AENG 252 :: Lecture 11

AENG 252 :: Lecture 11 :: FOOD STANDARDS AND REGULATIONS

U.S. FOOD SAFETY SYSTEM
The Food and Drug Administration (FDA) is charged with protecting consumers against food that is impure, unsafe, produced under unsanitary conditions, or fraudulently labeled. Through its Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Regulatory Affairs (ORA), the FDA regulates both domestic and imported foods, except meat and poultry and processed eggs and has primary responsibility for enforcing food safety laws including food import and export regulations. (FDA. 2001) Some of the activities of the FDA with particular impact on imported produce include

Inspecting food production establishments and food warehouses and collecting and analyzing samples for physical, chemical, and microbial contamination.
Establishing good agricultural practices and good manufacturing practices and other production standards, such as plant sanitation, packaging requirements, and Hazard Analysis and Critical Control Point programs.
Sampling and inspection of imported foods.
Working with foreign governments (and with FDA counterparts in these countries, if they exist) to ensure safety of imported foods.
Taking appropriate enforcement actions.
Educating industry and consumers on safe food handling practices.

The Centers for Disease Control and Prevention (CDC) work closely with state and local public health epidemiologists and laboratories to identify illnesses and clusters of illnesses that may be food borne. CDC surveys and studies various environmental and chronic health problems and administers national programs for prevention and control of vector-borne diseases (diseases transmitted by a host organism) and other preventable conditions.( CDC. 1999)
The U.S. Department of Agriculture (USDA) has several agencies that may play a role in assuring food safety by establishing the safety of imported fruits and vegetables.

The Agricultural Marketing Service (AMS) carries out a wide range of programs aimed at facilitating the marketing of agricultural products, assuring consumers a quality food supply, and ensuring fair trading practices. Certain agricultural commodities (including fresh tomatoes, avocados, mangoes, limes, oranges, grapefruit, green peppers, Irish potatoes, cucumbers, eggplants, dry onions, walnuts and filberts, processed dates, prunes, raisins, and olives in tins) must meet United States import requirements relating to grade, size, quality, and maturity. These commodities are inspected and the AMS must issue an inspection certificate to indicate import compliance.
The Foreign Agricultural Service (FAS) has primary responsibility for the USDA's overseas programs, including market development, international trade agreements and negotiations, and the collection of statistics and market information.
The Food Safety and Inspection Service (FSIS) regulates meat, poultry and egg products and maintains a comprehensive system of import inspection and controls.
The Economic Research Service (ERS) provides estimates of costs of food borne disease and conducts benefit/cost analyses of alternative regulatory options.
USDA’s Animal and Plant Health Inspection Service (APHIS) inspects imported agricultural products for disease and pests which might infect plants and animals. Through monitoring activities at airport terminals, seaports, and border stations, it guards U.S. borders against the entry of foreign agricultural pests and diseases.

            U.S. Environmental Protection Agency (EPA) includes regulating pesticides and assuring that drinking water meets standards for health. Through the Office of Pesticide Programs (OPP), EPA determines the safety of new pesticide products, sets tolerance levels for pesticide residues in foods.
INTERNATIONAL FOOD LAWS AND REGULATIONS
          Sanitary (human and animal health) and phytosanitary (plant health) standards are necessary to ensure that food is safe for consumers, to prevent the spread of pests and diseases among animals and plants and to ensure fair practices in trade. In recent years, world food trade has been profoundly altered by the adoption of agreements that provide a more precise framework for trade, and define the rights and the obligations of all partners. These agreements served to strengthen the status of institutions like the Codex Alimentarius Commission and the International Plant Protection Convention since these were used as a basis for harmonization.
THE URUGUAY ROUND AGREEMENTS
          The Uruguay Round of Multilateral Trade Negotiations, which concluded in 1994, established the World Trade Organization (WTO) to replace the General Agreement on Tariffs and Trade (GATT). The Uruguay Round negotiations were the first to deal with the liberalization of trade in agricultural products, an area excluded from previous rounds of negotiations. They also included negotiations on reducing non-tariff barriers to international trade in agricultural products and concluded with two binding agreements: the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement). The Agreement on the Application of Sanitary and Phytosanitary Measures confirms the right of WTO member countries to apply measures necessary to protect the life and health of humans, animals and plants (FAO, 2000).
          The Agreement on Technical Barriers to Trade was established with the objective of preventing the use of national or regional technical requirements, or standards in general, as unjustified barriers to trade (FAO, 2000). The agreement covers standards relating to all types of products including industrial and agricultural products. Not covered are food standards related to sanitary and phyto sanitary measures. It includes numerous measures designed to protect consumers against deception and economic fraud. Examples of food standards covered by the TBT Agreement are those related to quality and labeling. The TBT Agreement basically provides that all technical standards and regulations must have a legitimate purpose and that the impact or cost of implementing a standard must be proportional to the purpose of the standard. It also says that if there are two or more ways of achieving the same objective, the least trade-restrictive alternative should be followed. The agreement also places emphasis on international standards and WTO members are obliged to use international standards or parts of them except where the international standard would be ineffective or inappropriate in the national situation. The TBT Agreement does not include a program for harmonizing national standards.
CODEX ALIMENTARIUS
          The adoption of the SPS and TBT Agreements resulted in new emphasis and importance being placed on the work of Codex in establishing international food quality and safety standards.
Codex Alimentarius
The purpose of Codex is

