Delineation of Functions and Shared Responsibilities in the Regulation of Meat Products

December 28, 2009

DA-NMIS-DOH-FDA JOINT ADMINISTRATIVE ORDER NO. 2009-0001

 

WHEREAS, Republic Act No. 9711 (An Act Strengthening and Rationalizing the Regulatory Capacity of the Bureau of Food and Drugs (BFAD) by Establishing Adequate Testing Laboratories and Field Offices, Upgrading its Equipment, Augmenting its Human Resource Complement, Giving Authority to Retain its Income, Renaming it the Food and Drug Administration (FDA), amending certain sections of Republic Act No. 3720 as Amended, and Appropriating Funds Thereof), and Executive Order No. 175 series of 1987, amending Republic Act No. 3720 (Foods, Drugs and Devices, and Cosmetics Act) declares it a policy of the State to establish and maintain an effective food and regulatory system and undertake appropriate health manpower development and research, responsive to the country's health needs and problems. As such, the same law vests upon the Department of Health-Food and Drug Administration with the authority to adopt measures to ensure pure and safe supply of foods, cosmetics, and pure, safe, efficacious and good quality drugs and devices in the country;

WHEREAS, Republic Act No. 9296 (Meat Inspection Code of the Philippines)provides that it is the policy of the State to promulgate specific policies and procedures governing the flow of food animals, meat and meat products through the various stages of marketing and the proper preservation and inspection of such products;

WHEREAS, Rule 5.1 of the Implementing Rules and Regulations (IRR) of Republic Act No. 9296, provides that the Department of Agriculture-National Meat Inspection Service (DA-NMIS) shall be the sole national controlling authority tasked to implement policies, programs, guidelines and rules and regulations pertaining to meat inspection and meat hygiene to ensure meat safety and quality from farm to table;

WHEREAS, Republic Act No. 9296 and its IRR empower the DA-NMIS to formulate, issue and implement jointly with appropriate local government units, among others, licensing, registration and certification of meat handlers and meat brokers and licensing, registration and certification of meat and meat products;

WHEREAS, the same law above and its IRR define Meat Product as any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcasses of any food animals, excepting products which contain meat or other portion of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat industry, and which are exempted from definition as meat product by the Secretary of Agriculture under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat products; CSAaDE

WHEREAS, Rule 24.2 of the same Code mandates the DA-NMIS and the DOH-FDA to undertake an Agreement on the shared responsibility and delineation of functions in the regulation of meat products in accordance with their respective mandates;

NOW, THEREFORE, the following Joint Administrative Order covering the delineation of functions and shared responsibilities in the regulation of meat products are hereby adopted and prescribed for the information and guidance of all concerned.

SECTION 1

Scope

This Order covers the delineation of functions and shared responsibilities between DA-NMIS and DOH-FDA in the regulation of meat products and persons or establishments processing and/or distributing or marketing the same.

SECTION 2

Definition of Terms

For purposes of this Order, the following terms shall mean:

A. Abattoir or slaughterhouse — premises that are approved and registered by the controlling authority in which food animals are slaughtered and dressed for human consumption.

B. Accredit — the power of the National Meat Inspection Service (NMIS) to give authority to (a) any meat establishment engaged in slaughtering operation, preparation, processing, manufacturing, storing, or canning of meat and meat products for commerce; (b) any importer, exporter, broker, trader or meat handler; (c) any meat vehicle or conveyance; d) any person, firm, corporation as provider of government services such as independent or third party service providers, or independent inspection or audit agencies.

C. Adulterated — carcasses or any part thereof, whether meat or meat product under one or more of the following categories:

a. if it bears or contains any poisonous or deleterious substance which may render it injurious to health of the public; but in case the substance is not an added substance, such meat and meat product shall not be considered adulterated under this clause if the quantity of such substance does not ordinarily render it injurious to health of the public; TAECSD

b. if it bears or contains any added poisonous or deleterious substance other than one which is (i) a pesticide chemical in or on a raw agricultural commodity, (ii) a food additive, (iii) a color additive, for which tolerances have been established and it conforms to such tolerances;

c. if it consists in whole or in part of a filthy, putrid or decomposed substance, or if it is otherwise unfit for human consumption;

d. if it has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth or whereby, it may have been rendered injurious to the health of the public;

e. if it is in whole or in part, the product of a diseased animal or of an animal which has died other than by slaughter;

f. if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to public health;

g. if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with an existing regulation or exemption;

h. if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is;

i. if it has not been prepared in accordance with current acceptable manufacturing practice as promulgated by the Secretary of Agriculture by way of regulations; or

j. if it has passed its expiry date.

