Food-Label-Compliance.com - Food Labeling, Food Safety, and Food Science

December 15, 2017



Articles

December 12, 2017 - Woodhouse Shanahan has been engaged to provide Food Safety Modernization Act Compliance expertise to iRaiShimp SL, a leading consultancy to the international seafood industry, based in Valencia, Spain. A primary focus of our work will be the design and drafting of Food Safety Program documentation for exporters to the USA including Risk-Based Preventative Controls Plans, Seafood HACCP Plans, Sanitary Transportation Plans, and Intentional Adulteration Prevention Security ...
Tags:
November 2, 2017 - Lorman Education Services will sponsor a National CLE (Continuing Legal Education) class given by Charles Woodhouse on Food Law, the Food Safety Modernization Act, and the Clean Label Movement on February 7, 2018. Agricultural producers, food manufacturers, and the Food Technologists who safeguard America's food supply are facing unanticipated challenges as consumer activists increasingly demand cut-backs in the use of standard food additives. How will Food Lawyers advising ...
Tags:
November 1, 2017. - Charles Woodhouse is Co-author with Barbara Bennett Woodhouse, Professor of Law, Emory University, of a paper titled The Politics of Food. This article is part of the Hofstra University Special Symposium on Children's Human Rights in Fall Semester 2017. Charles Woodhouse has focused his portion of the presentation on the roles of USFDA, USDA, the USFTC, and the USEPA with respect to Childhood Nutrition, Toxicology, and Food Safety as they relate to the Rights of ...
Tags:
Woodhouse Shanahan serves as Counsel for technical Food Law and Food Science issues to Rhythm LLC a leading international design firm thatspecializes in the Consumer Packaged Goods industry. Rhythm provides end-to-end design services: brand ideation and strategy; packaging ideation and design development; compliance review of labeling and advertising claims; product launch support; and a wide variety of strategic marketing communication services structured to deploy, accelerate, and build an ...
Tags:
September 4, 2017 - Charles Woodhouse has been appointed to the Editorial Board of Sci-Tech Lawyer Magazine. Sci-Tech Lawyer is the flagship quarterly publication of the American Bar Association Science & Technology Law Section. His appointment will bring additional scientific and technical expertise in Food Science to issues related to Food Regulation in areas of emerging food technology applications such as use of nanomaterials in Food Processing and Food Preservation. Attorney Charles ...
Tags:
August 1, 2017. - Our new website is in development at www.food-recall-law.com and will feature our work on food industry Supply-Chain Risk-Management as developed in our recent articles in Sci-Tech Lawyer and Food Cosmetics & Nutraceuticals. Our goal is to assist clients in the prevention of Food Safety Incidents and Food Recalls and in the mitigation, through advanced planning and preparation, of such Incidents should they occur. Our focus is on putting in place systems and ...
Tags:

CRISPR/Cas9 Advances Plant Breeding

Published on Mon, Jun 12, 2017 by Charles Woodhouse
June 13, 2017 - This week's c&en (Chemical & Engineering News - June 12) cover article is titled CRISPR: A new toolbox for better crops. The article is highly recommended for Food and Agricultural Scientists. The article can be accessed on your institutional science database services or directly by members of the American Chemical Society. Crisper is of course the acronym for Clustered Regularly Interspaced Short Palindromic Repeats and excellent background information on CRISPR is ...
Tags:
June 2, 2017 - In his June 1 announcement of the Administration's decision to withdraw from the Paris Climate Change Agreement, President Trump cited two studies. The popular press - notably the New York Times - has devoted some attention to the validity and interpretation of this data. However, our readers are credentialed scientists who do not form their opinions based upon secondary sources. Therefore, our readers should download these two documents and make a personal assessment of: ONE ...
Tags:
May 1, 2017. - With a press release titled Make School Lunches Great Again, USDA Secretary Purdue has delayed long-standing USDA Sodium Reduction Target I Goals by 3-years to 2020. Thus, American children will be permitted to continue receiving up to 74% of the daily Tolerable Upper Intake Limit for Sodium in a single school lunch. We attach (1) the USDA Press Release; (2) the Proclamation signed by Secretary Perdue; (3) the 2012 Target Goals for Sodium Reduction; and (4) documentation of the ...
Tags:
April 28, 2017 - Charles Woodhouse will be Co-presenter with Barbara Bennett Woodhouse, Professor of Law, Emory University, of a paper titled Children's Rights and the Politics of Food. This presentation will be part of the Hofstra University Special Symposium on Children's Human Rights in Fall Semester 2017. Charles Woodhouse will focus his portion of the presentation on the roles of USFDA, USDA, the USFTC, and the USEPA with respect to Childhood Nutrition, Toxicology, and Food Safety as ...
Tags:
February 4, 2017 - Charles Woodhouse has published an article which orients Food Industry Attorneys and Food Executives to the important changes in Risk-Management practices which are necessitated by the "Clean Label Movement", FSMA, and new pardigms of 21st Century Supply-Chain Logistics. The article appears in the Winter 2017 issue of the American Bar Association's "Food Cosmetics and Nutraceuticals" (ABA Science & Technology Law Section). A PDF of the article is posted below:
Tags:
January 17, 2017 - FDA has issued a January 2017 Draft Guidance on Listeria Control in RTE Foods. This extraordinarily important and long-awaited document belongs in the Tool Kit of all Food Scientists and Food Engineers. At Woodhouse Shanahan we will be adding this document to the Technical Bibliography on all RBPC and HACCP Plans prepared for clients. We attach the document titled - Control of Listeria monocytogenes in Ready to Eat Foods: Guidance for Industry / Draft Guadance - below:
Tags:
January 6, 2017 - With forthcoming implementation of changes in Nutrition Labeling and revisions to RACCs, practitioners should read the two new Draft Guidances against 81 FR 33742 and 81 FR 34000. We post below the four operative documents: Reference Amounts Customarily Consumed: List of Products for Each Product Category, USFDA, January 2017. Questions and Answers on the Nutrition and Supplement Facts Labels, USFDA, January 2017. 81 CFR 33742 Nutrition Labels Final Rule, May 27, ...
Tags:
January 1, 2017 - We post below the two Presentations and the two Supply-Chain conceptualizations cited in Charles Woodhouse's forthcoming article "Food Lawyers Face Challenges from 21st Century Logistics, FSMA, and the Clean Label Movement". The first is a 2015 Presentation on "Getting from HACCP to HARPC" and the second is a December 2016 Presentation on "Third-Party Food Safety Certification". Following these documents are: Chart 1, Traditional Supply-Chain; and Chart 2, 21st Century ...
Tags:
December 14, 2016 - As our readers know, except for infant formula, Open Product Dating is not required by Federal Regulation. Nevertheless, a number of commonly used phrases appear on US food labels for both perishable and shelf-stable products in addition to the Closed Dating Codes required for Traceability. Finally, USDA FSIS has spoken and given its blessing to the phrase - Best if Used By - for products using optional Open Dating. Our Food Scientist readers who have studied Food ...
Tags:
December 12, 2016 - Deputy AG Sally Yates and Assistant Deputy Benjamin Mizer have delivered important remarks in the past week on the prosecution of administrative crimes which include violations related to both FDA and USDA matters. These timely remarks are of particular interest to Regulatory Food Scientists and Food Executives during the transition to the new administration at the Department of Justice. We post the text of both addresses below as well as a link to an important National ...
Tags:
December 7, 2016 - We have updated our 2015 PowerPoint (previously posted) on Third-Party Certification and Food Supply-Chain Risk-Management. Our Reading List in the PDF posted below has been updated to include important new books by Frank Yiannas, MPH and Professor Neal Fortin. The second edition of Fortin's text - Food Regulation: Law, Science, Policy and Practice - was released on December 1 by Wiley Science. Neal Fortin heads the Food Law Programs at Michigan State and it was my ...
Tags:
November 25, 2016 - An important article from the November 25 issue of Science, titled Republicans Ready a Regulatory Rollback, is must reading for food executives. Clearly, some provisions of FSMA are vulnerable to Congressional or Administration rescission or modification - but there are two points of view on what may happen in the next several years. However, first, I must state that our firm takes no position whatsoever on political issues – our responsibility is solely to ...
Tags:
November 15, 2016 - The greatest risk for the managers of an American food business may not be that FDA (or USDA, Meat & Poultry) will somehow intervene in the business and impose massive “regulatory costs” on the business. It is also not reasonable to excessively fear the possibility of criminal prosecution, always highly unlikely except under egregious circumstances. Rather, the greatest risk is always civil liability resulting from a Food Safety Incident which could be ...
Tags:
November 10, 2016 - FDA has now issued the Final Guidance Document on the VQIP (Voluntary Qualified Importer Plan). This document addresses one of the final important unresolved issues in FSMA (Food Safety Modernization Act) implementation. The advantages of participation in this "Green Lane" for Food Imports are clear. However, the requirements for qualification and the application process are complex and will present significant challenges to smaller importers. We post the Guidance ...
