US FDA Seafood HACCP: Indonesian Exporters 2025 Guide

A practical, action-first playbook for Indonesian seafood exporters to assemble a 21 CFR 123.12–compliant HACCP packet that US importers can use immediately. What to include, how recent it must be, formatting and translation tips, plus a one-page cover letter template.

If you export seafood to the United States in 2025, your shipment lives or dies on one thing. Can your US importer verify you run Seafood HACCP under 21 CFR Part 123. When import holds happen, it is rarely about product quality. It is almost always about paperwork that does not let the importer take an FDA-acceptable “affirmative step.” We have shipped thousands of boxes. The exporters that sail through send a clean, predictable packet every time.

Here is the exact system our Indonesia-Seafood Team uses. You can copy it today.

21 CFR 123.12 in plain language

US importers must verify that foreign processors follow Seafood HACCP. The regulation calls this taking an “affirmative step.” In practice, importers rely on documents you provide. If you give them a complete packet, they can verify quickly and clear your shipment.

What does an FDA‑acceptable affirmative step look like for imported seafood

FDA lists several acceptable approaches in 21 CFR 123.12. The most common for Indonesian exporters are:

Importer keeps a copy of your HACCP plan and a written guarantee that the plan is implemented for the products shipped. Often called a HACCP letter of guarantee.
Importer keeps a continuing or lot-by-lot certificate or letter from you stating the products were processed in accordance with 21 CFR Part 123.
Importer maintains an on-site audit report or independent third-party assessment that specifically evaluates compliance with US Seafood HACCP. Not just general GFSI.
Importer maintains records of their own or their agent’s inspection of your facility verifying HACCP compliance.

Our experience shows the fastest path is a compact packet containing your plan summary, a signed guarantee, and recent monitoring records for the actual lots.

Build a “ready-to-file” HACCP packet for US importers

We recommend one PDF per shipment. Use clear filenames and bookmarks. Here is the checklist we use.

Cover letter on your letterhead. One page. See template below.
HACCP letter of guarantee. Signed. States that named products were processed under your HACCP system meeting 21 CFR Part 123. Include facility address and latest reassessment date.
Seafood HACCP plan copy or summary. If you will not share the full plan, provide the plan table with CCPs, critical limits, monitoring frequency and records names for the products. Include the hazard analysis summary page.
Monitoring records for the specific lots shipping. Completed, signed, and reviewed. Examples:
- Receiving temperature logs and ice coverage checks.
- Histamine test results and harvest vessel control records for scombroid species like tuna and mahi.
- Validated cook time and temperature and rapid cooling logs for cooked products such as shrimp.
- Metal detection or X-ray if that is a CCP or verification step in your plan.
- Label check records for allergens and country of origin.
Sanitation monitoring records. Pre-op and operational sanitation for the production dates of the lots. Provide at least one week covering the production days.
Calibration records. Thermometers, data loggers, scales, and any histamine test equipment. Show the most recent calibrations that cover the production dates of the shipment.
Verification and review. HACCP verification signatures on records, internal audit highlights, and your annual HACCP reassessment statement.
Training proof. Seafood HACCP certificate for your HACCP coordinator or team lead.
Product labels in English. Final export labels and any inner pack labels. Match lot codes to the records.

Practical takeaways:

Combine into a single PDF with bookmarks. Keep it under 25 MB. Name it “12312_Packet_[Facility][Product][ShipDate].pdf”.
Sign and date everything. Use ink or secure e-signature. FDA expects importer records to be readable and in English on request.

Exactly how recent should monitoring records be

The regulation does not specify a number of days. Importers and FDA look for evidence tied to the shipment. What we provide that works consistently:

The complete batch records for the lots in the container. All CCP logs and reviews. If multiple production days are included, include each day.
Sanitation records for the production period plus the surrounding week. Seven consecutive days has worked best.
Calibrations that cover the production dates. If you calibrate monthly or quarterly, include the last two calibration events.
For high-risk hazards like histamine or cook steps, we add 30–60 days of recent monitoring records as “examples.” That gives the importer confidence in ongoing control.

Common questions we hear from US buyers

Do I have to share my full HACCP plan with a US importer

No. The law does not force you to give the full plan. But one of the easiest affirmative steps for the importer is to keep your plan and a guarantee on file. If you cannot share the full plan, share the CCP table and hazard analysis summary for the relevant products, plus recent monitoring records. In our experience, that satisfies 3 out of 5 importers immediately. The rest usually accept a redacted plan.

Is a third‑party audit like BRC or SQF enough

Not by itself. GFSI audits are valuable but do not automatically meet 21 CFR 123.12. If your audit explicitly assesses US Seafood HACCP requirements and the importer keeps the full report and scope, it can serve as the affirmative step. Most BRC or SQF certificates do not do that. Expect the importer to still ask for your HACCP plan summary and records.

