Because an inspection can be conducted at any time, the firm must continuously be ready for an inspection. Cleanliness and proper operating practices must be maintained at all times, for example. Likewise, firms are encouraged to have an inspection plan; that is, a plan for how the firm will respond when an inspector arrives. At a minimum, the firm should know which staff member will be expected to accompany the inspector and respond to the inspector's questions and requests. A state inspection that reveals a problem could be reported to FDA which then could make an effort to conduct its own inspection.
From a practical perspective, the number of food processing firms far exceed the inspection capacity of FDA and state agencies. Accordingly, FDA and state agencies often have an understanding that the state agencies will try to regularly inspect processing firms, and if a problem is identified, the state agency will inform the FDA. Subsequently, FDA could conduct its own inspection and take appropriate enforcement action. Federal and state law prohibit adulterated food. Within the scope of this broad prohibition is the idea that a food processor will conduct the manufacturing process to minimize the risk of adulteration.
In the past, these practices were referred to as Good Manufacturing Practices GMP and addressed topics such as personnel, buildings and facilities, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils contact surfaces , production and process controls, and warehousing and distribution see 21 CFR part Additional principles include 1 there is no way to guarantee that food is safe; the best that can be accomplished is to reduce or minimize the risk of unsafe food and 2 because every food and food manufacturing processes poses different risks, each business needs to address its own situation; there is no practical way for the government to develop enough regulations to address the full range of situations that comprise the diverse U.
The U. As explicitly stated by Congress in the Food Safety Modernization Act, hazard analysis and food safety plans will need to consider the risk of intentional attacks on food businesses. Although FDA has not yet proposed any regulations on this topic, such a regulation can be anticipated in the future. Until then, FDA does offer some thoughts on this critical topic; for example, see.
Food Safety Laws & Regulations
GMPs address personnel, buildings and facilities, plants and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, and warehousing and distribution. The broad topics of the new regulation are similar to the existing topics, but the new regulation provides additional details for GMPs. An early and enduring goal of U. Accordingly, federal law prohibits food from being misbranded; restated, federal law requires that food products be appropriately labeled. Similarly, federal law requires that food products contain appropriate components.
The standard of identity for food products is intended to address some of these concerns. Even though the underlying statute authorizes the standard of identity to include standards for quality , standard of identity regulations primarily address content, not quality. Firms that want to produce a food product that does not have a standard of identity may request petition the agency to set forth a standard of identity see 21 CFR Most food processing involves directly adding ingredients or substances to the food product.
Likewise, packaging as well as contacting the surface of processing equipment can indirectly impact the food. The discussion of this subsection focuses on several broad categories of substances that can be added to food as indicated in federal regulations. When considering substances that are directly or indirectly added to food, the assessment does not focus solely on the substance; the assessment also focuses on how the substance is used.
Accordingly, a regulation that allows substance X to be used for purpose A in processing food does not allow substance X to be used for purpose B. When reviewing a regulation for directly or indirectly adding a substance to food, be certain to investigate what the regulations has to say about both the substance and its use.
Substances that can be directly or indirectly added to food are placed in several broad categories. It is the responsibility of the firm to prove the substance is safe to use as the firm wants to use it. It is not the responsibility of government to prove the substance or its intended use is safe or unsafe. The primary differences between a substance that would be considered GRAS or a food additive is "GRAS substances are distinguished from food additives by the type of information that supports the GRAS determination, that it is publicly available and generally accepted by the scientific community, but should be the same quantity and quality of information that would support the safety of a food additive.
The consequence of this program is that 1 the GRAS review effort is not being completed but that review process was moving slowly anyway and may have been a reason for this proposal and 2 petitions for food additive regulations are not being pursued by food businesses if the notification program moves more quickly. In summary -- any food that contains an unsafe unapproved food additive is adulterated and thus prohibited. Substances can be directly or indirectly added to food if there is a regulation identifying the use of the substance as prior-sanctioned, GRAS or a food additive.
See subsequent sections titled Contact Surfaces and Packaging for more discussion of indirect food additives. Certifying each batch of color additive is different than the oversight process used for food additives. Also see 21 CFR parts Color additives are used for products other than food; for example, they are added to drugs, cosmetics, etc.
A Guide to U.S. Retail Pricing Laws and Regulations
Congress, in the Food Safety Modernization Act, imposed greater expectations on food processors in terms of assessing the safety of the raw ingredients using in food manufacturing. The question is "food processors, have you assessed the safety of the ingredients your firm is receiving and using in food processing?
