Tag Archives: produce

Specific Training Required Under FSMA: A Look at Each Rule

By James Cook
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All seven core rules of FSMA require general training of individuals or employees and qualified individuals requiring education, training or experience to perform specific tasks. By including training in these regulations, the FDA has made specific training mandatory.

Training Required by FSMA Final Rules

In the current Good Manufacturing Practices (cGMP) and preventive control rules, as per 21 CFR 117.4 and 507.4, all individuals engaged in the manufacturing, processing, packing and holding of food must have the education, training or experience to perform assigned duties and must be trained in the principles of food hygiene and food safety. However, the preventive controls qualified individual (PCQI) and qualified auditor, to rules 21 CFR 117.180 and 507.53, can be an individual who has successfully completed a class equivalent in curriculum to that recognized by the FDA, or have the necessary job experience. In both cases, the training must be documented, including the date of training, type of training and those personnel trained.

This means that all employees are to be trained in food hygiene and food safety to at least the standard presented in the regulations and more specifically as per the cGMP requirements. Additionally, individuals who are responsible for a specific critical control point will still need to be trained in HACCP. However, this will probably not be sufficient for an employee responsible for preventive control, as he or she may require training in Hazard Analysis Risk-Based Preventive Control (HARPC), or training specific to the area in which the employee is involved (e.g., allergens, sanitation, supply chain or recall programs, or preventive controls).

For the preventive control qualified individual and qualified auditor, the training needed may be that of the approved FDA curriculum, as developed by the Food Safety Preventive Control Alliance (FSPCA). Although this training course is not a regulatory requirement, FDA inspectors and other regulatory personnel who are auditing facilities will have completed this training, meaning qualified auditors will be expected to have this training, and eventually preventive controls qualified individuals (PCQIs) will be expected to do so too. The qualified auditor and a PCQI will still require the education, experience and other training to perform the specific job duties as listed in the regulations. Unfortunately, it is likely that neither the industry nor the government will have enough lead instructors ready to train everyone who would want or need to be trained before the compliance dates become effective. Additionally, this training course is not yet available for animal food, and the industry has been informed by FSPCA that a Foreign Supplier Verification Program (FSVP) training module will be added to the training course. The FSVP is discussed in the Supply-Chain Preventive Control module, and the fact that there are some similarities between these regulations helps individuals involved in the FSVP program, or in auditing it.

In the produce safety rule, training requirements are listed in subpart C 21 CFR 112.21, 112.22, 112.23 and 112.30. Personnel who require training are those handling covered produce and their supervisors. As with the cGMP and preventive control rules, the principles of food hygiene and food safety must be taught to these personnel. More specifically they must learn how to identify an ill or infected person, and be taught about microorganisms of public health significance, such as Salmonella, Listeria and E. coli O157 on food contact surfaces. Additionally, personnel who harvest covered produce must be trained in recognizing produce that is contaminated with known or reasonably foreseeable hazards to ensure it isn’t harvested. These personnel must be trained in the use of harvest containers and equipment to ensure that they are functioning properly, clean and maintained, and to identify when they are not. At the same time, employees must be trained in correcting any issues or in reporting them to a supervisor in order to have them corrected. All this training must be documented in the same way as the cGMP and preventive control programs.

Unlike the cGMP and preventive control rules, the produce safety rule’s requirement to have a qualified individual, supervisor or responsible party on each farm that has completed a recognized FDA course, or equivalent, is not optional. This course will be available through the Produce Safety Alliance and is anticipated to start in September 2016. The grower food safety course required for supervisors will include an introduction to produce safety, worker health and hygiene training, soil amendments, wildlife, domestic animals and land use, agricultural water, post-harvest handling and sanitation, as well as how to develop a food safety plan.

The training for produce, conducted by the Produce Safety Alliance and/or trained trainers, does not cover training for sprouts; training for sprouts is being developed by the Sprout Safety Alliance and will include topics specifically for sprouts, such as antimicrobial treatment of sprouting seeds.

In the FSVP, the qualified individuals must have the education, training or experience necessary to perform activities as per 21 CFR 1.503. These qualified individuals will develop the FSVP and those activities such as hazard analysis, supplier approval, determining verification activities and frequency, corrective actions and other activities for the FSVP. These personnel must be able to read and understand the records to be reviewed for this program. This means they must know English and may also need to know the local language at point of product manufacture or farming. 

At this time there is no structured training program for these individuals, but the FSPCA training program, alongside education and experience can provide the training necessary for these people to perform the job activities. A PCQI would be qualified for the role of a FSVP qualified individual, but the FSVP probably would not be qualified for the PCQI role. This is because the activities in the FSVP are not as complicated as those required by the cGMP and preventive controls rules, and therefore the FSVP qualifications would not need to be as stringent.