Does the HACCP compliance letter need to be updated for every shipment

A continuing guarantee updated at least annually works for most buyers. We include a shipment-specific cover letter that references the continuing guarantee and lists the lot codes. If your process or HACCP plan changes, issue a new guarantee immediately.

Do the documents need to be in English or is Bahasa acceptable

Provide English. FDA expects importer records to be available and legible in English upon request. We use bilingual forms in the plant and then supply English copies in the packet. If you translate, stamp “certified translation,” include the translator’s name and date.

What happens if the importer cannot verify HACCP. Will the shipment be detained

If the importer cannot show an affirmative step, FDA can detain the shipment at entry. The importer then scrambles to collect your documents. If this happens repeatedly, FDA can place the product or firm on Import Alert for Detention Without Physical Examination. We have seen weeks lost over a missing calibration log. Send a full packet up front.

Do Indonesian exporters need FSVP or just HACCP documents

FSVP is a US importer obligation. You do not “have” FSVP. But your documents support the importer’s FSVP recordkeeping. The packet above is Seafood HACCP focused and keeps things simple.

Product‑specific notes that prevent delays

We export everything from tuna to grouper to shrimp. The risk profile changes by species and process, so your packet should too.

Scombroid species and warm‑water pelagics. Tuna, mahi, wahoo, kingfish. Provide histamine control records. We include harvest vessel or landing temperature controls, receiving internal temperature checks, and histamine test results per lot. For raw tuna like Yellowfin Saku (Sushi Grade), Yellowfin Steak and Bigeye Loin, add your parasite control or freezing step if the product is intended for raw consumption.
Cooked ready‑to‑eat shrimp. Provide validated cook time and temperature logs and rapid cooling logs. Include pre‑op sanitation, environmental or post‑cook handling controls if part of your HACCP plan. We attach clear batch linkage for Frozen Shrimp (Black Tiger, Vannamei & Wild Caught).
Raw IQF fillets and portions. Snapper, grouper, cobia, mahi. Temperature control is the story. Supply receiving temperatures, storage logs, glazing records if used, allergen and label checks, and calibration. For retail‑ready items like Grouper Fillet (IQF) and Pinjalo Fillet (IQF), we include final labels in English and carton markings that match lot codes in the logs.

Recent trend. Through late 2024 and into 2025, FDA and importers are doing more remote records review. Clean scans and digital signatures speed approvals. Messy photos of clipboards do not.

One‑page cover letter template you can paste into Word today

Subject: Seafood HACCP Document Package – 21 CFR 123.12 Affirmative Step

Dear [Importer Name],

We are providing this Seafood HACCP document package to support your 21 CFR 123.12 importer verification for the following shipment:

Exporter: [Company legal name], [Facility address]
US Importer: [Company]
Products: [e.g., Yellowfin Tuna Saku, Grouper Fillet IQF]
Species and codes: [e.g., Thunnus albacares, Epinephelus spp]
Lot codes and production dates: [List]
Container/Booking: [Number]

Affirmative step provided: Copy of HACCP plan summary and signed HACCP letter of guarantee. Monitoring records for the listed lots are enclosed.

Documents enclosed:

HACCP letter of guarantee signed [date]. 2) HACCP plan summary and hazard analysis. 3) Lot‑specific CCP monitoring records. 4) Sanitation records [dates]. 5) Calibration records [dates]. 6) Annual HACCP reassessment statement [date]. 7) Labels in English. 8) Training certificate for HACCP coordinator.

Contact for technical questions: [Name, title, email, phone].

We confirm the products were processed in accordance with 21 CFR Part 123 Seafood HACCP.

Sincerely, [Name] [Title] [Company] [Signature]

Formatting and translation tips that avoid holds

Make it easy to trace. Put the lot code on every record page. If you use multiple production days, add a lot map page up front.
Use English file names. Example. “2025-02-12_Calibration_Thermometer_SN1234.pdf”.
Scan cleanly. 300 dpi, black and white for logs, color for labels. Single PDF with bookmarks.
Highlight the CCP values in the logs. We circle the measured number and the critical limit.
Cross‑check dates and time zones. Use 24‑hour time. Avoid ambiguous date formats. We use YYYY‑MM‑DD.
Redact but leave context. If you remove proprietary yield data, keep the CCP rows intact.

Final thought

Most US import headaches vanish when your packet answers the importer’s questions before they ask. If you want our editable packet template and a quick pre‑shipment check, Contact us on whatsapp. If you are aligning SKUs to hazard profiles, you can also View our products and we will point you to the exact records buyers expect for each item.