The Implementing Rules and Regulations (IRR) of Republic Act (RA) No. 9711, otherwise known as “The Food and Drug Administration (FDA) Act of 2009”, are promulgated to adopt, support, establish, institutionalize, improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and designed to: (a) protect and promote the right to health of the Filipino people; and (b) help establish and maintain an effective health products regulatory system and undertake appropriate health manpower development and research, responsive to the country’s health needs and problems.
Consistent with these objectives, the FDA recognizes the importance of pest management in the implementation of the Agency’s mandate to protect the health of the public, not only by ensuring that safe, effective and quality household/urban pesticide products are made available to the market, but likewise, in that the proper use, application, transfer, storage, and disposal of such household/urban pesticide products are carried out effectively.
This Circular further outlines the licensing provisions of Department of Health (DOH) Administrative Order (AO) No. 2019-0010, entitled “Guidelines on the Regulation of Operators of Pest Control, Certification of Pesticide Handlers, and Accreditation of Their Training Providers” issued on 18 June 2019, for compliance of all concerned establishments.
This Circular aims to establish the guidelines for the licensing and inspection of establishments or operators for non-agricultural pest control.
This Circular shall apply to all government and private establishments engaged in the business, service, or commercial application of household/urban pesticide products for purposes of non-agricultural pest control, and for other related purposes, as defined in RA 9711, DOH AO No. 2019-0010, and other related laws, rules, and regulations.
IV. GENERAL GUIDELINES
A. The terms used in this Circular shall have the same meaning as defined in RA 9711 and its IRR, DOH AO No. 2019-0010, and related laws and regulations. For the purpose of this Circular, the Pest Control Operator (PCO) establishment shall likewise be referred to as a PCO Authorization Holder; and, household/urban pesticides shall henceforth be referred to as household pesticides.
B. A License to Operate (LTO) shall be secured by a PCO establishment from the FDA through the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) prior to engaging in the business, service, or commercial application of household pesticides for the purposes within the scope of this Circular.
C. Establishments engaged in any of the following scope of work shall be required to secure the appropriate LTO as PCO from FDA:
1. Commercial Application of household pesticide products for purposes of pest control
2. In-house Application of household pesticide products for purposes of pest control
3. Government Service Application, local or national, of household pesticide products for purposes of pest control as part of their functions, programs or strategies
D. PCO establishments shall be categorized into the following based on their declared method of pest control:
1. Exterminator – a PCO establishment who uses liquid and powder forms of pesticides in the control/treatment of pests;
2. Fumigator – a PCO establishment who uses chemicals which, at a required temperature and pressure, can exist in a gaseous state in sufficient concentration to be lethal to a given pest organism, in the control/treatment of pests; or,
3. Exterminator/Fumigator – a PCO establishment using the methods of both an exterminator and fumigator in the control/treatment of pests.
The FDA may revise and create new categories in response to innovations in technology, control and management of pesticides, and in response to public health emergencies and concerns.
E. PCO establishments shall only use FDA-registered household pesticides in their pest control activities.
F. PCO establishments applying other non-pesticide products, such as but not limited to disinfectants for surfaces, as part of its pest control activities shall declare such as additional activities in its LTO application. Correspondingly, other health products, including disinfectants, under the jurisdiction of the FDA which are used during pest control activities must be duly-registered with the FDA.
Existing PCO establishments shall file a minor variation to its license for such additional activity. However, these guidelines do not apply to establishments engaged in the provision of disinfection services outside pest control.
G. A PCO establishment shall secure an LTO for the Main Office. In addition, a PCO establishment may simultaneously apply for an additional single Branch Office through major variation filed with the initial application. An inspection will be conducted by the FDA as part of the major variation application of the PCO establishment.
H. A PCO establishment with a main office and multiple branch offices may file an application to secure a single LTO from the FDA; Provided, that it is considered a single establishment er go a single legal entity; Provided, further, that the branch offices perform the same activity licensed under the LTO; Provided, lastly, that all branch offices and their corresponding addresses are declared in the LTO application and, if applicable, in subsequent major variation applications. The LTO, including the specific page bearing the address of the branch office, shall be displayed conspicuously in the PCO Establishment and in every branch office.
