You are a processor exporting to the U.S. or planning to. If the Preventive Controls rule (PC rule) applies to you, then you need a compliant Food Safety Plan hashtag#fsp. And, If you’re a PCQI, you should be familiar with the 21 CFR §117.136 under the PC rule. The provision that allows a manufacturer to rely on a downstream customer to control an identified hazard, instead of implementing a preventive control at their own facility. So, does that mean you can legally ship a product with a known pathogen hazard… without controlling it? Be cautious with the interpretation. This is one of the provisions that might be misread/misinterpreted. The answer may be a “yes”, but only under tightly defined conditions. I underline “tightly defined”. Because this is true only under very specific, tightly controlled conditions. It’s a conditional regulatory pathway, built on documentation, disclosure, and accountability. When does downstream reliance apply? This is especially relevant in supply chain situations where a facility receives raw materials that may carry inherent hazards, but has no lethal step to eliminate them, e.g., raw cocoa, coffee beans, flour, grains.. In such cases, control is intentionally placed downstream, not ignored. All these conditions should me met: Does this relax zero tolerance policy for pathogens such as Salmonella? No. § 117.136 addresses a specific gap: your facility has no lethal step to eliminate hazards inherent in raw ingredients. It does not mean a facility can allow Salmonella to persist and expect the customer to clean it up. FDA expectations for Listeria monocytogenes and Salmonella do not disappear at handoff. And under the FD&C Act, food must not be adulterated, regardless of where in the chain control is applied. What this provision does NOT mean It is not a relaxation of pathogen standards.Zero-tolerance expectations for Salmonella and Listeria monocytogenes remain in full effect at every step in the chain. It is not a default option.This is a conditional, documented pathway; it applies only where your process genuinely cannot control the hazard. It is not an exemption from GMP or sanitation.You must still prevent contamination and ensure your process does not introduce or amplify hazards. It is not a transfer of legal accountability.Under the FD&C Act, food must not be adulterated; this applies regardless of where in the chain control is applied. Therefore, even when control is deferred, you must still: Control may be transferred under certain conditions, but your responsibility cannot be, and that does not mean the zero-tolerance policy is relaxed. If you have questions about what FDA registration means for your facility, which regulations apply to your operation, or how to design compliant food labels and build a compliant HACCP and Food Safety Plan for the US and EU market, DFK Safe Food Environment provides regulatory consulting, FSPCA training, and FSMA compliance support for domestic and international food businesses.