Friday, July 26, 2013

UPDATED Import rules under FSMA released

FDA gives target release date for final piece of FSMA

The US Food and Drug Administration (FDA) told Inform (the AOCS membership magazine) in an email that “it is FDA’s intention to publish the proposed rule for Preventive Controls for Food for Animals prior to November 30, 2013.”

That rule is the remaining piece of the Food Safety Modernization Act yet to be released. Proposed rules on preventive control in human food and produce safety were issued in January 2013; proposed regulations on foreign supplier verification programs and the accreditation of third-party auditors were released on July 26. The comment period for those four rules closes on November 26.
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The US Food and Drug Administration (FDA) today released the next two proposed rules under the Food Safety Modernization Act (FSMA). FSMA, which President Obama signed into law in January 2011, aims to change the way FDA handles food safety from the current largely reactive system to one that stresses prevention.

The two new proposed rules concern Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors. Proposed rules on preventive controls in human food and produce safety were released in January 2013. The comment period for the two new rules will be 120 days; the comment periods for the produce safety and preventive controls regulations will be extended into November so that commenters can look at and respond to the regulations as a whole.

The AOCS Inform magazine news staff has asked FDA when the final FSMA regulation concerning preventive controls for animal feed will be released. We will post the reply when it is available.



FDA NEWS RELEASE


For Immediate Release: July 26, 2013
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA

FDA takes step to help ensure the safety of imported food

Agency releases new proposed rules under FSMA for verifying foreign suppliers and accrediting third-party auditors

In order to implement the bipartisan Food Safety Modernization Act (FSMA) signed by President Obama, the U.S. Food and Drug Administration today issued two proposed rules aimed at helping to ensure that imported food meets the same safety standards as food produced in the United States.

These proposals are part of the FSMA approach to modernizing the food safety system for the 21st century. FSMA focuses on preventing food safety problems, rather than relying primarily on responding to problems after the fact. The FDA encourages Americans to review and comment on these important proposed rules.

Under the proposed rules, importers would be accountable for verifying that their foreign suppliers are implementing modern, prevention-oriented food safety practices, and achieving the same level of food safety as domestic growers and processors. The FDA is also proposing rules to strengthen the quality, objectivity, and transparency of foreign food safety audits on which many food companies and importers currently rely to help manage the safety of their global food supply chains.

The new measures respond to the challenges of food safety in today’s global food system. Imported food comes into the United States from about 150 different countries and accounts for about 15 percent of the U.S. food supply, including about 50 percent of the fresh fruits and 20 percent of the fresh vegetables consumed by Americans. 

“We must work toward global solutions to food safety so that whether you serve your family food grown locally or imported you can be confident that it is safe,” said FDA Commissioner Margaret A. Hamburg, M.D. “Today’s announcement of these two new proposed rules will help to meet the challenges of our complex global food supply system. Our success will depend in large part on partnerships across nations, industries, and business sectors.”

Under the proposed regulations for Foreign Supplier Verification Programs (FSVP), U.S. importers would, for the first time, have a clearly defined responsibility to verify that their suppliers produce food to meet U.S. food safety requirements. In general, importers would be required to have a plan for imported food, including identifying hazards associated with each food that are reasonably likely to occur. Importers would be required to conduct activities that provide adequate assurances that these identified hazards are being adequately controlled.

“FSMA provides the FDA with a modern tool kit that shifts the paradigm for imports, as well as domestic foods, from a strategy of reaction to one of systematic prevention,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine. “Rather than relying primarily on FDA investigators at the ports to detect and respond to food safety problems, importers would, for the first time, be held accountable for verifying, in a manner transparent to the FDA, that the food they import is safe.”

FSMA also directs the FDA to establish a program for the Accreditation of Third-Party Auditors for imported food. Under this proposed rule, the FDA would recognize accreditation bodies based on certain criteria such as competency and impartiality. The accreditation bodies, which could be foreign government agencies or private companies, would in turn accredit third-party auditors to audit and issue certifications for foreign food facilities and food, under certain circumstances.

Importers will not generally be required to obtain certifications, but certifications may be used by the FDA to determine whether to admit certain imported food that poses a safety risk into the United States.
The two proposed rules, which are available for public comment for the next 120 days at
http://go.usa.gov/j5xG, will help the FDA create an integrated import oversight system that works efficiently to improve food safety and protect the public health.

