Transfer of Functions in the Regulation of Processed Meat ( Joint DOH-FDA-DA-NMIS Administrative Circular No. 2016-0002 )

June 29, 2016

JOINT DOH-FDA-DA-NMIS ADMINISTRATIVE CIRCULAR NO. 2016-0002

 

I. Rationale

Prior to the Republic Act No. (RA) 10611 Food Safety Act of 2013, the Department of Agriculture-National Meat Inspection Service (DA-NMIS) is the sole national competent authority tasked to implement policies, programs, guidelines, rules and regulations over meat and meat products pursuant to the Implementing Rules and Regulations (IRR) of RA 9296, otherwise known as the Meat Inspection Code of the Philippines. The IRR of RA 9296 was supplemented by the Joint DA-NMIS and Department of Health-Food and Drug Administration (DOH-FDA) Administrative Order No. 01 s. 2009, which delineated the functions and shared responsibilities of DA-NMIS and DOH-FDA in the regulation of meat products.

Pursuant to Section 15, Section 16, and Section 18 of Article V of the IRR of the Food Safety Act of 2013, the DOH, through the FDA, is now responsible for the assurance of safety of processed and pre-packaged food products, whether locally produced or imported, including meat products. Rule 39.3 (d) and 39.3 (e), Section 39 of Article XIII thereof states the efficient and orderly transfer and absorption of functions, duties and responsibilities from the DA-NMIS to DOH-FDA. Hence, the DOH and DA jointly issue and promulgate the rules and regulations herein.

II. Objectives

1. To ensure efficient and orderly transition of functions, duties, and responsibilities from the DA-NMIS to DOH-FDA on the regulation of processed meat; and

2. To provide guidance to all manufacturers, exporters, importers, distributors, wholesalers, and retailers of meat and meat products on the mandates of DA-NMIS and DOH-FDA.

III. Scope

This Joint Administrative Circular shall apply to all manufacturers, exporters, importers, distributors, wholesalers and retailers of meat and meat products for commercial distribution.

IV. Definition of Terms

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

1. Certificate of Product Registration (CPR) refers to an official document issued by the FDA and NMIS as proof that the product passed the registration requirements and standards for food. HTcADC

2. Confiscation/Seizure refers to the taking into custody of livestock and or poultry carcasses, edible or inedible part/s from said carcasses and processed meat by the controlling authority for its proper disposal for violation of pertinent rules and regulation.

3. Establishment refers to a sole proprietorship, a partnership, a corporation, an institution, an association or an organization engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of food products, including the facilities.

4. Label refers to a display of written, printed or graphic matter upon immediate container (not including package liners) of any article.

5. License to Operate (LTO) refers to an official document issued by DA-NMIS and DOH-FDA as proof that the establishment passed the licensing requirements and standards for meat establishment.

6. Meat refers to fresh, chilled or frozen edible carcass including offal derived from food animals intended for commercial distribution.

7. Processed Meat refers to meat that has undergone processing, including but not limited to heating, smoking, curing, drying, marinating, or combination of those processes that alter the meat's chemical composition intended for commercial distribution.

8. Post-Market Surveillance (PMS) refers to activities involved in safety and quality monitoring of food products. This shall also include, among others, adverse effects, events reporting, product safety update reporting, inspection of licensed establishments, monitoring of promotions and advertisements, and collection and testing of food products in the market.

9. Post Meat Establishment Control (PMEC) refers to the regulatory measures conducted on meat after certification for transport up to the time of retail sale for the enforcement of regulations governing meat inspection.

10. Recall refers to measures applied to remove unsafe or unsuitable meat and processed meat that have already been supplied or made available to consumers.

V. General Guidelines

1. The DA-NMIS shall have jurisdiction over meat.

It shall have regulatory authority over establishments slaughtering, importing, exporting, selling, offering for sale, transferring, or distribution including marketing and advertising and/or promoting meats.

2. The DOH-FDA shall have jurisdiction over processed meat.

It shall have regulatory authority over establishments manufacturing, importing, exporting, selling, offering for sale, transferring, or distribution including marketing and advertising and/or promoting processed meat.

VI. Specific Guidelines

1. Site, Design and Construction

The DA-NMIS and DOH-FDA shall enforce their respective requirements relative to location, standard design and construction of establishments.

