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Applications of Computer-Aided Manufacturing

---1 Background

In the United States alone there are an estimated 76 million illnesses (1 in 4), 325,000 hospitalizations, and 5,000 deaths caused by food borne disease. Three pathogenic bacteria Salmonella, Listeria, and Toxoplasma are responsible for 1,500 deaths. Food borne illness and disease is a major cause of morbidity worldwide, resulting in substantial costs to individuals, food processors, and national and international economics. Thus, there is a need to ensure that food processing is conducted in a sanitary environment, performed in a sanitary manner, and every appropriate consideration given to produce safe food of high quality.

The purpose of this section is to provide process engineers with an understanding of food regulations in the United States. This section is by no means comprehensive, and regulations are constantly changing as advances in science and perceived threats change.

Therefore, it’s recommended that individuals interested in producing food machinery, starting a food business, or producing a food product, contact the appropriate regulatory agencies prior to commencing production. Food produced and sold without proper regulatory inspection is not in compliance with federal, state, and local laws and may be deemed "adulterated." Producing adulterated food is a serious crime and persons found guilty may be subject to civil and criminal penalties, including prison.

Food regulations in the United States are a patchwork of rules and regulations that have developed over time. For a single food, there are numerous government agencies that have inspection roles. At the federal level, the primary agencies with regulatory responsibilities are the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services, and the Food Safety Inspection Service (FSIS), an agency within the United States Department of Agriculture. The FDA has the responsibility to ensure safety of all foods under the Federal Food Drug and Cosmetic Act (FFDCA) of 1938. The FFDCA Section 201(f) defines "food" as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles.

The FSIS has primary responsibility for meat, poultry, and egg products under the Meat Product Inspection Act (1906) (FSIS, 2006a), Poultry Product Inspection Act (1957) (FSIS, 2006b), and Egg Product Inspection Act (1970) (FSIS, 2006c). Other agencies have sup porting roles in various commodities and provide grading and export inspection services.

These will be identified in proceeding commodity sections as appropriate.

Prior to producing any food it’s recommended that one notifies the FDA. FDA notification is required of any individuals producing low-acid or acidified foods. A process filing may be required to be submitted detailing the particulars of the food, packaging, and the proposed process being considered. The FDA has a responsibility to respond with either a "non-rejection" letter or a letter with additional questions. Anon-rejection letter whereby the FDA acknowledges they have reviewed the proposed food process and don’t have any concerns at that point in time. Further details on process filings may be found on the FDA website (FDA, 2006a). Additionally, any company that produces or distributes foods must register with the FDA as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act) (FDA, 2006b).

----1.1 Federal Register

The Federal Register is the daily newspaper of the U.S. government. It publishes all proposed, interim, and final rules on federal regulations from all federal agencies (Federal Register, 2006). Development of new regulations starts with the U.S. Congress. In general, Congress passes a bill (Act), For example, Meat Product Inspection Act. The President agrees and signs this bill into a new law. This Act assigns regulatory responsibility to a specific person or department, For example, Secretary of the United States Department of Agriculture (USDA). The Secretary then determines what federal agency within their department will oversee regulatory inspection, For example, the FSIS. That agency is responsible for proposing rules (regulations) regarding the assigned regulatory responsibility. Initially, the designated agency will announce a proposed rule and a comment period, For example, 30, 60, or 90 days, in which interested parties (consumers, processors, industry associations, etc.) will provide feedback to the designated agency on the proposed rule. These comments will include both the technical merits and scientific merits.

The federal agency will then respond, as required by law, to all comments received and either modify the proposed rule, abandon the proposed rule, or issue a final rule. Final rules usually have an implementation period after which enforcement will begin. It’s important that affected parties participate in this rule-making process because non response is treated as acceptance of the proposed rule.

---1.1.1 Code of federal regulations

Federal Agencies compile and publish current regulatory requirements annually in the Code of Federal Regulations (CFR). This compendium of federal regulations is published and maintained by the United States Government Printing Office and can be purchased in hard copy or viewed in electronic form at their website (CFR, 2006). This document contains 50 volumes (referred to as Titles) and includes all federal agencies. For example, agriculture regulations (AMS) are listed in Title 7; animal and animal products regulations (FSIS) are listed in Title 9; food and drug (FDA) regulations are listed as Title 21, and protection of the environment (EPA) are listed as Title 40.

----1.2 United States Code

The United States Code is the codification by subject matter of the general and permanent laws (Acts) of the United States. It’s meant to be an organized, logical compilation of the laws passed by Congress. At its highest level, it divides the legislation into 50 topic areas called Titles. Each Title is further subdivided into any number of logical subtopics.

The United States Code has been published every six years with the most recent being the 2000 version (U.S. Code, 2006). Any law or individual provisions within a law passed by Congress are classified in the Code. However, legislation often contains many unrelated provisions that collectively respond to a particular public need or problem. For example, a farm bill might contain provisions that affect the tax status of farmers, their land management practices, and a system of price supports. Each of these individual provisions would belong in a different section in the Code. Thus, different parts of a law will be found within different Titles. Typically an explanatory note will indicate how a particular law has been classified into the Code. It’s usually found in the Note section attached to a relevant section of the Code, usually under a paragraph identified as the "Short Title." A further discussion of the United States Code can be found at the Cornell Law website (Cornell, 2006).

----1.2.1 State and local regulations

Many states have a department of agriculture and/or environmental and natural resources departments that regulate many aspects of food processing facilities. Many states have an administrative code similar to the CFR (usually adopted by reference) that states requirements for administrative responsibilities, inspection frequency, and permitting requirements for food processors operating in a particular state. In addition, some states allow local regulations/zoning requirements to be developed that can also impact food processing facilities. The local rules are not usually on-line, but can be located by contacting the county and/or city services department for the respective location of the food processing facility. These local rules deal many times with waste discharges, noise, odors, and other neighborhood concerns.

----2 Sanitation Programs

All meat, poultry, and egg processing plants are required to have a written sanitation program. Sanitation is the creation and maintenance of hygienic and healthful conditions in food processing plants. Sanitation involves an applied science that has the overall goal of providing a clean environment and to prevent food product contamination during processing. The universal goal of sanitation is to protect the food supply. An effective sanitation program includes benefits such as:

• Microbial and chemical monitoring;

• Control of food spoilage and lower consumer complaints;

• Increase the storage life of the product;

• Improve employee morale; and

• Reduced public health risks.

Specific sanitation requirements vary for each commodity. The FSIS has sanitation requirements for meat, poultry, and egg products in Title 9 Part 416 of the Code of Federal Regulations (CFR, 2006a). For FDA inspected food processors, there are also sanitation requirements. These are detailed in the current Good Manufacturing Practices (cGMP).

These are located in Title 21 Part 110 of the Code of Federal Regulations (CFR, 2006b).