to guide and promote the elaboration of definitions and requirements for foods and assist in their harmonization
to facilitate world trade
to promote consumer protection

            The name Codex Alimentarius is taken from Latin and translates literally as “food code” or “food law”. The Codex Alimentarius is a series of food standards, codes and other regulations adopted by the Codex Alimentarius Commission (CAC) that countries can use as models in their domestic food legislation and regulations, and which can be applied to international trade. Codex provides the assurance that any foods produced according to its codes of hygienic practices and complying with its standards are safe and nutritious and offer adequate health protection. The CAC was created in 1962 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Its main purpose is to promote consumer protection and to facilitate world trade in foods through the development of food standards, codes of practice and other guidelines (FAO/WHO, 1999). Since its inception, the CAC has been responsible for implementing the Joint FAO/WHO Food Standards Program (FAO, 2000).
          The CAC is an intergovernmental body with a current membership of 165 Member governments. Membership is open to all Member Nations and Associate Members of FAO and WHO. In addition, observers from international scientific, food industry, food trade and consumer associations may attend sessions of the Commission and of its subsidiary bodies. While observer organizations can fully participate in the proceedings of the meeting, by statute, only Member governments can participate in any decision process. To facilitate international trade, it has been necessary for efforts to be made to harmonize food standards. Those involved in harmonization efforts recognized that countries have the right to adopt standards they feel are appropriate to protect human, animal and plant health and the environment. They also have the right to take the steps necessary to assure these standards are met. However, preventing these standards from becoming barriers to trade is important to promote trade between countries (FAO, 1998).
          The Codex Alimentarius is a series of food standards, codes and other regulations adopted by the Codex Alimentarius Commission (CAC) that countries can use as models in their domestic food legislation and regulations, and which can be applied to international trade. Codex provides the assurance that any foods produced according to its codes of hygienic practices and complying with its standards are safe and nutritious and offer adequate health protection.The Codex Committee on Food Hygiene is currently developing a code of hygienic practice for fresh fruits and vegetables entitled “Draft Code of Hygienic Practice for Fresh Fruits and Vegetables”. This draft code addresses GAPs and GMPs that will help control microbial, chemical, and physical hazards associated with all stages of the production of fresh fruits and vegetables from primary production to packaging. To facilitate international trade, harmonization of food standards is necessary to prevent these standards from becoming barriers to trade between countries.
INDIAN STANDARDS
          There are a number of food laws being implemented by various Ministries/Departments. These are primarily meant for two purposes namely (1) Regulation of Specifications of food and (2) Regulation of Hygienic condition of Processing/Manufacturing. Some of these food laws are mandatory and some are voluntary. The details of various food laws in operation in India are as under:-
A. Food Laws
The main Acts/Regulations/Control orders to regulate trade

Prevention of Food Adulteration Act 1954
Plant Quarantine (Regulation of Import into India) Order, 2003
Meat Food Product Order 1973
Milk And Milk Product Order 1992
Bureau Of Indian Standards Act, 1986
Standards On Weight And Measurement Act, 1976
Livestock Importation Act, 1898
AGMARK Act ,1937
The Infant Milk Substitutes, Feeding Bottles and Infant Foods Act ,1992
Export (Quality Control and Inspection) Act, 1963
Essential commodities Act,1955
Indian Explosives Act,1884
Energy Conservation Act, 2001

