SECTION 1. Introduction - Artificial Insemination (AI) is a widely accepted technique in animal reproduction for the production of good quality animals. It also improves the reproductive efficiency in swine and reduces the risk of transmission of reproductive diseases such as but not limited to Aujesky ™s Disease, Hog Cholera, Parvovirus, Porcine Circovirus, Brucellosis, Leptospirosis, FMD virus, Porcine Reproductive and Respiratory Syndrome (PRRS) and Ebola Reston (ER) Virus.

SECTION 2. Purpose - This Implementing Rules and Regulations (IRR) shall apply to the registration and accreditation of all government and private swine artificial insemination centers and providers for the purpose of ensuring quality swine production and disease prevention in the Philippines, pursuant to the Consumer Act of the Philippines (Republic Act No. 7394) on Consumer Product Safety and Quality Standards and DA-BAI Administrative Order No. 02, series of 2009, Registration and Accreditation of Swine Artificial Insemination Centers and Providers.

SECTION 3. Definition of Terms - When used in relation to the implementation of this IRR, the following terms shall be defined as follows:

Accreditation - shall refer to the procedure by which an authoritative body gives formal recognition that a juridical person is competent to carry out specific tasks.

AI - shall refer to œArtificial Insemination , the process of depositing semen in the female genitalia using instruments rather than by natural service.

AI Center - shall refer to a private or government-owned facility, farm or laboratory that provides primarily boar semen and/or AI services.

AI Provider - shall refer to an individual, group or business entity that either carries, handles, markets, imports, distributes boar semen or offers AI services, or both.

AI Services - shall refer to the act of providing AI by trained technician.

Applicant - shall refer to any person, association, partnership, corporation, cooperative, or any government agency or instrumentality that is applying for the issuance of accreditation.

ASBAP shall refer to the Accredited Swine Breeders Association of the Philippines

BAI shall refer to the Bureau of Animal Industry of the Department of Agriculture.

BAI Director shall refer to the Director of the Bureau of Animal Industry

BFAD shall refer to the Bureau of Food and Drug of the Department of Health.

Boar shall refer to a male pig where the semen is collected and use for AI.

DA shall refer to the Department of Agriculture, mandated with the planning, formulation, execution, regulation and monitoring of programs and activities relating to agriculture, food production and supply.

DTI shall refer to the Department of Trade and Industry, a government agency tasked with the registration and licensing of single-proprietorship company/ies

GAHP shall refer to Good Animal Husbandry Practices or PNS 60:2008.

IRR shall refer to the Implementing Rules and Regulations, a set of legal documents that pertains to the execution of certain AOs and MOAs of the DA.

Laboratory shall refer to a private or government facility that is capable of testing and processing semen to determine its quality.

LDD shall refer to Livestock Development Division of the Bureau of Animal Industry. LGU shall refer to Local Government Unit

PCARRD - LRD - shall refer to Philippine Council for Agriculture, Forestry and Natural

Resources Research and Development - Livestock Research Department

PCSP - shall refer to the Philippine College of Swine Practitioners.

RAIC - shall refer to the Regional Artificial Insemination Coordinator, a DA regional personnel assigned to coordinate the implementation of AI programs at the regional level under the UNAIP.

RASAICAP - shall refer to the acronym of Registration and Accreditation of Swine Artificial Insemination Centers and Providers.

Registration is the action by which information about the AI centers and providers is collected, recorded, securely stored and made appropriately accessible and able to be utilized by the competent authority.

Resident Veterinarian - shall refer to a licensed government or private veterinarian practicing within the municipality, city or province where the AI center is located.

RFU - shall refer to the Regional Field Unit of the Department of Agriculture

Semen - shall refer to the liquid cellular suspension, fresh or frozen containing spermatozoa and secretions from the accessory reproductive organs of the male.

Semen Extender shall refer to compounds used in semen processing to prolong the viability of the spermatozoa and expand the ejaculate volume maximizing the number of semen doses made. It is also often called as diluents.

UNAIP - shall refer to the Unified National Artificial Insemination Program of the Department of Agriculture.