D. Certificate of Product Registration (CPR) — an official document issued as proof that the product passed the registration requirements and standards for food. ISDHcT

E. Confiscation — the taking into custody of livestock and/or poultry carcasses, edible or inedible parts or parts from said carcasses or meat products by the controlling authority for its proper disposal for having been the subject of violation of the rules and regulations.

F. Delineation — the division of functions or responsibilities among offices/units according to their respective mandates.

G. Facilities — the building, premises and equipment necessary for the manufacture, packing, repacking and holding of food.

H. Inspection — an act by an official inspector to ensure compliance with rules and regulations including but not limited to humane handling of slaughter animals, ante and post-mortem inspection, quality assurance program, hygiene and sanitation program, good manufacturing program, sanitation standard operating procedures, hazard analysis critical control point program, residue control program on any meat and meat product, meat establishment facilities, transport vehicles and conveyance.

I. Label — a display of written, printed, or graphic matter upon the immediate container (not including package liners) of any article.

J. License to Operate (LTO) — an official document issued by DOH-BFAD as proof that the establishment passed the licensing requirements and standards for establishments dealing with processed food.

K. Meat — fresh, chilled or frozen edible carcass including offal derived from food animals.

L. Meat Cutting Plant — a meat establishment where carcasses and primal parts are cut and packed into desired specifications. It may be a separate facility or an integral part of another meat establishment such as slaughterhouse, poultry dressing plant or meat processing plant.

M. Meat Establishment — premises such as slaughterhouse, poultry dressing plant, meat processing plant, cold storage, warehouse and other meat outlets that are approved and registered by the NMIS in which food animals or meat products are slaughtered, prepared, processed, handled, packed or stored. EDATSC

N. Meat Inspection System — a system to ensure the safety and quality of meat and meat products for human food including but not limited to humane handling of slaughter animals, ante and post-mortem inspection, quality assurance program, hygiene and sanitation program, good manufacturing program, sanitation standard operating procedures, hazard analysis critical control point program, residue control program, of a country. It covers regulatory activities such as registration, licensing, accreditation, and enforcement of regulations and supported by laboratory examination.

O. Meat Product — any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any food animals, excepting products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat industry; and which are exempted from the definition as a meat product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat products.  

P. Post Approval Control — regulatory measures conducted on meat and meat products after certification from transport up to the time of retail sale for the enforcement of regulations governing meat and meat product inspection.

Q. Prepared — slaughtered, canned, salted, rendered, boned, cut-up, or otherwise manufactured or processed.

R. Processed — all methods of manufacture and preservation but does not include pre-packaged fresh, chilled or frozen meat.

S. Recall — measures applied to return unsafe or unsuitable products that have already been supplied or made available to consumers.

T. Residue — any foreign substance including metabolites, therapeutic or prophylactic agents which are objectionable or hazardous to human health remaining in the meat or meat products as a result of treatment or accidental exposure.

U. Safe and Wholesome — meat and meat products that has been passed as fit for human consumption using the criteria that it a) will not cause food borne infection or intoxication when properly handled and prepared with respect to the intended use, b) does not contain residue in excess of set limits, c) is free of obvious contamination, d) is free of defects that are generally recognized as objectionable for consumers, e) has been produced under adequate hygiene control, and f) has not been treated with illegal substances as specified in the Act and other related legislation. HcACST

V. Shared Responsibility — mutual or joint allocation of available capabilities, facilities, resources and other forms of support, formalized through an Agreement or Undertaking between or among the concerned parties, to pursue a common goal.

SECTION 3

Delineation of Functions

The following functions are hereby delineated:

3.1 Establishments

3.1.1 Jurisdiction

3.1.1.1 DA-NMIS shall have sole jurisdiction over establishments manufacturing, importing, exporting, selling, offering for sale, transferring, or distribution including marketing and advertising and/or promoting meat products defined under Republic Act No. 9296 and its Implementing Rules and Regulations.

3.1.1.2 DOH-FDA shall have sole jurisdiction over establishments manufacturing, importing, exporting, selling, offering for sale, transferring, or distributing including marketing and advertising and/or promoting processed non-meat products or those products which contain meat or other portion of such carcasses in a relatively small proportion or historically have not been considered by consumers as products of the meat industry, which are hereinafter exempted from the definition as meat product by the Secretary of Agriculture.

