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Listeria monocytogenes, 48 (21.4%) E. coli O157:H7, 4 (1.8%) A quick overview of the various sections of FSMA is listed in the table below and provides a quick reference guide as to where FDA got the authority to publish a particular regulation. Additional uncertainty regarding the implementation of FSMA has been caused by “self-enactment” which means that instead of having to wait for the US FDA to publish and finalize regulations, if FDA did not meet the deadline in the law for finalizing such regulations, that provision would go into effect without any regulation. Since 2011, a number of FSMA self-enacting provisions have been finalized and are in-force today including: • Electronic registration of all food plants that ship food or food ingredients into the US marketplace. Registration requires renewal every 2 years and we are awaiting FDA’s announcement for the re-registration process which should start October 1, 2014. This registration is required for all food processing plants shipping food or food ingredients into the US market (excludes farms in most cases). • Suspension of a food processing plant’s registration. This decision is made at high levels at US FDA and if a plant loses its FDA registration, it can no longer ship food or food ingredients into the US market. At least one (1) US plant has had its registration suspended. 16 3/14 eFOOD-Lab international Salmonella, 58 (29%) Listeria monocytogenes, 35 (17%) E. coli O157:H7, 4 (2%) • Mandatory recall when a food processing company refuses to voluntarily recall a product. • “Recoupment Fees” – US FDA is authorized to charge $305 (US) per hour for work performed by FDA field staff during a product recalls, follow-up visit based on an on-site plant investigation or in some cases to further investigate a consumer complaint. • Penalty provisions for both individuals (up to $50,000 US) viewed by FDA as responsible for causing a foodborne contamination or illness outbreak as well as penalties against the plant (up to $250,000). • Administrative detention of any food when it has been determined by US FDA field staff and their supervisors that there is some uncertainty regarding the safety of a particular lot or lots of food. US FDA will require the company to hold the food for at least thirty (30) days while FDA field staff finished with their investigation. While there is an appeal process with US FDA, it can take up to thirty (30) days so for refrigerated and short shelf-life products, administrative detention can mean that the food company ends up destroying the product. • US FDA field staff access to food plant processing records prior to FSMA was restricted to those plant records documenting inter- Salmonella, 86, 37.6% Uncleared Allergens, 69, 30.1% Uneviscerated Fish, 5, 2.2% Excessive Urea, 2, 0.9% Foreign Object, 3, 1.3% Uncleared Sulfites, 11, 4.8% Other, 14, 6.1% E. coli O157:H7, 6, 2.6% Listeria monocytogenes, 33, 14.4% Salmonella, 86, 38.2% Uncleared Allergens, 75, 33.3% Uneviscerated Fish, 5, 2.2% Excessive Urea, 3, 1.3% Foreign Object, 3, 1.3% Uncleared Sulfites, 3, 1.3% Other, 9, 4.0% E. coli O157:H7, 1, 0.4% Listeria monocytogenes, 40, 17.8% Salmonella, 63 (28.1%) Uncleared Allergens, 85 (37.9%) Nutrient Imbalance, 8 (3.6%) Uneviscerated Fish, 6 (2.7%) Drug Contamination, 4 (1.8%) Other, 4 (1.8%) Foreign Object, 1 (0.5%) Undecleared Sulfites, 1 (0.5%) Uncleared Allergens, 88 (44%) Nutrient Imbalance, 6 (3%) Uneviscerated Fish, 1 (0.5%) Drug Contamination, 4 (2%) Other, 3 (1.5%) Foreign Object, 1 (0.5%) Undecleared Sulfites, 2 (1%) Fiscal Year 2010 Fiscal Year 2011 Fiscal Year 2012 Fiscal Year 2013 Qualit y Management


eFOODLab_International_03_2014
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