when sampling was stratified based on line 
item). 
 
If the adulterant associated with the import alert is detected in any sample unit analyzed from any 
portion or portions of the article, FDA may determine that the appearance of the violation 
remains for all portions of the detailed article.8  The overall sample size and the number of 
sample units collected from each portion, when applying the recommended sampling strategy in 
this document, are generally not adequate to provide sufficient statistical assurances to signal that 
the adulteration is restricted to the specific portion or portions of the article in which a positive 
sample unit(s) was identified, such that a reliable segregation of the article could be performed, 
portion-by-portion, on the basis of these limited sampling and analytical results.  As a result, it is 
unlikely that we would consider it reasonable to separate (and treat as violative) only the 
portion(s) of the article that test positive for the adulteration, based solely on the test results.9 
 
As part of the review of your request for release of an article subject to DWPE, we may request 
additional documentation to ensure that the products in the shipment do not appear adulterated.  
For example, we may request such additional information if our review of the national entry data 
for your products(s) shows there has been a history of mixed analytical results, such as 
successive shipments alternately having positive and negative results such that the results for a 
new shipment may not convincingly demonstrate lack of adulteration. 
 
When submitting analytical results of food testing as evidence in this scenario, the LAAF Rule 
requires owners or consignees to use a LAAF-accredited laboratory (see 21 CFR 1.1107(a)).  
The LAAF rule describes the oversight standards that apply to sampling and the documentation 
that a LAAF-accredited laboratory must submit to FDA with test results (see 21 CFR 1.1149 and 
21 CFR 1.1152(c)).  Generally, this documentation includes submission of the samplers 
 
8 Violative concentrations of some contaminants in a sample unit or appropriate composite analytical unit, as 
established in FDA regulations and guidance, may be applicable, e.g., florfenicol residue greater than 1.0 ppm.   
9 If the owner or consignee presents evidence to FDA that the adulteration does not apply to all portions of the 
detained article, FDA will consider such evidence. 
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applicable qualifications, a written sampling plan used to conduct the sampling, and a written 
sample collection report for each sample collected (see 21 CFR 1.1149(a)).  The written 
sampling plan must identify the sampler and sampling firm and must list the factors that will be 
controlled to ensure the sampling does not impact the validity of the subsequent analytical 
testing, including controlling for the representational nature of the sample (see 21 CFR 
1.1149(a)(2)).10,11  The LAAF Rule provides detailed information about what information must 
be submitted to FDA with analytical results (see 21 CFR 1.1152). 
 
B.  Recommended Analytical Methods 
 
For fish and fishery products subject to DWPE, the general methods found in the Analytical 
section of FDAs Compliance Programs, relevant to the specific adulteration identified in the 
import alert, may be used. 
 
For unlawful animal drug residues, see Chemotherapeutics in Aquaculture Seafood Compliance 
Program, CP 7304.018, https://www.fda.gov/media/71452/download or see Drug or Chemical 
Residues Methods https://www.fda.gov/food/science-research-food/laboratory-methods-food. 
 