3.1.1.3 DA-NMIS and DOH-FDA shall have joint jurisdiction on establishments producing or processing both meat and non-meat products with the former focusing on areas related to the handling, preparation and production of meat products and the latter focusing on the non-meat products. AacCIT

3.1.2 Site, design and construction

3.1.2.1 DA-NMIS and DOH-BFAD shall enforce their respective requirements relative to location, design and construction of establishments.

3.1.2.2 In case of joint jurisdiction, close coordination between the two agencies shall be adhered to in the approval of applications for construction.

3.1.3 Operations

3.1.3.1 DA-NMIS shall issue certificate of accreditation and DOH-BFAD shall issue license to operate to establishments under their respective jurisdictions.

3.1.3.2 In case of joint jurisdiction, close coordination between the two agencies shall be adhered to in the approval of applications for authority to operate.

3.1.4 Supervision

3.1.4.1 DA-NMIS and DOH-BFAD shall enforce their respective mandates relative to the operation of establishments under their respective jurisdictions.

3.1.4.2 Programs on Good Manufacturing Practices (GMP), Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis Critical Control Point (HACCP) currently implemented by both agencies shall be harmonized and leveling of procedures shall be jointly undertaken to ensure seamless interfacing in plants under joint jurisdiction.

3.1.4.3 In the course of supervision of DA-NMIS and DOH-BFAD over operation of establishments under their respective jurisdiction, observation of violation or non conformances posing imminent danger shall be notified to the other agency. SDHITE

3.2 Products

3.2.1 Category

3.2.1.1 The sole jurisdiction of the DA-NMIS over meat products shall include, but not limited to the following:

3.2.1.1.1 Non-heat treated

3.2.1.1.2 Heat treated, shelf-stable

3.2.1.1.3 Chilled and/or Frozen meat preparation

3.2.1.1.4 Dried meat products

3.2.1.2 DA-NMIS shall likewise have jurisdiction over new meat products developed from new technology. DA-NMIS shall call on other concerned agencies or entities to ensure that new meat products satisfy safety and quality standards prior to registration and trade.

3.2.1.3 Notwithstanding the above, the Secretary of Agriculture, upon the recommendation of the DA-NMIS in coordination with DOH-BFAD, shall endeavor to define and exempt products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat industry.

3.2.2 Standards

3.2.2.1 DA-NMIS shall initiate a review, in consultation with DOH-BFAD of existing standards of meat products with the participation of the DA Bureau of Agriculture and Fisheries Products Standards (BAFPS) and the Bureau of Product Standards (BPS) of the Department of Trade and Industry.

3.2.2.2 The formulation of new standards shall conform to the delineation over product responsibility. DHEACI

3.2.3 Registration

3.2.3.1 The registration of products shall likewise follow the delineation over product responsibility.

3.2.3.2 DA-NMIS and DOH-BFAD shall endeavor to harmonize the procedures and requirements for product registration with the existing procedure of DOH-BFAD.

3.2.4 Labeling

3.2.4.1 DA-NMIS and DOH-BFAD shall require the proper labeling of products under their respective product responsibilities in consonance with existing laws, rules and regulations.

3.2.4.2 The approving authority over labels shall follow the delineation over product responsibility.

3.2.4.3 DA-NMIS and DOH-BFAD shall closely coordinate in the labeling of meat products for purposes of compliance to RA 8976 (Food Fortification Law).

3.2.5 Certification

3.2.5.1 Any certification which may be required relative to the trade or otherwise (local and/or international) of the product shall be issued by the controlling authority following the delineation over product responsibility.

3.3 Importation and Exportation

3.3.1 The importation of meat products shall conform to existing DA Administrative Order No. 26 series of 2005 Rules and Regulations Governing Importation of Meat and Meat Products into the Philippines and Administrative Order No. 16, series of 2006 Pre-Border measures for the Export of Meat and Meat Products to the Philippines and other relevant rules and regulations that may be issued thereafter. aIcDCT

3.3.2 The exportation of meat and meat products, either fresh or processed from meat establishment utilizing materials domestically source or imported from other countries shall conform to existing DA-NMIS rules and regulations.

3.4 Post Approval Control

The conduct of post approval control such as but not limited to sampling, testing, recall, confiscation and disposal shall be in accordance to the delineation of product responsibility.