2. Operations

a. The DA-NMIS and DOH-FDA shall issue their respective LTOs to establishments under their respective jurisdictions.

b. In case of establishment with both slaughtering and processing activities in one building or location, close coordination between the two agencies shall be adhered to in the approval of LTO applications.

3. Supervision

a. The DA-NMIS and DOH-FDA shall enforce their respective mandates relative to the operation of establishments under their respective jurisdictions.

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

c. The DA-NMIS and DOH-FDA shall mutually share information involving any violation or non-conformance by establishments under their respective jurisdiction.

4. Products

a. Category

i. The sole jurisdiction of DA-NMIS is over fresh meat, i.e., warm, chilled, frozen, or thawed including minimally processed meat such as blanching and natural surface flavoring.

ii. The sole jurisdiction of the DOH-FDA is over processed meat. The DOH-FDA may call on other concerned agencies or entities to ensure that processed meat satisfy safety and quality standards prior to registration and trade.

b. Standards

i. The DOH-FDA and DA-NMIS shall coordinate with standard setting agencies to ensure alignment with the Philippine National Standard (PNS).

ii. The formulation of new standards shall conform to the delineation of jurisdiction over product category.

c. Registration

The DA-NMIS shall transfer to the DOH-FDA the list of registered processed meat with a valid CPR on or before the turnover of jurisdiction on processed meat from the former to the latter.

d. Labelling

The DA-NMIS and DOH-FDA shall require the proper labelling of products under their respective jurisdiction as provided under existing laws, rules and regulations, and standards. aScITE

e. Certification

i. Any certification which may be required relative to trade (local and/or international) of the meat and processed meat shall be issued by the controlling authority following the delineation of responsibility.

ii. The following certifications are issued by controlling authorities:

	Agency	Local	Export
a.	DOH-FDA	Good Manufacturing	Export
		Practices (GMP); and	Clearance; and
		Hazard Analysis Critical	Export
		Control Points (HACCP)	Commodity
			Clearance
b.	DA-NMIS	Good Manufacturing	Official Meat
		Practices (GMP);	Inspection
		Good Operating Practices	Certificate
		(GOP);	(OMIC)
		Hazard Analysis Critical
		Control Points (HACCP);
		Meat Inspection Certificate
		(MIC) for local meat;
		Certificate of Meat
		Inspection (COMI) for
		imported meat;
		Utilization Certificate of
		Imported Meat; and
		Meat Transport Vehicle
		Registration

5. Importation and Exportation

a. The importation of processed meat shall conform to the rules and regulations of the DOH-FDA and other concerned agencies.

b. The exportation of processed meat coming from domestic or imported materials shall conform to the existing DA-NMIS and DOH-FDA rules and regulations in accordance with their respective mandate.

6. Post Marketing Surveillance (PMS)/Post Meat Establishment, Control (PMEC)

The conduct of PMS/PMEC such as but not limited to sampling, testing, recall, confiscation/ seizure, and destruction shall be in accordance to the delineation of product responsibility.

7. Advertising and Promotion

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

8. Consumer Complaints

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

VII. Sanctions or Penalties

1. Sanctions and or penalties shall be meted out by the agency having jurisdiction over the establishment and or product as stipulated in RA No. 10611 (2013), RA No. 9711 (2009), RA No. 9296 as amended by RA No. 10536 (2013) and other relevant laws.

2. Administrative sanctions shall be imposed on erring establishments in accordance with the regulations of the DOH-FDA and DA-NMIS. In case the establishment is licensed by both agencies, notice of administrative sanctions imposed by one agency shall immediately be furnished to the other agency.

VIII. Transitory Provisions

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

1. The DA-NMIS shall provide the list of meat processing plants issued with a valid LTO and CPR of processed meat to DOH-FDA on or before 30 June 2016 and shall cease to accept applications thereafter.

2. Consumer complaints filed prior to 01 July 2016 shall be acted upon by the DA-NMIS until the closure of the case.

3. The DOH-FDA shall recognize the validity of the LTO including GMP and HACCP certifications issued to meat processing plant and CPR of processed meat issued by DA-NMIS as of 30 June 2016.