I. PCO establishments, including all its branch offices, if any, shall be under the supervision of a Supervising Pesticide Handler (SPH) having the credentials as prescribed in DOH AO No. 2019-0010, and its future amendments. The SPH shall be considered as the Qualified Person of the PCO establishment.
J. PCO establishments, including its branch offices, shall be subject to inspection and monitoring by the FDA Regional Field Offices (RFOs) in accordance with existing FDA rules and regulations.
K. PCO establishments, including its branch offices, shall continuously comply with existing FDA laws, rules and regulations.
V. SPECIFIC GUIDELINES
A. Application for Initial Issuance of License to Operate
1. Applications for the initial issuance of LTO as PCO establishment shall be submitted through the FDA Application System.
2. A Username and Password shall be secured in order to access the FDA Application System.
3. Upon accessing the FDA Application System, the following steps relative to the LTO application shall be accomplished:
a. Accomplishment of the Application Form embedded in the FDA Application System:
i. General Information
ii. Establishment Information
iii. Establishment Address for the following:
1. Main Office
2. Branch Office(s), if any
3. Warehouse/Storage Facility(ies)
iv. Name and information of the following personnel:
1. Authorized Representative
2. SPH or Qualified Person
3. PH or Other Technical Personnel
v. Upload of Documentary Requirements
4. All applications shall be deemed filed upon recorded payment of required fees and charges.
B. Requirements for the Initial Issuance of License to Operate
1. PCO establishments, including its branch offices, shall be required to have a physical office, warehouse, and storage facility. Virtual offices shall not be allowed.
2. PCO establishments shall submit the documentary requirements for the issuance of LTO as specified in Annex B of DOH AO No. 2019-0010, and its future amendments. Particularly for government agencies and government owned and controlled corporations, the requirements provided in Section VI.E. of DOH AO No. 2019-0010 shall also be submitted.
3. PCO establishments shall be supervised by a Qualified Person who is an FDA-certified SPH and shall employ FDA-certified Pesticide Handlers (PH).
However, in the absence of availability of FDA-accredited trainings for SPH and PH, the PCO establishment shall submit copies of any proof of attendance to training/s of their SPH and PH related to household/urban pest management issued by: (1) the Fertilizer and Pesticide Authority (FPA) following FDA Circular No. 2016-008; or (2) any reputable organizations within the last five (5) years from issuance of this Circular, in lieu of the required copy of ID of FDA-certified SPH and PH.
Further, subject to the issuance of the implementing guidelines on the certification of SPH and PH and the accreditation of training providers for SPH and PH, the PCO establishment shall ensure that its SPH and PHs receive the prescribed trainings and secure the appropriate certifications as a condition of its LTO.
4. Pest control operators shall have at least one (1) regularly employed FDA-certified supervising pesticide handler and one (1) in every branch office, if any. However, subject to satisfactory evaluation of the application and/or the inspection or audit of the pest control operator, the FDA may allow a pest control operator to employ less than the required number of supervising pesticide handlers to handle the main office and its branch offices, if any; Provided, that the supervising pesticide handlers and pest control operator remain to sufficiently fulfil their responsibilities under these Guidelines.
C. Pre-Assessment of Application
All applications for LTO as PCO establishment shall be preliminarily assessed for completeness of submitted documentary requirements. An incomplete submission shall not be accepted and the application shall not proceed to payment.
D. Evaluation of Application
Upon successful submission of the application and completion of the payment of fees and charges, a technical evaluation to review the veracity of the application, completeness and correctness of the documentary requirements submitted, and the compliance with administrative and technical standards shall be conducted by the FDA.
E. Inspection of PCO Establishment
1. Inspection of PCO establishment, including all its branches, shall be conducted prior the issuance of an LTO and/or applicable variations to the LTO, wherein further verification of compliance to documentary requirements and an assessment of the compliance to applicable standards of the PCO establishment shall be checked/audited.
2. The parameters for inspection are prescribed in Annex A of this Circular.
3. The PCO Establishment shall be subject to post-licensing inspections and Post Marketing Surveillance (PMS) of the FDA during the duration of the validity of its LTO to determine its satisfactory and continuous compliance to FDA standards, rules, and regulations.