SECTION 4. Program Structure and Functions

4.1 Over-all Management - The BAI Director shall approve the certificate of registration and accreditation upon the recommendation of the NTWC. He shall provide policy and over-all direction of the Program.

4.2 National Technical Working Committee (NTWC) -

Chairman	- Chief, Livestock Development Division, BAI
Vice-Chairman	- Representative from the Accredited Swine Breeders Association of the Phil. (ASBAP)
Members	- Technical Representatives from:
	- Academe with expertise on Breeding and Genetics
	- BAI - Animal Health Division
	- BAI - Livestock Development Division
	- BAI - Animal Welfare Division
	- International Training Center on Pig Husbandry
	- Livestock Development Council
	- PCARRD-LRD
	- PCSP
	- PSIRDFI - Philippine Swine Industry Research and Development Foundation Incorporated
Function:

The NTWC shall review, evaluate and validate the findings of the Regional Technical Working Committees (RTWC) and recommend measures/amendments on the criteria and procedures of accreditation as may be necessary. It shall assist the BAI Director in formulating policies for the Program and endorse approval of the accreditation.

It shall also conduct capability building activities for RTWC and develop the Manual of Operation.

4.3 National Secretariat

Function:

The National Secretariat (NS) in coordination with the RAIC shall provide application form to the applicants, conducts preliminary table evaluation, schedules farm visits, sends notice of renewal to accredited Centers/Providers, and acts as repository of all data pertinent to the RASAICAP.

The BAI Livestock Development Division (LDD) shall serve as the National Secretariat of the RASAICAP.

4.4 Regional Technical Working Committee (RTWC)

Chairman - DA Regional Technical Director for Operations
Co-Chairman - Designated Livestock Division/Section Chief/Chief Regulatory Division
Members - Regional Artificial Insemination Coordinator (RAIC)
	- Regional AWA Representative
	- Regional Animal Disease Diagnostic
	- Laboratory (RADDL) Representative
	- Provincial/City/Municipal Veterinarian where the applicant is located
	- ASBAP Representative
	- PCSP/local hog association representative if PCSP is not represented in the region
	- Representative of the Academe
Function:

The RTWC shall conduct an actual evaluation of AI Centers/Providers and submit the findings and recommendation to the NTWC. At least three (3) members can constitute the evaluation team, provided that none of the members of the team has direct interest in the center being evaluated.

The RAIC shall be designated as Secretariat of the RTWC.

SECTION 5. Accreditation Requirement -

5.1 All facilities should be registered pursuant to existing rules and regulations. AI Centers and providers shall be registered pursuant to the provisions of R.A. No. 7160 the Local Government Code of 1991, R.A. No. 8485 the Animal Welfare Act of 1998 and DILG Memo Circular No. 2005-01.

5.2 General Requirements for Registration

5.2.1 Application containing among others the name, address, age, citizenship, tax identification number and a latest passport size picture of the applicant and other pertinent circumstances pertaining to the establishment including the place where it is to be established.

5.2.2 Proof of registration as an establishment, as evidenced by any of the following:  

5.2.2.1 For single proprietorship, an authenticated photocopy of the Certificate of Business Name Registration issued by the Bureau of Domestic Trade of the Department of Trade and Industry.

5.2.2.2 For partnership, corporation and other juridical person, an authenticated photocopies of the Certificate of Registration by the Securities and Exchange Commission and the Articles of Incorporation

5.2.2.3 For Cooperatives, a Certificate of Registration from the Cooperative Development Authority

5.2.2.4 A valid Mayor ™s Permit for the Current Year.

5.2.3 A certification from a licensed resident veterinarian on the health aspects of the boars.

5.2.4 A certificate of attendance of the owner/manager and the veterinarian to BAI sponsored/accredited seminar on artificial insemination. 

5.2.5 An Environmental Clearance Certificate from the Department of Environment and Natural Resources, if applicable.

5.2.6 A municipal/city ordinance or resolution for the creation of the government AI center.

5.2.7 Payment of registration fee.

SECTION 6. Technical Requirement for Accreditation -

I. Minimum Standard Requirement for a Swine AI Center or Facility

1. Animal requirement

All boars shall be sourced from a BAI accredited swine breeder farm. These animals shall be supported with pedigree certificates and genetic performance issued by the farm of origin. Other details regarding pedigree and genetic performance will be contained in the manual that will be formulated by the NTWC.

