Tag Archives: USDA

USDA Releases Strategies to Reduce E. coli Levels at Beef Slaughterhouses

A special Working Group has determined that a reduction in O157 could be achieved in two ways: one, by the Agency improving how FSIS inspection personnel verify plant performance of sanitary dressing procedures, and two, by improving the information available to industry on how sanitary dressing should be performed.

Reduction of E. coli O157 illnesses since the mid-1990’s has been one of the Food Safety and Inspection Service’s greatest public health successes, with illnesses having dropped by over 50 percent since 1998. While overall illnesses are down significantly, the most recently available outbreak data shows a slight increase in illnesses from this dangerous pathogen. FSIS’ Strategic Performance Working Group (SPWG) has released a six-point strategy to turn the trend back in the right direction.

The SPWG includes professionals from across FSIS, including field personnel, microbiologists, and policymakers who come together periodically to tackle serious and stubborn challenges that limit the Agency’s successful performance of its mission. The SPWG previously developed the Salmonella Action Plan, which has been the agency’s blueprint for tackling Salmonella since December 2013. Now the SPWG is also recommending a multipronged approach to address pathogenic E. coli in beef slaughterhouses.

The SPWG determined that a reduction in O157 could be achieved in two ways. First, the Agency needs to improve how FSIS inspection personnel verify plant performance of sanitary dressing procedures through better training, more correlations, and developing a standard to assess industry’s performance of sanitary dressing. Drawing on the experience of its members, the SPWG also stated that the training would be most effective if it included photographs and real-world scenarios to effectively illustrate the issues discussed in the documents.

Second, the SPWG recommended improving the information available to industry on how sanitary dressing should be performed. The SPWG said the Agency could do so by publishing a guide containing suggestions for best practices.

More detailed information about the SPWG’s findings and recommendations mentioned here can be found on the FSIS website at Strategic Performance Working Group: Shiga Toxin-Producing E. coli Findings. We are confident in this approach and look forward to being able to report lower illness numbers as a result of this report and future issues that the SPWG will work to address.

This blog was originally posted on USDA.gov, by Philip Bronstein, FSIS Senior Microbiologist

USDA Approves Browning-Resistant GM Apples

The agency has described that the GE apples are “unlikely to pose a plant pest risk to agriculture and other plants in the United States and that “deregulation is not likely to have a significant impact on the human environment.”

The U.S. Department of Agriculture has decided to approve new types of apples that have been genetically modified to not brown soon after after being cut. The company that has developed the Arctic Granny and Arctic Golden varieties – Okanagan Specialty Fruits Inc. – is currently engaging in a voluntary food safety assessment consultation with the Food and Drug Administration regarding the varieties.

According to USDA, the decision to deregulate the apples and allow them to be commercially planted after assessments showed that “the GE apples are unlikely to pose a plant pest risk to agriculture and other plants in the United States” and that “deregulation is not likely to have a significant impact on the human environment.”

According to the company, Arctic apples will age, turn brown and rot like any other fruit, but produce less of the substance that causes browning. So when the apples are sliced or bruised, the fruit’s flesh retains its original color longer instead of turning brown.

Consumer groups opposed to genetically modified foods have indicated their disapproval of USDA’s decision. “Pre-sliced apples are a frequently recalled food product,” noted the Center for Food Safety. “Once the whole fruit is sliced, it has an increased risk of exposure to pathogens. Since browning is a sign that apples are no longer fresh, ‘masking’ this natural signal could lead people to consume contaminated apples.”

These groups are also concerned about the lack of standardized labeling for genetically modified crops and their processed forms. The Environmental Working Groups said that the approval of Arctic apples “underscores the need for a transparent and consistent national labeling standard.”

USDA’s announcement came the day after Sens. Barbara Boxer (D-CA) and Richard Blumenthal (D-CT) and Rep. Peter DeFazio (D-OR) reintroduced legislation to label genetically engineered food.

Jennifer McEntire Joins GMA as VP of Science Operations

McEntire currently serves as The Acheson Group’s vice president and chief science officer, focusing on supply chain risks and mitigation in the changing regulatory landscape and global food safety system.

The Grocery Manufacturers Association (GMA) has announced that Jennifer Cleveland McEntire will take over as the organization’s new vice president of science operations beginning March 3rd.

McEntire currently serves as The Acheson Group’s vice president and chief science officer, focusing on supply chain risks and mitigation in the changing regulatory landscape and global food safety system. Before then, she was a senior staff scientist and director and science and technology projects with the Institute of Food Technologists. This work allowed her to partner with the U.S. Food and Drug Administration, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service and the U.S. Centers for Disease Control.