These proposals work in concert with the proposed rules released in January 2013, for produce safety and preventive controls in facilities that produce human food. Those proposed rules are currently open for comment until September 16, 2013, but the FDA intends to grant a 60-day final extension of the comment period to allow commenters an opportunity to consider the interrelationships between the January proposals and the two proposals being announced today.

For more information:


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

# # #


Sebastian Cianci
Strategic Communications and Public Engagement
Office of the Deputy Commissioner for Foods and Veterinary Medicine
Food and Drug Administration
(240) 402-2291



Thursday, July 25, 2013

Response to Recent Paper on Omega-3 Fatty Acids and Prostate Cancer Risk

Brief Response to Recent Paper on Omega-3 Fatty Acids and Prostate Cancer Risk (by Prof. Bruce Holub, Dept. of Human Health and Nutritional Sciences, Univ. of Guelph. Guelph , ON, Canada  N1G 2W1 and Scientific Director , DHA/EPA Omega-3 Institute , Univ. of Guelph Research Park (www.dhaomega3.org)     Email: bholub@uoguelph.ca

Summary:
Brasky et al.  (in press/July 10 , J. of the National Cancer Institute (2013)) from the Ohio State University Comprehensive Cancer Ctr. in Columbus, Ohio have very recently reported (‘Plasma Phospholipid Fatty Acids and Prostate Cancer Risk in the SELECT Trial’) on the relationship between higher blood levels of omega-3 fatty acids and the risk of prostate cancer .This was a ‘case-cohort’ study from the US wherein the blood levels of long-chain omega-3 fatty acids (EPA-eicosapentaenoic acid , DPA-docosapentaenoic acid , DHA-docosahexaenoic acid) were measured in men aged 50 and over who were confirmed to have prostate cancer and those (controls) who were free of prostate cancer. The authors reported a positive relationship/trend based on statistical analyses between higher levels of long-chain omega-3 fatty acids (the sum of EPA/DPA/DHA omega-3 fatty acids) in the blood biomarker (omega-3 levels in blood plasma phospholipid) and total prostate cancer. They reported a significant positive relationship between higher blood levels of DHA and prostate cancer risk but no statistically-significant trend was found in the case of EPA. The authors concluded that ‘Recommendations to increase LComega-3 PUFA intake should consider its potential risks’.

Response from Prof. Holub:

It is noteworthy that this study did not evaluate the intake of long-chain omega-3 fatty acids to the risk of prostate cancer. The levels of EPA/DPA/DHA in the circulation are influenced by the metabolism of these fatty acids which differ between individuals including the metabolic conversion of dietary LNA (alpha linolenic acid, the short-chain and major omega-3 fatty acid in the N. Am. diet- representing  90 %  of the total omega-3 intake) to these long-chain omega-3 fatty acids. The blood levels of EPA/DPA/DHA also reflect the dietary intakes of these fatty acids (particularly EPA and DHA) from dietary sources (mainly fish/seafood) plus other foods  (including food enriched in EPA/DHA) plus supplements (nutraceuticals) containing EPA/DHA.

Numerous lifestyle factors (smoking , etc) have also been associated with differing blood levels of omega-3 fatty acids in the blood. Thus, this study does not allow for any direct connection of the higher blood levels of EPA/DPA/DHA combined, as associated with a moderately higher risk of prostate cancer (as reported in this paper), to a specific source such as dietary intake of total fish /seafood, specific types of fish/seafood , preparation of such (eg., salted , pickled) other food sources, fish oil supplements , other influencing factors. Thus, a quote from the research team in a recent widespread release that efforts to increase long-chain omega-3 fatty acid intakes (particularly from supplement sources) should consider the potential risks is premature and not well-founded in my opinion without directly assessing omega-3 intakes (via diet, fish/seafood, other foods enriched in EPA/DHA, fish oil supplementation) in relation to the risk of prostate cancer – which, these researchers did not do.

 It is noted that even moderate supplementation with EPA plus DHA omega-3 (one gram daily) over a 12 week period causes a very marked rise in EPA plus DHA levels in blood plasma phospholipid – to an average level of 7.93 % of total fatty acids (Thies et al., Am. J. Clinical Nutr., 73: 539-548 (2001). However, the average level of EPA plus DHA in the circulating phospholipid of those with prostate cancer was only 3.6 % in the study by Brasky et al. such that relating blood levels of long-chain omega-3 fatty acids to the risk of prostate cancer due to omega-3 supplementation  appears to be inappropriate .

