Q1:
Do preventative control measures exist?
NO NO
Critical control point Q3:
Could contamination with identified hazards occur in excess of acceptable
levels or could these increase to unacceptable levels?
Q2:
Is the step specifically designed to eliminate or reduce the likely occurrence
of a hazard to an acceptable level?
Is control at this step necessary for safety?
STOP*
Not a CCP YES Modify step,
process or product YES
Q4:
Will a subsequent step eliminate identified hazards or reduce likely occurrence to acceptable levels?
NO YES
YES
Not a CCP STOP*
NO
STOP
[*Proceed to next step in the described process.]
*
Not a CCP
NO YES
Figure 21.3. Application of decision tree toward CCP identification. (Adapted from FDA 1997.)
protects businesses dealing in fresh and frozen (not canned or cooked) fruits and vegetables “by establishing and enforcing a code of fair business practices and helping companies resolve business disputes.” The country of origin labeling (COOL) program shall apply to imported and domestic perishable agricultural products (including fresh fruits and vegetables).
Food, Drug, and Cosmetics Act
The Food, Drug, and Cosmetics Act (FD&C) passed by the US Congress in 1938 “authorized the FDA to demand evi- dence of safety of new drugs, issue standards for food, and conduct factory inspections.” The FDA ensures safety of all food except meat, poultry, and some egg products. The safety
of additives, including color additives, preservatives, etc., falls under FDA which issues list of generally recognized as safe (GRAS) list.
Nutritional Labeling and Education Act The Nutritional Labeling and Education Act (NLEA) (www.fda.gov) was passed by the U.S. Congress in 1990.
However, the regulations for nutritional labeling and other provisions became effective in August 1994. The law “pro- vides FDA with specific authority to require nutrition labeling of most foods regulated by the agency; and to require that all nutrient content claims (i.e., high fiber, low fat, etc.) and health claims be consistent with agency regulations.” The FDA has been issuing warning letters as part of broader ef- forts to improve enforcement and truthful labeling to food manufacturers including juice-making companies for mis- leading and false health and other claims on product labels.
Food Allergen Labeling and Consumer Protection Act
The Food Allergen Labeling and Consumer Protection Act (FALCPA) was enacted in 2004. It became effective in Jan- uary 2006. It is an amendment to Federal Food, Drug, and Cosmetics Act and requires that “the label of a food that contains an ingredient that is or contains proteins from a
‘major food allergen’ declare the presence of the allergen in the manner described by law.” The eight major food allergens—milk, egg, fish (e.g., bass, flounder, cod), crus- tacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat and soy—are be- lieved to account for over 90% of all food allergens in the United States.
Organic Labeling Regulation
The Organic Foods Production Act (NOP) of 1990 became fully implemented in 2002. The NOP sets rules and regula- tions for
r National standards for interstate marketing of organic agricultural products.
r Products to be sold or labeled as an organically produced product; an agricultural product should be produced and handled without the use of synthetic chemical, antibi- otics, germicides, radiations, or genetic modification.
r In order for a farm to produce organic foods, the land must be free of any harmful pesticides and fertilizers for a minimum of 3 years prior to start of organic produc- tion.
r A product to be labeled organic must contain over 95%
organic materials. A “made with organic” product must contain at least 70% certified organic agricultural prod- ucts. The remaining 30% may include conventionally
produced product excluding products using genetic mod- ification and radiation, but can include natural and syn- thetic ingredients or processing aids.
Kosher (Jewish) and Halal (Muslim) Certifications
Kosher (meaning “fit’ or “proper”) and Halal (meaning “law- ful” or “permitted”) certifications may be necessary for mar- keting fruits and fruit products in a specific target market (Jackson 2000). These certifications are made by recognized agencies. They certify to the fact that religious guidelines for production and handling of foods are being followed.
Occupational Safety and Hazard Act
With Occupational Safety and Hazard Act (OSHA) enacted in 1970, Congress created the Occupational Safety and Health Administration within the Department of Labor. Under this law, there is a “Standard Industrial Classification Code” for each employer. The OSHA “standards are rule that employers must use to protect their employees from hazards.” Under the OSHA rules, employees are required to use personal protec- tive equipment (respiratory protection, eye protection, and protection against excessive noise level) and follow safety precaution while using hazardous waste and chemicals. The basic goal is to prevent workplace injury, illness, and fatal- ity. Typically, a food processing facility should have a safety committee. It should have announcement or sirens in case of fire (code red for fire) to evacuate the building and should conduct periodic fire drills. It should also have emergency alert system for hazardous chemicals (code blue for chemi- cal hazard, no evacuation needed but an emergence support team attends to injured and the affected area is isolated) and weather (code white). It also creates group of emergency respondents trained in first aid and cardiopulmonary resusci- tation (CPR).
Bioterrorism Act
In the wake of 2001 terrorist attacks in the United States, Congress passed the Public Health Security and Bioterror- ism Preparedness Act 2002 (PL107-188). Among other pro- visions, the Act aims to protect safety and security of drinking water, food, and drug supply. The Act requires the “owner, operator, or agent in charge of a domestic or foreign facil- ity (exporting to United States) that manufacture/process, pack, or hold food (subject to FDA’s jurisdiction) for human or animal consumption to register with the FDA.” “Facili- ties are defined as any factory, warehouse, or establishment, including importers. Domestic facilities are required to reg- ister (the registration is one-time, not annual and does not require fee) whether or not food from the facility enters in- terstate commerce. The requirement applies to each covered
facility, not to firms or companies as a whole.” The examples of FDA-regulated foods include the following:
r Fruits and vegetables.
r Canned and frozen foods.
r Beverages (including alcoholic beverages and bottled water).
Farms, restaurants, retail food establishment, and nonprofit food establishments are exempt from registration.
The Act requires creation and maintenance of records to determine the source and receipt of foods (i.e., one up, one down) to allow FDA to address credible and serious threats.
In case of imported foods, the Act requires prior notice of food shipments describing the article, country of origin, grower, manufacturer, and shipper. The FDA and Customs and Border Protection (CBP) can issue civil monetary penal- ties against the violators importing food with no prior notice.