The

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

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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.
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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.
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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

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• Republic Act 3720 (Foods, Drugs,
• Devices and Cosmetics Act)

• ensures the safety, purity, and efficacy of drugs
  and devices being offered to the public

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• 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.

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• Republic Act 1071

• Regulates the sale of veterinary biologics and
  medicinal preparations

• Republic Act 64255

• Dangerous Drugs Act

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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
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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
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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
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DA AO No 35, series of 1975 and 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
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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

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Sanctions

• Creation of the Animal Feeds Standard Advisory
  Council

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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.
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• 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. The product fails the laboratory tests
conducted by the Laboratory Services Division or
from any accredited laboratory
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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
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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
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• 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
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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.

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• 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.  
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• 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  
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• 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
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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
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Banned Products
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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

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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

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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

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Thank you very much.