3.5 Advertising and Promotion

Permits relative to advertising and promotion shall be secured in accordance to the delineation of product responsibility.

3.6 Consumer Complaints

Consumer complaints involving products within the jurisdiction of DA NMIS and DOH-BFAD shall be governed by the relevant provisions of the Consumer Act of the Philippines (Republic Act No. 7394)and other applicable laws.

3.7 Sanctions and Penalties

3.7.1 Sanctions and/or penalties shall be meted out by the agency having respective with the jurisdiction over the establishment and/or product.

3.7.2 In case of joint jurisdiction, either agency, upon issuance of an order imposing fine, suspension, revocation or cancellation of accreditation, license or registration for violation(s) committed shall immediately notify the other agency of its action in writing.

SECTION 4

Sharing of Responsibilities

4.1 DA-NMIS and DOH-BFAD shall continue to coordinate and collaborate in assuring safety and quality of meat products available to the consuming public by efficient and effective delivery of services. Any doubts in the implementation and interpretation of the provisions of this Joint Administrative Order shall be resolved in favor of the protecting public health. EAHcCT

4.2 DOH-BFAD, with its membership in the Meat Inspection Board, shall provide recommendations and guidance on NMIS programs and activities on the regulation of meat products.

SECTION 5

Transitory Provisions

For smooth transition, the following directives are hereby imposed and made effective immediately:

5.1 The DOH-BFAD is requested to process, evaluate and shall forthwith endorse its final recommendations to DA-NMIS all initial applications for registration of Meat Products and licenses to operate of establishments which were submitted with the DOH-BFAD prior to the effectivity of this Order, and any registration or licensing fee paid thereof shall accrue to DOH-BFAD.

5.2 The NMIS shall, accordingly, issue the appropriate certificate of product registration or license to operate.

5.3 Right after the effectivity of this Order, all initial applications (product registration or license of establishments), together with all the required documents, shall be submitted with the DA-NMIS.

5.4 Renewal of the registration of meat products and licenses of establishments manufacturing, importing or exporting, selling, offering for sale, transferring or distribution shall be in accordance with the following: 

5.4.1 For renewal of Registration of Meat Products:

5.4.1.1 The DOH-BFAD shall process, evaluate and approve the registration of meat products, as well as, licenses of establishments manufacturing, importing (finished products or raw materials), or exporting the same which were submitted with the Bureau prior to the effectivity of this Order.

5.4.1.2 All approved applications for renewal shall thereafter be endorsed to DA-NMIS and the latter shall issue the appropriate registration certificate and/or licenses.

5.4.1.3 All persons applying for renewal applications (registration or license) after the effectivity of this Order are directed to submit their renewal applications together with the documents required with the DA-NMIS.

5.4.1.4 For this purpose, the original certificate of product registration or license to operate issued by DOH-BFAD must also be surrendered to DA-NMIS, otherwise the renewal application shall be denied outright.

5.5 A program to capacitate DA-NMIS personnel on their new functions shall be undertaken by the said Agency with the assistance of BFAD technical staff.

5.6 All records and relevant information shall be transferred by DOH-BFAD to DA-NMIS immediately from the effectivity of this Order.

5.7 All pending consumer complaints with the DOH-Center for Health Development involving meat products shall likewise be transferred to the Consumer Arbitration Officer of the Department of Agriculture.

5.8 The two agencies shall jointly undertake an information campaign to notify stakeholders of the transfer of functions and endeavor to continuously coordinate and cooperate with each other for the effective implementation of this Order and their respective functions and responsibilities.

SECTION 6

Repealing Clause

The provisions of existing Memorandum Circulars, Implementing Rules and Regulations and other issuances that are inconsistent with the provisions of this Order are hereby modified, revoked or repealed accordingly.

SECTION 7

Separability Clause

In the event one or more of such provisions are held unconstitutional, the validity of other provisions shall not be affected thereby. TIEHDC

SECTION 8

Effectivity

This Joint Administrative Order shall take effect fifteen (15) days after its publication in two (2) newspapers of general circulation.

NOW THEREFORE, the parties have herein below affixed their signatures to the joint DA-NMIS and DOH-FDA Administrative Order No. 2009-__ this 28th day of December, 2009.

(SGD.) ATTY. ARTHUR C. YAPSecretaryDepartment of Agriculture

(SGD.) FRANCISCO T. DUQUE IIISecretaryDepartment of Health