How to Obtain an FDA LTO for Animal Feeds with the BAI

August 20, 2024

Seal of the Bureau of Animal Industry with agricultural symbols within a green circle.

In the Philippines, securing a License to Operate (LTO) for animal feeds through the Bureau of Animal Industry (BAI), in coordination with the Food and Drug Administration (FDA), is a mandatory step for businesses involved in manufacturing, distributing, or importing animal feed products, ensuring compliance with stringent safety and quality standards to protect animal and public health. This comprehensive guide outlines the detailed process, requirements, and post-licensing steps for obtaining an LTO for animal feeds, tailored to help businesses navigate the regulatory landscape efficiently. With clear steps and expert insights, this article, crafted for Triple i Consulting, provides a roadmap for compliance, leveraging the firm’s expertise to streamline the complex process.

Why an LTO for Animal Feeds Is Essential

The LTO for animal feeds, issued primarily by the BAI with FDA oversight for certain veterinary products, serves as a cornerstone for regulatory compliance in the Philippines’ livestock, poultry, and aquaculture industries. It ensures that feed products meet safety and quality standards, safeguarding animal health and, by extension, public health. Below are the key reasons why obtaining an LTO is vital:

Ensures Regulatory Compliance: The LTO confirms that a business adheres to Republic Act No. 1556 (Livestock and Poultry Feeds Act) and related regulations, avoiding penalties or business suspension.
Protects Animal Health: Compliance with BAI and FDA standards ensures feeds are free from harmful substances, promoting animal welfare.
Safeguards Public Health: Safe feeds reduce the risks of foodborne illnesses in humans consuming animal-derived products.
Facilitates Market Access: An LTO is a prerequisite for legally manufacturing, distributing, or importing feeds, enabling market entry.
Builds Consumer Trust: Licensed businesses demonstrate commitment to quality, enhancing credibility with customers and stakeholders.
Supports Industry Standards: The LTO aligns with national efforts to maintain high standards in the growing animal feed sector.

Prerequisites for Obtaining an LTO for Animal Feeds

Before applying for an LTO for animal feeds, businesses must meet specific prerequisites to ensure eligibility and compliance with BAI and FDA requirements. These foundational steps prepare applicants for a smooth application process. The following are the essential prerequisites:

Registered Business Entity: The business must be registered with the Securities and Exchange Commission (SEC) for corporations or partnerships, or the Department of Trade and Industry (DTI) for sole proprietorships.
Compliant Facilities: Manufacturing or storage facilities must meet BAI standards, including proper sanitation, ventilation, and equipment.
Qualified Personnel: A licensed agriculturist, veterinarian, or chemist must be employed or contracted to oversee operations and ensure compliance.
Environmental Compliance Certificate (ECC): Issued by the Department of Environment and Natural Resources (DENR), this certificate verifies environmental compliance for manufacturing facilities.
Mayor’s Permit: A valid business permit from the local government unit where the facility operates is required.
Facility Floor Plan: To demonstrate compliance with BAI standards, a detailed layout of the facility, including storage and production areas, must be submitted.
Joint Affidavit of Undertaking: A notarized affidavit signed by the business owner and licensed professional, committing to regulatory compliance, is mandatory.
BAI-Laboratory Recognition Certificate: For manufacturers using external laboratories, a BAI-accredited lab certificate is required for product testing.

Step-by-Step Process to Apply for an LTO for Animal Feeds

The application process for an LTO for animal feeds involves multiple steps, primarily managed through the BAI’s Registration Trade System, with certain aspects coordinated with the FDA. This structured process ensures a thorough evaluation of applicants. Below are the steps to follow:

Prepare Required Documents: Compile all necessary documents, including SEC/DTI registration, Mayor’s Permit, ECC, facility floor plan, Joint Affidavit, and BAI-Laboratory Recognition Certificate (if applicable).
Access the BAI Registration Trade System: Register and submit the application through the Department of Agriculture’s Trade System, uploading all required documents in the specified format.
Pay Application Fees: Fees are settled based on business type: PHP 450–720 for commercial feed manufacturers (depending on production capacity), PHP 480 for importers/exporters, or PHP 60 for retailers.
Undergo Facility Inspection: Schedule and facilitate a BAI inspection to verify compliance with facility standards, typically completed within 10 days.
Await Application Review: The BAI reviews the application and inspection results, coordinating with the FDA for veterinary drug-related feeds if necessary.
Receive LTO Approval: Upon approval, the LTO is issued, valid for one to five years, depending on the business category. Notification is sent via the Trade System or email.

