FPA Pesticide Licensing & Regulations

• The discussion is compiled from several FPA documents (IRR, Manual and Charter).
• The purpose is a cohesive and aligned understanding of the topic.

Legal and Implementing Rules

• The FPA's Citizen Charter 1st edition (2021) regulates pesticide handlers, dealers & pest control operators by licensing to ensure safety in handling and use of pesticides.
• PD 1144 and Sections 1 and 2 of Article III of the FPA Rules and Regulations No. 1, Series 1977 state a license is needed to import, manufacture, formulate, export, repack, distribute, store or sell any pesticide.
• A separate license is required for each establishment or place of business.
• All commercial applicators of pesticides need to apply for a license and obtain a commercial applicator's license with an assigned license number before performing services.
• Each commercial applicator must obtain a license for each place of business in the Philippines.

Requirements and Procedure

• The FPA Operations' Manual (2022) highlights product quality and adherence to safety.
• The FPA designs and implements quality control standards for fertilizer and pesticide products, monitors safe handling, use, application, and compliance with industrial health and safety in manufacturing and formulation plants, and imposes penalties for violations.
• Local companies registered with the SEC and licensed by FPA and local subsidiaries of any foreign-based pesticide company can avail.
• Foreign suppliers or companies registered under the SEC as regional liaison offices are not allowed to apply for this service.
• Companies operating in the Philippines under Presidential Decree No. 218 are not allowed to apply for this service.
• Applicants should have already submitted a complete application for a license as pesticide manufacturer, formulator, extruder, repacker, and/or importer-end-user/institutional user.
• Applicants have to comply with the Occupational Health and Safety requirements of FPA and will be subject to inspection by the FPA Pesticide Audit Team.

Standards and Policies

• Formulation and packing are important processes in the production and distribution of pesticides that ensure the quality and stability of the product.
• The section describes the standard and requirements for the safe manufacture of pesticides particularly with regards to formulation and packing, as well as the health/safety and environmental aspects.

Common Types of Formulation

• Liquid Formulation: Materials are pre-weighed and charged into a mixing tank and blended for at least 30 minutes to attain a homogenous mixture.
• Powder Formulation: Materials are pre-weighed and charged into a ribbon-type blender with blending for about 20 minutes, depending on the batch size.
• Product pulverization to finer particles is done by milling if the specifications require it.
• Granular Formulation: Carriers are pre-weighed and charged first into the mixer before the liquid technical materials are sprayed inside with the rest of the materials mixed to coat and dry the granules.

Common Equipment Used in Formulation

• Liquid Formulation Equipments: Weighing Scales, Pneumatic Pumps, Blending/Mixing Tanks, Storage Tanks, Sandmill (Optional), Cooling/Heating Equipment (Optional).
• Wettable Powder Formulation Equipments: Weighing Scales, Ribbon Blenders, Pulverizing Equipment (Optional), Dust Collector, Bucket Elevators (Optional), Storage Bins/Hoppers, Densifiers (Optional).
• Granular Formulation Equipments: Weighing Scales, Munson Blender, Bucket Elevators, Storage Bins/Hoppers, Extruder for extruded dry formulations, Dryers granules.

Common Types of Packing

• Liquid Packing: Placing liquid formulated materials in suitable containers like glass bottles, plastic bottles/jugs, tin cans, or plastic/steel drums.
• Powder Packing: Placing powder-formulated materials into polyethylene bags, polypropylene sacks, paperboard boxes, fiber drums, etc.
• Granular Packing: Placing granular formulated materials into polyethylene bags, paper bags, corrugated cartons, fiber drums, etc.

Safety, Health, and Environmental Aspects - Facilities

• General Ventilation: Buildings should be well-ventilated to provide agreeable working conditions, with vents placed in the roof, walls, and near the floor.
• The system shall not remove toxic dusts or fumes.
• Local Exhaust (Source) Ventilation: It is the only effective way of stopping harmful dusts and fumes from being released into the workplace.
• The intake to the ventilation system shall be placed as close as possible to the source of the contamination.
• All sources should be enclosed as far as possible.
• Room Ventilation: Room ventilation is used where equipment cannot be ventilated locally.
• The source of contamination must be between the operator and the point of extraction with all openings reduced to a minimum.
• Emission Control: Discharged air from ventilation used to control dust sources must be filtered and vapors/odors may require specific treatment.
• Lighting: The plant must be sufficiently lighted (natural or artificial) to permit safe operation.