The period for reinspection shall be determined by the FDA, wherein a Certificate of Compliance following a satisfactory reinspection shall be required for any coinciding application for the renewal of the LTO of a PCO Establishment.
F. Decision on Application
1. The appropriate authorization shall be issued to an application that has satisfactorily complied with all applicable requirements and standards.
2. Any of the following or similar instances shall be a ground for disapproval, revocation, or suspension of the application or license:
a. The documentary requirements submitted show that the establishment does not meet the required technical requirements and/or appropriate standards;
b. The applicant made misrepresentations, false entries, or withhold any relevant data contrary to the provisions of the law or appropriate standards;
c. The owner has violated any of the terms and conditions of its license; and
d. Such other analogous grounds or causes as determined by the FDA.
3. Applications disapproved shall be without prejudice to filing of a new application if the grounds or basis of disapproval of the original application no longer exists. However, the disapproval of application shall mean outright forfeiture of payment.
4. Nothing in this section shall restrict the FDA in imposing the penalty of suspension, revocation, or cancellation of license for administrative violations of any other relevant laws or their IRR.
G. Validity of License to Operate
The validity of the LTO shall follow the provisions stipulated in DOH AO No. 2019-0010.
H. Renewal and Variation of License to Operate
1. Application for renewal shall be done within ninety (90) days prior to the expiration of the validity of the LTO.
Applications filed after the validity date of the LTO shall be subject to a surcharge or penalty equivalent to twice the renewal fee and an additional 10% per month or a fraction thereof of continuing non-submission of such application to a maximum of one hundred twenty (120) days. Any application for LTO renewal filed after the 120-day period shall be considered expired and the application shall be subject to a fee equivalent to the total surcharge or penalty plus the initial filing fee and the application shall undergo the initial filing and evaluation procedure. Further, CCHUHSRR shall take other regulatory actions as warranted.
2. In filing renewal and variation applications, the following shall be observed:
a. No application for variation of LTO shall be done when an establishment has a pending application for renewal of LTO, or vice versa.
b. Multiple variation applications may be accepted in a single filing containing different types of variation applications, provided, however, that it contains only one (1) major variation application. A single filing cannot contain more than one (1) major variation application.
c. A filed application must be completed until the issuance of the decision on the said application, before a new application can be accepted.
d. Variation applications shall only be applied within the validity period of the LTO. The validity of an LTO with approved variations shall remain the same and will not be extended.
3. PCO establishments shall submit the documentary requirements for the renewal or variation of LTO as specified in Annex B of DOH AO N o. 2019-0010, and its future amendments through the FDA Application System.
4. Variation applications shall be classified according to the requirement for inspection prior approval as presented in the table below. Variation applications requiring prior inspection shall be referred to as ‘major variation’, while those not requiring prior inspection shall be referred to as ‘minor variation’.
|Type of variation||Classification|
|Addition of Branch Office||Major|
|Transfer of location of the Main Office or any of the branches||Major|
|Transfer/Addition of Warehouse||Minor|
|Change of Ownership||Minor|
|Change of Business Name||Minor|
|Zonal Change in Address||Minor|
|Change of FDA-certified SPH||Minor|
|Additional activity (disinfection services)||Minor|
|Recategorization (exterminator, fumigator, exterminator/ fumigator)||Minor|
I. Processing Time
Applications shall be processed in accordance with the approved FDA Citizen’s Charter.
J. Fees and Charges
Applications shall be charged with the fees pursuant to the schedule of fees specified in Annex E of DOH AO No. 2019-0010, and its future amendments.
K. Post-marketing Surveillance (PMS)
PCO establishments, SPH and PH shall be subject to PMS activities of the FDA. Appropriate regulatory actions shall be imposed upon erring establishments, or individuals.
L. Standards Applicable for PCO Establishments, SPH, and PH
1. PCO establishments, SPH and PH shall ensure compliance to applicable standards, as prescribed in Annex B of this Circular.
2. Specific conditions, and requirements applicable for PCO Establishments, SPH and PH are prescribed in Annex C of this Circular.