1.1 There shall be at least two (2) boars of different breeds

1.2 Maximum age of boards - 4.0 years old including growing phase & productive life. ( An annual replacement rate of 50% to ensure infusion of improved genetics)

1.3 Minimum age of boar during first semen collection shall be seven (7) months old.

1.4 Good semen quality;

1.4.1 Fresh semen

a. Gross motility - at least 85%

b. Total sperm - 15 x 10⁹ sperm/ejaculation

c. Normal sperm % - >80%

d. Cytoplasmic droplets - - <15% Only proximal droplets are counted.

1.4.2 Processed semen dose

a. Gross motility % - at least 85%

b. Sperm concentration/dose (viable cells) - 3 to 4 billion cells/

c. Volume/dose - 80 to 100 ml

d. Semen extender - must be sourced from duly registered commercial suppliers

2. Animal housing and facilities

The building shall have an appropriate design, facilities, equipment and tools for an effective and functional operation;

2.1 Boar pen/stall

2.1.1 Boar may be housed in boar pen with dimension of at least 2 x 2m with partitions preferably made of concrete or vertical pipes or rods. The floorings should be slatted/partial-slats/solid, non-slip and has a slope of 1.2 to 2%

2.1.2 Ventilation and cooling

A monitor type of roofing is recommended to have ventilation.

2.1.3 Boar movement

Provision of alley from pen to collection area and vice versa.

2.2 Collection pen

2.2.1 The collecting pen should have at least a dimensions of 2 x 3 m.

2.2.2 The flooring shall have non slip surface preferably with rubber mat, with a slope of at least 1%.

2.3 The dummy sow shall be made preferably of metal or plastic for easy cleaning; a length of at least 91 cm and width of 25-30 cm, adjustable height.

3. Laboratory

The Laboratory shall be located adjacent to the collecting pen with the following minimum equipment and supplies:

3.1 Catheters should be disposable, spiral or foam

3.2 Dryer/Sterilizer

3.3 Glass slides and cover slips

3.4 Laboratory thermometer - at least 2 pcs spirit-filled or digital, 1000C

3.5 Microscope (monocular or binocular 10x eyepiece with 20x, 40x, and 100x oil immersion objectives)

3.6 Disposable plastic semen bottles/cochette/tubes (80-100 capacity)

3.7 Thermal collecting cups with filters (at least 3)

3.8 Semen density equipment (photometer/spermio-densimeter) regularly calibrated

3.9 Semen extenders

3.10 Semen storage unit, temperature of 16-170C

3.11 Water bath or other equivalent system

3.12 Weighing scale (2 kg capacity)

3.13 Stand-by generator (optional)

4. For Frozen semen

4.1 2 units liquid nitrogen (LN2) tank, (35-liter capacity), field tank, dip stick

4.2 Plastic goblets

4.3 Thermometer

4.4 Thawing flask

4.5 Stop watch

4.6 2 units water bath

5. Production protocol

5.1 Maximum Frequency of semen collections months

a. Junior boar (7-9 mos.) - once every 7 days

b. Junior board (10-12 mos.) - once every 5 days

c. Senior boar (13 - 48 mos.) - once every 3-4 days

5.2 Minimum frequency of morphological testing of semen of boars-every six

6. Processing protocol

6.1 Semen shall be processed using commercial extenders.

6.2 Amount of pure semen added to extender - not < 10 ml/dose or 2.5 to 4 billion sperm cells/dose

6.3 Water quality requirement

6.3.1 Suggested water quality specifications

Criteria	Standard
Bacteriology	<1 cfu/ml
Purity Inorganics	<18 MW  CM @ 250 C
Organics	< 0.001 AU @ 254nm
TOC	<50 ppb
pH	6.8 - 7.2

Legend: cfu/ml = colony forming units/ml;

ppb = parts per billion;