Electrical Equipment

• All electrical equipment (including electrically driven forklift trucks) used in plants handling flammable materials must be approved from a fire-safety viewpoint and maintained to a safe standard.
• Permanent electrical installations shall be used whenever possible and flexible electrical leads should be kept short.

Formulation and Filling Equipment

• Liquids (Fire-explosion Precautions): Electrical equipment near formulation and filling units must not produce sparks.
• Naked flames and spark-producing tools/accessories are prohibited without the plant manager's approval.
• All equipment must be adequately earthed with bonding straps or cables, including drums during emptying/filling.
• Charge build-up should be minimized by using dip-pipes.
• Powders being loaded into vessels containing flammable liquids, especially from conductive containers, pose a risk and loading should be done slowly from an earthed conducting container.
• Solids (Fire/explosion Precautions): Equipment must be protected with explosion suppression/venting/inert-gas-blanketing systems if the PDS states that a solid product presents a dust explosions hazard.
• Specialist’s advice must be sought.
• All equipment parts must be earthed using earth-bonding straps.

Industrial Hygiene Precautions

• Exhaust ventilation with a minimum air velocity of 0.5 m/sec must be provided at charging and discharging points.
• Empty packaging material should be collected carefully in a container to minimize dust in the working area.
• Filling and Packing Equipment: It shall be equipped with local exhaust (source) ventilation with a minimum air velocity of 0.5 m/sec/
• Liquid filling equipment shall be free of leaks and have a guard to prevent splashing on to operators, plus a collection container for drips and spills.
• All filling machines shall automatically close when de-energized.
• Filling and packing machines have protective guards to prevent fingers or clothing being caught.

Operational Procedures

• General:
  • Operations within the formulation and packing plant shall be closely supervised by a trained and experienced supervisor.
  • Area and line of responsibility shall be clearly defined and understood among several supervisors.
• Working instructions and procedures: The following written instructions and working procedures shall be readily available to the supervisor:
• Instructions for safe and correct operation of the equipment
• Formulation recipe, blending and packing procedures
• Product Data Sheets for ingredients and finished products
• Hygiene and safety instructions and procedures
• Equipment cleaning procedures
• Training: All personnel working in the formulation and packing plant shall be trained thoroughly when starting and regular training programs shall be held to prevent development of bad working practices.
• Safety and hygiene practices shall be part of the regular training program.
• Constraints:
  • Pesticides should not be formulated/packed in equipment also used for human/animal products like foodstuffs or cosmetics.
  • If non-pesticide products like brake fluids are blended in the same equipment, precautions should be taken for cross-contamination.
• Hygiene and Safety:
  • The supervisor must check that all necessary plant hygiene and safety equipment, such as exhaust ventilation equipment are operational.
  • He must ensure that operators are wearing the necessary personal protective equipment and that re-used equipment is properly cleaned and inspected.
  • The working area must be in a condition that permits safe working, without being crowded by containers.
  • Workers should avoid all contact with products, and must remove contaminated clothing, wash skin, and treat following PDS instructions.
• Formulation and Filling Procedures:
  • Strict precautions shall be taken to prevent cross-contamination.
  • An effective system shall be adopted followed for identifying the correct ingredients required by the recipe with strict procedures for dosing.
  • Accurate records shall be kept for batch/lot numbers and ingredient weights of each formulated product batch with regular product checks for quality and a established reference sample system.
  • The filling and packing of pesticides can be one of the most hazardous operations in a pesticide formulation and packing plant.

Packaging Materials

• Packaging materials are the standards and requirements for packaging materials.

Packaging Standards

• A packaging standard line
  • Formulation: Liquids
  • Packaging size: Small and Large
  • Packaging unit: Bottles, Canisters and Large Barrels
  • Formulation: Liquids
  • Packaging size: Small and Large
  • Packaging unit: Bottom Bags, Sacks and Drums
• UN Performance Tests on Packaging includes any packaging material for pesticide.
  • The main objectives of the UN performance test are to make transport of products feasible, ensure safety of people, property and environment and to generate data for use as a guide in the formulation of harmonized laws and regulations.
  • There are three (3) types of tests conducted on packaging: Material and Packaging Testing.
  • The objective is to determine the packaging design and specifications.

