Contains Nonbinding Recommendations 
 
Reconditioning of Fish and Fishery 
Products by Segregation 
 
Guidance for Industry 
 
Additional copies are available from: 
Office of Food Safety, Division of Seafood Safety  
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-2300 
 
http://www.fda.gov/FoodGuidances   
 
You may submit electronic or written comments regarding this guidance at any time.  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 
[FDA2019D3324] listed in the notice of availability that publishes in the Federal 
Register.  
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
April 2022    Contains Nonbinding Recommendations 
 
Table of Contents 
 
 
I. Introduction ..........................................................................................................1   
II. Background .........................................................................................................2   
III. Discussion ...........................................................................................................3   
A. Reconditioning by Segregation .......................................................................3   
1.  Segregation Based on a Production-Related Rationale Identifying the 
Cause of the Adulteration and Its Restriction to Only a Portion of 
the Article, Along with Confirmation Sampling and Testing ................ 3 
2.  Segregation Based on Sampling and Testing Results Alone ........................ 8 
B. Discussion of Sampling Recommendations .................................................11 
C. Proposal for Reconditioning by Segregation ..............................................12 
IV. References .........................................................................................................14  Contains Nonbinding Recommendations 
Reconditioning of Fish and Fishery 
Products by Segregation 
1
Guidance for Industry  
 
This guidance represents 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 as listed on the title page.  
 
I. Introduction 
 
This guidance is intended to clarify steps that owners of fish and fishery products, or their 
representatives, can take to segregate non-violative products from products adulterated with 
pathogens, unlawful animal drugs, scombrotoxin (histamine), and decomposition, to demonstrate 
compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).  Specifically, this 
document provides guidance for reconditioning by: 
 
1.  segregation based on a production-related rationale, supported by production records 
identifying the cause of the adulteration and its restriction to only a portion of the article,2 
along with sampling and testing to confirm that the segregation was successful; or 
2.  segregation based on the results of statistically significant sampling and testing.  Here the 
sampling and testing forms the basis for the segregation. 
 
This guidance does not supersede Compliance Policy Guide Sec. 160.700, Reconditioning of 
Foods Adulterated Under 402(a)(4) (Ref. 1).  Nor does this guidance apply in situations where 
reconditioning is proposed by means other than segregation, such as by cooking or conversion to 
animal feed.  Also, segregation alone may not be a reliable or acceptable means of 
reconditioning adulterated fish and fishery products that are adulterated under section 402(a)(4) 
of the FD&C Act. 
 
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract.  This document is 
intended only to provide clarity to the public regarding existing requirements under the law.  
FDA guidance documents, including this guidance, should be viewed only as recommendations, 
unless specific regulatory or statutory requirements are cited.  Throughout this guidance the 
terms you and your refer to persons or establishments that are owners of fish and fishery 
products, or their representatives, interested in bringing adulterated products into compliance 
with the FD&C Act by means of segregating non-violative product from adulterated product. 
 
1 This guidance has been prepared by the Office of Food Safety/Divisions of Seafood Safety and Seafood Science 
and Technology in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.  
2 As used in this guidance, the term article refers to the quantity of food deemed by us to be adulterated.   
  1  Contains Nonbinding Recommendations 
 
II. Background 
 
Anyone introducing, delivering, or receiving fish and fishery products in interstate commerce is 
ultimately responsible for ensuring that the food is safe and complies with all applicable laws 
and regulations.  
 
Domestic fish and fishery products 
Although voluntary destruction of violative goods before seizure is encouraged (see Ref. 2, RPM 
Section 6-1-2 F, Seizures, General Guidelines), a court may order a seized and condemned 
article of food (the group of products or lot(s)) to be delivered to the owner to be brought into 
compliance with the FD&C Act instead of destruction (section 304(d)(1) of the FD&C Act [21 
U.S.C. 334(d)(1)]).  The order may be made only after entry of a decree of condemnation, 
payment of the condemnation proceedings cost by the claimant, and execution of a good and 
sufficient bond by the claimant.  The court may by order, direct the article to be brought into 
compliance, referred to as reconditioning, under the supervision of an FDA employee, and the 
claimant must pay the expenses for such supervision.   
 