Tags:
October 12, 2016 - We apologize to our readers for the reduced rate of postings during the Fall Semester. Now that I am back in Graduate School again (for my MS Packaging) and also busy with American Bar Association work, keeping up on postings to this Blog has ben difficult. However, following up on my 2016 article on "Sanitary Transportation of Food" ("Food, Cosmetics and Nutraceuticals", Spring 2016), I have written an article titled "Supply-Chain Structures: Supply-Chain Guarantees and ...
Tags:
September 25, 2016 - FDA has now issued an Industry Guidance document clarifying enforcement discretion with respect to the use of the word Healthy on Conventional Food labels. This Guidance specifies criteria for use of Healthy for Conventional Foods that: (1) do not meet the criteria for labeling as low fat but still meet defined fat content profiles for mono and polyunsaturated fats; and (2) contain at least 10% of the DV (Daily Value) for the RACC (Reference Amount Customarily Consumed) ...
Tags:
September 20, 2016 - The September 2016 Draft Guidance for Industry – Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling - represents USFDA’s first definitive guidance on the required Substantiation Standard for Structure / Function Claims for a Conventional Food. Industry observers, including myself, believe that FDA is sending a strong signal that it intends to apply this Substantiation Standard (consistent with the position of the FTC) to ...
Tags:
AUGUST 24, 2016 - Today's Federal Register contains FDA's update of certain FSMA compliance dates related to the RBPC Final Rule. Of particular interest is the extension of the "Customer Provisions" compliance date allowing use of certain disclaimers to "downstream" customers. This postpones, but does not eliminate the need for practitioners to deal with the complex Supply-Chain interplay between "downstream" Continuing Guarantees and "upstream" Indemnification Agreements. How the anticipated ...
Tags:
AUGUST 20, 2016 - We comment on an exciting new book, receiving great praise in Nature, that we have added to our “reading list” of important science books for both the broadly educated scientist and the inquisitive non-scientist. Naturally, all Food Scientists will find this book to be “must” reading. Yong, Ed, I Contain Multitudes: The microbes within us and a grander view of life, Harper Collins, 2016. Writing in Nature August 11, 2016, Adrian Woolfson comments ...
Tags:
August 18, 2016 - FDA has issued a new Revised Draft Guidance for Dietary Supplement NDIs (New Dietary Ingredients) to replace the 2011 Draft Guidance. This document should be studied carefully as it confirms a narrow definition of Dietary Ingredients, further restricts permissible Grandfathered NDIs, and has articulated new policies on Synthetic Ingredients. It also makes important changes in Notification Procedures. We post the full text of the document below:
Tags:
August 13, 2016 - The Final Rule on GRAS Notifications and new requirements for substantiation and the qualifications for GRAS Panels have been issued in prepublication form by FDA. Taking up the language of FSMA, FDA will now require submissions to be signed by objectively qualified individuals. This Final Rule will be published in the Federal Register on August 17. This is important reading for Regulatory Food Science professionals and we urge our readers not to rely upon "media" accounts ...
Tags:
JULY 15, 2016 - FDA has released an updated Final Rule - Amendment to Registration of Food Facilities. We post the text of 81 FR 45912 July 14, 2016 below. Our readers should update their files with 81 FR 45912 which reflects important changes in several areas, most notability access to Registered Facilities for FDA Inspection.
Tags:
July 14, 2016 - S-762 the National Bioengineered Food Disclosure Standard has now passed in both the House and the Senate and the Enrolled Bill has been sent to the President for signature. It is important that professional regulatory scientists read the exact text of the Bill and not rely upon "media" coverage. The text of the Enrolled Bill is posted below:
Tags:
JULY 9, 2016 - We are now only 60-days from the most important compliance deadline under FSMA - the Risk-Based Preventative Controls Final Rule. To our great surprise, we are recording more downloads of this article from our 2014 posting that we experienced when the article was current. So - to assist our readers we post again the article from SciTech Lawyer, Summer 2014. Two years ago we issued the warning that food industry companies should immediately begin organizing their FSMA Compliance ...
Tags:
July 6, 2016 - The Eighth Circuit Court of Appeals has upheld the prison sentences for Austin (Jack) DeCoster and his son Peter. Our readers, as always, are cautioned against reading only "media" reports regarding this important and closely watched Food Safety prosecution under the "Park Doctrine" or "Responsible Corporate Officer Doctrine." Therefore, we attach below the full text of the Eighth Circuit decision issued on July 6 and urge our readers to study the actual decision in ...
Tags:
June 1, 2016 - On May 27, USFDA released the FSMA Final Rule on Intentional Adulteration. We post below the Federal Register Notice. The Intentional Adulteration (Food Defense) Rule cannot be interpreted alone, separately from the Risk-Based Preventative Controls Rule. As always, we remind our professional readers to pay little attention to popular and industry press "explanations" of these FSMA Rules. These articles are usually written by persons who are anxious to tell us "more than they ...
Tags:
April 19, 2016 - Charles Woodhouse's article on the Sanitary Transportation FSMA Final Rule appears in the Spring 2016 issue of Food, Cosmetics & Nutraceuticals published by the American Bar Association. A second article, also by Woodhouse, is planned for a subsequent issue. This first article presents a Compliance Flow Chart for US Food Importers and their overseas Suppliers. The second article will present a detailed discussion on the preparation of the Sanitary Transportation Plans ...
Tags:
April 18, 2016 - Section 402 of FSMA provides Whistleblower Protection to employees who bring Food Safety violations to the attention of regulatory authorities. Attorneys familiar with Labor Law will understand the implications of the Attorney Fee Provisions (including Expert Witness Fees) of this new OSHA Final Rule. As usual, we expect that our professional regulatory science readers will ignore media coverage and press releases and read the entire text of the Rule. The Final Rule ...
Tags:
April 11, 2016 - Charles Woodhouse has published his article titled Food Packaging: Supply-Chain Compliance, Innovation, Food Safety in the Association of Food Industries 2016 Annual Report to the US Food Industry. A copy of the article is posted below. Please note that the original text is difficult to read and footnotes were not carried into final publication. Therefore, we post a more readable text with all footnotes as pages 5-9 of the attached file.
Tags:
April 6, 2016 -- FDA has issued the Final Rule on Sanitary Transportation of Human and Animal Foods. Charles Woodhouse is currently preparing an article on the Sanitary Transportation Rule for the American Bar Association publication Food, Cosmetics and Nutraceuticals. When the article is published later this month we will post it here. In the meantime we post the Federal Registed Notice published on April 6.
Tags:
March 14, 2016 - Charles Woodhouse has published an article titled "Food Packaging: Supply-Chain Compliance, Innovation, and Food Safety" in the Association of Food Industries 2016 Annual Report to the US Food Industry. Space constraints in the Report require that End Notes be posted separately via an on-line link. Here posted is the full article and the End Notes. Attorney Shelly Garg of Sandler, Travis & Rosenberg is co-author.
Tags:
We have recently had several requests for information on statistical sampling protocols and note that it is very difficult to obtain copies of Military Standard 105D issued by the Department of Defense in 1963. As many of our readers know, the ANSI/ASQ standards are based upon MIL-STD-105D. As a courtesy to our readers we post MIL-STD-105D below. The extensive Sampling Tables and the clear explanation of Switching Rules in MIL-STD-105D is a most valuable resource for Quality Assurance ...
Tags:
February 23, 2016 - Perhaps the greatest challenge of 2016 for food industry executives is the preparation of the Risk-Based Preventative Controls Plan required by the Food Safety Modernization Act. We post below a recent presentation by Charles Woodhouse on this critical task.
Tags:
November 27, 2015 - As discussed in our earlier posts, the Produce (215 pages), Foreign Supplier Verification (127 pages), and Third-Party Certification (98 pages) Final Rules were published in the Federal Register on November 27. We post all three below in PDF format. These are the documents which should be used, in the future, for all citations by regulatory science professionals. Please disregard "Advance" copies of the text which we have given you in earlier posts.
Tags:
November 13, 2015 - FDA has posted Advance Texts of three more FSMA Final Rules: (1) Third-Party Certification; (2) the Foreign Supplier Verification Program; and (3) the Produce Final Rule. Please see texts posted below. But please, before starting any serious analysis, wait for the three Final Rules to appear in the Federal Register on November 27 since all citations must be to the final texts. Also - please note that, as is the case with the Proposed Rule and Final Rule on Risk-Based ...
Tags:
September 15, 2015 - FDA has now published the Draft Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11) which was released on September 11, 2015. This Draft Guidance relates to the Final Rules published in December 2014 and the additional Federal Register Notice (80 FR 39675 July 10, 2015) extending the Compliance date to December 1, 2016. Nutrition ...