In addition, the FDA has developed specific GMP's for some food processing such as bottled water, baby food, and seafood. These regulations are minimum sanitation requirements and many food processors exceed these requirements.

----2.1 Sanitation

Sanitation requirements for meat, poultry, and egg products are listed in Title 9 Part 416 and subdivided into two parts. Sections 416.1-416.6 are referred to as the Sanitation Performance Standards (SPS) and Sections 416.11-416.17 are referred to as the Sanitation Standard Operating Procedures (SSOP). Note: There are no sections between 416.7-416.10.

----2.1.1 Sanitation performance standards

Sanitation performance standards describe specific areas that inspection personnel will evaluate regarding sanitation performance. Establishments must comply with the regulatory performance standards for sanitation cited below, but may do so by whatever means they determine to be appropriate. No specific sanitary practices are required; FSIS inspection personnel will verify that official establishments comply with the performance standards. Section 416.1 is known as the "General Rules" and requires that "each official establishment must be operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to ensure that product is not adulterated." Section 416.2 describes specific concerns regarding buildings, grounds, and pest control. The information on buildings and grounds includes criteria for construction, ventilation, lighting, plumbing, sewage disposal, and water. In addition, the facility must be designed to allow management of pest (flies, rodents, birds, etc.).

It should be noted that pest control substances must be approved by the EPA for use in food processing environments and be used in a manner that does not adulterate product or create insanitation. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA reviews pesticides, cleaners, sanitizers, antimicrobials, etc., formulations, intended use, and other information; registers all pesticides, sanitizers, antimicrobials, etc., for use in the United States. It also prescribes labeling, use, and other regulatory requirements to prevent unreasonable adverse effects on the environment, including humans, wildlife, plants, and property. Any meat or poultry establishment using a pesticide, cleaner, sanitizer, antimicrobial, etc., must follow these FIFRA requirements.

Section 416.3 describes the appropriate selection of equipment and utensils and their respective installation and maintenance. Section 416.4 details the requirements for cleaning and sanitizing of food contact, non-food contact, and utensils. Section 416.5 describes the requirements for management of employee hygiene practices, including the person and their respective practices to prevent product adulteration. If any equipment, utensils, rooms, or compartments are found to be insanitary, then the inspector (FSIS/state) will place a tag on the equipment ( U.S. rejected). The equipment, utensil, room, or compartment cannot be used until corrective action has taken place to produce sanitary conditions.

----2.1.2 Sanitation standard operating procedures (SSOP)

Minimum requirements for sanitation operating procedures are stated in Title 9 Section 416.11-416.17 (CFR, 2006a). Each official establishment is required (shall) to develop, implement, and maintain written standard operating procedures for sanitation (Section 416.11). "The SSOP's shall describe all procedures an official establishment will conduct daily, before and during operations, sufficient to prevent direct contamination or adulteration of product(s)" (Section 416.12). The SSOP's cover the entire establishment and all shifts of operation. These procedures include a minimum frequency of cleaning, cleaning procedures, and designated plant personnel. SSOP's must be signed and dated by the "overall authority," usually the owner or plant manager. The FSIS also requires (shall) perform preoperational SSOP's prior to production and other SSOP's as written.

Monitoring procedures will be established by plant personnel to verify implementation of the SSOP's (Section 416.13). The written SSOP's must be routinely reviewed and effectiveness assessed. Revisions are required (shall) as necessary to keep them effective and current with respect to changes in facilities, equipment, utensils, operations, or personnel (Section 416.14). The establishment must also maintain daily records sufficient to document the implementation and monitoring of the SSOP's and any corrective action taken (Section 416.16). The establishment is required to maintain six months of written records, and they must be available to the FSIS upon request, within the last 48 hours of plant operation, or within 24 hours.

It’s the establishment's responsibility to implement the procedures as they are written in the SSOP's. If the establishment or the FSIS determines that the SSOP's fail to prevent direct contamination or adulteration of product, the establishment must implement corrective actions that include the appropriate disposition of product, restoration of sanitary conditions, and measures to prevent recurrence. It’s also required that SSOP's should describe the procedures that the establishment will take to prevent direct contamination or adulteration of product (Section 416.15).

The FSIS has the responsibility to verify that the establishment is conducting the SSOP's as written. Specifically they will verify the adequacy and effectiveness of the Sanitation SOP's and the procedures specified therein by determining that they meet the requirements of this part (416). Such verification may include:

• Reviewing the Sanitation SOP's;

• Reviewing the daily records documenting the implementation of the SSOP's and the procedures specified therein and any corrective actions taken or required to be taken;

• Direct observation of the implementation of the SSOP's and the procedures specified therein and any corrective actions taken or required to be taken; and

• Direct observation or testing to assess the sanitary conditions in the establishment.

---3 Hazard Analyses and Critical Control Point Program (HACCP)

The HACCP program is a systematic approach to the identification, evaluation, and control of food safety hazards. It’s a regulatory requirement for many areas of food processing, including meat (FSIS), poultry (FSIS), egg products (FSIS), seafood (FDA), and juice processing (FDA). There are HACCP requirements that are unique for each food process. The unique requirements are dictated by the responsible regulatory agency. From a scientific perspective, the HACCP program is a proactive approach to food safety and is based on seven principles:

Principle 1: Conduct a hazard analysis Principle 2: Determine the critical control points (CCP); Principle 3: Establish critical limits; Principle 4: Establish monitoring procedures; Principle 5: Establish corrective actions; Principle 6: Establish verification procedures; Principle 7: Establish record-keeping and documentation procedures; These principles when combined form a flexible food safety program that is adjustable as processing conditions change. The goal of the HACCP program is to eliminate, control, and/or prevent food safety hazards at the processing plant with then ultimate goal of protecting the consumer.

----3.1 Prerequisite programs

The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. These programs include sanitation (GMP's), preventative maintenance, ingredient receiving, recall, bio-security, etc. Many of the requirements for these programs are specified in federal, state, and local regulations and guidelines.

The HACCP is built upon the prerequisite programs. In developing a HACCP program, preliminary information on the products, processes, and prerequisite programs must be collected and a process flow diagram developed detailing specific practices within the food processing facility. The preliminary steps must be completed before development of the HACCP plan.

Principle 1: Conduct a hazard analyses -- Each process step is assessed for potential physical, chemical, and biological hazards.

Hazards are defined as those things that cause injury or illness. Physical hazards may include broken glass, wood, or bone shards. Chemical hazards may include cleaner, sanitizer, and pesticide residues. Biological hazards include pathogenic bacteria such as Sal monella enteritidis (SE) or E. coli 0157:H7.

Principle 2: Determine the CCP's For each process step where potential hazards exist there is an assessment of existing control measures. If control measures exist that prevent the introduction of a potential hazard (e.g., prerequisite programs) then no CCP is needed. But when a potential hazard exists and no control measures are present, then a CCP must be implemented.

