Thursday, October 17, 2013

Preparing for FSMA Compliance: Are You Ready?

Courtesy of Food Quality & Safety, a Wiley publication, www.foodquality.com
by Jim Bail 
By now, your organization has begun preparation to comply with the Food Safety Modernization Act or FSMA. This article provides background on FSMA and highlights some best practices that will help your organization with compliance.

Background

President Obama signed FSMA into law in 2011 and the FDA began publishing proposed rules in January 2013.
The Act makes extensive changes to U.S. food safety laws, most notably shifting focus from reacting to food safety problems to preventing them in the first place. By requiring a risk-based approach to identifying and implementing preventive controls, FSMA places new and more extensive requirements on food manufacturers, processors, growers, and importers. The Act focuses primarily on the following to minimize or prevent food safety hazards:
  • Produce safety,
  • Imported food safety,
  • Mandated inspections on a risk-based schedule,
  • Third-party laboratory testing,
  • Farm-to-table responsibility, and
  • Ability to require third-party ­certification for high-risk operations.
Another important component of the legislation provides for FDA recognition of accredited third-party audit and certification programs for imported foods a category that has grown steadily over the years.

Regulatory Update

Currently, the FDA is holding meetings and receiving comments on how to best implement the new law and promulgate effective regulations. Additional updates can be found at www.fda.gov/fsma.
The FDA is required to publish several rules that will be the basis for compliance enforcement once they are made final. These rules are to be presented in draft form to the public for a specified comment period. To date, two of the five proposed FSMA rules related to produce and processing have been published. The public comment period for the two proposed rules has already been extended, but a word of advice: Don’t wait.
Start preparing for FSMA now by reassessing your prerequisite programs and Hazard Analysis and Critical Control Points (HACCP) plans. Are SOPs or standard operating procedures current and adequate for their purpose? Has employee training been conducted and documented? The following are some key steps to keep in mind.
  1. Develop your Food Safety Plan.
  2. Identify, train, and qualify the experienced individual who is responsible for developing the facility’s Food Safety Plan.
  3. Identify and evaluate the hazards that could affect food manufactured, processed, packed, or held by your facility.
  4. Identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that the food you make is not adulterated.
  5. Monitor the performance of those established controls.
  6. Maintain records of monitoring as a matter of routine practice.
  7. If you are importing foods, you are responsible for compliance to FSMA by your foreign suppliers.
Once the basic food safety elements are developed and implemented for your operations, you may not have as much to modify once the final rules are published.
Identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility and food.

Action Plan

Where to start? It can be summed up in two words: Plan ahead. Companies can begin by performing a basic hazard analysis.
Prepare a written Food Safety plan that documents and describes the procedures used by your facility to comply with the requirements of the Act, including analyzing the hazards and identifying the preventive controls adopted to address those hazards. Your written plan, together with the documentation must be made promptly available to a duly authorized representative of the FDA upon oral or written request.
Identify, train, and qualify your skilled individual who is responsible for developing your facility’s Food Safety Plan. Establish your team with clearly defined roles and responsibilities.
Perform a hazard analysis. Identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility and food including:
  • Biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives;
  • Hazards that occur naturally, or may be unintentionally introduced;
  • Hazards that may be intentionally introduced, including by acts of terrorism; and
  • Develop a written analysis of the established hazards.
Identify and implement preventive controls, including any critical control points, to provide assurance that:
  • Validate your HACCP plan, control points, and limits using objective, scientific, and defensible data;
  • The hazards identified in the hazard analysis will be prevented, eliminated, or significantly minimized; and
  • The food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Food Drug and Cosmetic Act.
Monitor the effectiveness of the preventive controls you have implemented.
Establish corrective action procedures to ensure that if the preventive are not properly implemented or are found to be ineffective:
  • Appropriate action is taken to reduce the likelihood of recurrence of the failure;
  • All affected food is evaluated for safety; and
  • All affected food is prevented from entering into commerce if the owner, operator, or agent in charge of your facility cannot ensure that the affected food is not adulterated under section 402 or misbranded under section 403(w) of the Food Drug and Cosmetic Act.
Verify that:
  • The preventive controls implemented are adequate to control the hazards identified;
  • You are making appropriate decisions about corrective actions;
  • The preventive controls implemented are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and
  • There is documented, periodic reanalysis of the plan to ensure the plan is still relevant to the raw materials, conditions, and processes in the facility, and new and emerging threats.
Maintain records for not less than two years, documenting:
  • The monitoring of the preventive controls implemented;
  • Instances of nonconformance material to food safety;
  • The results of testing and other appropriate means of verification instances when corrective actions were implemented; and
  • The effectiveness of preventive controls and corrective actions.
Conduct a reanalysis of your preventive controls whenever a significant change is made in the activities conducted at your facility if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard, or not less frequently than once every three years, whichever is earlier. This reanalysis must be completed and additional preventive controls needed to address the hazard identified, if any, must be implemented before the change in activities at the facility is operative. You must revise the written plan if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed.
Completing these steps will help companies prepare for FSMA and be ready once the final rules are passed.