The law requires that any food facility receiving raw materials and other ingredients must establish and implement a risk-based supply-chain program for materials and ingredients for which the food facility has identified a hazard. The strategy then is to implement a supply-chain-applied control. The law also requires that if a receiving facility determines that the supplier is not controlling hazards, the receiving facility must take prompt action and document its prompt action to ensure the ingredients from the supplier do not cause food the receiving firm is processed to be adulterated.
See 21 CFR For example, materials used in constructing food-contact surfaces of food-processing equipment can migrate into food 21 CFR Accordingly, all plant equipment and utensils must be designed and made of material to be cleanable. The design, construction, and use of equipment and utensils also must prevent lubricants, fuel, metal fragments, contaminated water, or other contaminants from adulterating the food.
Food-contact surfaces should be corrosion-resistant and made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, cleaning compounds and sanitizing agents. Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives.
Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. Food packaging also raises the question of indirect food additives. If the substance e.
See 21 CFR , and The other broad prohibition in U. An early concern was that food was packaged in a way to mislead the consumer, such as disguising the quantity in the container or not filling the container. The next section addresses product labeling which is primarily directed at assuring the food product is not misbranded. Food products must be labeled so consumers have the information they need to make decisions based on nutrition and safety, such as allergens.
This information is to be available to the consumer at time of purchase so the consumer can consider the information in deciding which food to purchase and consume.
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This section introduces the basics of food labeling. For products regulated by FDA, the food business does its best to develop a label but it is only after it has begun to use the label that the business will learn whether FDA considers the label adequate. Food businesses, like any business, seek opportunities to promote their product, such as "the benefit of eating our product is???
Accordingly, Congress has included misleading statements in the definition of "misbranded"; that is, a food promotion or advertisement that misleads consumers will render the food misbranded and thus prohibit the food from being sold.
DATCP Home Food Safety Laws & Regulations
This section introduces regulations that have evolved over several decades to guide food businesses in the promotion or claims about their product. The discussion introduces "nutrient content claims" and "health claims". The question than is "what standard must be met to claim that a food is calorie-free or low-calorie or reduced calorie?
Likewise, what standards must be met to describe a food as free, low or reduced in total fat, saturated fat, cholesterol, sodium or sugars? Note that some claims are relevant to a base food, such as "reduced"; whereas other claims are absolute, such as "fat-free". Accordingly, the standards set forth the expectations in terms of either a comparison or in absolute terms.
If these standards are not met, the product will be considered "misbranded" and prohibited from being sold. For example,. Misleading advertising as well as misleading product labels will render the food "misbranded". The strategy when food is adulterated or misbranded is to separate the food from consumers. The following list sets forth a few points about product recall.
FDA now has authority to mandate a recall see 21 U. For example, 21 CFR 7. Another early step in the recall process is assess the risk associated with the product being recalled. The classes of recall are. The recall status report should contain 1 Number of consignees notified of the recall, and date and method of notification.
FDA or FSIS will monitor the recall process, but perhaps most significantly, decide whether the recall has been effective and whether the recall can be terminated. Each firm needs a recall plan ; there is not time to assemble all this information and prepare a recall strategy once a problem is identified. Another legal requirement is that food firms maintain records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of food products. Maintenance and inspection of records 21 U.
Subsection b was added by the Bioterrorism Act of and took effect in late Infant formula 21 U. Meat 21 U. Poultry 21 U. Egg 21 U. Records of interstate shipments 21 U.
The owner, operator, or agent in charge of a facility must establish and maintain the following records: 1 The written food safety plan, including the written hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures, and recall plan. Records be kept and be accessible 21 U.
Accordingly, management should recognize its responsibility in providing adequate training for new employees orientation sessions and regular review sessions to reinforce necessary practices and implement new practices as appropriate. Food must meet the regulations of the jurisdiction where it is located. For example, food produced in the United States and then exported to another nation for consumption must first meet U. If the standards of the two nations are quite different, the food company could have a challenge in meeting the requirements of both nations.
Many nations realize that substantially different standards could interfere with food trade. Accordingly, nations are willing to negotiate trade agreements. Nations also realize that negotiating a trade agreement with each other nation in the world would mean that each nation would need to enter into more than bi-lateral trade agreements.
Such trade agreements are based on the idea that if the standards of both trading nations are identical, a food company that is meeting the standards of the first nation would also be meeting the standards of the second nation. Efforts to establish a multi-lateral trade agreement have not been without challenges. To ease the negotiating process, many nations recognize that their national standards will not be identical to the agreed-upon standards, but at least the standards might be similar.
The effort to achieve a multi-lateral trade agreement often is described as attempting to "harmonize" product standards. Accordingly, U. It will then be up to the importing nation to decide whether that certification is enough to address any concerns the importing nation may have about the food.