Transcript Document

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
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.
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.
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.
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;
Republic Act 3720 (Foods, Drugs,
Devices and Cosmetics Act)

ensures the safety, purity, and efficacy
of drugs and devices being offered to the
public

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.

Republic Act 1071

Regulates the sale of veterinary
biologics and medicinal preparations


Republic Act 64255 –

Dangerous Drugs Act
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
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
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
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
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
Results
Analysis and Publication of
Quality Control Services
Creation
of the Animal Feeds Standard
Advisory Council
Sanctions
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.
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
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
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
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:
- Net weight in metric equivalent
Minimum % of Crude Protein, CP
- Name, brand or trademark and
nutritive purpose
Minimum % of Crude Fat, EE
Minimum % of Crude Fiber, CF
- Registration Number
Maximum % of Ash,% Moisture
- control number, code or batch
number and date of manufacture
Maximum % of Mineral Contents
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.
Laboratory
Results
Analysis and Publication of
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.
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
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;
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
Banned Products
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
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
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
Thank you
very much.