Fda handbook 8

Federal regulations are either required or authorized by statute. The rulemaking procedures that we follow come from U.

You can find more information about rules and rulemaking at the Reginfo. The proposed rule explains what we intend to require or intend to do, as well as our basis e. If we need more information or have not decided on the details of a regulatory path, sometimes we issue a request for comments or an advance notice of proposed rulemaking ANPRM. These kinds of Federal Register notices ask for public comment on broad issues or questions and seek data or other information.

We use the information provided by the public comments to help us formulate the specific policy to be put forth in a subsequent proposed rule. Once we have issued a proposed rule and received and reviewed the public comments, we decide whether further action is needed.

Based on the comments, we might decide to end the rulemaking process, to issue a new proposed rule, or to issue a final rule. Moreover, FDA interprets the findings considering available scientific information e. It is FDA's position that pesticides are not the alternative to preventing food defects. The use of chemical substances to control insects, rodents and other natural contaminants has little, if any impact on natural and unavoidable defects in foods.

The primary use of pesticides in the field is to protect food plants from being ravaged by destructive plant pests leaf feeders, stem borers, etc.

A secondary use of pesticides is for cosmetic purposes--to prevent some food products from becoming so severely damaged by pests that it becomes unfit to eat. This edition of The Food Defect Action Level includes the source of each defect and the significance of it i. Food processors may find this information helpful as a quality control tool in their operation. Food commodities Product are listed alphabetically. Each listing indicates the analytical methodology Defect Method used, as well as the parameters for the defect Defect Action Level.

However, it is available on the web at Macroanalytical Procedures Manual. Addition of foreign material, e. Small free-swimming marine crustaceans, many of which are fish parasites. In some species the females enter the tissues of the host fish and may form pus pockets.

Refers to the condition of the product which shows the evidence of the pest habitation or feeding, e. Consists of the bacterial breakdown of the normal product tissues and the subsequent enzyme induced chemical changes.

These changes are manifested by abnormal odors, taste, texture, color, etc. Intentional failure to remove inedible materials from the finished product, or the intentional addition or substitution of cheaper food or ingredient to a product. Any foreign matter in a product associated with objectionable conditions or practices in production, storage, or distribution.

Includes: objectionable matter contributed by insects, rodents, and birds; decomposed material; and miscellaneous matter such as sand, soil, glass, rust, or other foreign substances. Includes objectionable matter such as sticks, stones, burlap bagging, cigarette butts, etc. Also includes the valueless parts of the raw plant material, such as stems.

A condition due to the growth of an organism in a host, e. The presence of any live or dead life cycle stages of insects in a host product, e. Refers to downy mildew which is a fungus infection that causes yellow-brown spots on the leaves of edible greens in the mustard family. Refers to the results of the Howard mold count method which is reported as the percentage of positive microscopic fields that have been scored as either positive or negative based on the presence or absence of a minimum amount of mold hyphae.

Performed only on comminuted fruits and vegetables, and some ground spices. The source of the mold hyphae is rotten raw material that is processed along with sound raw material but is no longer visible due to the comminution process. Microscopic examination may be used to confirm the presence of characteristic hyphal filaments and fruiting structures. A condition where a product has a disagreable odor or taste of decomposed oils or fat. For example, rancid nuts frequently are soft, with a yellow, dark, or oily appearance, a bitter taste and a stale odor.

Plant tissue that is visibly decomposed, usually discolored with disagreeable odors and taste. The plant tissue has been invaded and is being digested by microorganisms. Although rot can also be caused by bacteria and yeasts, these organisms are secondary invaders. Molds are the primary organisms of decomposition and the presence of mold hyphae in the tissue is used to confirm rot.

A condition where the nut kernel is shrunken and not fully developed, commonly a result of climatic stress or infection by certain molds. Refers to the real or potential impact on the consumer due to the presence of a particular defect.

A listed defect can have more than one significance to the consumer e. In fruits, consists of the bacterial breakdown of the product and the formation of lactic acid and subsequent sour taste. A contaminant of the finished product that consists of fine grit that originates from the sand, dirt, and stones that contaminate the raw agricultural product at the time of harvest. Any condition where the product has been affected by organisms or the environment that it has no food value.

Mold MPM-V Average of 5 or more whole or equivalent insects not counting mites, aphids, thrips, or scale insects per grams of apple butter. Insect filth MPM-V Insects MPM-V Asparagus contains an average of 40 or more thrips per grams OR Insects whole or equivalent of 3mm or longer have an average aggregate length of 7mm or longer per grams of asparagus.

Mammalian excreta MPM-V Average of 4 or more larvae per grams OR Average of 10 or more whole insects or equivalent per grams excluding thrips, aphids and mites. Mold - post harvest infection Significance: Aesthetic. Insect larvae MPM-V Average of 40 or more thrips per No. Significance: Aesthetic. Rot MPM-V Average is 60 or more insect fragments per grams when 6 gram subsamples are examined OR Any 1 subsample contains 90 or more insect fragments.

Average is 1 or more rodent hairs per grams in 6 gram subsamples examined OR Any 1 subsample contains 3 or more rodent hairs. Stems MPM-V Average of 75 or more insect fragments per subsample of 50 grams when 6 subsamples are examined OR Any 1 subsample contains or more insect fragments.