regulatory Framework for Mariculture Projects in Puerto Rico

US COAST GUARD (USCG)

Division / Office Purpose

Waterways Management Manages the safe and efficient use of navigable waters.

Outcome / Result Synergy with Other Agencies

Letter of No

Objection / Permit (e.g., PATON)

USACE & NOAA: Ensures structures do not obstruct federal navigation channels.

Timetable & Application Fee

Timetable: 30 – 90 days. Fee: None.

Aids to Navigation (ATON)

Establishes and maintains markers for safe transit.

Marine Safety / Port State Control Inspects commercial vessels and facilities for safety compliance.

Private Aids to Navigation (PATON) Approval

DNER: Coordinates the placement of markers for mariculture leases in local waters.

Inspection Report / Safety Certificate EPA & Dept. of Health: Verifies facility safety and pollution prevention measures.

Timetable: 30 – 60 days. Fee: None.

Timetable: 14 – 30 days. Fee: Varies by inspection type.

US FISH AND WILDLIFE SERVICE (USFWS)

Division / Office Purpose

Ecological Services (ES) Reviews projects for impacts on threatened and endangered species.

Outcome / Result Synergy with Other Agencies

ESA Section 7

Consultation / BiOp

Office of Law

Enforcement (OLE) Regulates the legal trade and movement of wildlife species.

Migratory Bird Program Protects bird species that may interact with coastal aquaculture.

NMFS & USACE: Jointly manages species that transition between fresh and salt water.

Import/Export License & Permit Customs (CBP) & Dept. of Ag: Inspects shipments of non-native or protected aquatic species.

Technical Review / Depredation Permit

Fisheries & Aquatic

Conservation Focuses on the restoration of native fish and aquatic health.

Coastal Program Works on voluntary habitat restoration and protection in coastal areas.

Technical Assistance / Inter-agency Review

NOAA & DNER: Evaluates site selection to prevent interference with nesting or foraging grounds.

EPA & State Agencies: Provides data for Fish and Wildlife Coordination Act reviews.

Conservation Agreement / Technical Support Planning Board: Ensures projects align with regional coastal resilience and habitat goals.

Timetable & Application Fee

Timetable: 90 – 135 days. Fee: None (Federal consultation).

Timetable: 30 – 60 days. Fee: $100 – $250.

Timetable: 60 – 90 days.

Timetable: Variable (60 –120 days). Fee: None.

Timetable: 30 – 90 days. Fee: None.

NATIONAL OCEANIC AND ATMOSPHERIC AGENCY (NOOA)

• Role: Lead advisor on habitat conservation and protection of endangered species.

• Requirements:

o Essential Fish Habitat (EFH) Consultation: Assessment of impacts on managed fishery habitats.

o Endangered Species Act (ESA) Section 7 Consultation: Required if the project area overlaps with sea turtles, corals, or marine mammals.

o Marine Mammal Protection Act (MMPA) Compliance.

• Estimated Processing Time:

o Informal Consultation: 30 to 60 days.

o Formal Consultation: 135 days or more if integrated into the USACE/EPA permit timeline.

FOOD AND DRUG ADMINISTRATION (FDA)

Service / Area Regulatory Procedure

Product Processing Seafood HACCP (21 CFR Part 123)

Primary Requirements

Facilities must develop and implement a written Hazard Analysis Critical Control Point plan to manage biological, chemical, and physical hazards.

Facility Oversight Food Facility Registration

Medication (Drugs)

New Animal Drug Application (NADA)

Domestic and foreign facilities that process, pack, or hold food for U.S. consumption must register with the FDA.

All drugs used for fish must be FDA-approved. Sponsors must provide data on animal safety, effectiveness, and human food safety (residues).

Medicated Feed Veterinary Feed Directive (VFD)

Most antibiotics administered via feed require a written order from a licensed veterinarian.

Minor Species Use MUMS Act (Indexing)

Provides pathways for legal marketing of drugs for "minor species" (including many fish) without a full NADA, if the drug is for non-food use or has a low regulatory priority.

Category

SUMMARY OF THE REGULATORY PROCEDURES IN PR

Regulatory Matrix: Procedures by Project Phase and Scope

Regulatory Requirement / Procedure

Project Goal Research (Scientific Permit), Pilot (Limited Term), or Commercial (Full Lease)

Cultured Species Native (Stocking Permit) vs. Imported (Quarantine & USDA Certification)

Inland Hatchery Land-use permits, water extraction, and discharge management

Oversight Agency

DNER (PR) / NOAA

DNER / USDA / USFWS

OGPe (PR) / EPA

Nursery Phase Health certifications and biosecurity protocols Dept. of Agriculture / USDA

Grow-out: Water Column

Use of water column (non-bottom contact) permits

USACE / DNER

SUMMARY OF THE REGULATORY PROCEDURES IN PR

Regulatory Matrix: Procedures by Project Phase and Scope

Category Regulatory Requirement / Procedure Oversight Agency

Grow-out: Submerged Land

System (Pens/Cages)

Feeding Procedures

Navigable Waters

Harvest & Processing

Long-term leases for bottom-set cages or shellfish beds

Structural integrity and "Notice to Mariners" for floating structures

DNER

USACE / USCG

Feed source approval and nutrient load monitoring EPA (NPDES)

Section 10 Permits for obstacle-free maritime transit

HACCP certification and sanitary inspections

Distribution Commercial licenses and export documentation

USACE / USCG

Dept. of Health / FDA

Dept. of Treasury / Dept. of Ag

CONCLUSION AND RECOMMEDATIONS

▪ Establish a Lead Permitting Agency

Designate a single point of contact within to synchronize local and federal reviews.

▪ Pre-identify Aquaculture Opportunity Areas

Use marine spatial planning to identify specific zones for mariculture, Reduce time individual site assessment.

▪ Implement Unified Electronic Dashboards

Expand the use of digital portals like Puerto Rico’s Single Business Portal (OGPe) to (all state and federal agencies)

▪ Academic and Regulatory Collaboration

Scientific research serves as:

A critical foundation for informed decision-making,

To identify viable mariculture zones.

To integrate findings into regulatory framework, agencies can streamline the spatial planning process.

ACKNOWLEDGMENTS

Nilda Jiménez, Ph. D, Coordinator of Endangered Species Program, DNER

Ricardo López, Ph. D., Director of Fisheries Research Lab DNER

Biol. Javier Ramos Ortiz, Division of Maritime Public Domain and Water, DNER

Luz Remus, Ph. D. Subordenadora de la Industria de la Pesca Comercial, PRDA

Deborah Cedeño Maldonado, Senior Project Manager,Regulatory Branch USACE

José A. Rivera, NOOA, Fisheries

Arq. Marel del Toro-Cabrera, PR Historic Preservation Office

John Farchette

Carlos Farchette, Chair CFMC

Nichole Angeli, Ph. D., Director of Fish and Wildlife, USVI DPER

Sennai Habbers, Ph. D. Bureau Chief Fisheries, USVI DPER