Training Under Proposed Rules

In the proposal for Sanitary Transportation of Human and Animal Foods, 21 CFR 1.910, the FDA requires carriers of these products to train personnel who are engaged in transportation operations. This should include awareness of potential food safety problems that may occur to food during transport, basic sanitary practices that would address those problems and the responsibilities of the carriers in the regulation. As with all training in these regulations, the type of training, who was trained and when they were trained must be documented.

Since this is a proposal, the training for teaching the carrier’s responsibility is not yet finalized but will require nothing more than explaining that section of the regulation. The training of potential food safety issues and the problems that might occur during transport are handled during standard cGMP and food safety training.

For the proposed Intentional Adulteration rule, per 21 CFR 121.160, the personnel and supervisors assigned to the actionable process steps must receive training in food defense awareness and their responsibilities in implementing the migration strategies. Also, as per 21 CFR 121.130, the vulnerability assessment is to be performed by a qualified individual, and this individual is to be qualified through experience and/or appropriate training.

For basic food defense, the FDA offers various courses and information, such as Food Defense 101, on their food defense webpage. An online course is offered in English and Spanish and covers the awareness training and the regulations for employees. Upon course completion, a certificate is provided. The agency also has a downloadable food defense plan builder that can be used to develop a food defense program. The agency also provides vulnerability assessment software, but additional training in PAS 96 or ISO/TS 22000 food defense would aid qualified personnel in making sure that this vulnerability assessment is correct and that the strategies to reduce risks are appropriate and not excessive.

There is an abundance of training courses and materials available from the FDA, USDA FSIS, associations and industry. FSMA employee training requires having personnel with the proscribed education and experience to perform specific tasks, and that they be trained as soon as possible in order for them to develop the programs. Additionally, all personnel should be trained at least annually in food hygiene, food safety and food defense.

FDA

Part of FDA FY 2017 Budget Request to Hold Food Importers Accountable

By Food Safety Tech Staff
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UPDATE 2/22/2016 – According to an updated FDA alert, the FY2017 budget requests include an increase of $25.3 million of new budget authority to implement FSMA, with FDA focusing on two main areas:

  • National Integrated Food Safety System  ($11.3 million). Support state capacity to implement the produce safety rule via education and technical assistance to farmers and on‑going compliance support and oversight
  • New Import Safety Systems ($14.0 million). Implementing the FSVP rule, which makes importers responsible for ensuring that the foods they bring in from other countries are produced in a manner that is consistent with U.S. food safety standards

– END UPDATE –

FDA wants 8% more money for its FY 2017 budget, requesting a total of $5.1 billion.  Part of this $14.6 million net increase in budget authority will go toward FSMA implementation. Specifically related to food safety, FDA is asking for more than $18.4 million in budget authority and more than $193.2 million in user fees. According to an FDA press release, the agency will be using the budget to support federal and state efforts related to enforcing safety standards on produce farms. In addition, FDA wants to use the money “to hold importers accountable for verifying that imported food meets U.S. safety standards, as well as conduct food safety audits of foreign food facilities”.

FDA is also requesting more than $3 million for building and facilities funding, and more than $600,000 to support other areas to improve the agency’s infrastructure. The fiscal request is for October 1, 2016 through September 30, 2017.

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FDA Makes FSMA Education and Training Available

By Food Safety Tech Staff
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As part of FDA’s FSMA training vision, the agency has announced two funding opportunities aimed at providing outreach, education and training on the FSMA preventive controls rules.

The Native American Tribes Outreach, Education and Training cooperative agreement will provide up to $750,000 annually for three years. “FDA anticipates that federally recognized tribes will need food safety education and training that addresses the regulatory requirements of the applicable FSMA rules and also encompasses specific cultural practices associated with produce farming and food manufacturing/processing within tribes relevant to their status as sovereign nations,” according to an FDA release.

The Local Food Producer Outreach, Education, and Training agreement will award local food producers $1.5 million this fiscal year with the potential for two more years if federal funds are available. It aims to assist small and mid-size producers/processors with particular practices related to their scale of production and management practices. The agreement will focus on those involved in local food systems while considering “account diversified, sustainable, organic and identity-preserved agricultural production and processing.”