“Product safety is the number one priority for GMA and its member companies, and Jennifer’s appointment is part of our continued commitment to strengthen our world class food safety practice,” says Leon Bruner, GMA’s chief science officer. “Her considerable expertise and experience will no doubt strengthen our scientific and technical capabilities as well.”

McEntire earned her Bachelor of Science (magna cum laude) in food science from the University of Delaware. This was followed by a Doctor of Philosophy from Rutgers University where she was also a USDA National Needs Fellow in Food Safety. Her academic research focused on Listeria monocytogenes.

“It is an honor and pleasure to join GMA, whose accomplishments and leadership in food safety are widely recognized,” McEntire said. “I look forward to working with my colleagues at GMA and its member companies to further strengthen the safety of our food supply chain, both here at home and abroad.”

Safe Food Coalition Calls on OMB and USDA to Release Revised Poultry Rule for Public Comment

By Food Safety Tech Staff
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The Safe Food Coalition wants the public to be given an opportunity to comment on the changes made to the proposal before the rule is finalized.

Members of the Safe Food Coalition called on the Office of Management and Budget and the U.S. Department of Agriculture to release a revised version of USDA’s proposed rule to modify its poultry slaughter inspection program, open the rule up for a comment period of 120 days, and hold public meetings on the revised rule.

Last week, USDA announced it was sending a revised version of its proposed poultry rule to the Office of Management and Budget for review. In doing so, USDA officials said that the rule had been significantly changed based on stakeholder feedback.

However, in a letter to USDA Secretary Tom Vilsack and OIRA Administrator Howard Shelanski, members of the Safe Food Coalition noted that “stakeholders have no information about what those changes entail. We have raised numerous concerns about the negative impact USDA’s proposal will have on food safety and consumer protection. Many other public interest groups, members of Congress and even other government agencies have raised concerns as well. Considering the importance of this rule, the public should be given an opportunity to comment on the changes made to the proposal before the rule is finalized.”

The groups noted that the Food and Drug Administration is carrying out just such an action: “FDA published a proposed rule in 2013 implementing the produce safety provision of the Food Safety Modernization Act. Following the close of the comment period and in response to widespread stakeholder concerns, FDA announced that it would revise its proposal and re-publish it for public comment. FDA’s approach would ensure that the public has an opportunity to comment on substantial changes to its proposed rule before it goes into effect.”

Members of the Safe Food Coalition have repeatedly expressed serious food safety concerns with USDA’s proposed rule. 

FSMA: What’s the Latest, and What Do You Need to Know

By Michael Biros
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Is your company ready for ‘TACCP?’ Do you know how long you will be required to retain your records? Is your carrier up-to-date on the sanitary transportation section of FSMA? Dr. Bob Strong, Senior Food Safety Consultant at SAI Global, gives an overview of the newest updates on FSMA.

Questions were raised recently by brewers and distillers about spent grains being sold as animal feed. FDA recognizes that hazards will be minimal, but charges facilities with protecting spent grains during storage awaiting collection and during transportation as required under FSMA Section 103. This will require protection against physical and chemical contamination and references the inadvertent addition of industrial waste oil to used fryer oil that exposed 100,000 chickens to PCBs. The comment period for this is closed and the final rule is expected to be published this summer. The final rule is scheduled to take effect by August 30, 2015.

Record retention and availability applies to anybody who processes, packs, transports, distributes, receives, holds, and imports human or animal food. However, farms, restaurants, USDA plants, personal consumption, non-food packaging, and food contact packaging manufacturers (but not users of this packaging material) are exempt from this requirement.

The length of record retention depends on the perishability of the food product. If the shelf life is less than 60 days, both the handler and transporter must retain records for 6 months. If the shelf life is between 60 days and 6 months or if the food is animal/pet food, both the handler and transporter must retain records for 12 months. If the shelf life is greater than 6 months, the handler must retain records for 2 years, but the transporter must retain records for only 12 months. Records must be available within 24 hours of a request by FDA and civil action may be taken if records are not kept or made available. This final rule was published on April 4, 2014.

FSMA section updates

These updates are confined to Section 106 — Intentional Adulteration of Foods; Section 111 — Sanitary Transportation of Human and Animal Food; and Section 204 — Designation of High Risk Foods Relative to Record-keeping for Traceability.