M  = megaohm - cm (electrical resistance)

6.3.2 Other than the suggested water specifications, water should be sourced from the following purification methods:

Distillation
Deionization
Reverse Osmosis
Activated Carbon Absorption
Microporous Filtration
Ultra Filtration
Photo-oxidation

6.4 Temperature requirements of the laboratory and laboratory equipment

6.4.1 The laboratory if air conditioned, should have a temperature of 22-25⁰ C; and the semen storage unit at 16-17⁰ C.

6.4.2 The dryer incubator for pre warming of collecting cup and materials should be 35⁰ C.; and for sterilization should be 600C.

6.4.3 Water bath should be 35-37⁰ C.

6.5 Boar management system shall be in accordance to GAHP.

7. Storage, Maintenance and Handling of Diluted Semen

7.1 Storage of semen

7.1.1. Storage temperature should be at 16-17⁰ C

7.1.2 Invert the bottles twice a day to redistribute the sperm in the diluents or at 12 hours interval

7.1.3 Maximum storage of semen should be 7 days after which the semen should not be used

7.2 Handling of Semen

Semen dose should be transported and handled in a manner that protects the semen from temperature fluctuations and ultraviolet light.

Insulated container such as Styrofoam box with cool packs or battery-operated thermostatically controlled box can be used to transport semen.

8. Personnel Requirement

8.1 Laboratory Technician - one (1)

8.2 Caretaker/semen collector - one (1)

9. Boar Management

9.1 Farm and laboratory records should be maintained

9.2 Feeding and nutrition should maintain a Body Condition Score of 3

9.3 Water should be potable

9.4 Health

The boars shall be kept in good health at all times through proper management practices that include prevention, treatment and disease control. The boar must be serologically free from Aujesky ™s Disease (AD), Porcine Reproductive and Respiratory Syndrome (PRRS), Porcine Parvovirus, Brucellosis, Leptospirosis, Classical Swine Fever (Hog Cholera), Ebola Reston (ER) virus and Foot-and-Mouth Disease. However farm vaccinating against these diseases should provide evidence that they are free from clinical signs of these diseases. Vaccination shall depend on the disease situation of the area as declared by BAI.

9.4.1 Should comply with the minimum biosecurity requirements on location and facilities

9.4.2 Should comply with animal quarantine procedures

9.4.2.1 Isolation and quarantine (location, duration)

9.4.2.2 Certification of quarantine clearance.

9.4.2.3 Serological testing for the initial application on accreditation shall be borne by BAI and the succeeding tests shall be at the expense of the owner.

9.4.2.4 PRRS, PRV and HC vaccination shall be at least every six (6) months

9.4.3 Health program and monitoring plan should be done and approved by licensed veterinarian.

9.4.4 Deworming/demanging shall be done at least every 6 months or depending upon the parasitic load

9.5 Vaccination

9.5. 1 The boar must have vaccinations against:

9.5.1.1 Porcine Parvo Virus

9.5.1.2 Leptospirosis

9.5.1.3 Erysipelas

9.5.1.4 Hog Cholera virus

9.5.2 Vaccination against the following diseases will only be done where applicable

9.5.2.1 Foot and Mouth Disease

9. 5. 2. 2 Porcine Reproduct ive and Respirat ory Syndrome (PRRS)

9.5.2.3 Aujesky ™s Disease

9.5.3 AI Center or provider may institute other vaccination program on diseases that are endemic in the area.

10. Animal Welfare, Health and Safety Practices

10.1 Certificate of registration under Animal Welfare Act of 1998

10.2 Farm practices must be in accordance with Good Animal Husbandry Practices (GAHP)

II. Minimum Standard Requirements for AI Provider

1. AI Technician

1.1. Must have completed a Basic Course on Swine Artificial Insemination (AI) from a training institution duly recognized by BAI

1.1.1 Boar Management
1.1.2 Semen Evaluation, processing and handling
1.1.3 Heat Detection
1.1.4 Artificial insemination
1.1.5 Sow management

1.2 Experienced AI technicians should pass validation examination conducted by a recognized swine AI training institution.

