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Chapter 4: Policies, Procedures, and Requirements for the Audit of Fisheries Products on a Lot by Lot Basis

Product (Lot) Inspection Procedures - Scallop Moisture Determination

To establish uniform inspection procedures when certifying scallops for total moisture content.  This policy will only affect scallops for domestic use and will also not be required for lots less than 200 pounds unless other conditions warrant it (e.g., compliance history, buyers requirements).  Product intended for export will be inspected and certified relative to the importing country’s requirements.


On August 31, 1992, the Food and Drug Administration (FDA) through the Office of Seafood developed a policy memo entitled "Interim Labeling Policy Established for Scallops.”  The purpose of the policy was to “…provide consumers with a better indication about the amount of water in the scallop products they buy.”  At that time the FDA and the Seafood Inspection Program (SIP) along with many sectors of the industry including retailers and consumer groups were concerned that the practice of adding water and phosphate compounds to scallop adductor muscle meats was potentially deceptive, fraudulent and in violation of the Food, Drug and Cosmetic (FD & C) Act as it relates to adulterated food (21 USCS, § 342(b)(4)): “A food shall be deemed to be adulterated … if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.”

The FDA “Interim Labeling Policy” established moisture percentages that would differentiate non-treated scallops or what has been referred to as natural scallops from scallops that were subjected to water and/or a phosphate treatment.  Scallops less than 80.0% total moisture, if not subjected to processing conditions utilizing excessive water and/or phosphate treatment, could be labeled simply as scallops.  As opposed to scallop products whose total moisture analysis demonstrated a percentage of 80.0 % to 84.0% would have to be labeled “ X % Water Added Scallop Product” appearing in the principal display panel of the label.  The statement, "Processed with Sodium Tripolyphosphate," or any other polyphosphates used, is also to appear in the identity statement if the product has been processed with the ingredient.  In addition, the ingredient statement on the labels for these products must include water and sodium tripolyphosphate (or other phosphate, as appropriate).  Products having a moisture content over 84.0 % were considered adulterated under the FD & C Act.

It has been the SIP’s policy since the inception of the FDA policy to test all lots of scallops for total moisture using the “Ohaus method” or the official AOAC method.  The results of these analyses are noted on the certificate and the product would have to be labeled accordingly.  On May 18, 2004, the FDA rescinded their Interim Labeling Policy of August 1992.  In effect, the percentages that FDA used for defining labeling statements are no longer being enforced.  However, scallop products that are subjected to processing conditions that will result in added moisture and/or to food additives (e.g., phosphates) must be properly labeled both in the identity statement (i.e., on the principal display panel) and in the ingredient statement.


Because the FDA has rescinded its policy regarding the action levels of moisture content in scallops, the SIP will no longer use that criteria.  However because of the concern over improper labeling or misuse of the process, the SIP will continue to require that all lots of scallops over 200 pounds destined for domestic use be tested for total moisture using the “Ohaus method” or the AOAC method for total moisture.  The results of the analysis will be noted on the certificate, score sheet or memorandum.  If the inspector has definitive knowledge that the product has been treated in some way to add water to the product, the label must reflect that.  Also if the product tests over 83.0 % for total moisture, the SIP will assume that the product has been treated and must be properly labeled.  This assumption is based on studies and data collected by various governmental agencies, academia, and other organizations that have demonstrated total moisture content of scallops consistently less than 83%.

At this time there is no upper limit for moisture content.

The SIP will closely follow the development of the international Proposed Draft Standard for Quick Frozen Scallop Adductor Muscle Meat under the Codex Alimentarius Commission (the joint Food Standards Programme of the Food and Agriculture Organization of the United Nations and the World Health Organization).  The issues of moisture content limits, phosphate usage, and proper labeling are central elements in this draft standard.  The SIP will evaluate the data submitted regarding these issues during the development of this international standard, as well as any data that are obtained directly from foreign agencies or other sources with the intent of establishing appropriate moisture content and phosphate usage criteria for use by this Program.


{Note: “X%-water-added” is calculated by knowing the natural moisture content (A) and the moisture content after treatment (B).  X = (B-A)/(1-B).}


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