Principle 3: Establishing critical limits; Once a CCP has been identified then critical limits must be developed based on scientific evidence. The critical limits are the conditions under which one can control, reduce, or eliminate the potential hazard. For example, if it was determined that SE might be present in ready-to-eat (RTE) chicken breast and no existing control measures prevented its introduction, a CCP might consist of specifying a minimum cooking time and temperature to eliminate any potential SE from RTE chicken breast.

Principle 4: Establish monitoring procedures; Once a CCP has been established with appropriate critical limits it’s necessary to ensure proper operation. This requires establishing monitoring procedures and generation of records that document that critical limits have been met. For example, if one were required to cook chicken breast for a minimum time and a minimum temperature to eliminate any potential SE present, then records would document oven temperature and cooking time for each batch of chicken breast.

Principle 5: Establish corrective actions If a deviation (not meeting critical limit or monitoring procedures being inadequate) has been found to occur in the CCP, corrective action must be taken. Corrective action requires an assessment of what went wrong, what to do with the suspect product (product produced when the deviation occurred), how to fix the problem, and how to keep the problem from happening again.

Principle 6: Establish verification procedures

These are established practices periodically performed to ensure that the hazard analysis, established CCP's, established critical limits, and the established corrective actions are appropriate to ensure elimination, reduction, and/or control of all known hazards for the particular food product in question.

Principle 7: Establish record-keeping and documentation procedures; Written records of all HACCP activities must be kept and provided as appropriate for regulatory inspection of the food processing facility.

Further details on HACCP requirements for particular food processing may be found in the Code of Federal Regulations and under the appropriate regulatory agency. Further information on the scientific approach of the HACCP program can be located in the National Advisory Committee Microbiological Criteria in Food Document (NACMCF, 2000).

----4 Current Good Manufacturing Processes (cGMP) The Food and Drug Administration (FDA) requires all foods (excluding meat, poultry, and egg products) to meet the cGMP's. The cGMP regulations are printed in Title 21 Part 110 of the Code of Federal Regulations (CFR, 2006b). The cGMP regulations are general sanitation requirements that apply to all foods. They are subdivided into specific plant requirements. Within Title 21 CFR 110, definitions of food processes and products (Section 110.3), along with the specific definition of adulteration, are stated. Specific requirements for plant personnel are found in Section 110.10 and plant and grounds in Section 110.20.

In brief, these specific regulations dictate that plant personnel, plant (building), and grounds, must be constructed and managed in a sanitary manner so as not to lead to adulteration of food processed in the facility. Section 110.35 describes sanitary operation requirements for the facility, such as required cleaning of food contact and non-food contact surfaces, cleaners, and sanitizers. Sanitary facilities and controls (Section 110.39) dictate requirements for sanitary water, plumbing, toilet and hand washing station requirements, floor drain requirements, and placement of signs instructing employees in required hygiene practices.

Design of equipment and utensils (Section 110.40) for food contact are required to be constructed of non-toxic, corrosive resistant materials. "The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants." Each freezer and cold storage cooler is required to have a thermometer with an automatic control system or alarm system if under manual operation. All instruments and controls must be designed and maintained so as to not adulterate food. Any gases (air, nitrogen, etc.) introduced into the food or used to clean food contact surfaces or equipment must be appropriately treated so as to not adulterate the food.

"All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles (Section 110.80). Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures don’t con tribute contamination from any source. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination"(CFR, 2006b).

All food that has become contaminated to the extent that it’s adulterated shall be rejected, or if permissible, treated or processed to eliminate the contamination. Finished food products should be stored and transported appropriately so as to protect against product adulteration or container damage (Section 110.93).

Some foods, when processed under cGMP's, contain natural or unavoidable defects that are at low levels and are not hazardous to health. FDA establishes a maximum level of each defect in a food produced under cGMP's, called the defect action level (DAL) (Section 110.110). DAL's are established as needed and change as new technology and processing practices become available. DAL's don’t excuse the food from being adulterated by noncompliance with cGMP's, even when its effect produces defects below the DAL. In addition, the mixing of food exceeding a DAL with food below the DAL is not allowed. Even if the final product does not exceed the DAL, it would be deemed adulterated (CFSAN, 2001). A complete list of current DAL's for natural or unavoidable defects in food for human use that present no health hazard may be obtained upon request from the Center for Food Safety and Applied Nutrition (HFS-565), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.

Note: maximum levels for pesticide residues in raw agricultural products are determined by the EPA under FIFRA. FDA's DAL for pesticide residues are EPA's limits, unless an allowance for a higher level is made. Many food processes concentrate food products, and thus pesticides may cause the product to be considered adulterated if the DAL of pesticide residue is exceeded in the finished product. In addition, if the product is a ready-to eat product, it may not be blended to lower the pesticide residue. For example, the DAL for aflatoxin (a carcinogen produced by certain molds) in peanuts and peanut products are 20 ppb. A finished peanut or peanut product must contain less than 20 ppb aflatoxin if it’s to be sold for human consumption. If the amount of aflatoxin exceeds 20 ppm in dry roasted peanuts, they cannot be sold for human consumption.

Also, these dry roasted peanuts cannot be blended with dry roasted peanuts containing a lower level of aflatoxin to lower the overall level of aflatoxin. In addition, if peanuts containing less than 20ppb aflatoxin were used to produce peanut butter and the peanut butter (finished product) had an aflatoxin level above 20ppb then this product could not be sold for human consumption. Also, this peanut butter could not be blended with peanut butter containing less than 20ppb aflatoxin to lower the overall concentration below 20ppb.

----5 Meat Processing

Meat processing includes animals such as beef, pork, chicken, turkey, goat, and other minor animal species. Responsibility of meat inspection is delegated to the Secretary of the United States Department of Agriculture (USDA) under the Meat Products Inspection Act (1906) and Poultry Products Inspection Act (1968). Within the USDA, the enforcement of meat processing regulations is the sole responsibility of the Food Safety Inspection Service (FSIS). Many states also have (federal equivalent) state inspection programs that enforce federal food processing regulations (adopted by reference) for products produced and sold within a state. If a company ships product over state lines, it must be inspected by federal inspectors.

Federal regulations (FSIS) for all meat processors are listed under Title 9 of the Code of Federal Regulations (CFR, 2006a). Since 2000, all meat processing facilities are required to have a written sanitation program and a HACCP program. The goal of the sanitation and HACCP program is to prevent adulterated product from entering the food supply. A food is adulterated (as defined under Section 402 of the Federal Food Drug and Cosmetic Act) if it was produced, packed, or held under unsanitary conditions; or when an added poisonous or deleterious substance is present if the added substance "may render it injurious to health" or "bears or contains any food additive which is unsafe."