10 As stated in a previous footnote, FDA is taking a stepwise approach to implementation of the LAAF program 
based on laboratory capacity.  When there is sufficient LAAF-accredited laboratory capacity for the food testing 
covered by the final rule, we will publish one or more documents in the Federal Register giving owners and 
consignees 6 months notice that they will be required to use a LAAF-accredited laboratory for such food testing.  
At the time of publication of this draft guidance, food owners and consignees are not yet required to ensure that 
testing is conducted in accordance with the LAAF rule due to current insufficient laboratory capacity.  However, 
that will change if FDA publishes an applicable document in the Federal Register giving owners and consignees 
notice about the requirement to use an LAAF-accredited laboratory. 
11 For shipments that, (1) are not the subject of a Federal Register notice indicating that owners or consignees will 
be required to use an LAAF-accredited laboratory for food testing, but for which (2) sampling and analytical results 
are included in the evidence submitted in a request to secure release, we recommend that you provide FDA with a 
comprehensive submission that includes: 
1.  A detailed description of the detained article, and any pertinent attributes of the portion or portions within 
the article that may have been selectively sampled, including the identity, size (e.g., volume by weight, and 
number of pallets, cartons, vats, bags, etc.), composition, and configuration.  Documents such as invoices, 
packing lists, and manufacturers or shippers listing of production codes and photographs are helpful. 
2.  A detailed sample description of how the number of sample units collected was calculated including the 
total number of sample-sized units in the article, the smallest discrete component, the number of sample 
units collected from each portion of the article, the composition of each sample unit (e.g., the amount of 
product and number of pieces in each sample unit), the production code of each sample unit, a description 
and/or diagram of the locations (e.g., pallets, layers on pallets, cartons within layers) within the article or 
portions from where each sample unit was collected, the sampling method used (i.e., the manner or 
technique by which each sample unit is collected), and the sample preparation and shipping procedures 
used. 
3.  The identity and qualifications of the entity and individual(s) conducting the sampling. 
4.  Identification and accreditation, if any, of the laboratory and individual(s) that performs the specified 
analysis of the samples. 
5.  Documentation of the analysts qualifications (see Ref. 2, Sec. 4.1, Private Laboratory Guidance, 
Information About Private Laboratories, Private Laboratory Analysts). 
6.  A detailed description of the test method(s) and procedures used to analyze all of the sample units.  You 
may utilize the general methods found in the Analytical section of FDAs Compliance Programs, relevant 
to the specific adulteration at issue. 
7.  All original and complete sample collection reports and analytical data and reports regardless of the 
findings. 
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For adulteration associated with pathogens, scombrotoxin (histamine), and decomposition in fish 
and fishery products, see the Seafood Processor, Products, and Importer Inspection Program, CP 
7303.842, or as indicated elsewhere within that compliance program, 
https://www.fda.gov/media/71302/download. 
 
Alternatively, other methods that involve appropriate validation/verification procedures for the 
specific adulteration and sample matrix under consideration may be used.  If such alternatives 
are used, we recommend that you provide information that supports the use of the methods. 
 
Compositing of sample units to the extent indicated in the specific methods is acceptable. 
 
C.  Recommended Evidence for Requests for Removal from DWPE Under an Import 
Alert 
 
Foreign manufacturers or other interested parties may request to be removed from DWPE.12  
They should provide information to FDA to adequately demonstrate that the conditions that gave 
rise to the appearance of the violation have been resolved.  For example, it may be appropriate to 
provide evidence of a root cause analysis, relevant corrections to the manufacturing process, 
and/or other controls that have been implemented to address the violation, and hazard analysis 
critical control point (HACCP) documents, in addition to testing results for consecutive non-
violative shipments.  The Guidance section of the import alert may contain additional 
information for requesting removal from DWPE. 
 
For general guidance on removal from DWPE, including recommendations for the number of 
consecutive non-violative shipments that FDA may request, refer to FDAs Regulatory 
Procedures Manual (RPM), Chapter 9, Sections 9-8-15 and 9-8-16 (Ref. 2).  RPM Chapter 9 
includes recommendations about the number of consecutive non-violative shipments (typically 
five (5) or twelve (12)) that may help demonstrate that the conditions that gave rise to the 
appearance of the violation have been resolved.13  The testing submitted to FDA should be from 
a statistically robust number of samples based on the size of the article and representative of the 
affected article.  We recommend the sampling and testing protocols outlined in section III.A. of 
this guidance.  At the same time, we recognize that there may be circumstances where another 
sampling plan could be justified.  If you wish to use other levels of sampling and testing, you 
may submit them to us, and we will consider whether such requests are appropriate. 
 
