Back to top

2015, January 28 - More FSMA Rules Expected by Yearend

BAS Bulletin – January 28, 2015
(Extracted from the Gleaner – January 28, 2015)

Four years after the law's passage, the US Food and Drug Administration continues to formulate the rules and regulations for food exports under the Food Modernisation and Safety Act (FSMA), but expectations are that the process could be advanced by yearend.

Still, the coordinator of the Jamaican FSMA Secretariat, Beverley Miller, says local companies will likely get time to comply with those rules that are still under development.

The rules to be finalised by the end of 2015 include, she said, produce safety, which affect fresh produce exports, and preventive controls for human foods, which deals with the implementation of food safety systems.

However, there are other aspects of FSMA regulation-making, which are said to be less advanced.

The FSMA is an amendment of the Federal Food Drug and Cosmetic Act (FD&C) which was signed into law on January 4, 2011 by President Barack Obama. The Jamaican secretariat operates as a unit of the Bureau of Standards Jamaica (BSJ).

Miller says local firms which fail to satisfy legal requirements will likely face rejection/ detention of products entering the United States. Further, she said, should a reinspection of a facility be deemed necessary by the FDA, the FSMA provides for a reinspection fee of US$305 per hour.

"While the timelines for these regulations have not yet been determined, it is anticipated that the final regulations/rules could be published by the end of 2015. It is important to note that the FDA's intention is for compliance to take place on a staggered basis, with small and very small firms being given additional time to satisfy the requirements," the FSMA Jamaica coordinator said.

FSMA features include biennial registration, hazard analysis and risk-based preventive control procedures, which may include sanitation procedures for food-contact surfaces, such as utensils and equipment; manager, supervisor, and employee hygiene training; an environmental monitoring programme'; a food allergen-control programme, a recall plan, Good Manufacturing Practices certification, and supplier verification activities related to food safety.

"Until all requirements are legislated, firms are not expected to be fully compliant. In the interim, facilities are expected to be in compliance with current requirements whether under the Federal Food Drug and Cosmetic Act or the Food Safety Modernisation Act. The favourable outcome of the 2013 FDA inspections, which saw no regulatory actions taken against any of our food facilities, is indicative of our local firms' adherence to current requirements," she said.

Miller notes as well that food facilities/exporters were required to renew their registration with the FDA between October 1 and December 31 last year.
The Bureau of Standards does not have data on the totality of firms that are FSMA compliant.

"While the secretariat facilitated a number of firms in their renewal activity, the actual number of firms now registered is not currently available on the FDA website. The FDA website provides information on foreign countries having about 900 registered facilities as at February 19, 2014. Jamaica is not included on that list," Miller said.

For those companies which are not ready and which have to be re inspected, the fee charged will cover time spent conducting the physical surveillance and/or compliance reinspection at the facility, making preparations and arrangements for the re-inspection, travelling to and from the facility, preparing any reports and analysing any samples or examining any labels, if required, the coordinator said.

Resource Category: 


BAS Bulletins

Starting a Business

Preparing a Business Plan

Starting an Export Business

Jamaica Customs

HACCP & Food Safety Requirements

Certifications/Licenses & Permits