FSMA Final Rule on Produce Safety
SAFEGUARDS | Food NO. 195/15
On November 13, 2015 the United States Food and Drug Administration (US FDA) released the Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption final rule. This rule will be published in the US Federal Register on November 27, 2015 and compliance dates will be effective based on that date. This rule covers raw fruits and vegetables including nuts, with some exemptions and variances.
There are six key requirements, of which the following five apply to all produce; agricultural water, biological soil amendments, domesticated and wild animals, worker training and health and hygiene and equipment, tools and buildings and one requirement section that applies to sprouts.
No detectable level of generic E. coli would be allowed in water used for hand washing, food contact surface application, ice that is applied directly to produce and for sprout irrigation, so untreated surface water will not be allowable for these purposes. If positive E. coli is found, water is to be immediately discontinued for these uses and corrective actions must be taken before the water can be used for any of these purposes.
For water applied directly to produce other than sprouts, the generic E. coli amount is to be a geometric mean of 126 or less CFU/100 ml, with a maximum level of 410 CFU/100 ml. If criteria are not met, corrective action is to be taken as soon as possible, but no later than the following year. Farmers using this non-compliant water will have three options. Treat the water, allow time for microbes to die off in the field, or allow time for microbes to die off between harvest and end storage or through washing.
Testing of Water
For untreated surface water, an initial survey using a minimum of 20 water samples, as close to harvest time as possible, over two to four years with five samples each year thereafter to be tested for generic E. coli. For untreated ground water applied to produce except sprouts, an initial survey of four samples tested close to harvest, during the growing season or over a period of one year, with one sample each year thereafter to be tested for generic E. coli. For untreated ground water where no detectable amount of E. coli is allowed, four samples are to be taken during the growing season or over a period of one year, with one sample each year thereafter to be tested for generic E. coli. If any sample has a detectable amount of E. coli, then four samples are to be taken during the growing season, or over a period of one year, until the water is in compliance. This does not apply to water from public water systems, water in compliance with public water system standards or treated water per the treatment rules.
Biological Soil Amendments
Until the US FDA finishes their risk assessment and research, on raw manure they will not object to farmers complying with the United States Department of Agricultural National Organic program standard of 120 day intervals between application for crops in contact with soil, and 90 days for crops not in contact with the soil. Stabilized compost must meet specific microbial standards and application of this compost will be in minimal contact with produce.
Wild and Domestic Animals
Farmers are required to take all measures reasonably necessary to identity animal intrusion and not harvest produce that is likely to have been contaminated by animals. If contamination is found, a risk assessment is required and if significant risk is found, measures are to be taken to discourage animal intrusion using netting, flags or other methods. Farmers are not required to exclude animals from outdoor growing areas, to destroy animal habitats or clear borders around growing/drainage areas.
Worker Training and Health and Hygiene
Farm workers and their supervisors are to be trained in basic health and hygiene requirements. For example, the ill or infected are not to be in contact with food, and hand washing must be performed after using the toilet. These requirements can be met through a combination of training, education and experience.
Equipment, Tools and buildings
The rule establishes standards relating to equipment, tools and buildings to prevent the sources of contamination of produce through inadequate sanitation.
Spent irrigation water from sprouts is to be tested for pathogens and must be negative prior to product entering the commercial chain. The growing, harvesting, packing and holding environment for sprouts will need to be tested for Listeria monocytogenes or Listeria species. Seeds and beans to be used for sprouting will have to be treated to prevent the introduction of pathogens into or onto the seeds. Corrective actions will have to be taken if spent irrigation water is tested and found to be out of compliance.
Sprout growers will have one to three years, dependent on their size, to comply with the regulations, with no additional time to meet the water requirements.
The exemptions are; produce that is not a raw agricultural commodity, produce rarely consumed raw (as per the US FDA item list), food grains, produce used for personal or on-farm consumption and farms with a three year average value of produce sales of less than $25,000 USD.
The rules have a provision for qualified exemption and modified requirements. To qualify, farms must have food sales averaging less than $500,000 USD over three years, and sales to qualified end users must exceed sales to all others. A qualified end user is the consumer or a restaurant/retailer in the same state or Indian reservation as the farm, or not located more than 275 miles away from the farm. Modified requirements need specific documentation to be maintained and disclosed.
Any state, tribe and government may apply for a variance from any part of the rules, if it concludes that meeting that part of the rule itself, would be a problem based on the local growing conditions. The submitting group must be the authoritative body, must demonstrate the assurance that the produce will not be adulterated and must include relevant and scientific information to support this variance.
The compliance date is four years for those operations not involved in sprout activities, and very small businesses with more than $25,000 to $250,000 in average annual produce sales. For small businesses with more than $250,000 to $500,000 in average annual produce sales it is three years, for and all other farms two years from the effective date. The compliance date for the water quality standards testing and record keeping requirements, are an additional two years beyond the compliance dates for the rest of the rule.
For those operations that qualify for the modified requirements, the labeling requirements (if applicable) are to be met by January 1, 2020. The retention of records to prove qualification as of the effective date of the rule and all other modified requirements are four years for very small businesses and three years for small businesses.
SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information please visit our website www.foodsafety.sgs.com.
For enquiries, please contact:
Food Scientific and Regulatory Affairs Manager
t: +01 973-461-1493
© SGS Group Management SA – 2015– All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.