Bail is the director of supply chain food safety technical services for NSF International. He can be reached at foodsafetysolutions@nsf.org or 734-827-6844.

ADDITIONAL ASSISTANCE

NSF International has developed a free online tool (www.nsf.org/extranet/fsma) to determine compliance readiness and identify areas needing improvement. The 10-minute assessment tool helps identify potential gaps in food safety management systems and provides practical steps to develop and implement an effective control program. Participants receive a customized report upon completion.

Wednesday, October 16, 2013

Scientists at NSF International Discover Emerging and Potentially Harmful Adulterant Called N,alpha-diethylphenylethylamine (N,a-DEPEA) in a Dietary Supplement

The substance was found as part of a collaborative testing project conducted by scientists at NSF International, Harvard Medical School (HMS) and the National Institute for Public Health and the Environment (NIPHE) in the Netherlands.


Chemical structure of emerging and potentially harmful contaminant N,alpha-diethylphenylethylamine (N,a-DEPEA) (left) compared to chemical structure of methamphetamine, an illicit drug of abuse (right).
Chemical structure of emerging and potentially harmful contaminant N,alpha-diethylphenylethylamine (N,a-DEPEA) (left) compared to chemical structure of methamphetamine, an illicit drug of abuse (right
“Alarmingly we have found a drug in a mainstream sports supplement that has never been studied in humans,” says Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School who has conducted extensive research on supplements.
ANN ARBOR, Mich., CAMBRIDGE, Mass., & BILTHOVEN, Netherlands (PRWEB) October 14, 2013
Researchers from global public health organization NSF International, Harvard Medical School and the National Institute for Public Health and the Environment in the Netherlands have published an article in Drug Testing and Analysis describing the public health implications of an emerging and potentially harmful substance found in a dietary supplement sold in stores and online.
The substance, called N,alpha-diethylphenylethylamine (N,a-DEPEA), has a structure similar to methamphetamine and was found in a consumer dietary supplement product called Craze (marketed by Driven Sports, Inc.). Additionally, the substance (N,a-DEPEA) is not disclosed on the label. The substance was found as part of a collaborative testing project conducted by scientists at NSF International, Harvard Medical School (HMS) and the National Institute for Public Health and the Environment (NIPHE) in the Netherlands.
“Alarmingly we have found a drug in a mainstream sports supplement that has never been studied in humans,” says Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School who has conducted extensive research on supplements. “The health risk of using supplements adulterated with a drug should not be underestimated.”
In separate testing, NSF International scientists also detected N,a-DEPEA in a different supplement called Detonate by Gaspari Nutrition. Regulators may want to consider taking action to warn consumers.
“We urge consumers to remain vigilant about the dietary supplement products they choose, especially since products including Craze and Detonate are available in stores and online and encourage them to look for certification as a sign that the product has been tested and certified to be free of undeclared ingredients or harmful levels of contaminants,” said Ed Wyszumiala, General Manager of NSF International’s Dietary Supplement Certification Program, which helps protect consumers by verifying what is on the dietary supplement label is in the package and that the product does not contain other undeclared ingredients or unsafe levels of contaminants.
This collaborative testing project was developed in response to several failed urine drug tests by professional athletes after taking an over-the-counter workout product called Craze marketed by Driven Sports, Inc. After extensive testing and a review of the product’s label at NSF International’s laboratory in Ann Arbor, Mich., scientists at NSF International, HMS and NIPHE confirmed that the substance N,N-diethylphenylethylamine was listed on the label but N,a-DEPEA, an emerging and potentially harmful designer stimulant, was found. A review of this substance shows that N,a-DEPEA is likely less potent than methamphetamine but greater than ephedrine.
The compound that is listed on the label of Driven Sport’s Craze product, N,N-diethylphenylethylamine, is alleged to be a constituent of dendrobium orchid extract. This claim made by Driven Sports cannot be confirmed. After an extensive search of the scientific literature, NSF International, HMS and NIPHE scientists did not find any evidence to support the claim that N,N-diethylphenylethylamine or any phenylethylamines (PEAs) are constituents of dendrobium orchid extract.
As mentioned earlier, the article outlining the results of this collaborative testing project is published in Drug Testing and Analysis by NSF International Senior Research Scientist John Travis, Harvard Medical School’s Dr. Pieter Cohen and the National Institute for Public Health and the Environment’s Bastiaan Venhuis. The paper can be downloaded from Drug Testing and Analysis’ library.