Imported fish and fishery products 
An article of food imported or offered for import into the U.S. is subject to refusal of admission 
if it appears to be adulterated (see section 801(a)(3) of the FD&C Act [21 U.S.C. 381(a)(3)]).  
However, the owner or consignee may introduce testimony including evidence in support of an 
application for authorization to perform an action to bring the article into compliance with the 
FD&C Act (see section 801of the FD&C Act;  21 CFR 1.95).   
 
FDA may authorize action to bring an article detained under section 801(a)(3) into compliance 
upon the timely submission of an application for authorization to recondition (see section 801(b) 
of the FD&C Act [21 U.S.C. 381(b)]).  See also 21 CFR 1.95.3  Approved reconditioning 
operations are to be carried out under the supervision of an FDA officer or a U.S. Customs and 
Border Protection officer (21 CFR 1.96(a)(3)). 
 
Administratively detained fish and fishery products 
We may order the detention of any article of food if an officer or qualified employee has reason 
to believe, during inspection, examination, or investigation, that the article of food is adulterated 
or misbranded (see section 304(h) of the FD&C Act [21 U.S.C. 334(h)].  We intend to consider 
reconditioning proposals for administratively detained fish and fishery products on a case-by-
case basis.  
 
Authorization to recondition 
The courts may direct, or we may authorize, reconditioning of adulterated product by segregation 
as a means to bring an article into compliance with the FD&C Act.  Applications stating to 
simply segregate, sort, sample, test, convert, reject, or destroy the article or 
portion(s) of the article may be inadequate without detailed descriptions of the proposed methods 
 
3 Proposals for reconditioning products offered for import should be submitted on Form FDA 766 (Ref. 3, Form 
FDA 766) or another appropriately completed notice (such as a letter).  In addition, a good and sufficient bond must 
be executed (CBP redeliver bond) by the owner or consignee (see section 801(b) of the FD&C Act).   
  2  Contains Nonbinding Recommendations 
and processes to bring the article into compliance with the FD&C Act and specifying the 
disposition of any rejected article or portion(s).  All proposed reconditioning methods should be 
approved by us before their implementation, and all products should be held intact until release is 
authorized.  Following the reconditioning effort, we may collect and test audit samples at our 
discretion.  
 
Our approval of a reconditioning action as described in this guidance does not transfer 
responsibility for the safety or compliance of the products to anyone other than the owner.  
Moreover, the submission and/or authorization of a proposed reconditioning action to address 
one type of adulteration will not necessarily ensure that all adulteration or misbranding 
associated with the article will be addressed or that the proposal will serve as an acceptable 
reconditioning for any other type of adulteration or misbranding of the article needing to be 
resolved.  The owner remains responsible for the safety and compliance of the products.    
 
III. Discussion 
 
A. Reconditioning by Segregation 
 
Proposals for reconditioning by segregation should provide sufficient evidence that violative 
product can be reliably separated from non-violative product.  Proposals to separate out or 
destroy only those portions associated with samples we tested and found to be violative, 
followed by a non-statistically based sampling plan for the remaining portion(s), typically do not 
provide sufficient assurance that the remaining portion(s) are in compliance.  This approach is 
unlikely to give assurance that the action will successfully bring the article into compliance, and 
we do not recommend it as an appropriate reconditioning action. 
 
For the segregation of fish and fishery products adulterated due to pathogens, unlawful drugs, 
scombrotoxin (histamine), and/or decomposition, we recommend one of the following 
approaches: 1) an investigation by or on behalf of the owner of the article that, based on a 
production-related rationale, supported by production records, identifies the cause of the 
adulteration and its restriction to only a portion of the article, and offers a segregation strategy 
based on that root cause, followed by relatively modest sampling and testing to confirm that the 
segregation was successful in isolating and removing the adulterated portion(s); or 2) when the 
root cause has not been identified, sampling and testing in a sufficiently robust manner to 
provide statistical assurance that the adulterant is not present in other portions of the article.  
 
1.  Segregation Based on a Production-Related Rationale Identifying the Cause of the 
Adulteration and Its Restriction to Only a Portion of the Article, Along with Confirmation 
Sampling and Testing 
 
Production-related documents and records could identify occurrences or deviations as the root 
cause of an adulteration and may form the basis of a meaningful segregation.  You may provide 
production-based information specific to the article or its manufacture to support a science-based 
  3  Contains Nonbinding Recommendations 
assertion that only the identified portion(s)4 of the article are adulterated, such that the proposed 
segregation will effectively separate and isolate the affected and violative portion(s) from the 
non-violative portion(s).  The segregation is followed by sampling and testing to confirm that the 
segregation was successful.  In this approach, meaningful segregation is the action bringing the 
article into compliance, not the sampling and testing. 
 
