ROLE & FUNCTION
We are the Focal Point for the coordination of activities in support of Jamaica’s preparedness for the United States Food and Drug Administration (USFDA) inspections, to ensure that local facilities are in compliance with the requirements of the Food Safety Modernization Act (FSMA) and regulations.
The FSMS, established in September 2011:
- Identifies funding for strengthening of Jamaica’s food safety systems
- Provides support to enhance the capacity of regulatory agencies in providing guidance to manufacturers and exporters shipping fresh produce and processed foods to overseas markets
- Provides industry with information aimed at increasing their knowledge and understanding of the FSMA and the Safe Food for Canadians Act (SFCA)
- Coordinates the national process of participating in rulemaking activities of the USFDA and other foreign food regulators
- Facilitates/Coordinates inspections of local food facilities by FDA inspectors;
- Facilitates the communication of issues/concerns regarding FSMA/SFCA implementation from Jamaican food facilities to the USFDA and the CFIA
- Supervises the conduct of the Better Process Control School (BPCS) on behalf of the USFDA.
In fulfilling our responsibilities, the FSMS has inter alia:
- Coordinated the training (by the FDA) of over 60 food safety inspectors from various local companies
- Coordinated three (3) visits of FDA officials from the FDA Latin America Regional Office, which included presentations on FSMA to over 200 stakeholders and official visits to some facilities
- Facilitated the knowledge transfer of FSMA information to stakeholders through numerous webinars, primarily through collaboration with the Inter-American Institute for Co-operation on Agriculture (IICA)
- Submitted comments on the major proposed FSMA rules during the process of development
- Facilitated over fifty (50) inspections of local food facilities by the FDA. Inspectors of the BSJ ‘shadowed’ the FDA during the inspections of eighteen (18) processed food facilities
- Identified and sourced funding of over US$125,000.00 (from the Caribbean Development Bank and the International Trade Centre) for 2 Hazard Analysis Critical Control Point (HACCP) system ‘Train-the-Trainer’ projects benefitting 23 companies.
- Supervised 4 BPCS courses by the Chemistry Department of the University of the West Indies. Over 120 participants successfully completed the USFDA approved training
- Liaises on a regular basis with the FDA in resolving challenges faced by the Jamaican food industry.
OVERVIEW OF THE FSMA
The Food Safety Modernization Act, signed into law on January 4, 2011 is a comprehensive overhaul of the United States food safety regulatory framework, regarded by the USA as the ‘most sweeping reform of FDA’s food safety authority in more than 70 years’. The food safety law is based on widely accepted international norms and practices that have been adopted by Codex and are being pursued by many other countries. Science-based approaches are used to manage food safety systems which are effective in preventing food safety problems, strengthening public confidence and facilitating trade in safe food.
FSMA gives the Food and Drug Administration (FDA) broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods.
Under the FSMA, domestic and foreign facilities that manufacture, process, pack or hold human food for consumption by the citizens of the United States of America are required to register with the FDA and to renew their registration biennially between October 1 and December 31 of even-numbered years.
The critical regulatory framework for prevention of foodborne illness has been established through FDA’s development of seven major FSMA regulations:
- Produce Safety Regulation: This regulation affects produce growers, in that it establishes science-based standards focused on the growing, harvesting, packing and holding of produce on-farms. The key provision areas include agricultural water quality standards and testing, standards for using raw manure and compost, training, control of domestic and wild animals, equipment, tools, buildings, sanitation as well as worker health and hygiene.
- Preventive Controls (PC) for Human Food Regulation: Firms covered by this rule are required to have written plans that identify hazards, specify the steps that minimize or prevent those hazards, identify monitoring procedures and record monitoring results and specify what actions will be taken to correct problems that arise.
- Preventive Controls for Animal Food Regulation: The regulation also establishes certain Current Good Manufacturing Practices (CGMPs) that specifically address animal food.
- Foreign Supplier Verification Programs (FSVP) Rule: This regulation addresses import safety and is closely tied to the preventive controls and produce safety requirements. Importers are required to verify that food imported into the US has been produced to the same food safety standards that are required of US producers
- Third-Party Accreditation of Auditors: This regulation establishes a comprehensive, credible and reliable program of oversight based on third‐party audits and certification of foreign food facilities to help FDA make decisions regarding the admissibility of imported foods
- Mitigation Strategies to Protect Food against Intentional Adulteration Regulation: This regulation requires food businesses with $10M or more in total annual food sales to take steps to prevent FDA registered food facilities from being the target of intentional attempts to contaminate the food supply
- Sanitary Food Transportation Regulation: This regulation requires certain shippers, receivers, and carriers who transport food that will be consumed or distributed in the United States, to take steps to prevent the contamination of human and animal food during transportation.
Foreign inspections are mandated by FSMA. There is no cost for routine inspection; however FDA is authorized to charge for re-inspections (where an initial inspection identified serious deviations) to verify that corrective actions have been taken. The cost for re-inspection is reviewed annually and published in August prior to taking effect as of October 1 of that year.
Recognizing that food safety is more than just complying with regulations in a formalistic way, the FDA provides guidance, educational materials and technical assistance; and encourages the building of a food safety culture throughout the food system.