Chipotle to Adopt “Highest Level of Safety” Following E. Coli Outbreak

By Food Safety Tech Staff
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After bringing in IEH Laboratories and Consulting Group to reevaluate its practices after an E.coli outbreak that sickened dozens, Chipotle Mexican Grill announced it is implementing a program to ensure it achieves “the highest level of safety possible”. According to a press release issued today, Chipotle is enhancing its food safety program and taking the following actions:

  • Conducting high-resolution DNA-based testing of all fresh produce prior to shipment to restaurants
  • Conducting end-of-shelf-life testing of ingredient samples to ensure quality specifications are maintained throughout ingredient shelf life
  • Engaging in continuous improvements throughout its supply chain leveraging test result data to measure its vendor and supplier performance
  • Improving internal employee training related to food safety and food handling

The CDC and FDA investigation of the E. coli outbreak is ongoing and the source of the outbreak is still unknown.

GM Apples and Potatoes are ‘Safe’: FDA

Arctic Apples have ‘silenced’ genes that prevent them from turning brown when bruised, while genetic modification of Innate potatoes reduces the activity of genes that cause tubers to turn brown.

The U.S. Food and Drug Administration has completed its evaluation for two varieties of apples genetically engineered by Okanagan Specialty Fruits, Inc., and for six varieties of potatoes genetically engineered by J. R. Simplot Company and concluded that these foods are “as safe and nutritious as their conventional counterparts.”

Okanagan’s Granny Smith and Golden Delicious varieties of apples, known collectively by the trade name “Arctic Apples,” are genetically engineered to resist browning associated with cuts and bruises by reducing levels of enzymes that can cause browning.

Simplot’s varieties of Ranger Russet, Russet Burbank and Atlantic potatoes are collectively known by the trade name “Innate” and are genetically engineered to reduce the formation of black spot bruises by lowering the levels of certain enzymes in the potatoes. In addition, they are engineered to produce less acrylamide by lowering the levels of an amino acid called asparagine and by lowering the levels of reducing-sugars. Acrylamide is a chemical that can form in some foods during high-temperature cooking, such as frying, and has been found to be carcinogenic in rodents.

Foods derived from genetically engineered plants must meet the same legal standards, including safety standards, as foods derived from traditional plant breeding methods. Though producers of genetically engineered foods are not compelled to submit their products for FDA approval, both Okanagan, of British Columbia, Canada, and Simplot, of Boise, Idaho, submitted to FDA a summary of their safety and nutritional assessments.

“The consultation process includes a review of information provided by a company about the nature of the molecular changes and the nutritional composition of the food compared to traditionally bred varieties,” said Dennis Keefe, Ph.D., director of the FDA’s Office of Food Additive Safety. “This case-by-case safety evaluation ensures that food safety issues are resolved prior to commercial distribution.”

The changes are expected to make the produce healthier, more palatable and easier to transport and sell without spoilage, and hence result in less food waste. But the approval is expected to spark controversy among critics who argue that genetically modified foods will introduce potentially dangerous unknowns into the American food supply. Okanagan and Simplot may label their products as GMO, something that many consumer groups have advocated for.

Source: FDA.gov

Eating Organic Produce Lowers Pesticide Exposure

A recent study, published in the journal Environmental Health Perspectives, concluded that we consume fewer pesticides when we eat organic foods compared to their conventionally grown counterparts.

University of Washington’s Cynthia Curl and her fellow authors surveyed nearly 4,500 people about what they eat. They combined this information with average residue levels in those items from the U.S. Department of Agriculture’s Pesticide Data Program to estimate their intake of organophosphate pesticides (OPs). Organophosphates are a group of manufactured chemicals that are the most widely used insecticides today but are not allowed for use in organic farming.

Symptoms of sudden poisoning by organophosphates include headache, dizziness, weakness, diarrhea, nausea and vomiting, salivation, watery eyes and small pupils. Severe symptoms include seizures, slow pulse, difficulty breathing and coma.

Long-term exposure to organophosphates can cause confusion, anxiety, loss of memory, loss of appetite, disorientation, depression and personality changes. After exposure, people can also develop nervous system problems such as muscle weakness and numbness and tingling of the hands and feet, and some studies in adults and children have linked organophosphate exposure to lymphoma and leukemia.

In their study, Curl and her team also collected urine samples from 720 people to test for dialkylphosphate (DAP) metabolites — common byproducts of the body metabolizing most OPs. DAP concentrations supported the estimated pesticide exposure, and the researchers also found that the 240 participants who said they ate more organic produce had “significantly lower” DAP concentrations.

This isn’t the first study relating to chemical residues and food consumption, but it is the first to include information on organic food consumption habits. “The food composition — chemical residue method described in the present study may prove useful in future epidemiological studies of long-term dietary OP exposure, particularly if paired with information on organic food consumption, which may modify the observed exposure-response relationship,” the authors wrote. “As concern grows regarding potential effects of low-level OP exposures, the need increases for more sophisticated exposure assessment methods.”