Rationale 
 
You should provide applicable production records supporting the claim that only the specified 
portion(s) of the article were affected by the production-based condition while other portion(s) 
were not exposed to the same conditions that caused the adulteration.  The assertion should not 
be simply a hypothetical consideration that the adulteration might be restricted to only a portion 
of the article by some possible mechanism that could have potentially taken place.   
 
If the cause of the adulteration is related to information in one or more processors5 Hazard 
Analysis Critical Control Point (HACCP) plan(s) in effect at the time the product was 
manufactured, you should include the HACCP plan(s) in the reconditioning submission.  In 
addition, you should include relevant records, such as those related to monitoring, corrective 
action, verification, and sanitation, to assist our review.   
 
Confirmation Sampling 
 
In conjunction with the segregation, your proposal should provide protocols and criteria for 
sampling and testing to be performed on the portion(s) of the article segregated as non-violative 
to confirm that the reconditioning, i.e., the segregation, appears to have been successful.   
  
The sampling plan (e.g., number of sample units6, sample unit size, and accept/reject criteria) 
should be sufficiently rigorous to ensure that the article, which has already been found to be 
violative, has been successfully brought into compliance by the segregation action.  Collectively, 
the goal is for the analytical test results of all of the sample units to provide sufficient 
information to draw inferences about the condition of the larger mass making up the segregated 
portion(s) that the applicant maintains to be non-violative as a whole and, consequently, in this 
application, draw an inference about the overall effectiveness of the segregation.  Each portion of 
the article presented to us as having been brought into compliance by the segregation, i.e., any 
portion(s) identified as not having been exposed to the conditions that introduced or resulted in 
 
4 The affected article may be made up of more than one portion that can be identified by various attributes. For 
example, there may be distinct portions of an article that are segregable by attributes such as production code, 
market form, aquaculture pond, or combinations of such attributes.  As used in this guidance, the owner may present 
evidence that not all portions of the article are adulterated, but rather that only one or more portions of the article are 
adulterated and can be effectively separated out or segregated.  Owners may suggest different attributes as a basis 
for separating the article into different portions.  
5 Under 21 CFR 123.3(l), a processor is any person engaged in commercial, custom, or institutional processing of 
fish or fishery products, either in the United States or in a foreign country.  A [processor] includes any person 
engaged in the production of foods that are to be used in market or consumer tests.  
6 A sample unit is a small quantity of material randomly selected from a larger quantity of material (a portion in this 
application) intended to provide information on a given characteristic of the material (the presence, absence, or 
concentration of an adulterant in this application).   
  4  Contains Nonbinding Recommendations 
the adulteration in the violative portion(s), should be represented in the sampling scheme for 
sample collection and testing.  The sample units should be randomly collected representatively 
and proportionately from throughout the portions(s) presented to be non-violative such that, if 
there are multiple portions presented to be non-violative, there are more sample units that 
originate from the larger volume (by weight) portion(s) and fewer from the smaller volume 
portion(s).  The randomized sampling should ensure that every sample unit within the segregated 
portion(s) presented to be non-violative is a candidate for being sampled, e.g., from every pallet, 
vat, carton, etc. 
 
If adulteration is found in any confirmation sample unit from any portion(s) of the segregated 
article presented as non-violative, we would most likely find the reconditioning to be 
unsuccessful with respect to the article as a whole.  Such a finding would indicate that the 
rationale for the segregation was flawed and that the adulteration was not successfully segregated 
based on the partitioning parameter used to support the segregation action.  Further, the level of 
sampling and testing conducted for confirmation purposes is typically insufficient to provide 
statistical assurances for further segregation of the article.  As a result, it is not likely that FDA 
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 confirmation test results. 
 