To facilitate and expedite a review of a request for removal of fish and fishery products from 
DWPE, we recommend that the manufacturer or other party submit information to allow us to 
adequately assess whether the conditions that gave rise to the appearance of the violation have 
been resolved.  The purpose of this is so that we can have confidence that future shipments of the 
 
12 For some import alerts, being removed from DWPE may mean being removed from a Red List.  For other 
import alerts, being removed from DWPE may mean being added to a Green List.  For more information about 
import alerts, see FDAs Import Alerts website, available at http://www.fda.gov/industry/actions-
enforcement/import-alerts#typelist. 
13 For more information about the recommended numbers of shipments that may be appropriate in different 
circumstances, see RPM Chapter 9. 
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product will not appear violative.  Such documentation (which should be provided in English to 
facilitate review) may include the following: 
 
1.  Documentation of a root cause analysis.  The root cause analysis should consider all 
potential sources of adulteration and explain the basis for their elimination to demonstrate 
how the root cause was ultimately identified as the likely source of the adulteration.  If 
the likely source of the adulteration cannot be identified, then the root cause analysis 
should thoroughly investigate and evaluate all potential sources, implemented controls, 
and problems. 
 
2.  Documentation of corrective actions taken to address the likely or potential sources and 
routes of contamination identified in the root cause analysis.  The corrective actions 
should provide details on the controls implemented to prevent future adulteration based 
on the root cause analysis. 
 
3.  Documentation pertinent to current processing of the fish or fishery product(s), including: 
 
a.  Where applicable, a copy of the most current HACCP plan in effect by each 
processor involved with the processing of the product(s) for which removal from 
DWPE is requested. 
 
b.  Where applicable, HACCP monitoring records reflecting control and monitoring of 
the pertinent critical control point(s) and sanitation monitoring records.  We 
recommend providing records that cover five (5) production days to help demonstrate 
that the conditions that gave rise to the appearance of the violation have been 
resolved.  This may include records from: 
 
i.  The foreign manufacturer requesting removal from DWPE, and 
 
ii.  Each of the manufacturers suppliers or intermediary processors. 
 
4.  Documentation of food testing analytical results14 (see 21 CFR part 1, subpart R; see 
FDAs Regulatory Procedures Manual, Chapter 9, Sections 9-8-15 and 9-8-16 (Ref. 2) 
for information about the number of consecutive non-violative shipments that FDA may 
expect). 
 
The specific information that should be provided will depend on the nature of the violation at 
issue, the relevant history for the firm/product, the information in the relevant import alert, the 
nature of the growing, harvesting, or processing conditions, and other relevant information. 
 
 
14 As discussed in footnote 6, once there is sufficient LAAF-accredited laboratory capacity, owners and consignees 
will be required to use a LAAF-accredited laboratory to conduct food testing in this scenario.  At the time of 
publication of this draft guidance, food owners and consignees are not yet required to ensure that testing is 
conducted in accordance with the LAAF rule due to current insufficient laboratory capacity.  However, that will 
change if FDA publishes an applicable document in the Federal Register giving owners and consignees notice about 
the requirement to use an LAAF-accredited laboratory. 
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Note:  In some cases, manufacturers or other parties will have previously submitted information 
to FDA to secure release of individual shipments.  In some cases, that same information (for 
example, processing records) may also be relevant to the firms request to be removed from 
DWPE.  There is no need to submit the same information to FDA more than once.  To avoid 
duplication, the firms request for removal from DWPE may include references to the previously 
submitted information. 
 
A request for removal of a manufacturers product(s) from DWPE, along with information 
supporting the request, should be forwarded to FDA at the address provided in the import alert. 
 
