The

1. The Bureau of Animal Industry’s Regulatory Framework for FEED SAFETY by Ms Marina M. Estacio Officer-In-Charge Animal Feeds Standard Division Bureau of Animal Industry

2. ANIMAL FEED AND VETERINARY DRUGS AND PRODUCTS QUALITY CONTROL PROGRAM • VISION A dynamic and ethical feed and veterinary drug industry that conforms to standards and complies with regulations to assure quality and safety for optimum productivity of animals towards food security without sacrificing consumer safety and well-being.

3. FEEDS AND DRUG QUALITY CONTROL PROGRAM • MISSION To establish a set of rules, regulations and standards that are animal friendly and consumer friendly. To create an auspicious atmosphere for compliance and adherence to quality and safety of the various stakeholders.

4. To advocate responsible nutrition and rational drug use through outreach programs, databanking, international and local collaborations and linkages. To develop well-informed, credible and highly trained human resources who will respond to the needs of the clients.

5. The legal bases for the Regulatory framework for Feed Safety are: A. Republic Acts (RAs): • R. A. 1556 – “Livestock and Poultry Feeds Act” • an act to regulate and control the manufacture, importation, exportation, labeling, advertising, distribution and sale of livestock, poultry,aquaculture and specialty feeds and providing funds, therefor;

6. Republic Act 3720 (Foods, Drugs, Devices and Cosmetics Act) • ensures the safety, purity, and efficacy of drugs and devices being offered to the public

7. Republic Act 6675 (Generics Act of 1988) • promotes, requires, and ensures the production of an adequate supply, distribution, use, and acceptance of drugs and devices identified by their generic names.

8. Republic Act 1071 • Regulates the sale of veterinary biologics and medicinal preparations • Republic Act 64255 – • Dangerous Drugs Act

9. B. Administrative Orders (A.O.s) Administrative Order No. 38 (DA),series of 1990 -Regulations for the licensing of veterinary drug and product establishments and outlets AO 11 – Da-DOH 105, series of 1991 - Requirements for labeling materials and veterinary drugs and products AO DA 13-DOH 1, series of 1992 - Requirements for labelling materials of certain categories of veterinary drugs and products containing two or more active ingredients

10. DA No. 33 – DOH No.11, series of 1991 – Rules and regulations on registration of veterinary drugs and products DA No. 25, series of 1991 – Registration and licensing of veterinary drugs and product premixes and water solubles, and the corresponding manufacturers, importers, suppliers, distributors and retailers of said products with the Animal Feeds Standard Division, Bureau of Animal Industry

11. DOH No. 111D, series of 1991 – Guidelines on DA No. 41 advertisement and promotions of veterinary drugs and products DA No. 39 – DOH No. 111-B, series of 1991 – Rules and regulations to implement prescribing requirements for the veterinary drugs and products DA No. 3 – DOH No. 118, series of 1992 – Rules and regulations on the process of review and evaluation of questioned veterinary drugs and veterinary drug combinations

12. DA AO No 35, series of 1975and its amendments - Rules and Regulations Governing the Manufacture, Importation, Labeling, Advertising, Distribution and Sale of Livestock and Poultry Feeds and Feeding Stuffs DA-AO No 40, series of 1976 - Rules and Regulations Governing Quality Standards of Commercial Feed Ingredients

13. MAJOR PROVISIONS • Registration and Guarantees • Labelling requirements • Creation of the Animal Feed Control Division (AFCD) now called the Animal Feeds Standard Division (AFSD) • Inspection and Feed Sampling • Laboratory Analysis and Publication of Results • Quality Control Services

14. Sanctions • Creation of the Animal Feeds Standard Advisory Council

15. REGISTRATION • any person desiring to engage in the manufacture, importation, sale or distribution of feeds or feeding stuffs, veterinary drugs and products particularly water soluble and premixes should first be registered with the Bureau. • No animal feed, feedstuffs or Veterinary Drugs and Products are exempted from registration especially those offered for sale We adopted and used the existing standards and requirements of DOH for licensing and registration including the applicable regulations related to generic labelling for veterinary drugs since Jan. 1, 1992.