When a valid production-related rationale, supported by production records, identifying the 
cause of the adulteration is established to form the basis of a meaningful segregation, we 
recommend that the following confirmation sampling and testing  approach be included in an 
application to recondition an article (see Table 1, below).  The recommended confirmation 
sampling is based on the risk to health that the adulteration generally represents to consumers, 
with more sampling and testing recommended when the risk is expected to be greater.  While we 
generally recommend you follow the sampling plan in the Table below, 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 and we will consider 
whether your plan is appropriate:  
   
  5  Contains Nonbinding Recommendations 
Table 1:  Total number of sample units recommended to collect from the purportedly non-
violative portion(s) of the affected article based on the total number of sample-sized units within 
the purportedly non-violative portion(s) of the affected article.   
 
 
Total number of sample-sized units within the purportedly non-violative portions of the affected 
article 
100  200  300   500  1,000  5,000  10,000  50,000  100,000 
 
Total Number of Sample Units to Collect and Test from the Purportedly Non-Violative 
Portions of the Affected Article 
Pathogens or Scombrotoxin 
1001  190  233   263  282  296  297  300  300 
Unlawful animal drugs 
95  126  135  156  170  174  175  175  175 
Decomposition in scombrotoxin-forming fish and fishery products without scombrotoxic 
levels of histamine detected2 
95  126  135  141  145  150  150  150  150 
Decomposition in non-scombrotoxin-forming species of fish and fishery products2 
90  107  110  112  114  114  115  115  115 
 
1  Note that when the portion sizes are quite small, the number of recommended sample units may represent a 
significant portion of the article (in some cases, all of the article) to ensure statistical relevance and the 
recommended level of confidence. 
2 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 ppm or greater are considered scombrotoxic for 
this application. 
 
The term sample unit in this application refers to the smallest discrete intact component in the 
article or portion(s) of the article to be sampled and tested.  For example, for packaged products, 
a sample unit is the smallest discrete package.  For bulk fish and fishery products, each fish or 
fish piece (e.g., loin, fillet, or steak) may be a sample unit.  When the sample unit size is very 
small, multiple discrete intact components may be combined to ensure collection of an 
appropriate sample unit size (i.e., to treat multiple packages, fish, or fish pieces as a single 
sample unit even though they are discrete items).  FDAs Import Seafood Products Compliance 
Program, Attachment A, Sampling Schedule (Ref. 4), and Chemotherapeutics in Aquaculture 
Seafood Compliance Program for unlawful animal drug sampling (Ref. 5) may be helpful in 
determining the appropriate sample unit size for each product type and adulterant combination. 
 
The number of sample units recommended in Table 1 are provided for a range of product 
volumes making up the aggregate of non-violative portion(s) in the affected article.  The owner 
of the goods should be aware that, in order to ensure statistical relevance, when the total number 
of sample-sized units within the purportedly non-violative portion(s) is small, there may be a 
need to sample and test a large volume, or all, of the product.  You may wish to contact FDA if 
the total number of available sample units in all non-violative portion(s) of the article is less than 
  6  Contains Nonbinding Recommendations 
5,000 and you have questions about the appropriate sample size.  You may also wish to contact 
FDA if the number of available sample units is not close to one of the of sizes in the table, or if 
you have other questions about situations not shown in the table.  You may contact us with 
questions at: 
  
Office of Compliance 
Division of Enforcement 
Center for Food Safety and Applied Nutrition 
5001 Campus Dr., College Park, MD 20740  
Phone: 240-402-1750 
Email: CFSANEnforcement@fda.hhs.gov 
 
Assurance that this reconditioning approach is adequate rests on both the validity of the rationale 
supporting the segregation and the fact that the confirmation sampling and analysis is adequately 
inclusive and representative of the entire portion(s) of the article that the applicant maintains is 
non-violative.   
 
Example of Segregation Based on a Production-Related Rationale Identifying the Cause of 
the Adulteration:      
 
Note:  The following example is provided for illustrative purposes only; it should not be 
regarded as a model reconditioning proposal, in part because it lacks details pertinent to what 
we would look for in an actual proposal.  We recommend that you refer to the body of this 
guidance, and references cited herein, in developing a reconditioning approach and proposal 
specific to your situation. 
 