Meat slaughter plants are required by regulation to have an FSIS/state inspector on-site during processing to ensure the product is being produced in a sanitary manner and no unfit (diseased or contaminated) meat is being processed. Further meat processing facilities (ready-to-eat meat, hot dogs, hamburger, etc.) are required to have all processed meat products inspected to ensure the sanitary conditions of the facility and that only whole some food products are being produced.

In addition to the required inspection, optional product grading may be requested.

Grading of meat products is done by the U.S. Department of Agriculture's Agricultural Marketing Service (AMS) Meat Grading and Services Branch. The grading service is a voluntary, fee-based service, although required for many customers including hospitals, schools, and public institutions. Product grading is visual assessment of qualities such as tenderness, juiciness, and flavor. Quality grades for beef, veal, and lamb are word labels such as prime, choice, good, etc. and vary slightly for each product, although the grades are based on nationally uniform standards within a product category. Beef carcasses are also graded indicating the yield from the carcass. Pork is not graded. Poultry is graded A, B, or C, where B and C are usually used in further processed products. The mandatory inspections by the FSIS have no relationship to the AMS voluntary meat grading service.

Product labels for meat products include the name of the product, ingredients, quantity, inspection insignia, company's name and address, and qualifying phrases such as "cereal added" or "artificially colored." Product dating is voluntary, but if included must identify what the date means, stated as "sell by," "use by," "best if used before," or "expiration date." The Fair Packaging and Labeling act of 1967 (FTC, 2003) makes it illegal to mislead or mislabel the product.

Standards of identity for meat products are prescribed by regulation (USDA) so that the common or usual name for a product can only be used for products of that standard. The FSIS and FDA collaborate on the standards for meat and meat products. Some are defined easily in a couple of sentences while others are complicated by involved ingredients, formulations, or preparation processes. For example, the definition of a hotdog (skinless variety):

". . . have been stripped of their casings after cooking. Water or ice, or both, may be used to facilitate chopping or mixing or to dissolve curing ingredients. The finished products may not contain more than 30% fat or no more than 10% water, or a combination of 40% fat and added water. Up to 3.5% non-meat binders and extenders (such as non-fat dry milk, cereal, or dried whole milk) or 2% isolated soy protein may be used, but must be shown in the ingredients statement on the product's label by its common name. Beef franks or pork franks are cooked and/or smoked sausage products made according to the specifications above, but with meat from a single species and don’t include byproducts. Turkey franks or chicken franks can contain turkey or chicken and turkey or chicken skin and fat in proportion to a turkey or chicken carcass. Mechanically separated meat (beef, pork, turkey, or chicken) may be used in hotdogs, and must be so labeled. MSM is minced meat paste produced from meat scraps removed from bones (FSIS, 2002)." 2.6 Shell Eggs; The FDA and agencies of the USDA (FSIS, AMS, APHIS) carry out regulation, safety efforts, inspection, and grading of eggs in cooperation with each other. The FSIS and FDA share authority for egg safety. The FDA has authority for shell egg processing facilities, and the FSIS has responsibility for egg products inspection. The FDA also has responsibility for restaurant and foodservice and is working to strengthen egg handling requirements in the Food Code (food service regulations) and to encourage its adoption by states and local jurisdictions. The FDA and FSIS work together on the Egg Safety Action Plan to identify the systems and practices that must be carried out to meet the goal of eliminating Salmonella illnesses associated with the consumption of eggs by 2010 (FSIS, 2003).

The USDA works to educate consumers on the safe handling of egg products.

The Animal and Plant Health Inspection Service (APHIS) conducts activities to reduce the risk of disease in flocks of laying hens. The APHIS administers the voluntary National Poultry Improvement Plan (NPIP) that certifies that poultry breeding stock and hatcheries are free of certain diseases. Participation is required for producers that ship interstate or internationally. The APHIS National Animal Health Monitoring System monitors the prevalence of Salmonella in layer flocks.

Egg processing facilities are inspected by the FDA under the authority of the Secretary of Health and Human Services to inspect food manufacturing facilities. Inspections of premises, facility, inventory, operations, and required records are done as deemed appropriate. Shell egg packers are inspected at least once per calendar quarter. In addition, eggs must be packaged according to the Fair Packaging and Labeling Act.

The U.S. Department of Agriculture's Agricultural Marketing Service (AMS) administers the voluntary egg-quality grading programs for shell eggs paid for by processing plants. The AMS is responsible for the shell egg surveillance program to assure that eggs in the marketplace are equal to the assigned grade, by visiting egg handlers and hatcheries four times per year. The USDA shield on the egg carton means the plant processed the eggs according to AMS sanitation requirements and that the eggs were graded for quality and weight. Sanitation regulations require that eggs be washed and sanitized, and each egg coated with a tasteless natural mineral oil to protect it (AMS, 2006).

State Departments of Agriculture monitor compliance with official U.S. standards, grades, and weight classes by packers not using the voluntary AMS shell egg grading service. Eggs monitored by a state agency won’t have the USDA shield, but will be marked with a grade. State and local regulations (quality, condition, weight, quantity, grade, or labeling) are required to be at least equal to federal regulations and on many occasions have increased requirements.

There are three shell egg grades: Grade AA have whites that are thick and firm; yolks that are high, round, and practically free from defects; clean unbroken shells, and a Haugh unit measurement above 72. Grade A have the same characteristics as Grade AA except that the whites are "reasonably firm" and the Haugh unit measurement is above 60. Grade A is the quality most often sold in stores. Grade B eggs have whites that may be thinner and yolks that may be wider and flatter than eggs of higher grades. The shells must be unbroken, but may show slight stains. Grade B eggs are usually used to make liquid, frozen, and dried egg products. Egg are weighed individually and grouped based on weight. Egg weights per dozen are identified on the package: Jumbo (30 oz per doz), Extra Large (27 oz/doz), Large (24 oz/doz), Medium (21 oz/doz), Small (18 oz/doz), and Peewee (15 oz/doz).

Shell Egg cartons with the USDA shield must display the pack date in a three digit code starting with January 1 as 001 through December 31 as 365. Eggs are labeled with a "sell by" or expiration date. Labels on egg cartons must state that refrigeration is required.

Labels are not required to show origin of product, but individual states have the authority to require name, address, and license number of processor or packer to be included. In 2000, the FDA ruled that shell eggs be stored and transported at refrigeration temperatures not greater than 45°F (FDA, 2000).

The U.S. Department of Commerce under the Sanitary Food Transportation Act (1990) (FDA, 2002) requires that all vehicles dedicated to transporting food must transport only food.

----6.1 Egg products The FSIS is responsible for enforcement of the 1970 Egg Product Inspection Act (EPIA) (FSIS 2006c). Egg products are defined as eggs that have been removed from the shell for processing. The EPIA requires that a federal inspector provides direct inspection of egg products and additional inspection prior to entering commerce. EPIA requires that all egg products be pasteurized.