Tags:
September 12, 2015 -- We call our readers’ attention to Bill Marler’s excellent editorial in Food Safety News (September 9), “Why the CEO and Board Need to Pay Attention to FSMA”, in which he discusses the increasing level of federal prosecutions of food industry executives for regulatory crimes under the FDCA. We cannot attach the Marler article for copyright reasons but it can be read at www.foodsafetynews.com On that same day, Deputy Attorney General Sally Yates ...
Tags:
September 10, 2015 - FDA has released the pre-publication texts in advance of the September 17 Federal Register Notices. Our professional regulatory-science readers will now be able to check the Final Rules for key changes from our anticipated revisions of the Proposed Rules. In the weeks ahead, you will see numerous articles in the general and business press, written primarily by unqualified individuals who will tell you “more than they know” about these major changes to ...
Tags:
August 1, 2015 -- We call our readers’ attention to a timely and important peer-reviewed article pointing out one of the most basic principles of Food Safety and Food Liability Management that has appeared in advance copy (scheduled for February 2016 publication) in Food Control. The principles expounded in this article were major themes in a science-based audit management lecture that I delivered to Italian exporters at an industry meeting in April 2015 in Sicily. For my development ...
Tags:
July 24, 2015 -- FDA has issued a Supplemental Proposed Rule that would: (1) require declaration of the percent daily value (%DV) for added sugars; and (2) change the current footnote on the Nutrition Facts label. To assist our readers we have posted below: (1) the Supplemental PR; (2) the March 2014 PR on Nutritional Label changes; (3) the March 2014 PR on Serving Size; and (4) a PDF of today’s FDA web page announcement. As always – we remind our professional Regulatory ...
Tags:
July 23, 2015 -- FDA has issued a Draft Guidance on Model Accreditation Standards for Certification Organizations as well as a Proposed Rule on User Fees for accreditation of auditors. We post below the Draft Guidance, the User Fee Proposed Rule, and the original Federal Register Notice of July 29, 2013. We anticipate the Final Rule being issued later this year.
Tags:
July 20, 2015 - Swiss Reinsurance has issued two reports on the cost of US Food Recalls which topped $15 Billion in 2013. Among the key findings are: (1) the number of recalls per year in the US has almost doubled since 2002; (2) food contamination costs US health authorities $15.6 billion per year; (3) nearly 9 million Americans became sick from contaminated food in 2013; (4) the median food recall costs the affected company more than $10 million per incident; and (5) a globalized food ...
Tags:
July 16, 2015 - The House Agriculture Committee has approved and sent to the floor "The Safe and Accurate Food Labeling Act of 2015". This bill, if enacted, will accomplish four objectives: (1) preemption of state level GMO labeling regulation and state level restrictions on GMO crops; (2) establish a national policy on GMO Labeling; (3) establish a national system for "GMO Free" certification; and (4) require FDA to finally issue regulations defining the use of "natural" and similar terms in ...
Tags:
July 1, 2015 - As our readers know, the FDA Food Code has been adopted into state law by all 50 states in one of its recent iterations. The Food Code is updated every four years by FDA with the most recent full-update in 2013. From time-to-time FDA has issued Supplements when timely changes are appropriate between major revisions. We attach below the 2013 Supplement issued on June 30, 2015.
Tags:

FDA Removes PHOs from GRAS Status

Published on Wed, Jun 17, 2015 by Charles Woodhouse
June 17, 2015 - Readers should note today's Federal Register Notice announcing that FDA has removed PHOs from GRAS Status. Partially Hydrogenated Oils must be removed from all foods sold in the USA by June 18, 2018. We post today's Federal Register Notice below:
Tags:
June 15, 2015 - FDA has now released the Draft Guidance for Industry on the Voluntary Qualified Importer Program (VQIP). For background please read Charles Woodhouse's article from SciTech Lawyer Magazine which is available on a post below (June 1) and his article on Importer Food Safety Vulnerability Review also posted below (May 15).
Tags:
June 10, 2015 - USDA FSIS has released Guidelines for Control of Listeria monocytogenes (Lm) in Retail Delicatessen Operations. Given the numerous recent Food Safety Incidents related to Lm in Deli Products, this has become a serious Food Liability issue for Retail Grocery Operations. We post a copy of the new Guidelines document below:
Tags:
June 1, 2015 - With important new FSMA Final Rules beginning to issue in the next several months, we again post our article from the Summer 2014 issue of SciTech Lawyer Magazine. This is important background for understanding the forthcoming Final Rules. Particularly important is the Final Rule on Risk-Based preventative Controls that FDA plans to issue in July 2015.
Tags:
May 15, 2015 - The Association of Food Industries has published an article written by Charles Woodhouse (principal author) on Importer Food Safety Vulnerability Review. This article discusses in detail important food importer vulnerabilities brought about by the implementation of the Food Safety Modernization Act.
Tags:
December 1, 2014 - FDA has now published, in the Federal Register, the Final Rules on Restaurant and Vending Machine Labeling. We post below the Federal Register files in PDF Format for the convenience of our readers.
Tags:
September 29, 2014 - FDA has issued four revisions to FSMA Proposed Rules. The revised proposed rules are: Produce, FSVP, RBPCs for Human Food, and RBPCs for Animal Feeds. We post the Federal Register Notices below:
Tags:
September, 21, 2014 - Charles Woodhouse, Food Law Attorney and Food Scientist, was an invited speaker at the annual Federal Judges' Training Conference at the Court of Appeals for the Federal Circuit held in Washington DC. He addressed the audience of Federal District and Appellate Judges on recent legal developments related to the implementation of the Food Safety Modernization Act. The presentation was based on Charles Woodhouse's recent article in "SciTech Lawyer" magazine (published by the ...
Tags:

Apology to Readers

Published on Mon, Sep 1, 2014 by Charles Woodhouse
September 1, 2014 - Please excuse our suspending regular postings for the Fall Semester. Charles Woodhouse is teaching his US Food Imports Regulation course this semester at Michigan State. Due to the heavy workload involved, we simply do not have time to maintain our regular blog posts. We will resume postings in January 2015.
Tags:
July 10, 2014 - Charles Woodhouse will speak at the Court of International Trade Judges' Tranining Conference in Washington in September. The topic will be the interaction of FSMA (Food Safety Modernization Act) Proposed Rules, issued by USFDA, and Customs practice and procedure. Charles Woodhouse teaches "US Food Import Regulation" as an Adjunct Professor in the Michigan State University College of Law LLM Global Food Law Program.
Tags:
June 25, 2014 - SciTech Lawyer, published by the American Bar Association Section of Science & Technology Law has posted an advance copy of Charles Woodhouse's article from the Summer 2014 issue. We post a copy of the article titled "Preparing for the Food Safety Modernization Act" below. The article will also be available on the Science & Technology Section website in July.
Tags:
June 12, 2014 - The US Supreme Court has issued its decision in Pom Wonderful v. Coca-Cola. The full text of the decision is posted below. This important breaking-news in Food Law will be widely discussed in the coming days. My advice is to read the full decision before you spend time on general media coverage written by non-lawyers who are anxious to tell you "more than they know".
Tags:
June 11, 2014 - Many of us have been following the media-fuss over the FDA Warning Letter to an artesanal cheesmaker in New York State. The over-reaction of the US artesanal cheese industry has now produced a far more negative effect. To slightly mis-quote Shakespeare's Hamlet, these people are now "Hoist by their own Petard". In the clarification posted below, FDA releases a surprising statistic on the prevalence of Listeria in artesanal cheese facilities that will do significant long-term ...
Tags:
May 28, 2014 - The Center for Science in the Public Interest (CSPI) has filed a Complaint in Federal District Court (District of Columbia) seeking to compel USDA/FSIS to act on CSPI's May 25, 2011 Petition to declare AMR (Anti-Microbial Resistant) Salmonella strains as adulterants under the meaning of the FMIA and the FDCA. The Complaint, in Paragraph 11, lists the relevant strains which CSPI seeks to have declared as adulterants (Hadar, Heidelberg, Newport, Typhimurium). We post a copy of ...
Tags:
May 14, 2014 - The FDA has filed a Motion to Dismiss in Center for Food Safety v. Hamburg. Please see our post of February 22 below (a copy of the original Complaint is posted there). Please also see below a copy of the Motion to Dismiss filed on May 14.
Tags:
May 6, 2014 - Senator Lamar Alexander (R-TN), the ranking Republican on the Senate HELP Committee (Health, Education, Labor, and Pensions) has written to FDA Commissioner Hamburg requesting clarification on FDA's use of Draft Guidances rather than formal Notice-and-Comment Rulemaking. As practitioners of FDA law know, some outstanding Draft Guidances date back to the last Century and, in the absence of Final Rules, often provide FDA's stakeholders with inadequate information on which to make ...
