The document discusses various food control enforcement and control agencies from international to private levels. It provides details on key international agencies like FAO, WHO and UNICEF and their roles. For federal agencies, it describes the roles of FDA, USDA, NMFS and others. It also discusses state agencies, commercial agencies, professional societies, private agencies and cooperative agency programs. Finally, it provides an in-depth overview of Hazard Analysis and Critical Control Points (HACCP) including its 7 principles for establishing and maintaining an effective HACCP plan.

1. FOOD MICROBIOLOGY
Topic: Food Control Enforcement & Control
Agency
-Dr. Bharti Wadekar
Faculty, Microbiology ID
ZSCT’s Thakur College of Science,
Mumbai

2.  Food Control Enforcement & Control Agency:
 International agencies, Federal agencies (FDA, USDA), FSSAI
 Introduction to HACCP

3.  ENFORCEMENT AND CONTROL AGENCIES
 Enforcement and control agencies range from international to private, as the following:
 International Agencies
 Branches of the United Nations which are concerned with international food commerce
include the
(1)Food and Agricultural Organization (FAO),
(2) the World Health Organization (WHO),
and (3) the International Children’s Emergency Fund (UNICEF).
 FAO is primarily concerned with food production through improved methods of
production, processing, preservation, and distribution of foods.
to develop or agree upon various international standards for the food industry.

4. WHO activities are more related to the health of the consumer and the
maintenance of food wholesomeness.
Food regulation and control is the concern of all countries, and it is therefore
inevitable that many of the standards or regulations developed are quite
different from one country to another.
The joint FAO/WHO Food Standards Commission is a forum for the cooperation
among nations

5.  These finalized international standards were to be published in a food Codex
Alimentarius as either regional or worldwide standards. Membership in the Codex
Alimentarius Commission is voluntary and is composed of member nations of FAO and
WHO.
 As of 1986 there were about 150 international standards adopted by the commission.
 Subsidiary groups of this organization have published a Code of Practice on General
Principles of Food Hygiene and several Codes of Hygienic Practice for specific
commodities (Olson, 1978).
 Specific examples of international microbiological criteria for foods and food industries
can be found in the National Research Council subcommittee report on Microbiological
Criteria.

6.  Committee on Food Protection.
 Food Nutrition Board (Food Protection committee, 1985).
 The International Commission on Microbiological Specifications for Foods (ICMSF)
is a voluntary body which has focused primarily on establishing international
sampling plans and methods of analysis.
 This group has been responsible for organizing collaborative studies on sampling
plans and laboratory methodology with other groups, including the International
Dairy Federation (IDF) and the Association of Official Analytical Chemists (AOAC).
 The ICMSF’s first publication contains sampling plans and some methodology
(ICMSF, 1974).

7.  Federal Agencies
 The authority of U.S. federal enforcement agencies is confined to foods shipped
interstate or foods produced in or shipped into territories.
 The Federal Register, published almost daily, contains news announcements of
agencies of the federal government pertaining to food standards and inspection.
 The Code of Federal Regulations summarizes and gets such information from the
Federal Register.
 Periodically the Agricultural Marketing Service publishes separate listings which
update regulations and recommendations regarding the inspection, standards, and
grades of various foods.

8.  The Food and Drug Administration (FDA)
 The Food and Drug Administration of the Department of Health, Education, and
Welfare (HEW) enforces the Federal, Drug, and Cosmetic Act as amended in 1980.
Basically, the functions of the FDA relate to the agency’s responsibility for ensuring
that all foods are safe and wholesome and that all foods are honestly and
informatively labeled.
Two of the main operational programs include the FDA Compliance Policy Guides
(FDA, 1982a) and the FDA Food Defect Action Levels (FDA, 1982b).
The Compliance Policy Guides contain specific microbiological criteria for various
foods and feeds.
Specifications are given for total or aerobic plate counts, coliforms, coagulase-
positive staphylococci, food-borne pathogens, mycotoxins, bacterial indicators, and
Escherichia coli.

9.  Food Defect Actions Levels deal mostly with the level of natural defects that may be
tolerated in a particular food or commodity.
 The natural defects are not necessarily related to any particular health hazards.
 Rather, they are specified levels of natural defects above which the FDA may remove
products from the marketplace.
 The concept of defect action levels has been
extrapolated to microbiological criteria. For
example, a survey was conducted in several
shrimp-breading processing plants in an
attempt to establish good manufacturing
guidelines.
 The data generated from this survey were
used to develop a microbiological defect
action level for raw breaded shrimp (FDA,
1983).

10.  United States Department of Agriculture (USDA)
 Through
• the Agricultural Marketing Act,
• the Egg Products Inspection Act,
• the Wholesome Meat Act (Federal Meat Inspection Act), and
• the Wholesome Poultry Products Act (Poultry Inspection Act),
• the USDA has legislative authority to promote the marketing of safe, high-quality
agricultural products.
 Egg and egg products, meat and poultry products, and dairy products are covered by
the USDA Agricultural Marketing Service (AMS) and the Food Safety and Inspection
Service (FSIS).
 Specific microbiological criteria have been established by the AMS under the authority
of the Agricultural Marketing Act.