----7 Seafood Processing The term "fish" includes all fresh or saltwater finfish, molluscan shellfish, crustaceans, and other forms of aquatic animal life. Birds are specifically excluded from the definition because commercial species of birds are either non-aquatic or, as in the case of aquatic birds such as ducks, regulated by the USDA. Mammals are also specifically excluded because no aquatic mammals are processed or marketed commercially in the United States.

Fishery products must comply with the Federal Food, Drug and Cosmetic Act as amended and the Fair Packaging and Labeling Act, as well as the Low-Acid Canned Food (LACF) program and the Seafood HACCP regulations (CFSAN, 2005a). Seafood HACCP considerations include many and various concerns related to specific species, pathogens from harvest area, parasites, natural toxins, decomposition-related hazards, environmental contaminates, pathogen growth and formation due to inadequate processing, allergens, etc.

The FDA provides in-plant inspections quarterly for most seafood processors to ensure compliance with Seafood HACCP and GMP's. FDA reviews also examine economic/fraud issues (CFSAN, 2002a). The FDA conducts risk assessments and periodical lab evaluations through the Center for Food Safety and Applied Nutrition (CFSAN). They analyze for a vast array of defects including chemical contaminants, decomposition, net weight, radio-nuclides, various microbial pathogens, food and color additives, drugs, pesticides, filth, and marine toxins such as paralytic shellfish poison.

The FDA has the authority to detain or temporarily hold food being imported into the United States while it determines whether the product is misbranded or adulterated. The FDA has the authority to set tolerances for man-made contaminants, except for pesticides, which are set by the EPA. The FDA also regulates the use of food and color additives in seafood and feed additives and drugs in aquaculture. FDA has regulations for food plant sanitation (GMP's), standards of identity, and common or usual names for food products.

The FDA conducts mandatory surveillance and enforcement inspections of domestic seafood harvesters, growers, wholesalers, warehouses, carriers, and processors. The FDA provides financial support by contract to state regulatory agencies for the inspection of food plants, including seafood. The FDA also provides technical assistance and training to the states through its State Training and Information Branch and conducts training through its Education and Training Staff. The CFSAN provides assistance to industry and the consuming public. The FDA provides extensive technical assistance in seafood safety and sanitation to foreign governments through the World Food and Agriculture Organization (FAO) and the United Nations.

There are two specific regulatory programs: the Salmon Control Plan and the National Shellfish Sanitation Program (NSSP) (CFSAN, 2003) recently augmented by the Interstate Shellfish Sanitation Conference (ISSC). These are voluntary programs involving the individual states and the industry. The Salmon Control Plan is a voluntary cooperative program among the industry, FDA and the Food Products Association (FPA). The plan is designed to eliminate over-processing, improve plant sanitation, and to improve product quality in the salmon canning industry.

The NSSP provides for the sanitary harvest and production of fresh and frozen molluscan shellfish. It’s administered through the FDA and participants include the 23 coastal shellfish producing states and 9 foreign countries. The National Shellfish Sanitation Program Manual of Operations covers things such as the proper evaluation and control of harvest waters and a system of product identification that enables trace back to harvest waters. Imported shellfish products into the United States are regulated by the FDA. The FDA negotiates Memorandums of Understanding (MOU) with each foreign government to ensure that molluscan shellfish products exported to the United States are produced in an equivalent manner to U.S. products.

----8 Fruits, Vegetables, and Nuts

The U.S. Department of Agriculture's Agricultural Marketing Service (AMS) administers grading programs of fruits, vegetables, and nuts in cooperation with state regulatory agencies under the Agricultural Marketing Act of 1946 (AMS, 2005). Grading is voluntary, except when required by specific laws, regulations, or government contracts. Grading services provide buyers and sellers with an objective, third-party evaluation of a product's quality and condition. Grading is performed according to U.S. Grade Standards. Factors such as product color, maturity, sugar and acid content, size, and defects help determine a product's grade. More than 300 standards have been developed for fresh and processed fruits, vegetables, nuts, and related products. For example, the State of Texas has published their grading requirements for tomatoes and other fruit (State of Texas, 2006).

The AMS also administers the Perishable Agricultural Commodities Act of 1930 (PACA), a law that prohibits unfair and fraudulent practices in the U.S. produce industry.

Most traders of fresh or frozen fruits and vegetables are required to maintain a valid PACA license, which is issued by the AMS.

The AMS oversees the operations of research and promotion boards by industry personnel to ensure they work in the best interest of their grower and handler constituents.

Research and promotion programs aim to expand markets for specific commodities on a national basis. Examples of existing programs include blueberries, honey, mushrooms, peanuts, popcorn, potatoes, and watermelons.

The AMS also administers fruit and vegetable marketing orders, which allow growers of agricultural products the authority to work together to develop dependable markets for their products. These groups of growers have the ability to establish minimum quality standards to keep inferior products from depressing markets, using research and promotion projects, and applying volume controls to stabilize the short-term rate of commodity shipments or allocate supplies between primary and secondary outlets. Currently, there are 35 marketing orders in effect for fruits, vegetables, and related crops, covering 31 commodities grown in 20 states.

----9 Beverages

---9.1 Alcoholic beverages

Beer, wine, liquors, and other alcoholic beverages are subject to the Federal Alcohol Administration Act (FAAA) of 1936 (Title 27 section 8) (U.S. Code, 2002). The FAAA is administered by the Department of the Treasury Alcohol and Tobacco Tax and Trade Bureau (TTB) and the Department of Justice and the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF). The TTB collects taxes and helps to ensure that alcohol beverages are produced, labeled, advertised, and marketed in compliance with federal law to protect the consumer and to protect revenue (TTB, 2006). The ATF regulates the qualification and operations of distilleries, wineries and breweries, as well as importers and wholesalers.

The ATF National Laboratory Center tests products to ensure that all regulated ingredients are within legal limits in order to protect the consumers from identifiable health risks in accordance with FDA recommendations. The ATF Labeling and Formulation Division examines all label applications to ensure labels don’t contain misleading information and adhere to all regulatory mandates. CFR Title 27 part 16 contains the Alcohol Beverage Health Warning Statement (ATF, 2006b).

Sanitation and deleterious substances in alcoholic beverages are under the jurisdiction of the FDA. All cooking wines, diluted wine beverages, and cider beverages with less than 7% alcohol by volume are also under the jurisdiction of the FDA: Compliance Policy Guide (CPG) 7101.05 labeling diluted wines and cider with less than 7% alcohol; CPG 7101.04 labeling de-alcoholized wine and malt beverages; CPG 7120.10 use of synthetic alcohol in foods (FDA, 2005).