Post-LTO Requirements for Animal Feed Businesses

After securing an LTO for animal feeds, businesses must fulfill additional regulatory requirements to operate and market their products fully. These steps ensure ongoing compliance and product safety. The following are the key post-LTO requirements:

Obtain Certificate of Feed Product Registration (CFPR): Each feed product must be registered with the BAI, requiring submission of BAI-AFVDBCD Form No. 2, a Certificate of Analysis from a BAI-accredited lab, product label, and proof of payment.
Secure Sanitary and Phytosanitary Import Clearance (SPS-IC): For imported feeds, submit BAI-AFVDBCD Form No. 3, proforma invoice, Certificate of Analysis from the country of origin, and import permit application.
Maintain Compliance Records: Keep detailed production, testing, and distribution records for BAI or FDA audits.
Renew LTO Timely: Monitor the LTO validity period (one to five years) and initiate renewal at least 60 days before expiration to avoid disruptions.
Comply with Labeling Standards: Ensure all feed products meet BAI and FDA labeling requirements, including ingredient lists, nutritional content, and manufacturer details.
Conduct Regular Quality Checks: Perform ongoing testing through BAI-accredited laboratories to ensure consistent product quality and compliance.

Navigating Recent Regulatory Changes for LTO Compliance

Recent regulatory shifts, particularly FDA Memorandum Circular 2024-001 and BAI Memorandum No. 01-06 s. In 2024, the BAI and FDA clarified the division of responsibilities between them, impacting the LTO process for animal feeds. Understanding these changes is essential for compliance. Below are the key updates and their implications:

BAI’s Primary Role: The BAI retains primary authority for issuing LTOs for animal feed establishments, covering manufacturers, distributors, and importers.
FDA Oversight for Veterinary Products: The FDA now regulates LTOs and Certificates of Product Registration for veterinary drugs and certain livestock feed products, requiring coordination for specific applications.
Transition for Existing LTOs: Businesses with BAI-issued LTOs expiring in 2024 or later may need to reapply with the FDA for products under its jurisdiction, such as medicated feeds.
Updated Application Systems: The BAI Registration Trade System and Intercommerce Network Services streamline LTO and product registration processes, requiring applicants to use these platforms.
Enhanced Documentation: Additional requirements, such as ECCs and Joint Affidavits, reflect stricter compliance standards introduced in recent regulations.
Fee Adjustments: Fees remain consistent (e.g., PHP 450–720 for manufacturers), but businesses should verify current rates through the BAI Trade System.

Given the complexity of these regulatory changes and the intricate application process, partnering with an experienced consultancy like Triple i Consulting is highly recommended. The firm’s expertise in navigating BAI and FDA requirements, combined with its ISO 9001:2008 certification, ensures businesses can efficiently secure and maintain their LTO for animal feeds, avoiding costly delays or non-compliance.

Key Takeaways

Securing an LTO for animal feeds through the BAI, with FDA coordination for specific products, is vital for businesses in the Philippines’ animal feed industry to ensure compliance, protect animal and public health, and access the market. Companies can operate legally and confidently by meeting prerequisites, following the application process, fulfilling post-LTO requirements, and staying updated on regulatory changes. The process, while detailed, is achievable with proper preparation and expert guidance. Triple i Consulting, a trusted provider of regulatory compliance services, offers tailored support to simplify this journey, ensuring businesses meet all requirements efficiently.

Is Assistance Available?

Yes, Triple i Consulting provides expert guidance to navigate the complex FDA LTO for animal feed processes. Contact us today to schedule an initial consultation with one of our experts: