Phytosanitary Irradiation
Phytosanitary irradiation for market access to the U.S. is regulated under 7 CFR §305, which outlines approved treatments for quarantine pests. Under the bilateral Operational Work Plan between Mexico and the U.S., a wide range of fresh commodities—including mango, guava, fig, dragon fruit, guanábana, carambola, mandarins, tangerines, grapefruit, oranges, prickly pear, and Manzano pepper—may be exported if treated at authorized irradiation facilities. Orchards, packing houses, and irradiation plants must be certified and comply with strict traceability and segregation protocols. The USDA and SENASICA conduct joint inspections and audits at the plant to ensure compliance. The irradiation dose must meet or exceed phytosanitary standards—typically 150 Gy for fruit fly host commodities, and 400 Gy as a generic dose when other regulated pests are present. Treated products must be clearly labeled, and transportation must maintain the integrity of phytosanitary security throughout the supply chain.
Medical Device Sterilization, Rules and Regulations
Medical devices exported to the U.S. must comply with stringent regulatory standards to ensure safety and effectiveness. The primary framework is defined by the U.S. Food and Drug Administration (FDA) under 21 CFR Parts 800–820, which includes requirements for quality systems and sterilization validation. Devices must be sterilized using validated processes that meet ISO 11137 for radiation or ISO 13485 for quality management systems. The FDA’s Center for Devices and Radiological Health (CDRH) oversees submissions such as 510(k), PMA, or EUA, depending on the device class. Sterilization methods must include dose audits, bioburden assessments, and routine dosimetry. Facilities must follow Good Manufacturing Practices (GMP) and maintain detailed records for traceability. For radiation sterilization, only FDA-cleared and routinely monitored sources may be used. Regular inspections by the FDA or accredited third parties verify compliance. Labeling must reflect the sterilization method and expiration date. Noncompliance can lead to import alerts, detention, or recall.
Pharmaceuticals Rules and Regulations
Sterility assurance for pharmaceutical ingredients in the U.S. is governed by a robust regulatory framework led by the Food and Drug Administration (FDA) under 21 CFR Parts 210 and 211, which define requirements for aseptic processing, contamination control, and cleanroom standards. Facilities must follow Good Manufacturing Practices (GMP) and validate sterilization methods such as irradiation or moist heat, with evidence supporting a Sterility Assurance Level (SAL) of 10⁻⁶. The use of ionizing radiation must comply with ISO 11137, and the facility’s quality system should align with ISO 13485. The United States Pharmacopeia (USP <71>) provides testing standards for sterility and microbial limits. Facilities are expected to implement HACCP to identify and control potential biological hazards. PIC/S guidance may also inform best practices, particularly for harmonization across manufacturing sites. All processes must be documented, traceable, and subject to FDA inspections and audits to maintain compliance for domestic and international distribution.
Food Safety Condiments, Spies and Additves
The irradiation of condiments, spices, and food additives in the U.S. is regulated by the FDA under 21 CFR Part 179, which authorizes the use of ionizing radiation for microbial reduction and insect control. The maximum permitted dosefor these products is typically 30 kGy, ensuring safety without compromising quality. Facilities must operate under strict Good Manufacturing Practices (GMP) and implement Hazard Analysis and Critical Control Points (HACCP) plans to monitor critical safety steps. Documentation and traceability are essential to demonstrate compliance. Products must be labeled as irradiated if sold to consumers in packaged form. FDA registration and periodic inspections ensure operational and procedural integrity. For international trade, Customs-Trade Partnership Against Terrorism (CTPAT) certification may be required. Facilities must control contamination risks and validate dose delivery systems. All treated products must meet both domestic and export market requirements.
Sterility Assurance Pet Treats and Animal Feed
Sterility assurance for pet treats and animal feed in the U.S. is regulated primarily by the FDA’s Center for Veterinary Medicine (CVM). Products must comply with the Federal Food, Drug, and Cosmetic Act (FFDCA), which mandates safety, labeling, and sanitary processing. While full sterilization is not always required, processes like irradiation or heat treatment must be validated to ensure microbial reduction. Facilities must operate under Good Manufacturing Practices (GMP) and implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) under the FSMA (Food Safety Modernization Act). The use of irradiation is permitted under 21 CFR Part 579, with clear dose limits and labeling requirements. Regular inspections and preventive controls are enforced by the FDA, with oversight on imports and domestic production. Certifications such as HACCP and CTPAT enhance regulatory credibility for international trade. Documentation, traceability, and process validation are key to demonstrating compliance and ensuring product safety.
Food Safety Fresh and Frozen Foods
The irradiation of fresh and frozen foods in the U.S. is regulated by the FDA under 21 CFR Part 179, which specifies approved uses and maximum permitted doses for each food category. For fresh fruits and vegetables, the maximum dose is 1.0 kGy, used primarily for insect disinfestation and delayed ripening. Frozen meats and poultry can be irradiated up to 4.5 kGy for microbial control, while fresh, refrigerated meat is permitted up to 7.0 kGy. Spices and dried vegetable seasonings have a much higher approved dose, up to 30 kGy, for sterilization purposes. The treatment must not compromise food safety, nutritional value, or sensory quality. Facilities must comply with GMP, implement HACCP, and validate dose uniformity through dosimetry. Irradiated foods must be labeled with the Radura symbol and a disclosure statement when sold directly to consumers. All treatments must be conducted using FDA-cleared sources and methods in certified facilities.