Tags:
April 11, 2014 - A Final Rule on use of Ionizing Radiation for pathogen control in crustaceans is scheduled to issue in the Federal Register on April 14. Absorbed doses of up to 6.0 kiloGray will be permitted. Readers should remember that, subject to certain exceptions, an irradiated food must be labeled with the "radura" and carry required disclosure statements. We attach a pre-publication copy of the Final Rule below:
Tags:
April 8, 2014 - We post below the abstract of the article published in the April 2014 issue of the Journal of Animal Science. Readers with access to academic journal services should, of course, read the full article. This research points to another possible avenue for the control of pathogenic bacteria in meat and processed foods.
Tags:

NRDC Issues Report on GRAS Process

Published on Mon, Apr 7, 2014 by Charles Woodhouse
April 7, 2014 - The Natural Resources Defense Council has issued a report titled "GRAS: How the Loophole Swallowed the Law". As our readers know, we generally do not comment on the merits of such controversial matters - particularly when participants choose to use "conclusory" language as opposed to measured scientific and legal argument. Nevertheless, this report will be a significant factor in the current public-policy debate over GRAS reform. Therefore, we direct our readers to the ...
Tags:
April 4, 2014 - The Court of Appeals for the DC Circuit has vacated the March 28 decision (see post below) and has ordered a rehearing en banc on May 19. Thus, the March 28 decision for USDA is again in question and Canada continues to maintain that the current USDA Meat COOL Rule violates the WTO TBT Agreement. A copy of the Order is posted below:
Tags:
March 28, 2014 - The Court of Appeals for the District of Columbia Circuit has issued a decision in favor of USDA in the Country of Origin (COOL) meat labeling dispute. The 15-page opinion is posted below. Our professional readers will want to carefully review the text of decision as it is not possible to understand the nuances of this important matter from news media reports. Clearly, Mexico and Canada will be taking this important issue back to the WTO.
Tags:
March 27, 2014 - The European Food Safety Authority has issued, in EFSA Journal, Part II of its series of Scientific Opinions on "risk posed by pathogens in food of non-animal origin" (Salmonella and Norovirus in Leafy Greens). We post this document below along with Part I (previously posted) - outbreak data analysis and risk ranking of food/pathogen combinations.
Tags:
March 10, 2014 - On March 10, the Center for Science in the Public Interest filed a Complaint for Declaratory and Injunctive Relief in the US District Court for the District of Columbia. The Complaint seeks a court-order to compel FDA to begin the long-delayed rule-making process for labeling of immediate containers and provision of point-of-sale information to disclose to consumers the possible presence of methylmercury in major commercial seafood species known to contain significant levels ...
Tags:
March 4, 2014 - The Journal eLife (Editor, Randy Schekman, 2013 Nobel Prize, Physiology & Medicine) has published a potentially important article on acquired resistance to ionizing radiation in E. coli. The research was conducted at Lawrence Berkeley National Laboratory and University of Wisconsin - Madison. The abstract of this open source article is posted below and interested readers can access the full text at the eLife website. Normal 0 false false false EN-US X-NONE ...
Tags:
February 27, 2014 - USFDA has today released the two pre-publication texts for the Proposed Rules on Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion. The two pre-publication texts are respectively 367 and 145 pages in PDF format. As always we urge our Regulatory Food Science professional readers to ignore the "industry media" and read the actual documents. It is not possible for a non-scientist, non-lawyer ...
Tags:
February 22, 2014 - Under the 1997 Proposed Rule (never issued as a Final Rule), FDA has permitted the Self-Affirmation by Petitioners of GRAS Status for Food Additives for nearly 16 years. This practice was strongly criticized by the GAO (Government Accountability Office) in a 2010 GAO Report. Now, this practice has been challenged in a lawsuit filed by the Center for Food Safety in U.S. District Court for the District of Columbia. This lawsuit will focus attention in the coming year on this ...
Tags:
February 21, 2014 - On February 20, FDA settled the Center for Food Safety lawsuit* with a Consent Decree agreeing to specific dates for the issuance of the "Big Seven" FSMA Final Rules. We post the Consent Decree below, urging our readers to read the actual document as opposed to media reports. The Final Dates are: August 30, 2015 Preventative Controls for Human Food - FSMA Sec. 103(a) and 103(c) August 30, 2015 Preventative Controls for Animal Food - FSMA Sec. 103(a) and 103(c) October ...
Tags:
February 18, 2014 - OSHA has published its Interim Final Rule on Employee Retaliation Protection pursuant to Section 402 of the Food Safety Modernization Act. We have previously commented on this important FSMA provision in our October 2013 article published by the American Bar Association - "Preparing for FSMA". We post the Interim Final Rule below. Also we post FSMA Section 402 for the convenience of our readers.
Tags:
February 7, 2014 - President Obama traveled to Michigan State University today to sign the Agricultural Act of 2014 ("The Farm Bill"). Following the Conference Report on January 27, the House voted 251/166 on January 29 and the Senate followed with a 68/32 vote on February 4. We note that the Act represents a shift from direct payments to producers to an enhanced "insurance system" with an expanded role for Risk Management Agency programs. Please see our post of January 28 for information on ...
Tags:
February 3, 2014 - FDA has issued its first statement on the criteria to be used in connection with the designation of "high risk foods" pursuant to the requirements of Section 204 of the Food Safety Modernization Act ("FSMA"). We post below the Memorandum and, for our readers' convenience, the full text of Section 204 of FSMA.
Tags:
February 1, 2014 - FDA has now issued the last of the "Big Seven" proposed rules pursuant to the Food Safety Modernization Act. The Sanitary Transportation Rule is estimated by FDA to affect some 83,000 businesses involved in the US food supply-chain. The rule will affect equipment, operations, training, and record keeping for shippers, receivers, and carriers who transport food in the United States. It will also affect exporters to the United States if the food product will be transported by ...
Tags:
January 28, 2014 - As the Agriculture Act of 2014 ("The Farm Bill") moves to a final vote in the House, the Food Safety Insurance Study remains in the Bill. This provision instructs the FCIC (Federal Crop Insurance Corporation) to fund the one-year study. We post an excerpt from Section 11022 below: Normal 0 false false
Tags:
January 28, 2014 - Despite extensive discussions between FDA and produce growers, dealers, and retailers, Section 12311 of the Agricultural Act of 2014 ("Farm Bill") does not appear to require any significant changes by FDA. A caveat is that the text posted below is, of course, provisional as of January 27. Rather, the intent of Congress is simply that FDA be "flexible" with respect to regional differences in cultural practices and to the varying size of business entities in the ...
Tags:
January 15, 2014 -- FDA has issued a Draft Guidance for Industry document on Distinguishing Liquid Dietary Supplements from Beverages. A PDF of the Draft Guidance is posted below:
Tags:
December 24, 2013 - FDA has Issued the FSMA Intentional Adulteration Proposed Rule. We post below three documents: (1) the Federal Register Notice; (2) the Fact Sheet; and (3) the explanatory diagrams which illustrate the Proposed Rule.
Tags:
FDA has updated GFI 209, 213 with New Guidance on Antimicrobial Use in Food Animal Production. As has been FDA's practice thusfar, reliance is placed upon voluntary guidelines. A PDF of the Draft Guidance is posted below:
Tags:
We thank our readers for their patience during our first semester of teaching US Food Import Regulation. We will now reaume our normal pace of postings on important developments in food regulation and food labeling. This week FDA has issued the 2013 update of the Food Code. As our readers know, all 50 US states have now adopted a version of the FDA Food Code. For the record we list the Food Code annual edition and the number of adopting states: 1993 (2); 1995 (2); 1997 (2); 1999 (7), 2001 (5); ...
Tags:
We are pleased to post the first issue of the American Bar Association's FOOD, COSMETICS AND NUTRACEUTICALS NEWS in which our article "Preparing for the Food Safety Modernization Act" appears.
Tags:
I apologize for the temporary suspension. This semester I am teaching a new graduate (LLM) course at MSU College of Law - US Food Imports: Process, Regulation, and Food Safety. This topic is very much "my baby" enabling me to bring together 35 years of Food Import/Export professional experience as a banker, import executive, Customs and FDA attorney, and Food Scientist. The demands upon my time from this course, the first time this subject has ever been taught at an American law school, mean ...
Tags:

FDA Issues Gluten Free Labeling Rule

Published on Fri, Aug 2, 2013 by Charles Woodhouse
August 2, 2013 - FDA has issued the long-awaited Final Rule on Gluten Free Labeling. Please see posted below the Final Rule, the Q&A, and the Press Release.
Tags:
Normal 0 false false false EN-US X-NONE X-NONE
Tags:
July 1, 2013 We post an updated essay "Preparing for the Food Safety Modernization Act" as we wait for the release, by USFDA, of the Proposed Rules on the Voluntary Qualified Importer Program (VQIP) and the Foreign Supplier Verification Program (FSVP). Charles Woodhouse's 2011 MS Thesis of the same title won the Michigan State University's Mather Food Safety Award. He is Co-Editor of "Food, Cosmetics and Nutraceuticals News" published by the American Bar Association. He is currently ...