The owner of a detained import shipment of 12,000 lbs. of decomposed seafood (non-
scombrotoxin-forming species) performs an investigation and discovers processing 
records that reveal 2,000 lbs. of product manufactured on a particular production day 
was exposed to abusive time/temperature conditions that are likely to have caused 
decomposition of the product.  The production day corresponds to the production code of 
the sample analyzed and found adulterated by FDA.  However, the records show that 
10,000 lbs. of product from six other days production included in the detained import 
shipment (or seized domestic article) were not exposed to the abusive conditions.  
Submitting the processing records for all seven days as support, the owner prepares an 
application proposing to recondition the article by segregating and destroying the 2,000 
lbs. of product manufactured on the affected production date using clearly identifiable 
production codes on the product packaging.  The remaining 10,000 lbs. of product from 
production dates believed to be unaffected by the abusive conditions will thus be 
segregated from violative product. 
 
As confirmation of the success of the segregation, the owner intends to sample and test 
the 10,000 lbs. of product from the six unaffected production codes.  Using the 
recommended sampling scheme in this guidance document for 10,000 lbs., 115 sample 
units are to be randomly collected across product from the six codes that are believed 
non-violative, proportionately, based on the percentage of weight that each code 
contributes to the whole of the product comprising the six codes.  If there is a finding of 
  7  Contains Nonbinding Recommendations 
decomposition in any sample unit from any of the six production codes, FDA is likely to 
conclude that the segregation effort was unsuccessful as to all six production codes (not 
just the one(s) in which there is a finding of decomposition).   
 
2.  Segregation Based on Sampling and Testing Results Alone   
 
When the root cause for the adulteration in an article has not or cannot be identified, you might 
consider segregation of the article on the basis of sampling and test results alone.  Segregation 
of violative and non-violative portions within an article may be possible by partitioning the 
article into portions when you believe the adulteration can be identified and isolated in some, 
but not all, portions of the article.  Under this approach, you would then test individual 
portion(s).  In this approach, it may be possible to partition (i.e., establish portions within the 
article for the purpose of further sampling and testing) based on product or production 
distinctions such as production date or manufacturing code, market form, raw material supplier, 
or some other attribute that could potentially be linked to the adulteration that was found.  The 
portion(s) from which the original finding of adulteration was detected should be segregated as 
violative and should not be included in further sampling or testing.  In some circumstances, it 
might make more sense to only identify one portion of the remaining article as purportedly non-
violative (i.e., not subdivide the remaining article into multiple portions).  For each portion(s) 
you identify as purportedly non-violative, you should apply a statistically sound sampling plan 
to that portion(s).  (More information about statistically sound sampling plans is provided 
below.)7  Note that, whereas both segregation approaches discussed in this guidance involve use 
of sampling and testing, this second approach is solely based on sampling and testing (by 
contrast, the first segregation approach involves a production-related rationale followed by 
sampling and testing).  The owner of the goods should be aware that, from a statistical 
standpoint, the number of sample units8 to be collected and tested from each of the remaining 
portions to assure that they are not adulterated may be substantial and, particularly in the case of 
smaller volume portions, all or most of the product might need to be sampled to ensure 
statistical relevance. 
 
If you choose a statistical sampling and testing approach to segregate adulterated portions of an 
article, we recommend using a single sampling plan of attributes, particularly a plan with a zero 
acceptance number,9 to determine the number of sample units to collect and test from each 
portion in the article.  Single sampling plans of attributes ensure a low probability of 
acceptance, or a high probability of rejection, for portions that contain adulterated product when 
implemented with appropriate statistical parameters that are protective of consumers.  Just like 
the recommended sampling in Table 1, the recommended sampling in Table 2 is based on the 
risk to health that the adulteration generally presents to consumers, with more sampling and 
testing warranted when the risk is expected to be greater.  The number of sample units that 
should be collected and tested depends on the number of sample units making up each 
 
7 Regardless of whether you choose to sample and test a single remaining portion or multiple portions of the article, 
you should ensure that the sampling and testing you conduct is appropriately representative.  Any violative findings 
from the identified portion would likely be applicable to the entire remaining portion (i.e., would likely indicate that 
the entire remaining portion is violative). 
8 See footnote 6 for a description of a sample unit.    
9 These are sampling plans that are designed to minimize the probability of overlooking nonconformities in 
products. 
  8  Contains Nonbinding Recommendations 
individual portion to be tested as demonstrated in the following table of examples (see Table 2, 
below).  The sample units should be randomly collected representatively and proportionately 
from throughout the portions(s) to be sampled and tested.  The randomized sampling should 
ensure that every sample unit within the segregated portion(s) is a candidate for being sampled, 
e.g., from every pallet, vat, carton, etc.  While we generally recommend you follow the 
sampling plan relevant to the type of adulteration and number of sample sized units for your 
product that is listed in Table 2 below, 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 and we will consider whether your plan is appropriate:  
 
   
  9  Contains Nonbinding Recommendations 
Table 2:  Total number of sample units recommended to collect from individual portions of the 
affected article to be tested based on the total number of sample-sized units within the 
individual portions.   
 