To recap, FSMA does not apply to facilities regulated by USDA (meat, poultry, and eggs). Also exempted are juice manufacturers, seafood processors, alcohol-related facilities, low-acid canning (except to expand their hazard analysis), and small businesses.

FDA is considering modified requirements for warehouses and having Preventative Controls only if they are storing refrigerated products.

Section 106 — Intentional Adulteration of Foods

The intent of the proposed rule is for companies to begin using a “qualified individual” to develop a written food defense plan. This plan will protect against intentional adulteration of food for the purpose of causing harm to consumers. The plan should focus on actionable process steps, mitigation strategies, monitoring, corrective actions, and verification.

The regulation exempts very small businesses, companies with a majority of sales to very small businesses, storage facilities (except for bulk liquid storage), alcoholic beverage manufacturers, and animal feed manufacturers and distributors.

Actionable areas and mitigation strategies:

Key actionable areas identified by FDA include: bulk liquid receiving and loading, bulk liquid storage and handling, secondary ingredient handling, and mixing and similar activities. Deliberate acts of contamination may come from acts of terrorism; disgruntled employees, consumers, or competitors; or economically motivated adulteration such as the melamine tainted milk incident.

Companies must identify and implement mitigation strategies, establish procedures to monitor these strategies, implement corrective actions, verify that monitoring is being conducted, train supervisors assigned to actionable process steps, and maintain records.

Examples of mitigation strategies include restricting access to potential adulteration points such as loading and receiving areas, bulk liquids, secondary ingredient handling rooms, and open processing points. Facilities must require tankers to be sealed after loading and the seals must be checked at receiving.


FDA is asking for comments on using HACCP principles to develop food defense plans. They are considering calling a control point a TACCP (Threat Assessment Critical Control Point). They are also trying to identify the risk of adulteration to specific processes. Some examples of low risk foods that are hard to adulterate are: shell eggs, whole produce, game meats (not ground), peanuts/tree nuts, and sugar cane/beets. FDA has extended the comment period through June 30, 2014. 

Section 111 — Sanitary Transportation of Human and Animal Food 

This section builds upon the previously issued Sanitary Food Transportation Act of 2005. It has five major sections: vehicle and transportation equipment, transportation operations, information exchange, training, and records.

The regulation exempts shippers, receivers, and carriers that have less than $500k in total annual sales; the transportation of raw agricultural commodities by farm vehicles; food being shipped through the US to another country; food imported to be exported, but not consumed in the US; shelf stable foods that are completely enclosed in a container; the transportation of compressed gases; and the transportation of live animals.

Vehicles and transportation equipment

The proposed rule will establish requirements for the design and maintenance of vehicles and equipment to ensure that they do not cause contamination of the food being transported. This includes bulk and non-bulk containers, bins, totes, pallets, pumps, fittings, hoses, gaskets, and loading/unloading systems.

The regulation identifies the potential for cross-contamination from: incorrect use of packing materials (reusing wood containers for produce that once held raw meat); using the same hoses or pumps with different allergens or raw and ready-to-eat products; and pallets in poor condition (splintering or projecting nails).

The proposed rule will establish requirements for cleaning, inspection, maintenance, loading/unloading, and operation of transportation equipment to ensure no contamination or temperature abuse of the products during transport. This includes the growth of spoilage bacteria as well as pathogenic bacteria. This will be achieved by ensuring adequate temperature controls, separation of foods with different temperature requirements, and the cleanliness and physical condition of trailers, tankers, pallets, etc.


Carriers, shippers, and receivers will be required to exchange information regarding prior cargos, the cleaning of bulk transportation equipment, and temperature controls. A log of prior loads must be kept. FDA will not restrict what can be hauled. Rather, they will regulate the cleaning between loads. Wash tickets must be kept and shared with customers. Washing may include sanitizing where necessary.

The carrier must communicate with the shipper and receiver that temperature sensitive foods were transported under the required temperature conditions. This requirement can be waived for short hauls or if the shipper loads a temperature recording device with the shipped products. The shipper and receiver are required to specify in writing the temperature requirements to the carrier. The receiver must confirm compliance.

Training, records and waivers

Carrier personnel must complete training in sanitary transportation practices and must have documentation of this training. This will include personal hygiene for drivers and loading/ unloading workers, training in security, accessibility to hand washing, and avoiding cross contamination in handling mixed loads. Procedures, training, cleaning, prior cargos, and temperature control must be recorded and properly maintained.