2. Group or Business Entity

2.1 Must be registered as per requirement based on Section 5 Item 5.1 (Accreditation Requirement) of these Rules and Regulations.

2.2 Semen or boar must be sourced or traceable from accredited swine breeders or accredited AI centers.

2.3 Should comply with II.3 of Minimum Technical Requirements (Semen Importers) if Group or Business Entity will import semen.

3. Semen Importers

3.1 The local supplier of imported semen must be accredited by the BAI as per requirement of Section 6 of this IRR.

3.2 Imported semen must be supported by pedigree and health certificate issued by appropriate recognized breeders ™ association or appropriate government issuing authority,

3.3. Health certificate issued by BAI National Veterinary Quarantine Service

SECTION 7. Procedural Guidelines for Accreditation - The applicant must follow these procedures for application of initial certification of accreditation:

7.1 Applicant accomplishes the application form that is downloadable from the BAI website or from the nearest DA RFU and submit them to the BAI either through regular mail, fax, email (Bureau of Animal Industry, Visayas Avenue, Diliman, Quezon City 1100) or to the nearest DA RFU whichever is convenient.

7.2 Upon filing of notarized application, the applicant pays the corresponding fees to the Cashier of the BAI/DA RFU, in person or through bank transfer.

7.3 The RTWC conducts on-site inspection/evaluation to determine compliance with standards and technical requirement. In the conduct of on-site inspection, they shall follow the biosecurity protocols (downtimes) set by the AI Centers.

7.4 The NTWC through the National Secretariat reports the findings or results of evaluation to BAI Director for appropriate action.

7.5 The BAI Director approves or disapproves the application for accreditation.

7.5.1 If approved, the BAI Director issues a certificate of accreditation to the applicant upon payment of fee within ten (10) working days.

7.5.2 If disapproved, the BAI Director sends the findings and recommendations to the applicant for compliance. Failure to comply within thirty (30) days shall be a ground for denial of the application. Hence, the applicant has to re-file his application and pays the required accreditation fee.

SECTION 8. Fees -

8.1 The following schedule of fees for the accreditation shall be paid to the Cashier of the BAI/DA RFU in person, or through bank transfer.

8.1.1 AI Center

8.1.1.1 Individual

Registration/Processing Fee

P 100.00 Accreditation Fee P3,000.00 Renewal Fee P1,500.00

8.1.1.2 Business Entity/Corporation/Partnership

Registration/Processing Fee P100.00 Accreditation Fee P3,000.00 Renewal Fee P1,500.00

8.1.2 AI Provider

8.1.2.1 Individual

Registration/Processing Fee P100.00 Accreditation Fee P500.00 Renewal Fee P 250.00

8.2 The BAI is authorized to adjust the accreditation fee from time to time upon the recommendation of the NTWC.

SECTION 9. Renewal of Certificate of Accreditation - Renewal of Certificate of Accreditation shall commence on the third year and every two (2) years thereafter.

9.1 Application for renewal of accreditation shall be filed ninety (90) days before the expiry date to the BAI/DA RFU.

9.2 The applicant shall follow the following procedures for renewal of certificate of accreditation.

9.2.1 Applicant accomplishes the required documents and submits them to the BAI. Upon filing of application, the applicant pays the corresponding fees for renewal to the Cashier of the BAI/DA RFU, in person or through bank transfer.

9.2.2.Documents Requirements:

9.2.2.1 Notarized Application for Renewal

9.2.2.2 Certification of Accreditation

9.2.2.3 Current Certification of Accreditation

9.2.2.4 Current Mayor ™s Permit

9.2.2.5 Current Certification of Registration

9.2.2.6 List of Equipment/Instruments

9.2.2.7 List of Boar Stock/Inventory

9.2.3 The BAI conducts evaluation to determine compliance with standards and technical requirements for accreditation. In case the renewal of accreditation is sent to the DA RFU, evaluation shall commence within thirty (30) days upon receipt of documents from the RAIC.