----9.2 Carbonated beverages The manufacture of carbonated beverages is covered under cGMP's. In addition, the beverages must adhere to FDA regulations for ingredients, flavors, and colors (ingredients, flavors, and colors in soft drinks are used in other foods); water (soft drinks are at least 90% water), and labeling. The water used in soft drinks far exceeds FDA standards for water because the trace elements allowed in water can affect the taste of the soft drink, so manufacturers use sophisticated filtrations systems. It should be mentioned that in certain carbonated beverages, where sodium benzoate and ascorbic acid (Vitamin C) are included, breakdown of sodium benzoate can occur and benzene can be created. Benzene is a known carcinogen. The FDA currently does not have limits on benzene allowances in carbonated beverages, but EPA has a maximum contaminant level of 5 ppb in drinking water (EPA, 2006).

----9.3 Bottled water Bottled water is regulated by the FDA under the FFDCA as a food. The FDA regulations include standards that meet all EPA regulations for potable water. Manufacturers are required to use cGMP's and follow specific bottled water GMP's. Manufactures are also responsible for producing safe, wholesome, and truthfully labeled products complying with all applicable food regulations. Specific regulations for bottled water are in Title 21 of the Code of Federal Regulations: 21 CFR 165.110a standards of identity for spring water and mineral water; 21 CFR 165.110b establishes allowable levels for contaminates that are as stringent as the EPA standards for public water supplies; 21 CFR 129 establishes GMP for processing and bottling drinking water; 21 CFR 101 labeling regulations; and 21 CFR 110 cGMP's regulations for foods also apply to bottled water.

Bottlers must have source approval, provide source protection, and do source monitoring on a continuing basis. Bottlers must submit a sample for testing chemical, physical, and radiological parameters annually. Samples must be tested for bacteria at least weekly, although many bottlers do in-house tests daily, including bacterial analysis, physical and chemical parameters, dissolved solids, pH, turbidity, color, and conductivity. The bottled water industry must also comply with state standards and trade association standards for International Bottled Water Association (IBWA) members. IBWA standards are more stringent in some cases than the federal standards and the IBWA works with the FDA and state governments.

Importers must meet the standards of their own country as well as all U.S. regulations.

If the source for the bottled water is a community or municipal water system, it must be stated on the label unless it’s further subjected to distillation, deionization, or reverse osmosis. The EPA regulates all community and municipal water systems.

GMP regulations for the processing and bottling of drinking water (21 CFR 129) require bottled water be safe and processed, bottled, held, and transported under sanitary conditions. Processing regulations include protection from contamination, sanitation of the facility, quality control, and sampling and testing of source and final product for microbiological, chemical, and radiological contaminates. Bottlers are required to maintain source approval and testing records for inspectors. The FDA monitors and inspects bottled water products and processing plants under its general food safety program, not a specific bottled water program.

Standards of identity and quality in 21 CFR 165.110a describe "bottled water" and "drinking water" as water intended for human consumption sealed in containers with no added ingredients except safe and suitable antimicrobials and fluoride within limits set by the FDA. The FDA has also defined different types of bottled water including: "artesian water," "artesian well water," "ground water," "mineral water," "purified water," "sparkling bottled water," and "spring water." 2.9.4 Fruit and vegetable juices

After outbreaks in 1996 (E. coli in unpasteurized apple juice) and 1999 and 2000 (Salmonella in unpasteurized orange juice), the FDA ruled that juice processors must use Hazard Analysis and Critical Control Point (HACCP) principles for juice processing. The HACCP regulation applies to juice products sold as or used in beverages in both interstate and intrastate commerce. In addition, all juice processors must comply with (cGMP).

Processors are required to use processes that achieve a 5-log, or 100,000-fold, reduction in the numbers of the most resistant pathogen (e.g., E. coli, Salmonella, cryptosporidium parvum) in their finished products compared to levels that may be present in untreated juice. Juice processors may use microbial reduction methods other than pasteurization, including approved alternative technologies (such as the recently approved UV irradiation technology) or a combination of techniques. Citrus processors may opt to apply the 5-log pathogen reduction on the surface of the fruit, in combination with microbial testing to assure that this process is effective. Processors making shelf-stable juices or concentrates that use a single thermal processing step are exempt from the microbial hazard requirements of the HACCP regulations.

The guidance document and the first edition of the Juice HACCP Training Curriculum are available on-line (NCFST, 2003).

Juice used as in ingredient in foods other than beverages (e.g., fruit flavored candy) does not have to comply with HACCP regulations. Juice concentrates intended for uses such as flavorings or sweeteners are not included because they are not used in beverages.

Fruit and vegetable purees or pulp used as ingredients in beverages must comply. There is a retail exemption for providing directly to consumers. A retailer does not sell or distribute to other business entities, For example, a juice bar or produce stand. Imports and exports must comply.

For more specific information see: Title 21 part 146 specific juices; Title 21 part 73.250 fruit juice color additives; Title 21 part 110 GMP's.

----9.5 Pasteurization

The process of pasteurization was named after Louis Pasteur who discovered that spoilage organisms could be inactivated in wine by applying heat at temperatures below its boiling point. Pasteurization has historically been defined only in certain foods such as milk, fruit juices, and liquid egg products and treatment requirements vary between individual foods. Historically, the parameters for pasteurization in these designated products have been defined as heat treatments sufficient to remove specified pathogenic organisms.

For example, minimum temperature and time requirements for milk pasteurization are based on thermal death time studies for Coxelliae burnettii, the most heat resistant pathogen found in milk. Therefore, time-temperature treatments approved for milk (pasteurized) produces a 5-log reduction in C. burnettii using an approved heat treatment. For fruit juice, "under the [Juice HACCP] rule, the 5-log reduction must be targeted to the 'pertinent pathogen.' The 'pertinent pathogen' is the most resistant microorganism of public health concern that may occur in the juice. The pertinent pathogen may vary with the type of juice and the type of treatment used, though typically it would be Salmonella or E. coli O157:H7."

With the passing of the 2002 Farm Bill (Farm Security and Rural Investment Act), the FDA was/is required to review (by petition) alternative food processing technologies for their equivalence to pasteurization, and make a determination of the appropriateness of the "pasteurization" label. At this time, no additional guidance has been published by the FDA regarding its planned expansion of the definition of pasteurization to include alter native, non-thermal technologies.

----9.6 Milk and milk products

One of the FDA's responsibilities under the FFDCA is the regulation of foods shipped in interstate commerce, including milk and milk products. The National Conference on Interstate Milk Shipments (NCIMS) is a voluntary organization directed and controlled by the member states and open to all persons interested in its objective of promoting the avail ability of a high-quality milk supply. It’s governed by an Executive Board whose members include representatives from state departments of health and agriculture, the FDA, the U.S. Department of Agriculture, and industry. Through these collaborative efforts, the NCIMS have developed a cooperative, federal-state program (The Interstate Milk Shipper Program) to ensure the sanitary quality of milk and milk products shipped interstate. The program is operated primarily by the states, with the FDA providing varying degrees of scientific, technical, and inspection assistance as provided by FDA Publication No. 72-2022, "Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers" (Procedures Manual).