The topic of dietary intake of fish and EPA/DHA prostate cancer was reviewed by MacLean et al. (J. Am. Medical Assoc., 295: 403-415 (2006). In the 4 studies as reviewed directed to fish consumption, 1 demonstrated a favourable effect, 1 showed a trend for a favourable effect, and 2 did not find an association. This review also reported on no significant association with the incidence of prostate cancer with marine omega-3 fats, EPA, or DHA consumption.
It is of interest to note that the present authors (who submitted their revised article on May 24, 2013) did not include reference to the publication by Torfadottir et al. in April of 2013 in Plos One (8(4): e59799)). These latter researchers reported upon finding no association between overall fish consumption in early or midlife and prostate cancer risk. However, there was some evidence that ‘salted’ or ‘smoked’ fish may increase the risk of advanced prostate cancer. Interestingly, men consuming fish oil in later life had a lower risk of advanced prostate cancer and no association was found for early life or midlife consumption. They concluded that fish oil consumption may be protective against the progression of prostate cancer in elderly men.

Finally, it is important to emphasize that Mozaffarian et al. have recently published on April 2, 2013 (Ann. Intern. Med., 158: 515-525 (2013) their findings from a major population study relating the levels of the summed and individual levels of long-chain omega-3 fatty acids in older US adults to all-cause mortality. Interestingly, the same biomarker (omega-3 fatty acids in blood plasma phospholipid) was used in the study by Mozaffarian et al. as used in the study by Brasky et al. Also, the distributions of long-chain omega-3 levels across the subject sub-groups (quintiles/quartiles) were generally quite similar. The study by Mozaffarian et al. (2013) reported a highly significant trend for total and individual long-chain omega-3 fatty acids such that higher blood levels were associated with less mortality.  Individuals with higher levels of total omega-3 fatty acids had a 27 % lower risk while higher levels of EPA and DHA were respectively associated with 17 % and 20 % less total all-cause mortality.

Tuesday, July 16, 2013

Day 3: 2013 Institute for Food Technology Annual Meeting and Expo

Well, the conference has finally come to an end. Thank you to everyone who came by our booth and played a friendly game of Plinko!

The conference was educational and entertaining. Stories about new products and market trends from the IFT Expo will be seen in Inform magazine in the near future. Here are a few more pictures from the big event.

AAK showing a new low-saturated fat coating chocolate for confectionary applications.

IOI Edible Oils celebrated its time at IFT with cupcakes and cake pops showcasing their baking and confectionary oils.

The Ocean Spray Cooperative

Plinko was a popular attraction at the AOCS booth.

Marketing and Public Relations Specialist Liz McMillen showcases the many AOCS books before the conference ends.

Monday, July 15, 2013

Day 2: 2013 Institute of Food Technology Annual Meeting and Expo

The IFT Annual Meeting and Expo finished up on its second day today. It's been great to see so many AOCS members among the exhibitioners and visitors. Today there were several sessions related to lipids, omega-3 fatty acids, mid-chain triglycerides, and conjugated linoleic acids in pet foods. Pet nutrition has been another popular topic on the expo floor, as has been determining counterfeit veterinary drugs. Many companies also featured food samples made or fried with omega-9 oils, including DuPont, Bunge, and Dow Agrosciences.

Companies have also drawn a line between who use GMO and who does not. While the performance of GMO and non-GMO products is similar, consumer perception has affected many business and processing decisions for IFT attendees.

Below are a few more scenes from the IFT Annual Meeting and Expo.

View from the top of the cafe.

Bunge's food truck featured long lines of people waiting to sample the omega-9 applications.


Roquette promoted their line of microalgae products, ready for commercial production.
The final day of the IFT Annual Meeting and Expo is Tuesday, July 16!

Risk Assessment on Acrylamide -EFSA to provide a scientific opinion on the potential risks for human health

EFSA’s experts have identified hundreds of scientific studies to consider for the Authority’s first full risk assessment of acrylamide, a chemical compound that forms in starchy food products during high-temperature cooking (including frying, baking and roasting). In 2005, EFSA stated that acrylamide may be a human health concern and that efforts should be made to reduce exposure to this substance through the diet. EFSA’s comprehensive assessment of this scientific issue will allow EU decision-makers to take account of the latest scientific findings in managing possible risks associated with the presence of acrylamide in the food chain.