Tags:
May 30, 2013 - This week FDA, pursuant to the requirements of the FSMA, issued a advanced copy of the Final Prior Notice Rule. When the official Federal Register Notice issues (in a few days) we will update this post and comment.
Tags:
May 29, 2013 - As we wait for the Federal Register Notice, we post the Shrimp Countervailing Duties Fact Sheet released on May 29 by DOC. When the FR Notice issues, it will be posted here.
Tags:
May 14, 2013 In a unanimous decision written by Associate Justice Elena Kagan, the US Supreme Court has affirmed that the doctrine of patent-exhaustion does not apply recombinant DNA technology. This decision is of immense importance to the to the development of genetically modified food animals and plants. This decision (a brief 14 pages in the slip-opinion) must be read by all Regulatory Food Science professionals. We post Bowman v. Monsanto (decided on May 13, 2013) below:
Tags:
May 3, 2013 The interagency FDA and USDA working group has issued a Risk Assessment for Listeria at the retail deli level. All Food Safety professionals working on RTE Foods need to review this important document. Interagency Risk Assessment: Listeria monocytogenes in Retail Delicatessens is posted below:
Tags:
May 2, 2013 Responding to widespread demand from Consumer and Environmental Groups, Congressman Peter DeFazio (D-OR) has sponsored the Genetically Modified Food Right-to-Know Act (HR-1699). The full text of the Act was released by the GPO today. As always, our readers are cautioned not to rely upon media coverage, but to read the full text of the Bill. A version of the Act has also been introduced in the Senate by Senator Barbara Boxer. The House Bill is attached below. When the Senate ...
Tags:
In the New York Times of March 20, we were most interested in a provocative article titled, “In a New Aisle, Energy Drinks Sidestep Some Rules”. As food labeling practitioners, we are most accustomed to thinking that the movement of manufacturers from FDA regulated food products to the much more loosely regulated Dietary Supplement sector is a “one-way street”. This article highlights a manufacturer who has reversed the paradigm by which we view such matters. Our ...
Tags:
Post 3/13/13: To address the widespread problem of seafood labeling fraud, Representative Ed Markey (D-MA) has introduced the Safety and Fraud Enforcement for Seafood Act (“SAFE Seafood Act”). Senator Mark Begich (D-Alaska) has agrees to sponsor parallel legislation in the Senate. As always, we urge our readers, Regulatory Science professionals, to not waste time on the industry press coverage of the Act (written by reporters who are not credentialed in law or science and who ...
Tags:
Post 3/12/13: With reference to our Post of November 18, 2011, students and practitioners of food labeling will want to study the USDA’s response to the WTO Panel’s decision on the consolidated cases WT/DS 384 (Canada) and WT/DS 386 (Mexico). Our readers will recall that in 2008, Canada and Mexico independently requested consultations with the United States, pursuant to Articles 1 and 4 of the Understanding on Rules and Procedures Governing the Settlement of Disputes (DSU), ...
Tags:
On March 1, FDA released its Environmental Factors Analysis of the 2011 Chamberlain Farms Salmonellosis outbreak. This report closely followed the February 25 letter to United Fresh Produce Association announcing to the industry that FDA would implement enhanced inspection of cantaloupe packing facilities during the 2013 production season. Most important, the Western Growers Association released its long-awaited Cantaloupe Food Safety Guidelines. We post below: (1) the FDA Letter to United ...
Tags:
The March 3 issue of Emerging Infectious Diseases contains a major study tabulating 1998-2008 United States data for hospitalizations and deaths attributed to some 17 food commodities. During this period estimated annual foodborne illnesses in the US population averaged 9.64 million. Not surprisingly, Produce was linked to 45.9 percent of estimated annual illnesses with Leafy-Greens at 22.3 percent. Aquatic Food Products represented 6.1 percent of the total with Fish at 2.7 percent, Crustacean ...
Tags:
PLOS ONE HAS PUBLISHED (Feb. 27) a major study on the linkage between dietary-intake of sugar and the development of type 2 diabetes. The Relationship of Sugar to Population-Level Diabetes Prevalence: An Econometric Analysis of Repeated Cross-Sectional Data Sanjay Basu, Paula Yoffe, Nancy Hills, Robert H. Lustig Research Article | published 27 Feb 2013 | PLOS ONE 10.1371/journal.pone.0057873 http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0057873 “ABSTRACT: While ...
Tags:
We post below the link to the major research study on the Mediterranean Diet and Cardiovascular Disease published in the New England Journal of Medicine on Feb. 25, 2013. You may access the full article as well as Tables and Figures at this link: http://www.nejm.org/doi/full/10.1056/NEJMoa1200303?query=featured_home#t=article
Tags:
Groeb Farms of Onsted, MI and Honey Holdings of Baytown, TX have signed Deferred Prosecution Agreements (DPAs) with the Justice Department in one of the largest cases of Antidumping Duty evasion in recent years. The two defendants have admitted to importing falsely labeled honey to evade Antidumping Duties totaling more than $180 million. We post below the Informations and the DPAs for both Groeb Farms and Honey Holding as well as the Press Releases of the US Attorney for the Northern ...
Tags:
On February 21, the US Department of Justice announced the criminal prosecution of individual corporate officers and employees related to the 2009 peanut products related Salmonella outbreak. This may prove to be the beginning of a much greater willingness of the Justice Department to apply the criminal sanction to executives in relation to food contamination incidents. Readers are referred to our Essays Page posting of Nov. 8, 2011 (discussion of the importer provisions of the FSMA) in which ...
Tags:
Although advanced copies have been widely circulated to seafood industry insiders, Oceana has now permitted release of its new (Feb. 21, 2013) survey on seafood species substitution at the retail and restaurant level in the United States. Without comment we post the Summary and full Report below (both dated 2/21/2013. This report will be a highly controversial topic of discussion in industry and regulatory circles. We will say, however, that our readers who are Regulatory Science professionals ...
Tags:
Representatives Peter DeFazio (D-OR) and Jared Polis (D-CO) have announced that they will introduce national legislation to require GMO labeling on human food products. The text of the bill is not yet available on THOMAS, but will be posted here when released by the GPO. We note that, despite the defeat of California Proposition 37 in November, GMO labeling legislation is advancing at the state level in Washington, New Mexico, Iowa, and Maryland.
Tags:
As required by Congress, FDA has issued its Summary Report - Antimicrobials Sold or Distributed for Use in Food-Producing Animals – 2011. This release was accompanied by the release by CDC of its 2010 NARMS report - National Antimicrobial Resistance Monitoring System. As one of only a handful of credentialed scientists in Congress, Louis Slaughter is our only national legislator with a degree in microbiology. (See “Too many lawyers, too few scientists” posted on our Essays ...
Tags:
As expected, on February 5, FDA issued as a Final Rule "Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption". The Final Rule issued without change from the text of the IFR of May 11, 2011 (76 FR 25538). Regulatory Food science professionals should understand that, as evidenced by the recent New Mexico incident, FDA intends to aggressively use this sweeping new power which was granted by Congress in the Food Safety Modernization Act. We post a PDF of the ...
Tags:
As provided in FDCA section 512, the FDA has released its 2011 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Production Animals. We post the report below:
Tags:
The January 25, 2013 issue of MMWR (Vol. 62, No. 3) includes the report on Foodborne Disease Outbreak Surveillance Data for 2009-2010. For the convenience of our readers we have posted pages 41-47 below.
Tags:
In the January 25 issue of MMWR (Mortality and Morbidity Weekly Report) the CDC has published the "Surveillance for Foodborne Disease Outbreaks 2009-2010" data analysis. We post the report below:
Tags:
On January 4, FDA released the Proposed Rules under the FSMA for both Produce Safety and for Risk-Based Preventative Controls. We will be preparing reviews of both documents for submission to the American Agricultural Law Association and will post our reviews on this Blog in due course. These are lengthy documents – the Produce Proposed Rule is 547 pages and the Risk-Based Controls Rule runs to 680 pages. Both the Summary Document and the full-text of each is posted below: Standards ...
Tags:
Slipping a major and highly controversial announcement into the long Holiday Weekend, FDA has issued a "Finding of No Significant Impact" (FONSI) on Genetically Engineered Salmon. This extraordinarily important announcement represents a substantial step towards the first human food approval by FDA for a Genetically Engineered food production animal. Making controversial announcements on the eve of Holiday Weekends has long been a staple of American politics. However, this transparent trick ...
Tags:
Apparently, bowing to congressional pressure (see our Post of Sept. 19, 2012), USDA has relaxed serving size maximums for meat and grain products. The Healthy Hunger Free Kinds Act, signed by President Obama in December 2010 (see our Post of Dec. 13, 2010), was intended to apply science-based nutrition standards to this important program for America’s children. Posted below is a December 7, 2012 letter from USDA to State School Lunch Program administrators. We also Post the ...