Shippers, carriers, and receivers who hold valid permits and are inspected under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety Program may be waived from these requirements only when they are involved in shipping Grade A milk and milk products. Transportation of food relinquished to consumers may also be waived (such as the pizza delivery guy).

Section 204 — Designating High Risk Foods for the purpose of record keeping related to Traceability

This proposed rule designates high-risk foods based on known food safety risks. The criteria for modeling and scoring risk are:

  1. Frequency of Outbreaks and Occurrence of Illnesses: This must include chemical and microbiological food safety hazards. Chemical hazards include allergens, mycotoxins, pesticides, and heavy metals.
  2. Severity of Illness: This will take into account illness duration, hospitalization, and mortality.
  3. Likelihood of Contamination: This is based on number of recalls and contamination that has been known to occur.
  4. Pathogenic Growth Potential/Shelf Life: Strong growth potential is likely at temperature at which the food is intended to be held and stored, including refrigeration and room temperature. This will be coupled with shelf life where longer shelf life can increase risk.
  5. Manufacturing Process Contamination Probability/Intervention: High probability has recurring or frequent detection of contamination. Low probability has infrequent detection of contamination or where contamination is introduced post manufacturing. This will be coupled with the availability and implementation of control measures.
  6. Consumption: This is the percent of the population that consumes the food.
  7. Economic impact: Lower is defined as $100-500k impact per year and higher is greater than $10m per year.

Organic Testing: What You Need to Know

By Food Safety Tech Staff
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Are you interested in labeling your product as organic? This article provides a comprehensive guide to understanding the USDA’s requirements for organic testing.

According to the United States Department of Agriculture (USDA), Organic is a labeling term that indicates that the food or other agricultural product has been produced through approved methods that integrate cultural, biological and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity. Synthetic fertilizers, sewage sludge, irradiation and genetic engineering may not be used. 

Where did the legal definition of organic originate from? The Organic Foods Production Act (OFPA), enacted under Title 21 of the 1990 Farm Bill, is the law that made “organic” a legal term. The intent of the OFPA of 1990 was to establish national standards for the production and handling of foods labeled as organic. The OFPA of 1990 authorized a new USDA National Organic Program (NOP) to set national standards for production, handling and processing of organically grown agricultural products. Additionally, the OFPA established the National Organic Standards Board (NOSB) which advises the Secretary of Agriculture in setting the standards upon which the NOP is based. 

The main goals of the OFPA of 1990 include:

  • Establish national standards governing the marketing of certain agricultural products as organically produced products; 
  • Assure consumers that organically products meet a consistent standard; and
  • Facilitate interstate commerce in fresh and processed food that is organically produced. 

What is the National Organic Standards Board?

The National Organic Standards Board (NOSB) is appointed by the Secretary of Agriculture, and is a Federal Advisory Committee comprised of the members listed below:  

  • Four farmers/growers; 
  • Three environmentalists/resource conservationists; 
  • Three consumer/public interest advocates; 
  • Two handlers/processors; 
  • One retailer; 
  • One scientist (toxicology, ecology, or biochemistry); and
  • One USDA accredited certifying agent.   

The responsibility of the NOSB is to recommend adding and/or removing materials from the National List (see next question). In general, synthetic substances are prohibited and non-synthetic substances are allowed. Additionally, the NOSB must review all materials every five years and recommend renewing, removing or changing each listing. The NOSB meets twice per year in a public forum to discuss the issues and vote on their final recommendations. All meetings are free and open to the public. Recommendations by the NOSB are not official policy until they are approved and adopted by the USDA. 

What is the National List?

A uniform National List of materials was mandated by Congress as part of the OFPA of 1990. The purpose of this list is to clarify which materials are acceptable and unacceptable to use in organic production, processing and handling in the United States. How has the Recent Final Ruling Published by the NOP on November 8, 2012, Affected the OFPA of 1990? On November 8, 2012, the NOP published a final ruling clarifying a provision of the OFPA of 1990 and the regulations regarding the requirement of periodic residue testing of organically produced agricultural products by accredited Certifying Agents. The final rule amends the USDA’s NOP regulations to clarify that “accredited certifying agents must conduct periodic residue testing of agricultural products that are to be sold, labeled or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients or food group (s)).” 

The final rule requires that Certifying Agents, on an annual basis, sample and conduct residue testing from a minimum of five percent of the operations that they certify. This action will help further ensure the integrity of products produced and handled under the NOP regulations.” The effective date of this final rule is January 1, 2013, and Certifying Agents must be fully compliant with the five percent requirement for the 2013 calendar year. The primary goal of this rule is to align the NOP regulations with the requirement for residue testing of organic products under the OFPA of 1990. Residue testing is a significant part of the organic certification process because it provides a quantitative means to monitor compliance with the NOP and discourages the mislabeling of agricultural products. 