The Interstate Milk Shippers Program relies upon the Grade A Pasteurized Milk Ordinance (PMO) and related technical documents referred to in the Procedures Manual for sanitary standards, requirements, and procedures to follows to ensure the safety and wholesomeness of Grade A milk and milk products. The PMO is the basic standard used for the certification of interstate milk shipments in all 50 states. The PMO is incorporated by reference in federal specifications for procurement of milk and milk products and widely recognized as a national standard for milk sanitation. Grade A Pasteurized Milk Ordinance is: "An ordinance to regulate the production, transportation, processing, handling, sampling, examination, labeling, and sale of Grade A milk and milk products; the inspection of dairy farms, milk plants, receiving stations, transfer stations, milk tank truck cleaning facilities, milk tank trucks and bulk milk hauler/samplers; the issuing and revocation of permits to milk producers, bulk milk hauler/samplers, milk tank trucks, milk transportation companies, milk plants, receiving stations, transfer stations, milk tank truck cleaning facilities, haulers, and distributors; and the fixing of penal ties" (CFSAN, 2002b).

Milk and milk products intended for interstate sale are subject to the Interstate Conveyance Sanitation regulations. State and local regulations vary regarding sale of milk products, such as who can purchase unpasteurized milk from a dairy farm. Sources of Grade A milk and milk products intended for use on interstate conveyances are subject to the Interstate Conveyance Sanitation regulations (21 CFR 1250). They are considered approved for purposes of 21 CFR 1250.26, if they have a state or local permit, are under the routine inspection of a state or local regulatory agency, and meet the provisions of the Procedures Manual.

----10 Canned Foods

Canned foods (hermetically sealed containers) have specific regulatory requirements with the exception of alcoholic beverages and carbonated beverages. These requirements vary depending on the classification of the food product. Canned foods are classified into four categories depending on pH and water activity under the FFDCA: acid, acidified, low acid, and exempt (CFSAN, 2006). Water activity is the amount of free water available to support bacterial growth and ranges from 0 to 1.0. If the finished food has a water activity less than 0.85 the food is considered exempt from these acid regulations. Most common foods (meat, fruit, vegetables) have a water activity between 0.90 and 1.0. Adding salts and sugars can lower water activity. However, all foods must still be processed under cGMP's and apply appropriate food labeling regulations. Every processing facility that processes low-acid or acidified food products must be registered with the FDA (FDA Form 2541). The official process for each product container combination must also be filed (FDA Form 2541a) and signed by a process authority.

Low-acid canned foods (LACF) are those with a pH greater than 4.6 and a water activity greater than 0.85. Many foods (meats and vegetables) fit this category. Federal regulations require that processors register and file processing information with the FDALACF Registration Coordinator and must comply with mandatory provisions of 21 CFR 108, 110, 113, and 114.

Acidified foods are defined as those low-acid foods, which have had their pH reduced to 4.6 or below by the addition of acids or acid foods. Examples include pickles, relishes, pickled vegetables (beets, cauliflower, etc.), salsa, and barbecue sauces. Any product that uses a combination of vinegar or other acid, acid foods (e.g., tomatoes, tropical fruits, peppers) is an acidified food. According to 21 CFR 114.80(a)(1) all acidified foods "---shall be thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of non-health significance capable of reproducing in the food under the conditions in which food is stored, distributed, retailed, and held by the user." Official processes for acidified foods include maximum pH as well as thermal processes. The thermal processes methods are often described as "hot-fill/hold" or "hot water bath/steam bath." Acid Foods are foods that have a natural pH of 4.6 or below. "Natural pH" means the pH prior to processing. However, if a processor receives an acid food (including fermented foods with a pH of 4.6 or below) and during processing allows the pH to rise above 4.6 (through washing, lye peeling, etc.) and then adds an acid or acid food to reduce the pH to 4.6 or below, that product would be considered an acidified food. Thus, it would need to meet 21 CFR 114.80 (see above).

----11 Foodservice/Restaurants Restaurants and food service establishments that only prepare and serve food (no manufacturing) directly to consumers are not considered food processors. They are regulated by the FDA and usually inspected by state and local authorities under Memorandums of Agreement with the FDA. Many states and territories have used the Food Code as a basis for their regulations. An example of the requirements for restaurants and foodservice establishments can be found for the City of Austin, Texas. ( Austin-Travis County, TX, 2006).

The FDA publishes the Food Code every four years with 2005 being the most recent (CFSAN, 2005b). The Food Code is a model that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry (restaurants, grocery stores, and institutions such as nursing homes). Local, state, tribal, and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy.

The Association of Food and Drug Officials (AFDO) reported in June 2005, that 48 out of 56 states and territories have adopted food codes patterned after one of the five versions of the Food Code, beginning with the 1993 edition. Those 48 states and territories represent 79% of the U.S. population.

----12 Export Foods

The inspection process for imported foods has changed considerably in the last five years with the passage of The Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Inspection of imported foods into the United States became the responsibility of the U.S. Customs and Border Protection (CBP) under the Department of Homeland Security in 2003. Memorandum of Agreements between FSIS, APHIS, AMS, FDA, and CBP explain who has inspection responsibility based on the type of food or animal being exported or imported, and tariff/duty fee collection.

Food imported or exported from the United States requires treaties between countries.

In developing these treaties, FSIS and FDA representatives work with the Department of State, Department of Commerce, Department of Homeland Security, and Congress to ensure that adequate consideration is given to safety of food being imported or exported.

Once treaties have been established, Memorandum of Agreements (MOA) are created between the FSIS or FDA and the food safety agency counterpart in the foreign country regarding inspection criteria for imported or exported product. For example, poultry products being exported to Russia must meet Russian export requirements (FSIS, 2006d). Russia and the FSIS have agreed to these criteria and FSIS inspectors will inspect and certify (certificate of export) that poultry was produced according to Russian requirements. Russian requirements may be different than U.S.

requirements for poultry. These agreements are reviewed annually and renegotiated as appropriate.

The U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) oversees the exportation of live animals and animal products and issues health certificates on the condition of the original animal. The USDA, AMS, and FDA are the agencies primarily responsible for the certification of dairy products exported for human consumption. For aquaculture and fish products, the U.S. Department of Commerce, National Oceanic and Atmospheric Administration is the primary agency responsible for providing certification for fish meal, fish oil, and certain other seafood products. The FDA also certifies seafood products, such as blocks of frozen fish.

As a recognized authority for exports to European Community member countries, APHIS can provide export background information and certification endorsement for some types of aquacultured fish, shellfish, or other products.