IV.  Conclusion 
 
This guidance provides recommendations for collecting a representative sample and testing when 
fish and fishery products are subject to DWPE due to the appearance of adulteration caused by 
pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition.  The 
guidance provides recommendations for requests for removal from DWPE.  Importers of fish and 
fishery products remain subject to the statutory prohibition against the introduction or delivery 
for introduction into interstate commerce of adulterated food (section 301(a) of the FD&C Act 
(21 U.S.C. 331(a))).  Nothing in this guidance prevents owners of seafood products from 
conducting sampling for purposes unrelated to this guidance (i.e., unrelated to demonstrating 
admissibility of an article of seafood or requesting removal from DWPE).  If you have questions 
about evidence to submit, you may contact the appropriate office listed in this guidance to ask 
questions specific to the article offered for entry. 
 
Following the receipt and review of the sample collection reports, laboratory results, and any 
associated corrective and preventive action documentation requested by, or submitted to, FDA, 
we may collect and analyze audit samples before making a final decision on the admissibility of 
any article. 
 
  For questions related to a detention or regarding the process of submitting evidence of 
admissibility, contact the compliance officer listed on your FDA Notice of Action. 
  For questions on policy or sample collection recommendations, contact the Office of 
Compliance, Division of Enforcement, CFSAN, at 240-402-1750 or 
CFSANEnforcement@fda.hhs.gov. 
  For questions or issues concerning preparation of samples for analysis or analytical 
methodology, contact the Office of Regulatory Science, Office of Regulatory Affairs 
(ORA), at oraorsprivatelabimportalerts@fda.hhs.gov. 
  For questions related to the LAAF Rule, contact FDALAAFInquiry@fda.hhs.gov. 
  For general questions or issues involving import operations, including requests for 
removal from DWPE, contact the Division of Import Operations at 301-796-0356 or 
FDAImportsInquiry@fda.hhs.gov. 
 
 
 
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V.  References 
 
The following references are on display at the Dockets Management Staff (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov.  FDA has verified the website address, as 
of the date this document publishes in the Federal Register, but websites are subject to change 
over time. 
 
1.  FDA, Derivation of Sampling Recommendations Related to Recommendations for Collecting 
Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and 
Fishery products Subject to Detention Without Physical Examination (DWPE) and Removal 
of a Foreign Manufacturers Goods from DWPE: Guidance for Industry. 
2.  FDAs Regulatory Procedures Manual, Chapter 9, Section 9-8-15, Removal From Detention 
Without Physical Examination, and Section 9-8-16, Removal of Products 
Manufacturers/Countries Except Fresh Produce.  Accessed online at 
https://www.fda.gov/media/71776/download.  
 
 
VI.  Appendices 
 
Appendix A  Sampling Schedule Recommendations 
 
Appendix B  Amount of Product Recommended Per Sample Unit 
 
   
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Appendix A  Sampling Schedule Recommendations 
 
Table 1 provides recommended numbers of sample units to collect and test when an article of 
fish or fishery product is subject to DWPE due to the appearance of adulteration by pathogens, 
unlawful animal drugs, scombrotoxin (histamine), and/or decomposition, and the sampling and 
testing results are submitted to demonstrate admissibility.  The number of sample units to be 
collected may be adjusted based on the total size (by weight) of the article.  However, as can be 
seen in Table 1 below, to ensure statistical relevance, the number of sample units to be collected 
becomes impractical for articles that are small in total amount (by weight) because the number of 
sample units to be collected eventually equals the amount of product in the article. 
 
The recommendations in the main body of this guidance document are applicable to collecting a 
proportionate number of sample units to represent all portions of the article (e.g., lines or codes) 
such that inferences of test results can apply to the entire article, as opposed to portions of the 
article.15  
 
Our sampling recommendations are as follows: 
 
Table 1:  Total number of sample units to collect and test from the affected article  
based on the number of sample-sized units within the affected article. 
 