1. Prevention of Food Adulteration Act (Ministry of Health)
          The Act lays down specifications for various food products and is mandatory. The Ministry of Health in 1995 had constituted a Task Force. This Task Force recommended that there should be emphasis on good manufacturing practices instead of detection of adulteration and prosecution. It also expresses concern about lack of laboratory equipments and quantified persons. In addition it also suggested that the name of PFA Act be changed to Food Safety Act.
2. Agriculture Produce (Grading & Marking) Act (Ministry of Rural development)
          This Act is commonly known as AGMARK and is voluntary. The Act lays down the specifications for various agricultural commodities including some processed foods.
3. Laws being operated by Bureau of Indian Standards (BIS)
          BIS is the largest body for formulating standards for various food items. These standards are also voluntary.
4. Essential Commodities Act
          A number of quality control orders have been issued under Essential Commodities Act such as FPO, MMPO, Meat Product Order and Vegetable Oils Control Order. These orders are mandatory and primarily meant for regulating the hygienic conditions. They need to be clubbed under one order which may called Food Products Order.
B. Harmonization of Food Laws
          The review of multiple laws is necessary to have a uniform and logical approach for regulating the quality of food. The following action is being taken by various Ministries:-
1. The Ministry of Civil Supplies & Consumer Affairs has brought out a paper for consideration of Committee of Secretaries (COS). The paper recommends that BIS should formulate standards for all food items in the country. This will be a major step towards harmonization of food laws and is still under consideration of COS for finalization.
2.   The Task Force had advocated promotion of food safety and quality. The Task Force has further made following suggestions

Food Regulation Authority (FRA) be set up to formulate and update food standards for domestic and export market.
FRA should replace the PFA to conform to international standards. The Task Force has given ten specific recommendations such as provision of storage, simplification of sampling procedure, simplification of procedure for nominee, time limit for prosecution, standard methods of analysis to be prescribed, penalty should graded according to the gravity of offences and provision of adequate/infrastructure and laboratories.
Harmonization of Indian standard with quality norms of Codex and WTO.
The Central Committee of food Standard (CCFS) should be replaced by FRA Governing Body for expeditious decisions.

THE FOOD SAFETY AND STANDARDS BILL, 2005

A Bill to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto. The Central Government shall, by notification, establish a body to be known as the Food Safety and Standards Authority of India to exercise the powers conferred on, and to perform the functions assigned to, it under this Act. The Food Authority shall consist of a Chairperson and the following twenty-two members out of which one third shall be women, namely
1. Seven Members, not below the rank of a Joint Secretary to the Government of India, to be appointed by the Central Government, to respectively represent the Ministries or Departments of the Central Government dealing with

Agriculture
Commerce
Consumer Affairs
Food Processing
Health
Legislative Affairs
Small Scale Industries who shall be Members ex officio

2. Two representatives from food industry of which one shall be from small scale industries;
3.   Two representatives from consumer organizations
4.   Three eminent food technologists or scientists
5.   Five members to be appointed by rotation every three years, on each in seriatim from the Zones as specified in the First Schedule to represent the States and the Union territories.
6.   Two persons to represent farmers’ organization.
7.   One person to represent retailers’ organizations.
REFERENCES
CDC. 1999. PulseNet. The National Molecular Subtyping Network in Place to Combat Foodborne Illness. Press Release. Updated 2/18/99. Available via the Internet at http://www.cdc.gov/ncidod/dbmd/pulsenet/pulsenet.htm
FAO. 1998. Food Quality and Safety Systems. A Training Manual on Food Hygiene and the Hazard Analysis and Critical Control Point (HACCP) System. Food Quality and Standards Service, Food and Nutrition Division,Food and Agriculture Organization of the United Nations.
FAO. 2000. Manual on Multilateral Trade Negotiations on Agriculture: A Resource Manual. SPS and TBT Agreements. FAO, Rome. 2000.
FAO/WHO. 1999. Understanding the Codex Alimentarius. Available via the Internet at http://www.fao.org/docrep/w9114e/w9114e00.htm
FDA. 1999. Import Program System Information. Food and Drug Administration,Office of Regulatory Affairs. Available via the Internet at http://www.fda.gov/ora/import/ora_import_system.htm
FDA. 2001. Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration. Available via the Internet at http://www.fda.gov/opacom/morechoices/smallbusiness/blubook.htm#baseinfo.
FRUIT PRODUCTS ORDER (FPO) REGULATIONS IN FOOD SAFETY
INTRODCUTION
The Food Safety and Standards Act, 2006
         An Act to consolidate the laws relating to food and to establish the food Safety and Standards Authority of India for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto.”
The following laws were consolidated:

The Prevention of Food Adulteration Act, 1954 (37 of 1954)
The Fruit Products Order, 1955
The Meat products Order, 1973
The Vegetable Oil Products (Control) Order, 1947
The Edible Oils Packaging (Regulation) order, 1998
The Solvent Extracted Oil, De oiled Meal, and Edible Flour (Control) Order, 1967
The Milk and Milk Products Order, 1992
Any other order issued under the Essential Commodities Act, 1955 (10 of 1955) relating to food

“Food Safety” means assurance that food is acceptable for human consumption according to its intended use.
“Food Safety Management System” means the adoption of Good Manufacturing Practices, Good Hygienic Practices, Hazard Analysis and Critical Control Point and such other practices as may be specified by regulation, for the food business”
THE FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA
As per the Gazette notification of India under S.O.2127 dated 28.08.2008, the activities of FPO have been transferred to the Food Safety and Standards Authority of India from 01.12.2008 onwards.
Duties and Functions of Food Authority

To regulate and monitor the manufacture, processing, distribution, sale and import of food so as to ensure safe and whole some food
To specify the standards and guidelines in relation to articles of food and specifying an appropriate system for enforcing various standards notified under this Act
Accreditation of certification bodies in certification of food safety management system for food businesses
Enforcement of quality control in relation to any article of food imported into India
To provide scientific advice and technical support to the Central Government and the State Governments in matters of framing the policy and rules in areas which have a direct or indirect bearing on food safety and nutrition.

ABSTRACTS OF FRUIT PRODUCTS ORDER, 1955.

CLAUSE 4(1): No person shall carry on the business of manufacture of Fruit & Vegetable Products except and in accordance with the terms of an effective licence granted to him under this order.
CLAUSE 5(2): The following fee being appropriate fees shall be payable for one term or part thereof to be paid ONLY WHEN INSTRUCTED BY THIS OFFICE.

Categories	Minimum manufacturing area, m2	Raw materials stores, m2	Finished goods area, m2	Total area, m2	Minimum height, feet	Licence fee, Rs.
HOME SCALE B: Annual Production of fruit products Except Canned vegetables Not exceeding 10 M.T.	25	10	15	50	10	100
COTTAGE SCALE: Annual Production of fruit products Exceeding 10 MT & upto 50 MT	60	20	40	120	10	250
SMALL SCALE-A: Installed Capacity of not exceeding 1 MT per day or Annual production ranging over 50 MT and upto 100 MT	100	40	60	200	14	400
SMALL SCALE-B: Installed Capacity upto 2 MT per day And total annual production of more than 100 MT & Upto 250 MT	150	50	100	300	14	600
LARGE SCALE: Installed Capacity of more than 2MT fruit Products per day or total Annual production of 250 MT And above	300	100	200	600	14	1500

NOTE:

Area occupied by Machinery shall not be more than 50% of manufacturing area.
WATER: Every licensee shall arrange for atleast l Kilo litre per day of potable water and its availability. Water shall be adequately increased as per production. Free flowing pipe water supply shall be made available to the processing hall.
The workers engaged in Fruit & Vegetable processing shall be got medically examined for their fitness to ensure that they are not suffering from any contagious diseases.
For Large/Small Scale B category units, a qualified CHEMIST shall be appointed as QUALITY CONTROL INCHARGE.
All the workers engaged in the production of Fruit & Vegetable products shall be provided with clean APRONS AND HEADWEARS.

FRUIT PRODUCTS ORDER (FPO) 1955

Constituted under Section3 of Essential Commodities Act
Aims at regulating Sanitary & Hygienic conditions in the manufacture of Fruit Products.
Mandatory for all Manufacturers of Fruit and Vegetable Products to obtain a licence under FPO.
Implemented by the Food Safety and Standards Authority of India through Directorate of Fruit & Veg. Processing at its Regional Offices.

Products covered under FPO 1955

All types of Processed Fruit and Vegetable products (eg:- Pickles,Jams,juices etc..)
Sweetened aerated water
Non- Fruit Vinegar & Non- Fruit Syrup.