NSF International helped develop the only accredited American National Standard for dietary supplements (NSF/ANSI Standard 173). NSF’s accredited dietary supplement certification program is based on this standard. The program includes a label and formulation review, testing to verify the supplement does not contain harmful levels of contaminants, and two facility audits annually to confirm compliance to good manufacturing practices (GMPs). Products certified to the stringent NSF Certified for Sport® program include additional steps to screen supplements for more than 180 athletic banned substances.
“NSF International’s Dietary Supplement and Certified for Sport® Certification Programs help retailers, consumers and athletes to make more educated decisions knowing that what is on the label matches what is in the container and they are not consuming any unintended substances like N,a-DEPEA,” said Wyszumiala. The NSF program is used by the NFL, NHL, MLB, PGA, LPGA, the Canadian Centre for Ethics in Sport (CCES) and the New York City Police Department.
For more information about NSF International’s dietary supplement certification programs, visit NSF's website or contact Peter Langlais at HS(at)nsf(dot)org or +1 734-545-2023.
Editor’s note: If you would like to set up an interview with an NSF Health Sciences expert, contact Greta Houlahan at media(at)nsf(dot)org or 734-913-5723.
If you would like to set up an interview with an expert from Harvard Medical School, contact David Cecere at dcecere(at)challiance(dot)org or 617-591-4044.
About the Craze testing project: Samples of Craze were purchased online and in stores in the U.S. and Europe. Each sample had a different lot number. Samples were analyzed by NSF International (Ann Arbor, Mich.) using ultra performance liquid chromatography (UPLC) coupled to an LTQ Orbitrap XL mass spectrometer. Samples were also analyzed by the Netherlands’ National Institute for Public Health and the Environment using a UPLC-quadruple-time-of-flight mass spectrometer. The identity of N,a-DEPEA was confirmed using nuclear magnetic resonance with a reference standard by the Korean Forensic Service. The results of this collaborative testing project were submitted to the United States Food and Drug Administration (FDA).
More background about Detonate testing: Detonate was purchased from a U.S. retail store. The analysis was performed by NSF International (Ann Arbor, Mich.) using ultra performance liquid chromatography (UPLC) coupled to an LTQ Orbitrap XL mass spectrometer. The identity of N,a-DEPEA was confirmed by comparison of the chromatographic retention time, accurate mass measurement and product ion fragmentation to that of a reference standard.
About NSF International: NSF International is an independent global organization that writes standards, and tests and certifies products for the food, water, consumer goods and health sciences industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. Operating in more than 150 countries, NSF is accredited by the American National Standards Institute (ANSI) and has been collaborating with the World Health Organization since 1997 in water quality and safety, food safety and indoor environments.
The NSF Health Sciences Division offers training and education, consulting, auditing, GMP and GLP testing, certification, R&D and regulatory guidance for the pharmaceutical, medical device and dietary supplement industries throughout the product life cycle. NSF wrote the only accredited American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard. The NSF Health Sciences Division operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America.
NSF International offers ISO 13485 registrations for medical devices and CE marking delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR), as well as drinking water filtration certification through the NSF Global Water Division. Additional services include safety audits for the food and water industries, environmental and sustainability services through NSF Sustainability and training courses through NSF Training and Education.

Contact


Friday, May 24, 2013

NSF’s 2013 Household Germ Study Featured on the Dr. Oz Show!



Lisa Yakas , Microbiologist and Manager of NSF’s Home Product Certification Program (HPC), was interviewed on the Dr. Oz show yesterday to discuss NSF’s most recent germ study findings in the kitchen. The five minute keynote segment describes NSF International as “the top germ fighting organization in the nation” and includes footage of NSF’s lab, our scientists, details of the study, NSF Marks and links to HPC. We also extended the coverage by providing  a full website package to Dr. Oz including a written germ study byline article and information for a cleaning tips  slideshow.  The Dr. Oz show gets an average of 3.4 million viewers a day!

Take a look at the segment.

This type of earned media on the Germ Study is a result of a dedicated team which includes NSF’s labs, business unit and marketing.  A very special thanks to Drs. Robert Donofrio and Ratul Saha who authored the study, the HPC team, including Sarah Krol, Ashley Breitner and Lisa Yakas, the Communications team, Greta Houlahan, Cheryl Luptowski, Kelly Nichols and Monica Milla and Production’s Peg Meller.