Number of sample-sized 
units within the affected  50  100  200  350  500  1,000  5,000  10,000  50,000  100,000 
article (see Note below) >>  
Pathogens, Unlawful 
Animal Drugs, or  50  95  126  137  141  145  150  150  150  150 
Scombrotoxin 
Decomposition in 
Scombrotoxin-forming 
Fishery Products without  48  78  105  109  110  116  119  120  120  120 
Scombrotoxic Levels of 
Histamine Detected* 
Decomposition in Non-
Scombrotoxin-forming 
45  69  74  87  87  87  90  90  90  90 
Species of Fishery 
Products* 
* When chemical indices of decomposition are applicable, e.g., histamine or indole, all sample units 
should be tested by sensory and chemical analyses.  Histamine levels at 200 parts per million (ppm) or 
greater are considered scombrotoxic for this application. 
 
Note:  To determine the Number of sample-sized units within the affected article, Appendix B 
provides the amount (by weight) of product recommended for collection to represent each 
sample unit.  Depending on the type of product and its packaging, the recommended sample unit 
 
15 This guidance does not apply when owners or other representatives seek to segregate non-violative products from 
products that they acknowledge are adulterated.  FDAs recommendations for sampling and testing in that situation 
can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-
reconditioning-fish-and-fishery-products-segregation. 
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amount (by weight) in Appendix B may be collected by withdrawing the smallest discrete intact 
component (e.g., whole fish, fish fillet, shrimp, can, tub, bag, etc.) in the article.  For packaged 
products, it may be the smallest discrete intact package in the article (e.g., can, tub, bag, etc.).  
For bulk products, it may be a single fish or fish piece (e.g., loin, fillet, or steak).  When the 
packages, fish, or fish pieces are very small, we recommend that you collect multiple packages, 
fish, or fish pieces to meet the recommended sample unit amount (by weight) in Appendix B.  
For other products, the smallest discrete intact component collected may be a larger amount (by 
weight) than the sample size unit amount (by weight) from which the recommended sample unit 
amount in Appendix B can later be drawn by the laboratory and tested.  However, the smallest 
discrete intact component should not be used for more than one sample unit.  To determine the 
recommended number of sample-sized units within the affected article, divide the amount (by 
weight) of the article by the recommended collection amount (by weight) for each sample unit 
(see Appendix B), adjusting for the product type and packaging as shown in Examples 1-3 
below. 
 
Example 1:  When the exact amount for the sample unit is collected, the total amount (by 
weight) of product in the article is divided by the sample unit amount (by weight) 
recommended in Appendix B.  This scenario applies when the recommended sample unit 
amount (by weight) equals the smallest discrete component (by weight) which can be 
single or multiple small fish or fishery product from a bulk container or single or multiple 
small packages. 
 
-  Sample calculation example 1:  The recommended sample unit amount (by 
weight) in Appendix B is 8 oz. (0.5 lbs.) and the smallest discrete intact 
component is an 8 oz. package.  The article consists of 35,000 pounds of product.  
The total number of sample-sized units in the article to be applied in the Table 
is 70,000 units (35,000 lbs.  0.5 lbs. = 70,000 sample-size units). 
 
or 
 
Example 2:  When the smallest discrete intact component of the article is a larger 
amount (by weight) than the recommended sample unit amount (by weight), the total 
amount (by weight) of product in the article is divided by the smallest discrete intact 
component amount (by weight).  This scenario applies when the recommended sample 
unit amount (by weight) is less than the smallest discrete component (by weight) which 
can be a fish or fishery product from a bulk container or a package. 
 
-  Sample calculation example 2:  The recommended sample unit amount (by 
weight) in Appendix B is 8 oz. (0.5 lbs.).  The article consists of 1 lb. packaged 
units that are destroyed once opened, thus, a 1 lb. package is the smallest discrete 
intact component that will be collected to represent a sample unit.  The article 
consists of 35,000 pounds of product.  The total number of sample-sized units 
in the article is 35,000 units (35,000 lbs.  1 lbs. = 35,000 sample-size units). 
 
or 
 
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Example 3:  When the article consists of a mix consisting of two or more discrete 
portions, the total amount (by weight) of product in the article is divided proportionately 
by the smallest discrete intact component amount (by weight) for each portion.  This 
scenario applies when the smallest discrete intact component in the article is not uniform 
(e.g., consists of 1 lb. and 2 lbs. packages, etc.), which can be a fish or fishery product 
from a bulk container, packaged, or both. 
  