Important Clauses under FPO-1955

Clause-4:- No person shall carry on the business of a manufacturer except under and in accordance with the items of an effective licence granted to him under this order in Form-B.
Clause-5:- Every application for grant of licence under Cl.4 shall be made in duplicates to the licensing officer in Form-A and shall be accompanied by a fee of such amount as is appropriate to the each of the clause of licence.
Clause-7:-Every manufacturer shall manufacture fruit products in conformity with the sanitary requirements and the appropriate standard of quality and composition specified.
Clause-9:- Every Manufacturer shall submit by the 31st of January of every year to the licensing officer a return in duplicate in Form-C in respect of each class of Fruit products manufactured, sold and exported by him during the previous term.
Clause-12:- every manufacturer to whom any directions or order is issued in pursuance of any provision of this order shall be bound to comply with such directions or order any failure shall be deemed to be a contravention of the provisions of this order.

Documents to be submitted for grant of FPO license

Application in Form A (Copy enclosed)
Plan of the factory showing the dimensions in metres /sq.metres duly ear-marking the area for Processing, raw-materials store & finished goods Store.
List of Machinery and Equipments showing the Capacity, Horse-power Used, Number and Source of supply of each Machine.
Proof of possession of factory premises – Rental/Lease Agreement and Property Tax receipt indicating Name of Owner & address of unit .
N.O.C. from the Local Government Authority.
Water Analysis Report –Chemical & Bacteriological, from Public Health Laboratory /GOVT. APPROVED LABORATORY and the report should indicate that the water has been drawn from the factory premises either by The representative of the laboratory or by the Public Health Authority. Under remarks column, it shall clearly indicate that the water is fit for drinking purpose /Potable.

CLAUSE 7
Every manufacturer shall manufacture fruit products in conformity with the sanitary requirements and appropriate standards of quality and composition specified in the Second Schedule of this Order.
THE SECOND SCHEDULE (see Clause 7)
PART 1 (A): SANITARY REQUIREMENTS OF A FACTORY OF FRUIT PRODUCTS

The premises shall be adequately lighted, ventilated & cleaned by white washing/ colour washing or oil painting.
Windows and doors shall be fly proofed, doors fitted with automatic closing springs. Roof shall be permanent. Floor cemented.
The equipment and the factory shall not be used for manufacture of repugnant products like fish, meat, eggs etc., However, permission may be granted a special case if arrangements are made for disinfection of premises after changing from meat products to fruit products (One month idle gap will be required for change over).
The premises shall be located in a sanitary place with open surroundings, preferably in industrial area/estates. The premises shall not be used as or communicated directly with Residence.
Adequate arrangements for cleaning equipments, machinery, Containers, tables and raw materials shall be provided.
Copper, brass or iron equipments, containers or vessels are not permitted , in the preparation, packing or storage of fruit Products.
The water used shall be potable and shall be got examined Chemically and bacteriologically by a Public Health Laboratory (if no municipal water is available at the premises). The water sample should be drawn for such examination by the Public Health Authority of the area where the premises is located or should be drawn in the presence of the above authority. Free flowing tap water of 1 kilo litre per day shall be made available.
Adequate drainage system and provisions for disposal of refuse shall be made.
Sufficient number of laterine & urinals shall be provided for workers.
Wherever cooking is done on open fire, proper outlets for the smoke/steam etc., like chimney, exhaust fan etc., shall be provided.
The workers engaged in the factory shall be healthy and shall be medically examined, inoculated and vaccinated, whenever required.
The workers shall be provided with aprons, head-wears, gloves etc., and shall be personally neat and tidy.
Grant-in-aid: For setting up or up gradation of food processing units, Ministry of Food Processing Industries is giving grants. More details can be obtained from the Ministry’s web site – www/mofpi.nic.in

Office Details:
The enforcement of FPO 1955, is being carried out from four regional offices located at

New Delhi
Mumbai
Kolkatta
Chennai
Guwahatti

The jurisdiction of our office covers Southern States of India i.e. Tamil Nadu, Kerala, Karnataka, Andhra Pradesh, Pondicherry and Lakshadweep.
Southern Regional Office is located at
Office of the Deputy Director(F&VP)
Food Safety And Standards Authority Of India,
C-1-D, Rajaji Bhawan, Besant Nagar,
Chennai-600 090
Tel:- 044-24912421, Fax:- 044-24463569
Address of the Food Safety and Standards Authority of India
Food Safety and Standards Authority of India
Ministry of Health and Family Welfare, Government of India,
FDA Bhawan,Kotla Road, New Delhi-110002
Website: www.fssai.gov.in; Tel: 011-23220992

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