Examples of materials being tested for packaging are

• Metal
• Lacquer
• Plastic
• Paper and cardboard
• Packaging testing include water absorption of corrugated cardboard boxes
• Stress crack corrosion on PE-canisters and lacquer quality on iron steel drums
• Compatibility Test and are conducted to determine if packaging will be able to store its content under different conditions and for a certain minimum length of time
• Main tests include loss of content and water content loss.
• The other tests are weight loss or gain, the appearance of the packaging and the appearance of the closure
• Performance Test includes the Drop test, Leak proofness test, Hydraulic pressure test and Stacking test.

Regulatory Requirements for Pesticide Containers

• Packaging containers and related outer packaging shall comply with all national standards and regulations which apply to packaging.
• Pesticides shall only be packaged in containers designed to provide protection against product deterioration, compaction, weight change or any other form of spoilage.
• The container shall be able to withstand all anticipated levels of handling, storage, stacking, loading and unloading conditions, and shall not be adversely affected by changes in atmospheric conditions such as pressure, temperature and humidity.
• The inner surface of the container or closure may be coated or lined with substances or materials resist corrosion and to be inert toward the contents.
• The outer surface of the container shall be made of or be coated with materials which resist corrosion or other forms of deterioration and are suitable for direct label printing or the attachment of a printed label.
• The shelf life of the container and its contents shall not be less than two (2) years and the "best before date" (month, year) shall be clearly indicated on the label..
• Containers of a specific design which have been tested and qualified for a particular product shall be retested if they are used for another product, or with a new formulation of the same product.
• Used containers or reconditioned packaging shall only be reused when its quality has been tested to be equal to that of the original packaging.

Filling pesticide containers

• Strict quality control shall be instituted in the container filling sites to maintain the high standard of the pesticide containers and its contents.
• All liquid containers shall have a headspace of at least 5%.

Types and Specifications of Pesticide Containers

• Inside Containers are defined as those, which require an overpack to provide protection during shipment, handling and storage.
• Examples are bags containing not more than 10 Kg, bottles containing not more than 1 Kg or 1 L and metal containers containing not more than 10 Kg or 2 L.
• Overpacks are defined as containers, such as boxes or cartons, which provide essential levels of protection to one or more inside containers.
• Bulk containers are defined as rigid wall packages which may be metal, polyethylene or fiber drums or heavy duty corrugated paper boxes.
• Drums containing not more than 250 Kg or 200 L.

Selection of Appropriate Pesticide Containers

• Solid Products include small packages, usually up to 3 kilos capacity, from ready made packaging.
• Examples are bags, pouches, canisters, cans, glass or plastic jars which have closures in order to prevent leak.
• Liquid Products include small containers size up to 5 liters capacity from available stock packaging of standard varieties and drums manufactured from steel and plastic.
• Large liquid containers are typically sized between 10 to 200 liters capacity.
• Liquid shall always be packed in containers with closed heads and heads drums should be seamed or welded onto the body.
• Pressure Packages include containers will contain the contents under pressure at ambient, be packaged in containers designed to be pressure resistant, and gauge of the metal used for the body and heads.
• Overpacks are used to hold one (1) or more containers together and are constructed from film bags, shrink wrappings, paper bags or corrugated boxes and can protect the side containers.
• Closures in rigid containers should be the right selection to ensure successful packaging of containers and are closures for liquid containers should be determined by the rate of pour required and the viscosity of the formulation.

Testing of Pesticide Containers

• The performance of tests on containers is a useful means of determining the probability of the container providing the level of protection in these Container Requirements and Standards.
• Test procedures can be developed with varying levels of complexity, depending on the facilities and personnel available.
• The determination of successful pesticide packaging can usually be done by means of practical procedures.
• In safety, The 2 common problems are User Safety and Environmental Safety.
• Present Trends in Pesticide Packaging are selecting Packaging materials increasing in ease of disposal in order to help the environments.

Innovation to reduce exposure include

• Squeeze Bottle On or Squbo to reduce risk of contamination
• Water Soluble Bag or WSB in gel form to minimize risk of exposure since the user only handles the bag