Number of sample-sized units within the portion to be tested 
100  200  300   500  1,000  5,000  10,000  50,000  100,000 
 
Number of Sample Units to Collect and Test from the Portion1  
Pathogens or Scombrotoxin 
1002  200  300   500  950  2,253  2,588  2,907  2,950 
Unlawful animal drugs 
100  200  285  388  527  695  721  742  745 
Decomposition in scombrotoxin-forming fish and fishery products without scombrotoxic 
levels of histamine detected2 
95  155  189  225  258  290  294  298  298 
Decomposition in non-scombrotoxin-forming species of fish and fishery products3 
90  137  161  184  205  224  227  229  229 
 
1 Sampling should be representative across lines/codes within the portion as may be appropriate, and the inference 
is made to the portion tested as a whole. 
2 Note that when the portion sizes are quite small, the number of recommended sample units may represent a 
significant portion of the article (in some cases, all of the article) to ensure statistical relevance and the 
recommended level of confidence. 
3 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 ppm or greater are considered scombrotoxic for 
this application. 
 
Here again, the term sample unit in this application refers to the smallest discrete intact 
component in the article or portions of the article to be sampled and tested.  For example, for 
packaged products, a sample unit is the smallest discrete package.  For bulk fish and fishery 
products, each fish or fish piece (e.g., loin, fillet, or steak) may be a sample unit.  When the 
sample unit size is very small, multiple discrete intact components may be combined to ensure 
collection of an appropriate sample size (i.e., to treat multiple packages, fish, or fish pieces as a 
single sample unit even though they are discrete items).  FDAs Import Seafood Products 
Compliance Program, Attachment A, Sampling Schedule (Ref. 4), and Chemotherapeutics in 
Aquaculture Seafood Compliance Program for unlawful animal drug sampling (Ref. 5) may be 
helpful in determining the sample unit size for each product type and type of adulteration. 
 
The number of sample units recommended in Table 2 are provided for a range of product 
volumes making up the aggregate of remaining, purportedly non-violative portions(s) in the  
article.  The owner of the goods should be aware that, in order to ensure statistical relevance, 
when the total number of sample-sized units within the purportedly non-violative portion(s) is 
  10  Contains Nonbinding Recommendations 
small, there may be a need to sample and test a large volume, or all, of the product.  You  may 
wish to contact FDA if the  number of available sample units is not close to one of the sizes in 
the table, or if you have other questions about situations not shown in the table.  You may 
contact us with questions at: 
 
Office of Compliance 
Division of Enforcement 
Center for Food Safety and Applied Nutrition 
5001 Campus Dr., College Park, MD 20740  
Phone: 240-402-1750 
Email: CFSANEnforcement@fda.hhs.gov 
 
In this sampling approach, if one sample unit is found to be adulterated, it is an indication that 
the entire portion from which the sample was taken may be treated as adulterated.  Especially in 
the scenarios involving larger numbers of recommended samples (where the safety risk is 
generally higher), generating sufficient assurances of the safety of the product by end-product 
testing may become impractical, particularly if the test is destructive.    
 
B. Discussion of Sampling Recommendations 
 
The recommendations provided in Tables 1 and 2 include sample sizes based on a critical 
nonconformities sampling approach for hazardous, or potentially hazardous, substances, and/or 
for substances that adversely affect usage, as described in section 2.5.3 of the Codex 
Alimentarius document, General Guidelines on Sampling CAC/GL 50-2004, and in the 
International Organization for Standardizations documents, section 2.15 of ISO 2859-0 and 
section 8.2.4, ISO/TR 8550-1:2007(E).  While the equation in these references guided us in 
developing the sampling recommendations reflected in the draft guidance, we determined that it 
would be appropriate to modify the equation to account more accurately for situations in which 
the portion(s) to be sampled may be smaller.  The original published formula is n = (N-(d/2))(1-
1/(d+1)) where, N is the lot size,  is the specified probability of failing to find at least one critical 
nonconformity (1- ) is the selected confidence level desired, d is the maximum number of 
critically nonconforming items allowed in the lot (d=Np where p is the maximum percent, 
expressed as a fraction, of nonconforming units specified for the portion(s)).  The equation was 
modified to n = (N-((d-1)/2))(1-1/d) to more appropriately apply to smaller portion sizes as well 
as larger portion sizes.  We used 95% confidence levels for detecting low prevalence (0.1% to 
2.0%) of a health risk adulterant in an article and 90% confidence level for detecting low 
prevalence (1% to 2%) of a non-health risk adulterant.   
 