4. Renewal of the registration of processed meat and licenses of establishments manufacturing, importing or exporting, selling, offering for sale, transferring, or distributing processed meat shall be in accordance with the existing FDA guidelines on renewal of authorizations.

5. The DOH-FDA may call upon DA-NMIS for technical assistance related to the transfer of functions over processed meat.

6. The two agencies shall jointly undertake an information campaign to notify stakeholders of the transfer of DA-NMIS regulatory functions on processed meat to DOH-FDA and endeavour to continuously coordinate and cooperate with each other for the effective implementation of this Circular.

IX. Repealing Clause

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

X. Separability Clause

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

XI. Effectivity

This Joint Administrative Circular shall take effect 15 days after its publication in two (2) newspapers of general circulation and submission of copy to National Administrative Register at UP Law Center, Diliman, Quezon City. HEITAD

NOW THEREFORE, the parties have herein below affixed their signature to the Joint DA-NMIS and DOH-FDA Administrative Circular No. ________ this _____ day of ____________.

(SGD.) JANETTE P. LORETO-GARIN, MD, MBA-H	(SGD.) PROCESO J. ALCALA
Secretary	Secretary
Department of Health	Department of Agriculture

ANNEX A

Delineation Table

	Bases of	DA-NMIS	DOH-FDA	Joint DA-NMIS/
	Delineation					DOH FDA
a)	Product	Raw meat (including yakitori),	Processed Meat
		Mechanically Separated Meat
		(MSM) and Minimally
		Processed Meat 1
b)	Process	Slaughtering, blanching 2	Canning, thermal process,	Sharing of
		(as initial process for	curing, marination, salting,	inspection reports
		dressing), dressing,	drying, cooking, and other	as additional
		fabrication/cutting,	processing technologies	basis for issuance
		chilling, freezing	which alter the chemical	of respective
		and thawing	structure of the meat	authorizations
c)	Establishment	Slaughterhouse, poultry	Manufacturing plant,	Sharing of
		dressing plant, meat cutting	commissaries, distribution	records of
		plant, cold storage of raw	center of processed meat,	authorizations
		meat, distribution center of	warehouse of	from NMIS to
		raw meat	processed meat	FDA
d)	Issuance of	Authorizations:	Authorizations:	Sharing of
	permit/	1.	License-to-Operate for	1.	License to Operate	records of
	authorization		Establishments		(inclusive of	authorizations
		2.	Meat Inspection Certificate		Processed Meat	from
			(MIC) for Local		Products in Cold	NMIS to FDA
		3.	Certificate of Meat		Storages)
			Inspection (COMI)	2.	Certificate of Product
			for Imported		Registration for Processed
		4.	Meat Transport Vehicle		Meat Products
			Registration
		Certifications:	Certifications:
		1.	Good Manufacturing	1.	Good Manufacturing
			Practices (GMP)		Practices
		2.	Good Operating Practices	2.	HACCP Certification
			(GOP)
		3.	Hazard Analysis Critical
			Control Points (HACCP)
		4.	Utilization Certificate of
			Imported Meat
e)	Import and	NMIS:	Export/Commodity	Coordination
	export controls			Clearance depending on	between NMIS
		1.	Official Meat Inspection	the country of	(for the raw
			Certificate (Export)	destination	materials) and
		2.	Certificate of			FDA (for
			Utilization (Imported)			the processed
						finished product)
						documents;
						Coordination as
						well with BOQ
f)	Transport	Registration of Meat	Included in GMP	-
	vehicle of meat	Transport Vehicle on Raw
	and processed	Meat — Fresh Warm
	meat	Chilled, Frozen and Thawed
		(of food animal origin)
g)	Handling of	Raw Meat — Fresh Warm,	Processed Meat Products,	Epidemiological
	Consumer	Chilled, Frozen and Thawed	Cooked Meat	Investigation
	Complaints					(Joint DA-DOH
						Team)
h)	Sales and	Raw Meat — Fresh Warm,	Processed Meat Products,
	Promo Permit	Chilled, Frozen and Thawed	Cooked Meat
1. Minimally processed meat refers to meat with added salt and pepper specifically for the purpose of enhancement of natural flavors.
2. Blanching refers to a heat process typically applied to a food for the purpose of inactivating enzymes and/or fixing the product colour. (CAC/RCP 8-1976)