16. Registration refusal occurs when: 1.The product is not freely sold from the country of origin. 2.The product contains ingredients that are already banned for use in food producing animals. 3. The product documents and registration materials are incomplete. 4. Theproduct fails the laboratory tests conducted by the Laboratory Services Division or from any accredited laboratory

17. 5. If the brand thereof is identical or will likely be confused, with another brand already applied to a registered feeding stuffs. 6. If brand thereof is identical or will likely be confused, with another brand already applied to a registered feeding stuffs. 7. If the specific name of each and every ingredient of mixture, base or concentrates and supplement if not clearly stated 8. If feeds or feeding stuffs do not conform to the provisions of this Act

18. Post registration monitoring: Manufacturers and importers are requested to submit a post marketing surveillance for products that are newly registered in the country Manufacturers and importers submit their monthly production and importation reports

19. Labelling requirements • every container of feed or feeding stuff should be • properly labeled and affixed with a tag or label, containing • a legible and plainly statements certifying, among others: Minimum % of Crude Protein, CP - Net weight in metric equivalent Minimum % of Crude Fat, EE - Name, brand or trademark and nutritive purpose Minimum % of Crude Fiber, CF Maximum % of Ash,% Moisture - Registration Number Maximum % of Mineral Contents - control number, code or batch number and date of manufacture

20. INSPECTION AND FEED SAMPLING - the Director and/or his inspectors shall be: *permitted at all times to enter and inspect any premises and/or conveyances in which feeds or feed ingredients are sold, produced, transported, or held in possession for sale or distribution *open any package containing or supposed to contain any feed or feeding stuff, and take there from samples for analysis without cost *permitted to inspect only records or documents which are necessary in verifying the volume of production and/or importation for proper assessment of the inspection fee as provided for in this Act.

21. Laboratory Analysis and Publication of Results Prescribing methods of chemical and biological tests to determine purity and safety of feeds and feeding stuffs, and rules and regulations for the supervision and control of said testings; Publication of results of analysis and test of samples of feeds and feedstuffs collected from feed ingredients suppliers and feed manufacturers; at least 3x in a year preferably in January, May and September, specifying both in compliance and not in compliance with the guaranteed analysis or quality standard set under this Act or under the rules and regulations.  

22. Quality Control Services • any person desiring to engage in the manufacture of mixed feeds for commercial purposes should establish a quality control laboratory and retain services of licensed chemist and a licensed veterinarian or an animal nutritionist to be responsible for anlaysis and test of mixed feeds before released for sale to determine conformity with feed formula of particular feed or feeding stuff. -all persons engaged in the manufacture of feeds for poultry and swine for commercial purposes should maintain livestock to be fed with its manufactured feeds for experimental purposes; number of said experimental animals should not be less than the following: Poultry – 50 for broilers, 50 day-old pullets; 50 growers and 50 layers Swine – 5 piglets, 5 growers, 5 breeding gilts 5 sows and 5 finishers

23. Creation of the Animal Feeds Standard Advisory Council CHIEF, ANIMAL FEED CONTROL DIVISION, BUREAU OF ANIMAL INDUSTRY, CHAIRMAN CHIEF, LABORATORY SERVICES DIVISION, BUREAU OF ANIMAL INDUSTRY, MEMBER ONE MEMBER FROM THE ANIMAL HUSBANDRY DEPARTMENT, U.P. COLLEGE OF AGRICULTURE ONE MEMBER FROM THE LEGAL DIVISION, DEPARTMENT OF AGRICULTURE AND NATURAL RESOURCES; ONE MEMBER FROM THE LEGAL UNIT, BUREAU OF ANIMAL INDUSTRY;

24. ONE MEMBER FROM THE DULY RECOGNIZED FEED MILLERS ASSOCIATION; ONE MEMBER FROM THE DULY RECOGNIZED SWINE RAISERS ASSOCIATION ONE MEMBER FROM THE DULY RECOGNIZED SWINE RAISERS ASSOCIATION, and ONE MEMBER FROM THE PHILIPPINE SOCIETY OF ANIMAL SCIENCE RECOMMENDED

25. Banned Products

26. Ban on the Use of CHLORAMPHENICOL Reasons: • Public health danger from residues in meat, milk, and eggs • Antibiotic for life threatening infection • Human tolerance for residues cannot be established • Possibilities of a plastic anemia • Alteration of microbial ecology

27. Banning of NITROFURANS • Carcinogenic at 0.15% w/w concentration in feed for one year, including mammary tumors • Recognized both as mutagen and carcinogen by USFDA

28. Banning of Olaquindox and Carbadox • Long withdrawal period of 70 days • Parent compounds possess genotoxic potential • Possible exposure of workers handling the product to the parent molecules may pose a real risk of irritation, allergy anaphylactic shock and other cumulative effects • Absence of specific toxicity studies on the metabolites and the slight increase in the incidence of adrenal cortex adenomas in male mice have prompted the JECFA not to establish an acceptable daily intake

29. Thank you very much.