Using this statistical sampling equation, the amount of sampling recommended can be structured 
commensurate with the level of concern, and risk to consumers, associated with the type of 
adulteration to be addressed.  We take this risk-based approach to our sampling 
recommendations because we believe that it is appropriate to recommend more statistically 
rigorous sampling when the health risk to consumers is higher (and correspondingly, that it is 
appropriate to accept less rigorous sampling when the health risk to consumers is lower).  The 
more severe the potential risk, the greater the need for more sampling because we want to 
  11  Contains Nonbinding Recommendations 
minimize the probability that adulteration is present in the product but not detected by sampling 
and testing. 
 
A proposal to recondition an adulterated product by segregation acknowledges that an article has 
been adulterated.  From a statistical standpoint, the number of sample units FDA typically uses 
for routine surveillance sampling is inadequate to provide confidence in the safety or compliance 
of an individual portion associated with an adulterated product.  The probability of detecting 
adulteration is higher when the defect rate is higher, but substantially lower when the defect rate 
is lower.  Thus, to provide assurance that adulterated product has been effectively segregated 
from non-adulterated product as part of reconditioning, a more rigorous sampling plan than that 
used in our routine surveillance sampling is advisable.  It is generally recognized that, short of 
sampling every unit in an article, sampling and testing alone cannot absolutely ensure the 
absence of contamination in a portion of the article, particularly when the contaminant is present 
at very low levels and is not uniformly distributed throughout the article.  Therefore, when 
adulteration is identified in one portion of an article, even if an owner of a fish or fishery product 
used the same sampling plan as FDA typically uses for routine surveillance sampling to sample 
and test the rest of the article and got all negative results, there would still be a reasonable 
possibility that the remaining portion of the product is adulterated.  
 
Generally, the critical nonconformities statistical approach is associated with situations where 
high assurances of identifying adulteration in an article are warranted because of the level of risk. 
This is consistent with the types of adulteration with which FDA is typically concerned in 
reconditioning scenarios.   
 
Because adulterants in seafood are not usually uniformly spread throughout a production lot, 
shipment or entry, we have used, and recommend using, the selected critical nonconformities 
approach for sampling when the owner of the goods proposes to recondition known adulterated 
product through segregation.   
 
C. Proposal for Reconditioning by Segregation10 
 
We recommend you include the following information in a proposal to recondition adulterated 
fish or fishery products by segregation: 
 
For segregation based on a production-related rationale identifying the cause of the adulteration 
and its restriction to only a portion of the article, along with confirmation sampling and testing: 
1.  An explanation supported by processing and/or manufacturing records demonstrating the 
conditions under which one or more portions of the article became adulterated while 
other portions did not, and how segregation will isolate and separate the adulterated 
portions from the non-violative portions.  Also, we recommend that you state how the 
article can be practically segregated based on the proposed parameter for segregation, 
e.g., by existing markings on the packaging or cartons; 
 