Tags:
Industry observers are becoming increasingly critical of FDA's protracted delay in issuance of important FSMA (Food Safety Modernization Act) Proposed Rules, some of which have been held at OMB (Office of Management and Budget) for more than one-year. The Center for Food Safety has now received a response to its Complaint filed in August (Center for Food Safety v. Margaret Hamburg) which we discussed in our August 30 Post (below). On November 30, FDA filed a Motion to Dismiss and for Summary ...
Tags:
The extraordinary controversy caused by the revelation of CFIA (Canadian Food Inspection Agency) memos dating back as far as 2008 is raising serious questions about Food Safety both in Canada and among Canada's export customers. We recommend that our readers simply study this brief document rather than reach conclusions based upon often inaccurate media reports. We think that our readers, Regulatory Food Science professionals, can assess this memo without assistance from the media or this ...
Tags:
Regulatory Food Science professionals must read the full text of FDA Commissioner Margaret Hamburg's "Suspension Letter" issued to Sunland Inc. in connection with the latest peanut product contamination incident. This is the first use of FDA's newly granted authority to suspend the registration of Food Facilities and block all sales and movement of the relevant products in both interstate and intrastate commerce as well as the import or export of these products. This unprecedented move to ...
Tags:
The Safe Food for Canadians Act had its Senate Third Reading on October 17 and its House of Commons Second Reading October 23. Following the approval of the Standing Committee on Agriculture and Agri-Food on November 7, the bill now is before the House Commons for its final vote. The progress of this legislation through Parliament may be followed at: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=5654811&Language=E&Mode=1 The text of the legislation as of November 20 is posted ...
Tags:
It came as no surprise that, on Friday November 16, the FDA made clear to the public its plan to get “in front” of the current controversy over the discontinuity in the regulation of so-called “Energy Drinks”. FDA Commissioner Margaret Hamburg had two unpleasant days of “grilling” on the 14th and 15th before House and Senate Committees over FDA’s perceived “passivity” in allowing a regulatory discrepancy in the supervision of compounding ...
Tags:

Published on Thu, Nov 1, 2012 by Charles Woodhouse
Tags:
While we generally confine our comments on FDA matters to Food and Dietary Supplements, the lessons of the ongoing regulatory failure in the compounding pharmacy scandal should prove valuable to regulatory food science professionals. As always we believe that knowledge is best attained by reading original documents as opposed to press "coverage". Therefore, we post the Markey Report (10/29/2012) and the important US Supreme Court Decision, Thompson v. Western States Medical, 535 US 357 ...
Tags:
House Energy and Commerce Committee Ranking Member Henry A. Waxman (D-CA) will introduce the Delivering Antibiotic Transparency in Animals Act of 2012 (the DATA Act). DATA will require antimicrobial manufacturers to provide detailed information to FDA on the use of antibiotics in food animal production and will require reporting by feed mills on antimicrobial use in animal feeds. As of October 19, the text of DATA was not available on the Library of Congress Thomas system. We will post the text ...
Tags:
Senator Barbara Boxer (D-CA) has written to FDA Commissioner Margaret Hamburg to urge FDA action to curb seafood labeling fraud. Citing the recent Oceana study, Senator Boxer asks, in the attachment to her letter of October 15, for detailed information on FDA's current programs to detect and reduce economic fraud in seafood labeling. The Oceana study is available on the Oceana website: Widespread Seafood Fraud Found in Los Angeles, Oceana, April ...
Tags:
Because of the extraordinary potential impact of Proposition 37 on US Food labeling, we follow this controversy closely. Both the EU's EFSA (Oct 4) and Germany's BfR (Oct 1) have published reviews that are sharply critical of the methodology and experimental design of the Seralini GMO maize carcinogenicity study. We note that the October 11 issue of Nature provides useful perspective (Nature, vol. 490, p. 158, 11 Oct 2012). These reviews and the continuing controversy will, no doubt, be a ...
Tags:
In view of Proposition 37 being on the ballot in California six weeks from now (see our June 15, 2012 post), we call our readers’ attention to a Food and Chemical Toxicology journal article in press that links GMO-maize to carcinogenicity effects in rats. This draft article is copyright protected. However, it has been made available by the Sustainable Food Trust on its ...
Tags:
Congressmen Steve King (R-IA) and Tim Huelskamp (R-KS) have introduced the "No Hungry Kids Act" which seeks to overturn School Lunch Program Nutrition Standards issued by the USDA in January 2012. In a statement on his website, Congressman King explains his perception that: “Recently released school lunch standards have left children around the nation hungry during their school day due to extreme calorie rationing. The "No Hungry Kids Act" repeals the USDA rule that created the new ...
Tags:
Because of our interest in the so-called “Food Disparagement Laws” which have now been enacted in 13 states, we note with some interest the filing of the BPI v. ABC complaint in South Dakota State Court. Our readers may want to view our February 7, 2012 post on the introduction by U.S. Representative Scott DesJarlais (R-TN) of the proposed Federal “Protecting Foods and Beverages from Government Attack Act of 2012”. This legislation would prohibit the use of federal money ...
Tags:
The search for statistically significant evidence as to the possible association of health benefits with consumption of organic foods continues. Please see our posts on the UK’s FSA study (July 15, 2009) and the French AFSSA study (December 22, 2009). A Stanford University research group has published its metadata review in the Annals of Internal Medicine (Sept. 4, 2012 issue). Its stated conclusion is that, “(t)he published literature lacks strong evidence that organic foods are ...
Tags:
Two non-profit advocacy groups - the Center for Food Safety and the Center for Environmental Health – have filed a complaint for declaratory and injunctive relief against FDA. The complaint, filed in the United States District Court for the Northern District of California, seeks to compel FDA to issue Food Safety Modernization Act (FSMA) rules that have been excessively delayed, in the opinion of these advocacy groups, at OMB. The complaint states, in somewhat dramatic language for a ...
Tags:
The Safe Food Coalition has again written to USDA Secretary Tom Vilsack urging action on required labeling for mechanically tenderized non-intact beef products. Here are two statements from the USDA website on pathogen risk related to mechanically tenderized non-intact beef. “Due to the low probability of pathogenic organisms being present in or migrating from the external surface to the interior of beef muscle, cuts of intact muscle (steaks) should be safe if the external surfaces are ...
Tags:
Thirteen US Senators have addressed a letter to FDA Commissioner Margaret Hamburg asking for stronger restrictions on antimicrobial use in food-animal production. The request focuses upon the two, relatively weak, "draft guidance" documents: #209 (June 2010); and #213 (April 2012). The letter, dated August 13, and the two Draft Guidance documents are posted below for our readers, convenience. Signing the letter were thirteen US Senators: Dianne Feinstein (D-CA), Frank R. Lautenberg (D-NJ), ...
Tags:
The FDA has released its second Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices. Although the Report contains relatively little new information, some instructive statistics are revealed which illustrate the magnitude of the tasks facing FDA in implementing the Food Safety Modernization Act and supervision some $417 billion of domestic food products and $49 billion of food imports. The Report states that there are 421,000 active Registered Facilities (167,000 domestic and ...
Tags:
The Canadian Food Inspection Agency (CFIA) has released its draft proposal for the Canadian Unified Food Safety System for a comment period which will remain open until October 31. Regulatory Food Science professionals, with an interest in Canadian issues, should download and read the complete document posted below. Please see our June 8 post on the Safe Food for Canadians Act (S-11, 1st Session, 41st Parliament).
Tags:
An in-depth study of FDA Food Advisory and Food Recall Procedures has been issued by the Government Accountability Office (GAO). This is timely information since Congress is considering adding a Recall Insurance Product to the Farm Insurance Programs managed by USDA Risk Management Agency (RMA). We can also look for forthcoming changes to Chapter 7 of the FDA Regulatory Procedures Manual (Recalls) and to possible passage of the 2012 Farm Bill with this important amendment. (See our July 16 post ...
Tags:
In a June 18 letter to Agriculture Secretary Thomas Vilsack, Dr. Urvashi Rangan, Safety and Sustainability Director of Consumers Union has expressed concerns regarding USDA standards of review for “antibiotic free” labels on meat and poultry. Secretary Vilsack addresses these concerns in a July 8 reply to Rangan. Our readers will want to review the text of both letters rather than rely upon possibly inaccurate media reports of this important discussion. We post copies of both ...
Tags:
Congressman Dennis Cardoza (D-CA) has introduced in the House, a parallel to the Senate Feinstein-Chambliss amendment to the 2012 Farm Bill. Cardoza's amendment would require USDA-RMA to study the addition of Recall Insurance to the existing crop insurance programs of the Risk Management Agency. We post below the Senate amendment to S-3240 (the Agriculture Reform, Food, and Jobs Act of 2012) co-sponsored by Senators Dianne Feinstein (D-CA) and Saxby Chambliss (R-GA) as well as the Cardoza ...