Current methods of analysis for periodic residue testing

What are the current methods of analysis for periodic residue testing that meet the requirement of this recent ruling? The NOP uses monitoring data compiled by the USDA Agricultural Marketing Service (AMS), Science and Technology Program and United States state agricultural laboratories to evaluate the residual pesticides remaining on foods. The current method used to obtain this data is a modified QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method. 

The NOP, USDA AMS and Science and Technology Program collaborated to create a “target” analyte list (NOP 2611-1) of all pesticides/metabolites/environmental contaminants that have been found in samples analyzed for the USDA Pesticide Data Program. Certifying Agents should use laboratories attempting to analyze as many compounds on the USDA’s Prohibited Pesticides for NOP Residue Testing list (NOP 2611-1). 

What are USDA’s laboratory selection criteria for testing organic products?

The criteria of the food testing laboratory that the USDA prefers a Certifying Agent performing the periodic residue testing for a Certifying Agent are listed below.

1. Laboratories should hold current accreditation to either: 

  • ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories; or
  • An alternate standard approved by the NOP on a case-by-case basis. Certifying Agents should contact their NOP Accreditation Manager for additional information. A copy of the accreditation certificate should be provided to the certifying agent prior to shipping samples and should be attached to laboratory results when they are reported back to the Certifying Agent.  

2. Laboratories should participate in an international proficiency test program. A proficiency testing program is the determination of the calibration or testing performance of a laboratory by means of inter-laboratory comparison. A copy of the proficiency test results from the most recent round of proficiency testing should be available from the laboratory together with any corrective actions taken if the laboratory has failed the proficiency test.  

3. Laboratories should be capable of screening for the “target” analyte list of pesticides included on the document NOP 2611-1, analyzing the samples using gas chromatography (GC) and/or liquid chromatography coupled to a mass spectrometer (MS) or tandem mass spectrometer (MS/MS).  

4. Laboratories should provide evidence that their analytical method is appropriate for the submitted sample and that suitable validation data are available. Correspondence should be available to the certifying agent documenting that the method meets the laboratories’ minimum internal quality assurance requirements.

5. Certifying Agents should direct the laboratory to provide analytical results as follows:  

  • If no residue is detected, then the result should be provided as not detected (ND). The limit of detections should be provided.
  • If some residue is detected below the limit of quantification (LOQ), then the result should be provided as “Trace” or “BQL” (below quantifiable level). 
  • If residue is detected at or above the LOQ, then the result should be reported in parts per million 9ppm). Parts per million (ppm) is equivalent to milligrams per kilogram (mg/kg). 


  1. Federal Register Vol. 77, No. 218 Friday, November 9, 2012. Pages 67239-67532. Accessed at http://www.gpo.gov/fdsys/pkg/FR-2012-11-09/pdf/FR-2012-11-09.pdf on November 20, 2012.  
  2. Mary V. Gold. Organic Production/Organic Food: Information Access Tools. United States Department of Agriculture (USDA) National Agricultural Library. June 2007. Accessed at http://www.nal.usda.gov/afsic/pubs/ofp/ofp.shtml on December, 5 2012.  
  3. Organic Trade Association. Organic Foods Production Act Backgrounder. Accessed at http://www.ota.com/pp/legislation/backgrounder.html on December 5, 2012. 
  4. Public Law 101-624-November 28, 1990. Title XXI-Organic Certification. Accessed at http://nationalaglawcenter.org/assets/farmbills/1990-9.pdf on December 5, 2012. 
  5. United States Department of Agriculture (USDA) National Agricultural Library. Mary V. Gold. June 2007. Accessed at http://www.nal.usda.gov/afsic/pubs/ofp/ofp.shtml on December, 5 2012. 
  6. United States Department of Agriculture (USDA). NOP 2611 Laboratory Procedures for Residue Testing Rev02 November 08, 2012. Accessed at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088988 on November 20, 2012. 
  7. United States Department of Agriculture (USDA). National Organic Program. Accessed at http://www.ams.usda.gov/AMSv1.0/nop on November 20, 2012.  
  8. United States Department of Agriculture (USDA). National Organic Program, National Organic Standards Board (NOSB) Accessed aton November 20, 2012.