10 For imported product, you should consider the validity of the FDA charge(s); if you conclude that the charges are 
valid, you can submit a proposal for reconditioning the violative article (Ref. 6, RPM, Section 9-10-5, Import 
Operations and Actions, Response (Hearing) to Notice of FDA Action - Detained, Conduct of Hearing).   
  12  Contains Nonbinding Recommendations 
2.  Any relevant documents and records related to the processors HACCP plans11;  
3.  A detailed description of the article to be reconditioned (e.g., product names, lot or 
portion sizes (invoices or inventory documents are helpful), production codes, etc.), of 
the manner in which you propose to establish portions (if you choose to establish more 
than one portion of the article), and of the samples to be collected from each portion.  The 
sample description should include the number of sample units from each portion, the 
composition of each sample unit (e.g., the size and number of pieces in each sample unit), 
and assurance that the sample units will be collected in a manner that will be 
representative of the entire portion and will be held and transported in an appropriate 
manner; 
4.  Identification of the entity (individual(s) and affiliation) conducting the sampling, and 
assurance that the sample collection will be appropriately executed and documented; 
5.  Identification and accreditation, if any, of the laboratory that will analyze the samples; 
6.  A detailed description of the test method(s) and procedures to be used to analyze the 
sample(s); 
7.  Documentation of the analysts qualifications; 
8.  A clear explanation of the accept/reject criteria to be applied to the analytical findings;  
9.  The time and place where such sampling and testing operations will be carried out and 
the approximate time for their completion (21 CFR 1.95(b)); 
10. Assurance that we will be provided all original and complete sample collection reports 
and analytical data and reports regardless of the findings; and 
11. A clear description of the intended disposition and handling of rejected portions of the 
article, including the original violative portion.  Examples of dispositions for rejected 
portions include: destruction (specify mode and logistics of performing destruction); 
reprocessing in a manner that eliminates the violative nature of the product (a separate 
application for authorization to recondition should be submitted for these portions); or 
diversion to an appropriate non-food use. 
 
For segregation based on sampling and testing results alone: 
 
See items 2 through 11 above. 
 
  For questions related to an enforcement action or related to the process of submitting a 
proposal to recondition a violative article, contact the compliance officer handling the seizure 
of your goods or, if the article is an import, the compliance officer listed on the FDA Notice 
of Action. 
 
11 The HACCP plans and related records may be relevant to determine if the manufacturers had appropriate controls 
over any of the product produced within the article to prevent the adulteration.  For submissions related to 
decomposition in scombrotoxin-forming fish or fishery products, the HACCP plans and records may also be 
relevant to determining whether the entire article is adulterated, given the potential association with time and 
temperature abuse and scombrotoxin (histamine) formation. 
  13  Contains Nonbinding Recommendations 
  For questions on policy or sample collection recommendations, contact the Office of 
Compliance, Division of Enforcement, CFSAN, at 240-402-1750. 
  For questions or issues concerning preparation of samples for analysis or analytical 
methodology, contact the Office of Regulatory Science, ORA, at 301-796-6600. 
  For questions or issues involving import operations, contact the Division of Import 
Operations, ORA, at 301-796-0356.  
 
 
IV. References  
 
The following references are on display at the Dockets Management Staff, 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 addresses, but websites are subject to 
change over time. 
 
1.  Compliance Policy Guide Sec. 160.700, Reconditioning of Foods Adulterated Under 
402(a)(4), 
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073
853.htm  
 
2.  FDAs Regulatory Procedures Manual (RPM), Section 6-1-2 F, Seizures, General Guidelines 
for Seizures, Voluntary Reconditioning.  Accessed online at 
http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/U
CM074317.pdf    
 
3.  Form FDA 766, Application for Authorization to Relabel or to Perform Other Action of the 
Federal Food, Drug, and Cosmetic Act and Other Related Acts (electronically fillable form).  
Accessed online at 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM072766.pdf  
 
4.  FDA Compliance Program CP 7303.844, Import Seafood Products Compliance Program, 
Attachment A, Sampling Schedule.  Accessed online at 
https://www.fda.gov/media/78911/download 
 
5.  FDA Compliance Program CP 7304.018, Chemotherapeutics in Aquaculture Seafood 
Compliance Program, Part III. 1. C. Sample Collections.  Accessed online at Compliance 
Program: 7304.018 Chemotherapeutics in Aquaculture Seafood (fda.gov) 
 
6.  RPM, Section 9-10-5, Import Operations and Actions, Response (Hearing) to Notice of FDA 
Action - Detained, Conduct of Hearing.  Accessed online at  
http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/U
CM074300.pdf  
 
  14  Contains Nonbinding Recommendations 
7.  CAC, Codex Alimentarius Commission, General Guidelines on Sampling CAC-GL-50, 
2004, p. 28 available at: 
http://www.fao.org/uploads/media/Codex_2004_sampling_CAC_GL_50.pdf  
 
8.  International Organization for Standardizations documents, section 2.15 of ISO 2859-0 and 
section 8.2.4, ISO/TR 8550-1:2007(E).   
 
 
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