11.  These microbiological standards are for processed milk products and for raw
milk. The AMS also has a single microbiological criterion for egg and egg
products, mainly that the products be free of salmonella.
 The Federal Meat Inspection and the Poultry Inspection Act give the USDA the
authority to carry out programs in the meat and poultry processing industries.
 Apparently, the Food Safety Inspection
Service (FSIS) has responsibility for these
products. Specific microbiological criteria
have been established for many meat and
poultry products, and they are listed as
USDA meat and poultry advisory criteria.

12.  National Marine Fishery Service (NMFS)
 The United States Department of Commerce/National Marine Fishery Service
(USDC/NMFS) is a fee-for-service fisheries products inspection program.
 Most of the criteria applied have to do with organoleptic evaluation of the
product and examinations of the processing facility. However, USDC/NMFS is
involved through several memorandums of understanding with federal
agencies to establish microbiological criteria for food.

13.  United States Army Natick Research and Development Center
 Food procurement and food protection for military purposes involve problems that
are not always encountered in civilian food service. Therefore, the Department of
Defense, through the Defense Standardization and Specification Program, has
established numerous microbiological criteria for the procurement of foods.
 The Natick Microbiology Branch is concerned with microbiological problems
involved in military ration development and the establishment of microbiological
criteria for initial procurement.

14.  State Agencies
 State food laws usually are enforced through a State Department of Public Health,
Agriculture or Sanitary Engineering.
 Some states have microbiological standards or guidelines for food. Many states publish
a state level equivalent to that of the Federal Register. For example, Maryland publishes
the Maryland Register, a weekly that contains numerous announcements of the various
state agencies.
 Commercial Agencies
 Food associations or institutes make recommendations or even attempt regulation
within their own industries.
 Thus the National Food Processors Association has set microbiological standards for
sugar and starch for canning; the American Dry Milk Institute has established
bacteriological standards for dry milk; the American Bottlers of Carbonated Beverages
has bacteriological standards for sweetening agents used in soft drinks, etc.

15.  Professional Societies
 The American Public Health Association has published many recommended methods
for the bacteriological and microbiological examination of foods; the International
Association of Milk,
 Food and Environmental Sanitarians has also published Recommended Procedures
for the Investigation of Foodborne Illnesses (International Association of Milk, Food,
and EnvironmentalSanitarians, 1976).

16.  Private Agencies
 Several private agencies approve and list tested foods, e.g., the Good Housekeeping
Institute.
 The Processing Industry
 Many specific food processing industries and/or companies have established their
own in-house microbiological criteria for both finished products and raw materials
and ingredients.
 Usually the larger the company, the more sophisticated its microbiological testing
program.

17.  Agency Cooperative Programs
 The Food and Drug Administration, state agencies, and the private shellfish industry
voluntarily cooperate in the National Shellfish Sanitation Program. In addition to
cooperating on the standardization of regulations for shellfish sanitation, the NSFP
also maintains a list of countries that participate in the program.
 The FDA and USDA cooperative is a Salmonella surveillance program for dry milk
products.
 The Retail Food Protection Program (FDA) is another example of a federal-state
cooperative program. Several publications, including the Vending of Food and
Beverages (FDA, 1978), the Retail Food Store Sanitation Code (FDA, 1982c), and the
Food Service Sanitation Manual (FDA, 1976), serve as a source of technical assistance
to various state agencies.

18.  The United States Public Health Service and the FDA have established the Grade
A pasteurized Milk Ordinance (PMO). Cooperating states use the PMO as their
basic standards for certifying interstate milk shippers. Even individual milk
processors use the PMO as an acceptable reference or standard for various
aspects of milk sanitation.
 As already mentioned, the National Marine Fishery Service (NMFS) through the
United States Department of Commerce interacts and cooperates with other
federal agencies, including the FDA and the Department of Defense.
 Additionally, the NMSF has specific agreements with numerous state agencies.
Microbiological criteria for shellfish and other seafoods which have been
developed between federal and state agencies are contained in the National
Fisheries Institute Handbook (Martin and Pitts, 1982).

19.  HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)
 HACCP is basically a statement of a preventive system of controls based on the hazard
analysis and critical control points.
 Hazard analysis involves the identification of ingredients and products which might
have a pronounced effect on food safety: might be consumed by special populations
such as infants or the elderly; or might have no history of implication as the source of
pathogens.
 Once the sensitivity of the ingredients is known, various critical
control points can be identified. This involves the identification
and control over those processing parameters whose loss of
control would result in an unacceptable risk to consumers.
Microbiological critical control points have been summarized for
frozen foods and canned foods.
 Ito (1974), Peterson and Gunnerson (1974), and Bauman (1974)
should be consulted the HACCP concept is really a sophisticated
food-control option.