3. The FDA shall continuously develop, issue and update the standards applicable for PCO establishments, SPH, and PH.
M. Responsibilities of PCO Establishments, SPH and PH
All PCO establishments, SPH, and PH shall be responsible for ensuring the safe conduct and execution of their pest control activities. The responsibilities of PCO establishments, SPH and PH are summarized in Annex D of this Circular.
N. Prohibited Acts
The following activities shall be prohibited:
1. The operation of a PCO without a valid authorization from the FDA.
2. The conduct of pest control activities by personnel other than the SPH and PH duly-certified by the FDA.
3. The use of unregistered household pesticide products and other unauthorized non-pesticide products which are under the jurisdiction of the FDA.
4. Failure to comply to the specific conditions and requirements for a PCO establishment.
5. Failure to fulfil the responsibilities of the PCO Establishment, SPH, and/or PH.
6. Other prohibited acts that pose threat to the safety, quality and efficacy of the health product, as provided for by RA 9711, DOH AO No. 2019-0010, and other relevant regulations.
VI. TRANSITORY PROVISIONS
A. The FDA shall make the application process for LTOs for PCO Establishments upon the effectivity of this Circular.
B. All covered establishments are directed to proceed with the completion of the documentary requirements and consequently lodge their applications for the issuance of LTO.
C. A two-year transitory period starting upon effectivity of this Circular, however, shall be provided to allow affected stakeholders to fully and completely comply with all the provisions set forth in DOH AO No. 2019-0010, this Circular, and their future amendments.
1. The first six (6) months of the transitory period shall serve as the pilot implementation for FDA Application System. The covered areas or regions for the said pilot implementation shall be communicated through an FDA Advisory.
At the end of the pilot implementation or earlier, based on a satisfactory assessment of the said pilot implementation, a full implementation will be commenced similarly announced through an FDA Advisory.
2. The transitory period shall serve as moratorium period where no other public or private establishment shall require any FDA LTO prior to the conduct of Pest Control Operations, while covered establishments are in the process of complying with the new guidelines. CCHUHSRR, in coordination with the FDA RFOs, shall conduct the necessary dissemination campaigns and trainings for external stakeholders. Additionally, the FDA RFOs shall coordinate with Local Government Units to coordinate in the implementation of these Guidelines.
3. The required inspection prior the issuance of the initial LTO of a PCO Establishment, including already existing branch offices, during the transitory period is waived for the purposes of the issuance of the said authorization. Upon the renewal of LTOs, an inspection prior renewal shall be required to determine satisfactory compliance to these Guidelines.
4. As a general rule, PCO establishments shall have an SPH each in the main office and in every branch office, if any. However, during the transitory period and subject to satisfactory evaluation of the application and/or the inspection or audit of the PCO establishment, the FDA may allow a PCO establishment to employ less than the required number of SPHs to handle the main office and its branch offices; Provided, that the SPH remains to sufficiently carry out his/her duties and responsibilities as provided in Annex D of this Circular; Provided, further, that there shall be a Standard Operating Procedure providing for the in-person and remote supervision of pest control activities in multiple branches, in order to ensure that the SPH is able to directly supervise all pest control activities of the PCO establishment, which shall be submitted as part of its LTO application and reviewed upon inspection.
D. Further, the FDA is not precluded from instituting regulatory flexibility in implementing the provisions of this issuance, in light of declaration of public health emergencies, or similar situations, as deemed necessary.
VII. PENALTY CLAUSE
Any person found in violation of this Circular shall be deemed a violation of Republic Act No. 3720 as amended by Republic Act No. 9711 and shall be penalized accordingly following the Uniform Rules of Procedures laid down under Book III of the Implementing Rules and Regulations of Republic Act No. 9711.
VIII. REPEALING CLAUSE
All administrative issuances, department circulars and memoranda and other regulations inconsistent with this Circular are hereby withdrawn, repealed and/or revoked accordingly.
IX. SEPARABILITY CLAUSE
If any part, term of provision of this Circular shall be declared invalid or unenforceable, the validity or enforceability of the remaining portions or provisions shall not be affected and this Circular shall be construed as if it did not contain the particular invalid or unenforceable part, term, or provision.
This Circular shall take effect on 2 January 2023 subject to publication in a newspaper of general circulation and filing with the University of the Philippines Office of the National Register (UP-ONAR).