An EFSA statement in 2005 noted that there may be a potential health concern with acrylamide which is considered to be both carcinogenic and genotoxic in test animals. In September 2012, EFSA received a proposal from organisations belonging to four EU Member States (Denmark, France, Germany and Sweden) to consider new scientific findings on the possible carcinogenicity of acrylamide. Subsequently, EFSA accepted a request from the European Commission to provide a scientific opinion on the potential risks for human health of acrylamide in food.

EU Member States are requested to perform yearly monitoring of acrylamide levels and EFSA has assessed these data in four annual monitoring reports. The last report from 2012 did not reveal any considerable differences from previous years in the levels of acrylamide in most food categories assessed. In April 2013, EFSA launched a call to food business operators and other stakeholders to submit additional analytical data on acrylamide levels in foods and beverages collected from 2010 onwards. The Authority has also consulted consumer organisations, NGOs and the food industry through its Stakeholder Consultative Platform to find out about ongoing and recent research related to acrylamide in food. EFSA will also consider related international developments, including work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Using these results and other available scientific information, experts on EFSA’s Panel on Contaminants in the Food Chain (CONTAM Panel) will assess the toxicity of acrylamide for humans and update its estimate of consumer exposure through the diet. EFSA’s experts aim to complete this full risk assessment and publicly consult on their draft scientific opinion in mid-2014. The feedback received will assist the Panel in finalising its scientific opinion, scheduled for the first half of 2015.

Notes to editors:
Acrylamide forms from sugars and an amino acid that are naturally present in food. Acrylamide has been found in products such as potato crisps, French fries, bread, biscuits and coffee. It was first detected in foods in April 2002.

Read More: Acrylamide in food – EFSA to publicly consult on draft opinion in 2014

Find Out More
More from AOCS
Definition
This method is used for the determination of glycidyl (glycidol) fatty acid esters (GEs) in edible oils using double solid-phase extraction (SPE) and liquid chromatography—mass spectrometry (LC-MS) using HPLC.
Scope
Applicable for the determination of glycidyl fatty acid esters (GEs) in edible oils and fats.
Troy D. Haines, Kevin J. Adlaf, Robert M. Pierceall, Inmok Lee, Padmesh Venkitasubramanian, Mark W. Collison. Journal of the American Oil Chemists' Society. January 2011, Volume 88, Issue 1, pp 1-14.

Sunday, July 14, 2013

Day 1: Institute of Food Technologies 2013 Annual Meeting and Expo

The Institute of Food Technologies 2013 Annual Meeting and Expo began today, July 14, 2013 and will run through July 16 at the Robert McCormick Center in Chicago, Illinois, USA. The event began with a keynote address from CNN reporter and Time Magazine editor-at-large Fareed Zakaria. His message was a simple one: look at history, and you will see that when human beings confront a problem constructively and positively, they will find a way to solve it. Zakaria told IFT members not to worry, though it was human nature to do so. For many companies exhibiting at the IFT expo, there were several things to worry about: the use of genetically modified organisms (GMO), the increased production of high-oleic acids, packaging, labeling, and other issues involving edible oils in food science.

With 20,000 attendees from over 100 countries, more than 200 new products, and over 100 companies in attendance, the IFT Annual Meeting and Expo has brought together some of the greatest minds in food sciences and edible oils to consider many possible solutions to these issues. Several AOCS members and member companies are in attendance, such as Bunge, Archer Daniels Midland, Cargill, and many more. AOCS is also at the expo at Booth 4515. For those unable to attend, here are a few early highlights. Members who have a Twitter account can also receive updates and information about the meeting by following IFT's hashtag #IFT13.
Fareed Zakaria during the keynote address. He also advised IFT members to consider ancillary product costs such as water and energy consumption in creating food products.

3rd floor of McCormick Place for the IFT Expo

Expo entrance

Technical specialist Gina Clapper at the AOCS booth, Booth 4515, at the IFT Expo.


The Soy Connection booth, part of the United Soybean Board.
More to come from the IFT Expo!

Wednesday, July 3, 2013

There's an app for that! You can now read Inform on your mobile device!

Read Inform magazine anytime, anywhere by downloading the free mobile app!

Access Inform magazine from the convenience of your mobile phone or tablet and gain quick access to current and past Inform issues. The Inform app is available on Apple, Android, Kindle, and Window devices. Visit the AOCS website to learn more about the app and details on themed Inform collections, only found on the app. 


The app is free for everyone to download.

AOCS Members, use your AOCS login credentials for access.
Nonmembers pay just $2.99 per issue.



Find out more here.

Happy reading!