9.2.4 The BAI approves or disapproves application for renewal of Certificate of Accreditation

9.2.4.1 If approved, the BAI renews the Certificate of Accreditation

9.2.4.2 If disapproved, the BAI sends the findings to the applicant for compliance. Failure to comply within thirty (30) days shall be ground for suspension/revocation of accreditation.

The details will be contained in the Operation Manual that will be developed by the NTWC.

SECTION 10. Initial Seed Fund - In carrying out the activities of the RASAICAP, one million pesos (P1,000,000.00) initial fund shall be provided to the BAI through the DA Livestock Program Fund.

SECTION 11. Use of Accreditation Fees - The proceeds from this program shall be deposited under the Trust Fund 184.

The use of registration/accreditation fees shall be used exclusively to sustain the activities of the program such as the conduct of evaluation and monitoring of AI Centers, meetings, honoraria, consultations, capacity building and promotional activities subject to the usual Government Accounting Rules and Regulations.

SECTION 12. Monitoring of AI Centers/Providers - The BAI shall conduct an on-site monitoring visits of registered and accredited AI Centers/Providers. The monitoring visits shall document the output and performance of the accredited AI Centers/Providers.

SECTION 13. Terms and Conditions of Accreditation -

13.1 An accreditation shall be granted in accordance with prescribed registration and accreditation requirements and on the basis of specific conditions and limitations established during the evaluation.

13.2 An accreditation that is not renewed until the expiry date shall be considered lapsed and registration shall be cancelled. A new application for the issuance of accreditation shall be required.

13.3 The accreditation as herein granted as well as any right under the accreditation cannot be assigned or otherwise transferred directly or indirectly to any party.

13.4 The BAI shall be notified of any change in management name or ownership. In case of tranfer of location, a new application and supporting documents for accreditation shall be required.

13.5 A separate accreditation shall be required for all Satellite Centers or Branches maintained in separate premises but operated by the same management.

13.6 The Accreditation Certificate shall be placed in conspicuous areas seen by the public. A copy of the rules and regulations shall be readily available for guidance of all personnel in the Center.

SECTION 14. Validity - The accreditation shall be valid for a period of two (2) years, unless earlier cancelled for just cause.

SECTION 15. Violations and Sanctions - Any violations on the Rules and Regulations and or any terms and conditions of accreditation shall be a ground for suspension or revocation of Certificate of Registration and Accreditation.

The BAI shall recommend to appropriate LGU/s the immediate suspension or cessation of business of the AI Center/Provider if upon evaluation or monitoring visit is found to be violating the rules and regulations. Preventive suspension shall not be less than sixty (60) days.

Grounds for suspension are genetic and quality of semen issues. The cancellation of accreditation shall be due to health problems and breach of protocols.

Notice of suspension will be served thru a formal written communication.

SECTION 16. Revocation of Accreditation -

16.1 The BAI shall cause the revocation of registration and accreditation of any AI Center and Provider to have violated any provisions of the rules and regulations governing the registration and accreditation of AI Centers and Providers.

16.2 The BAI shall cease to promote the AI Center/Providers found to be violating the provisions of these rules and regulations.

SECTION 17. Reapplication for Accreditation - An AI Center/Provider where its Certificate of Registration/Accreditation has been revoked may reapply for the issuance of a new one upon compliance with the requirements established hereunder and/or the correction of the deficiency or violation which resulted in revocation.

SECTION 18. Separability Clause - The provisions of these Rules and Regulations are hereby declared separable, and in the event that one or more of such provisions are declared invalid the validity of all other provisions shall not be affected.

SECTION 19. Amendment Clause - As the need arises, the rules and regulations may be recommended for amendment by the NTWC for approval by the Secretary, Department of Agriculture.

SECTION 20. Effectivity - The Rules and Regulations shall take effect fifteen (15) days after its publication in a newspaper of general circulation and upon its filing with the National Administrative Register at the UP Law Center, Diliman, Quezon City.

Recommending Approval:

(SGD.) DR. EFREN C. NUESTRO
  Director IV
  Bureau of Animal Industry

Approved:

(SGD.) PROCESO J. ALCALA
  Secretary
  Department of Agriculture