20. Many government agencies and other organizations have relied on various food
control measures, including
(1)education and training,
(2)inspection of processing facilities or food handling operations, and
(3)microbiological surveys and testing.
The HACCP concept is a new approach, but it also utilizes some of the above
principles.
There are seven discrete activities that are necessary to establish, implement, and
maintain a
HACCP plan, and these are referred to as the ‘seven principles’ in the Codex
Guideline (1997).
The seven principles are on next slides:

22.  Principle 1: Conduct a Hazard Analysis
• Identify hazards and assess the risks associated with them at each step in the
commodity system.
• Describe possible control measures. Hazards (biological, chemical, and physical) are
conditionswhich may pose an unacceptable health risk to the consumer.
• A flow diagram of the complete process is important in conducting the hazard analysis.
The significant hazards associated with each specific step of the manufacturing process
must be listed. Preventive measures (temperature, pH, moisture level, etc.) to control
the hazards are also listed.
 Principle 2: Determine the Critical Control Points (CCPs)
• A critical control point is a step at which control can be applied and is essential to
prevent or eliminate a food-safety hazard, or reduce it to an acceptable level.
• A Critical Control Point (CCP) is a point, step, or procedure in a food process at which
control can be applied and, as a result, a food-safety hazard can be prevented,
eliminated, or reduced to an acceptable level.
• A food-safety hazard is any biological, chemical, or physical property that may cause a
food to be unsafe for human consumption.

23.  Principle 3: Establish Critical Limits
• Each control measure associated with a CCP must have an associated critical limit
which separates the acceptable from the unacceptable control parameter.
• A critical limit is the maximum or minimum value to which a physical, biological, or
chemical hazard must be controlled at a critical control point to prevent, eliminate, or
reduce the hazard to an acceptable level.
 Principle 4: Establish a Monitoring System
• Monitoring is the scheduled measurement or observation at a CCP to assess whether
the step is under control, i.e. within the critical limit(s) specified in Principle 3.
Monitoring is a planned sequence of measurements or observations to ensure the
product or process is in control.
• It allows processors to assess trends before a loss of control occurs. Adjustments can
be made while continuing the process. The monitoring interval must be adequate to
ensure reliable control of the process.

24.  Principle 5: Establish a Procedure for Corrective Action, when Monitoring at a CCP
indicates a Deviation from an Established Critical Limit
• These are actions to be taken when monitoring indicates a deviation from an
established critical limit.
• The final rule requires a plant’s HACCP plan to identify the corrective actions to be
taken if a critical limit is not met.
• Corrective actions are intended to ensure that no product injurious to health or
otherwise adulterated as a result of the deviation enters commerce.
• HACCP is intended to prevent product or process deviations. However, should loss of
control occur, there must be definite steps in place for disposition of the product and
for correction of the process. These must be pre-planned and written. If, for instance, a
cooking step must result in a product center temperature between 165°F and 175°F,
and the temperature is 163°F, the corrective action could require a second pass
through the cooking step with an increase in the temperature of the cooker.

25.  Principle 6: Establish Procedures for Verification to Confirm the Effectiveness of the
HACCP Plan
• Such procedures include auditing of the HACCP plan to review deviations and product
dispositions,and random sampling and checking to validate the whole plan.
• The HACCP regulation requires that all plants maintain certain documents, including
its hazard analysis and written HACCP plan, and records documenting the monitoring
of critical control points, critical limits, verification activities, and the handling of
processing deviations.
• The HACCP system requires the preparation and maintenance of a written HACCP
plan together with other documentation.
• This must include all records generated during the monitoring of each CCP and
notations of corrective actions taken. Usually, the simplest record keeping system
possible to ensure effectivenessis the most desirable.

26.  Principle 7: Establish Documentation Concerning all Procedures and Records
Appropriate to these Principles and their Application
• Validation ensures that the industry or the plant complies with the required design or
plan; that is, they are successful in ensuring the production of safe products.
• Plants will be required to validate their own HACCP plans. FSIS (Food Safety and
Inspection Service) will not approve HACCP plans in advance, but will review them for
conformance with the final rule. Verification ensures the HACCP plan is adequate, that is,
working as intended.
• Verification procedures may include such activities as review of HACCP plans, CCP records,
critical limits, and microbial sampling and analysis. Requirement of FSIS is that the HACCP
plan includes verification tasks to be performed by plant personnel.
• Further, verification tasks would also be performed by FSIS inspectors. Both FSIS and
industry will undertake microbial testing as one of several verification activities.

27. Verification has several steps:
HACCP system verification activities include the following:
• Review of the HACCP system and its records
• Observation of operations at CCPs
• Asking employees questions,especially those that monitor CCPs
• Routine checks of monitoring procedures and equipment
• Review of critical limit deviations and non-conforming product handling and
dispositions
• Internal auditing of the HACCP system
• External third-party auditing of the HACCP system
• Microbiologicalsampling of product contact surfaces
• Microbiologicalsampling of the product
• Official evaluation of the product