Tags:
In two articles in its July 2012 issue, the Journal of Food Protection presents one possible approach to the assessment of the societal “costs” of foodborne illness. While these attempts to measure costs are, at best, somewhat subjective, these articles represent a useful benchmark for future attempts to measure societal impacts. Copyright restrictions make the complete texts of the articles, of course, only available to researchers with database access. However, we are permitted to ...
Tags:
There are a number of provisions in the current Senate and House versions of the 2012 Farm Bill that are of major importance to the Produce Industry. To facilitate our ongoing discussion, we post the latest available texts of the two operative documents: S-3240 - the Agriculture Reform, Food, and Jobs Act of 2012 - passed in the Senate on June 26. We post the July 10 GPO print. HR-6083 - the Federal Agriculture Reform and Risk Management Act of 2012 - which went through mark-up on July 11. At ...
Tags:
Congresswoman Lois Capps (D-CA) and Congressman Richard Hanna (R-NY) have introduced the Organic Standards Protection Act (HR 5962), to ensure that products bearing the USDA organic seal comply with the Organic Foods Production Act of 1990. The bill grants USDA new investigatory and “stop-sale” authority for products fraudulently labeled and sold as certified organic while protecting the rights of producers and handlers during an appeal process. The bill increases recordkeeping ...
Tags:
California Secretary of State Debra Bowen has certified "The California Right to Know Genetically Engineered Food Act" for the November 2012 General Election ballot. The popular press has, as usual, done a poor job of reporting on this issue. Our Regulatory Food Science professional readers will want to read the full text of the measure which we post below. The requirements of the Act are highly specific, narrowly focused, and include significant exceptions. Please read the Press Release of ...
Tags:
On June 7, the Harper Government introduced legislation to reform and unify the Canadian Food Safety system. We post below a complete text of The Safe Food for Canadians Act (S-11, 1st Session, 41st Parliament) which was tabled in the Senate on Thursday. There will be a great deal of superficial discussion of the SFCA in the media, often written by commentators who have read only the Press Releases and are telling you more than they know. Our readers, Regulatory Food Science professionals, will ...
Tags:
With reference to our posts of April 17, 2012, March 23, 2012 and May 27, 2011, United States Magistrate Judge Theodore H. Katz has once again issued an Order in favor of the National Resources Defense Council (NRDC). The National Resources Defense Council (NRDC) and a coalition of other environmental groups including the Center for Science in the Public Interest (CPSI), and the Union of Concerned Scientists have challenged USFDA's approval of the prophylactic use of Penicillin and ...
Tags:
Food Labeling and Food Science professionals have been awaiting the decision of FDA on the Petition of the Corn Refiners Association to permit HFCS to be labeled as "Corn Sugar". The FDA decision, contained in a letter written by Michael Landa, Director of CFSAN, was released on May 30. Rather than read the often inaccurate and conclusory articles in the popular and "food safety" media, Regulatory Food Science professionals should read the full text of the letter (and footnotes) which we post ...
Tags:
Food Safety professionals will need to carefully review the Final Rule published by USDA’s Food Safety Inspection Service on in the May 8 Federal Register. The Rule presents alternative and partially conflicting requirements for manufacturers, distributors, and retailers of multi-ingredient products which may contain ingredients subject to the jurisdiction of both FDA and USDA. The document is titled: Requirements for Official Establishments To Notify FSIS of Adulterated or Misbranded ...
Tags:
Regulatory Food Science professionals should read the opinion piece published in this week’s issue of Nature by Harvard University Government Professor Daniel Carpenter. Science professionals have been deeply dismayed by the recent overruling of FDA Commissioner Margaret Hamburg by HHS Secretary Kathleen Sebelius on a scientific committee decision which 70-years of precedent firmly establishes as a matter of agency sole discretion. The Carpenter article summarizes and analyzes many of ...
Tags:
Congresswoman Louise M. Slaughter (D-NY) and Congressman Edward J. Markey (D-NY) have issued a joint-demand for information to FDA Commissioner Margaret Hamburg regarding recent reports and prior FDA studies which may indicate that significant levels of antimicrobial residues may be present in DGS. The Ethanol production byproduct, DGS (Distillers Grains with Solubles) is extensively used as a livestock and poultry feed ingredient. The May 11, 2012 letter to FDA Commissioner Margaret Hamburg is ...
Tags:
California State Senator Ted Lieu, one of the country's most active state legislators in the area of Food Safety, has asked USDA/FSIS to regulate the use of transglutaminase (referred to in the popular media as "meat glue"). In his letter to FSIS Administrator Alfred Almanza, Senator Lieu articulates four reasons for regulatory action: (1) the possible transfer of pathogens from external surfaces to the interior of "formed" products where they may not be destroyed by cooking; (2) the difficulty ...
Tags:
As our readers know, we follow nanotechnology developments in the areas of food additives and food contact materials with great interest. Both in the European Union and in the US, regulators are struggling to develop strategies based upon evidence based regulatory food science principles. Nanotechnology offers the potential for substantial benefit to both the food industry and to consumers. However, because, under specific circumstances, nanoparticles can cross cell membranes, this technology ...
Tags:
Lieutenant Colonel William C. Shanahan, founding principal of Woodhouse Shanahan, has returned from his tour of duty with the US Army in support of Operation Enduring Freedom in the Afghanistan Theater of operation. While deployed to Afghanistan, Lt Col Shanahan was assigned as the Executive Officer of the Counterinsurgency Training Center in Kabul. His duties also included Director of District Stability Framework, curriculum development, and liaison and project officer to ISAF and the various ...
Tags:
Please see our March 30 post discussing FDA’s rejection of the appeal by the Natural Resources Defense Council (NRDC) and other environmental groups to ban bisphenol-A (BPA). This week’s Washington Post article on BPA is an indication that environmental and consumer groups will continue the pressure on FDA to reconsider this decision. The article can be accessed on the Washington Post website: Freinkel, Susan, If the food’s in plastic, what’s in the food?, Washington ...
Tags:
Charles Woodhouse will be a featured speaker on Produce Food Safety Compliance and Food Recall Management at the July 2012 Food Regulation Current Issues Seminar at Michigan State University in East Lansing, Michigan. The program is sponsored by Michigan State University's Institute for Food Laws and Regulations (IFLR). The two-day seminar for food industry executives will be held on July 18 and 19 on-campus at MSU and program information may be obtained from on the IFLR website. ...
Tags:
This document, released on April 13, is a valuable resource for industry professionals primarily because of its excellent and detailed summary of reports, reviews, and peer-reviewed articles on this controversial subject. Critics of antimicrobial use in food-producing animals are unlikely to be satisfied by the two relatively weak principles articulated in the Guidance Document. We post below the Guidance Document and the associated FDA Strategy Statement and Q&A:
Tags:
On April 3, the FDA issued the Second edition of the Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (known as the “Bad Bug Book”). The Handbook is now available for download in Kindle without charge which represents a major convenience for users who expect to keep their standard reference library on Kindle, instantly available on the i-Pad. The Bad Book can be downloaded for the following link to Kindle or as a ...
Tags:
On March 30, USFDA rejected a petition by the Natural Resources Defense Council (NRDC) and other environmental groups to ban bisphenol-A (BPA), saying there was not enough scientific evidence to establish risks to human health. In its announcement, and in an associated Fact Sheet, FDA conceded that this was not the “final word” and confirmed its committment to further research on the safety of BPA. In its petition, the NRDC had sought a ban on BPA in food packaging, food containers, ...
Tags:
The European Centre for Disease Prevention and Control (ECDC) has published a literature review titled “Assessing the potential impacts of climate change on food- and waterborne diseases in Europe”; Stockholm: ECDC; 2012. In the report, the ECDC presents the findings of a comprehensive literature review, in which it identifies the published links between six Food and Waterborne (FWB) pathogens (Campylobacter spp., Cryptosporidium spp., Listeria spp., Norovirus, Salmonella spp. and ...
Tags:
With reference to our post of May 27, 2011, United States Magistrate Judge Theodore H. Katz has issued an Order in favor of the National Resources Defense Council (NRDC) The National Resources Defense Council (NRDC) and a coalition of other environmental groups including the Center for Science in the Public Interest (CPSI), and the Union of Concerned Scientists have challenged USFDA's approval of the prophylactic use of Penicillin and Tetracyclines in animal feeds. These approvals date back ...
Tags:
An article which is likely to receive considerable attention will appear in the April issue of Scientific American. The article, entitled Food Poisoning’s Hidden Legacy is written by science journalist Maryn McKenna. Due to copyright restrictions we cannot, of course, post the article. However, most of our readers subscribe to, or will have access to, Scientific American and should use the citation below: Food Poisoning’s Hidden Legacy, Maryn McKenna, p. 26, Scientific American, ...