-  Sample calculation example 3:  The recommended sample unit amount (by 
weight) in Appendix B is 8 oz. (0.5 lbs.).  The article consists of different sized 
(smallest discrete intact) packaged units that are destroyed once opened.  The total 
number of sample-size units should be the sum of the sample-size units 
calculated proportionately based on the total weight of the product for each 
package size.  The article consists of 35,000 lbs. of product for which 20,000 lbs. 
are packaged in 1 lb. sealed bags and 15,000 lbs. are packaged in 2 lbs. sealed 
bags.  The total number of sample-size units in the article is 27,500 units 
((20,000 lbs.  1 lb.) + (15,000 lbs.  2 lbs.) = 27,500 sample-size units). 
  
Our sampling recommendations are based on achieving the following levels of confidence for 
detecting the different types of adulteration, as follows:16 
  For pathogens, unlawful animal drugs, and scombrotoxin  95% confidence that 
contamination is present in no more than approximately 2.0% of the units in the article; 
  For decomposition in scombrotoxin-forming fish and fishery products  95% confidence 
that contamination is present in no more than approximately 2.5% of the units in the 
article; and 
  For decomposition in non-scombrotoxin-forming fish and fishery products  90% 
confidence that contamination is present in no more than approximately 2.5% of the units 
in the article.17 
 
The table reflects our general recommendations.  You may propose alternative sampling plans 
and explain the basis for such alternatives. 
 
The table reflects sampling recommendations only, and the levels of confidence we recommend 
for detecting the different types of adulteration should not be misinterpreted to signify acceptable 
levels of the identified adulterants in the food. 
 
   
 
16 The recommendations are derived from a critical nonconformities statistical application.  
17 FDA may consider the article adulterated when the contamination is detected in any sample unit within the 
recommended sample number. 
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Appendix B  Amount of Product Recommended Per Sample Unit 
 
The recommended amount (by weight) of product to be collected for each sample unit as 
applicable to the relevant adulteration that forms the basis of the article being subject to DWPE 
is provided in the table below: 
 
Recommended Amount (by 
Application  Weight) of Product to be 
Collected for Each Sample Unit 
Pathogens   
    Salmonella or Listeria monocytogenes  114 grams (4 oz.) 
    Other Pathogens  227 grams (8 oz.) 
Unlawful Animal Drugs   
    Unless Otherwise Noted  454 grams (1 lb.) 
    Shrimp   
        Fresh, Frozen,   454 grams (1 lb.) 
        Whole, In-Shell, Breaded  680 grams (1.5 lbs.) 
    Crab or Crawfish   
        Processed  454 grams (1 lb.) 
        Whole, In-Shell, Cut Pieces  680 grams (1.5 lbs.) 
    Frog Legs  680 grams (1.5 lbs.) 
    Finfish  454 grams (1 lb.) 
Scombrotoxin (Histamine)    
    Unless Otherwise Noted    250 grams (can be obtained from 
the 1 lb. decomposition sample 
unit in most instances) 
    Cans or Retorted Pouches/Cups   142 grams (5 oz.) or  
1 can/cup/pouch if > 5 oz. 
Decomposition   
    Unless Otherwise Noted    454 grams (1 lb.)  
    Cans or Retorted Pouches/Cups    
         Scombrotoxin-Forming Fishery   142 grams (5 oz.) or  
           Products  1 can/cup/pouch if > 5 oz. 
         Non-Scombrotoxin-Forming Fishery  1 can/cup/pouch regardless of 
           Products  weight 
 
15