Food regulated by the FDA requires a Certificate of Export indicating that the FDA regulates the product and the company is not under any enforcement action (CFSAN 2002c). In addition, a shipper's export declaration form must be filed with the U.S. Bureau of Customs and Border Protection. AMS has responsibility to provide organic certification of exported products, laboratory testing to certify products for export, and quality grading of exported food. USDA Grain Inspection, Packers and Stockyards Administration (GIPSA) administers the U.S. Grain Standards Act and certifies all grain being exported or imported. In addition, they register all grain companies.

Alcoholic beverages imported or exported must meet the requirements of the Federal Alcohol Administration Act. These federal requirements are enforced by the Bureau of Alcohol, Tobacco, and Firearms (ATF, 2006a).

----13 Imported Foods Cooperative Agreements between the CBP, FDA, and USDA ensure inspection of all food, plants, animals, and their respective products entering the United States.

Companies importing food into the United States must provide prior notice (excluding meat, poultry, and eggs) to the FDA for shipment inspection before any food product enters the United States. FDA receives approximately 170,000 prior reviews each week (CFSAN, 2005c).


Specific information required in the prior notice includes (CFSAN, 2005d):

• The complete FDA product code;

• The common or usual name or market name;

• The trade or brand name, if different from the common or usual name

• or market name;

• The quantity described from smallest package size to largest container;

• The lot or code numbers or other identifier of the food, if applicable;

• The manufacturer;

• All growers, if known;

• The country from which the article originates;

• The shipper;

• The country from which the article of food was shipped;

• The anticipated arrival information;

• Information related to U.S. Customs entry process;

• The importer, owner, and consignee; and

• The carrier.

The FSIS has the statutory authority to require countries/companies that produce meat and poultry products for import to the United States have equivalent food safety systems. While foreign food regulatory systems need not be identical to the U.S. system, they must employ equivalent sanitary measures that provide the same level of protection against food hazards as is achieved domestically. The FSIS determines equivalency by performing records review, on-site inspection visits, and port-of-entry inspections. In addition, all meat, poultry, and egg products must meet FSIS labeling requirements.

The FSIS has responsibility for inspection of imported shell eggs from all countries.

However, a memorandum of understanding allows AMS to conduct these tasks on behalf of FSIS.

The FDA does not have statutory authority to require countries shipping food (excluding meat, poultry, and egg products) to have equivalent food safety systems. The FDA periodically inspects individual producers of imported U.S. foods during the year. FDA inspectors require that foods meet U.S. food regulations (e.g., cGMP's). In addition, all food companies importing acidified or low-acid food into the United States must obtain, prior to shipping food, a canning establishment number and have an approved process on file with the FDA (FDA, 2006c).

APHIS National Center of Import and Export has responsibility to monitor the health of animals presented at the border and regulate the import and export of animals, animal products, and biologics.

For further questions on importing or exporting foods, contact the Foreign Agricultural Service (FAS). They assist companies in completing paperwork and direct them to appropriate regulatory agencies for permits, reviews, and certificates of export (FAS, 2006).

----14 Organic Food Processing

Organic foods have averaged 17% growth for the past ten years, with total sales estimated at 14 billion dollars (2005 data) (OTA, 2006). For most foods, organic versions cost one to three times more than non-organic. With increasing demand, there was a need to develop federal requirements for labeling organic foods. On October 21, 2002 the National Organic Standards (NOS) became law (Federal Register, 2000). The NOS are administered by the USDA Agricultural Marketing Service. The NOS defines requirements for food to be labeled "organic." The term "organic" refers to self-sustaining practices based on natural processes. For example, in organic crop farming integrated pest management is used to control pests rather than manufactured (synthetic) insecticides. For plant nutrients, animal manure, or crop rotation are used instead of manufactured (synthetic) fertilizers. Organic farming is a holistic approach where inputs and outputs (harvested crops) are managed with a goal to enhance the environment and provide economic sustainability.

In theory, an organic food processor must follow this same principle. However, it’s difficult to clearly establish an equivalent food process comparable to "organic" production practices. In order for a processor to be certified organic, he/she must follow the NOS and be inspected by an accredited certifying agent (AMS, 2006). Within the NOS, there is a National List of Allowed and Prohibited Substances. The NOS specifically prohibits irradiated foods and foods produced from genetically modified organisms being labeled "organic." A processor can only label a product "organic" if it contains a minimum 95% organic food and 5% allowed ingredients. In addition, an organic food processing facility must maintain the organic integrity of the product. It can not contact non-organic food or packages. For example, slaughtered, organic beef must be identified and traceable through out the facility. In addition, no commingling of organic and non-organic is allowed during processing, storage, or transport. The organic food must be produced in a sanitary manner, equivalent to the non-organic food.

Certified organic processing facilities and products must comply with all state and federal food safety regulations. Written records must be kept documenting all organic food processes. Annual inspections are required of all processors using the organic label.

Organic processing should strive to retain the nutritional value of food. For example, organic Rice Krispies are made with cane juice instead of high fructose corn syrup. Physical and biological processes are preferred over chemical methods, the intent being to produce a food that is equivalent to one produced in a home kitchen. Organic foods cannot contain artificial coloring or artificial preservatives.

There are three categories of "organic" food as defined in the NOS. Foods containing 100% organic ingredients can be labeled "100% organic." This label implies only organic ingredients and organic processing aids are present in the product. The "organic" label allows only foods containing 95% or more organic ingredients and a maximum 5% approved ingredients (non-organic) in the product. Finally, food labeled "made with organic" must contain 70% or more organic ingredients (AMS, 2006). Foods labeled as "organic" or "100% organic" may display the USDA Organic Seal.

Since the National List of Allowed and Prohibited Substances is continuously updated, it’s recommended that food processors contact a certifying agent prior to commencing organic processing, in order to ensure compliance. Further information on the National Organic Standards can be found at the following websites:

USDA AMS: Accredited Certifying Agents http://www.ams.usda.gov/nop/CertifyingAgents/Accredited.html USDA AMS: National Organic Program http://www.ams.usda.gov/nop/indexIE.htm Organic Trade Association www.ota.com International Federation Organic Agricultural Movements http://www.ifoam.org/ 2.15 Conclusions Food regulations in the United States are a patchwork of federal agencies based on a 100 years of history. For the food process engineer, it’s difficult to become an expert in food law, and detailed focus should be given to areas of greatest priority. Prior to initiating any formal work in building, testing, or evaluating a "new" piece of equipment, contact should be made with the appropriate federal agency(ies) depending on what food will be processed, handled, or packaged. This agency will be able to provide guidance regarding what procedures need to be followed and designated responsibilities for regulatory agency and equipment manufacturer. In closing, it should be stated that the existing U.S. food safety system, while far from perfect, does provide for high-quality and safe foods to be enjoyed by the consumer. The open, decision-making process, based on scientific knowledge, is seen as a role model by many countries.



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