Tags:
The Center for Science in the Public Interest has issued a White Paper titled "Antibiotic Resistance in Foodborne Pathogens: Evidence of the Need for a Risk Management Strategy". The documents is an important review of the issues in the current debate over the use of antimicrobials in food animal production. The White Paper is accessible through the following link: http://www.cspinet.org/new/201203081.html
Tags:
At the current International Conference on Emerging Infectious Diseases in Atlanta, CDC researcher Hannah Gould has presented data which may indicate an increase in the prevalence of foodborne disease associated with US food imports. The Press Release (posted below) has attracted considerable attention in the media which, of course, reports these preliminary epidemiological findings as established fact. Our readers should await the actual study which will be published later this year.
Tags:
Led by Senator Barbara Boxer (D-CA) and Congressman Peter DeFazio (D-OR), fifty-five Members of Congress have written to FDA Commissioner Margaret Hamburg urging her to require labeling of GE Foods. The text of the letter with a list of the signatories is posted below. The occasion for this action is a recent citizen petition to congress which can be accessed at: http://justlabelit.org/
Tags:
On February 29, FDA Commissioner Margaret Hamburg testified before the House Subcommittee on Agriculture and detailed FDA's proposed $220 million in Food Establishment Registration Fees. Our readers, regulatory food science professionals, will want to read her entire testimony (which we post below), not just the FSMA discussion. We note that Commissioner Hamburg terms these User Fees "novel user fee revenue" and that the industry is already mobilizing to push-back on these User Fees for general ...
Tags:
On February 23, 2012, FDA issued an Interim Final Rule, effective March 1, 2012, Amending 21 CFR Part 1, Subpart J, § 1.361 to incorporate language conforming to changes made to Sections 414 and 704 of the FDCA as amended by § 101 of the FSMA. We post below: Federal Register Notice (77 FR 10658, 23 Feb 2012). Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act. Guidance for Industry Questions and Answers ...
Tags:
A research team led by Brian Jackson of the Dartmouth Toxic Metals Superfund Research Project has documented high levels of inorganic arsenic in brown rice syrup used as a sweetener in many “organic” processed foods. The Dartmouth Toxic Metals website is a useful resource for food science professionals interested in trace metals in food products. http://www.dartmouth.edu/~toxmetal/ ABSTRACT: BACKGROUND: Rice can be a major source of inorganic arsenic (Asi) for many sub-populations. ...
Tags:
On February 15, the European Commission and USDA signed an Equivalency Agreement granting mutual recognition of US and EU organic standards for most food products. We post the Letter from USDA and the USTR to the European Commission and ask our readers to note the exceptions listed in Appendix 1 and Appendix 2. We also attach the USDA GAIN Report on the Agreement, the EU Implementing Regulation (Regulation (EU) no. 126/2012, OJ L 41 of 15.2.2012, p. 5), and the Press Release issued by USDA. The ...
Tags:
The Fiscal year 2013 Budget of the U. S. Government was released by the Office of Management and Budget on February 13. As we are dissatisfied by simplistic journalistic reviews of the Budget in the business press, we urge our readers to review the actual document posted below. Our readers will be interested in pages 65-70 (Department of Agriculture) and pages 107-115 (Health & Human Services). The FDA FY 2013 Budget can be broken out from the HHS numbers. For this observer, the Table on ...
Tags:
Members of Congress Rosa DeLauro (D-CT) and Frank Pallone (D-NJ) have introduced the “Arsenic Prevention and Protection from Lead Exposure Act of 2012”. From its acronym APPLE, the Act is alternatively titled the “APPLE Juice Act of 2012”. The Act requires FDA to set tolerances (Maximum Contaminant Levels – MCLs), under Section 406 of the FDCA (Tolerances for Poisonous Ingredients in Food), for arsenic and lead in beverages containing fruit juices. The Act further ...
Tags:
Posted below is the February 7 FSIS Constituent Update Special Edition. FSIS has extended from March 5, 2012 to June 4 2012, the implementation of routine sampling of ground-beef and its precursor products for six STEC E. coli serotypes (O26, O45, O103, O111, O121, and O145).
Tags:
Food & Water Watch, Consumers Union, and the Center for Food Safety have filed a Food Additive Petition with FDA’s Office of Food Additive Safety. The petitioners request that FDA evaluate GE salmon and its components as a food additive and argues that the current review process, evaluating GE salmon as a new animal drug is inappropriate since the GE inputs constitute “a novel substance added to food”. We post the Petition below as well as a copy of the Center for Food ...
Tags:
U.S. Representative Scott DesJarlais (R-TN) has introduced H.R. 3848 the "Protecting Foods and Beverages from Government Attack Act of 2012". This legislation would prohibit the use of federal money for advertising campaigns against any food or beverage deemed safe and lawfully marketed under the Federal Food, Drug, and Cosmetic Act. As many of our readers know, so-called “food disparagement laws” were passed in various states in the 1990’s. The Center for Science in the ...
Tags:
The first revisions since 1983 for statistical sampling and inspection of food containers - Standards for Condition of Food Containers – have been issued for comment by the USDA Agricultural Marketing Service (USDA/AMS). We post the Federal Register Notice below. However, it is necessary to review the Definitions in 7 CFR 42.102 (which we also post below for our reader’s convenience) in order to understand the Federal Register Notice. For reference purposes, the standards (1983) ...
Tags:
Readers interested in the ongoing debate about the relative food safety attributes of conventional and organic food animal products will want to review a recent publication in PLos ONE. O’Brien AM, Hanson BM, Farina SA, Wu JY, Simmering JE, et al. (2012) MRSA in Conventional and Alternative Retail Pork Products. PLoS ONE 7(1): e30092. doi:10.1371/journal.pone.0030092 Abstract In order to examine the prevalence of Staphylococcus aureus on retail pork, three hundred ninety-five pork samples ...
Tags:
The New England Journal of Medicine has published an opinion piece written by Pieter Cohen of Harvard Medical School which is strongly critical of FDA’s approach to Dietary Supplement New Ingredient Notification. Readers who have access to the NEJM should read this article which has been misinterpreted by journalists in the industry press. We have seen this opinion piece erroneously referred to as a “study” in the press. Serious students of food safety should read the NEJM ...
Tags:
Please see our December 12, 2012 comments (on our “Essays” page) on FDA’s refusal to define “Natural”. Across the country, consumer rights attorneys are filing false advertising complaints against manufacturers for making “natural” and “pure” product characterization claims. Posted below are two recent complaints filed in US District Courts in California and New Jersey. We can expect to see many similar complaints filed across the country in ...
Tags:
The House Energy and Commerce Committee has issued a Report on the 2011 Listeria monocytogenes Outbreak associated with Cantaloupe. The Report is highly critical of the role of third-party auditors and inspectors in the conditions that led to the outbreak. Food Safety professionals are cautioned to read the documents posted below and not to rely upon the reports of so-called "journalists" on this important matter. The full text of the Report and the January 10 letter to FDA Commissioner Hamburg ...
Tags:
On January 4, FDA issued a Press Release and Q&A on the Order of Prohibition that will issue in the next several days. The extra-label use of cephalosporin drugs in major food-producing animals (cattle, swine, chickens and turkeys) will be significantly restricted. We post below an advance copy of the Federal Register Notice that will appear in the coming week. We also post the Press Release / Q&A:
Tags:
A McGill University research team has published an intriguing comment on the so-called “hygiene hypothesis” relating the prevalence of food allergies to family SES (Socio-economic Status). Ben-Shoshan, M., et al., Demographic Predictors of Peanut, Tree Nut, Fish, Shellfish, and Sesame Allergy in Canada, Journal of Allergy, Vol. 2012, Article ID 858306, doi:10.1155/2012/858306. Copyright © 2012 M. Ben-Shoshan et al. This is an open access article distributed under the Creative ...
Tags:
A group of environmental and consumer organizations, led by the International Center for Technology Assessment, has filed a complaint in the US District Court for the Northern District of California which seeks to compel FDA to act on a 2006 Petition regarding the affirmative regulation of nanotechnology by FDA. Because of the increasing use of nanotechnology in foods and food contact materials, we follow this issue closely in both the US and the European Union. We note that FDA has published, ...
Tags:
On December 28, USDA/FSIS announced the extension of the effective date for implementation of the Final Rule “Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products” (75 FR 82148) to March 1, 2012. On December 29, 2010, The Food Safety and Inspection Service (FSIS) published the final rule “Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products” (75 FR 82148). This rule amends the Federal ...
Tags:
On December 27, FDA issued “Guidance for Industry on Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation”. The purpose of this document is to provide guidance to egg producers on certain provisions contained in FDA’s July 9, 2009, final rule “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” (74 FR 33030), including how to implement Salmonella Enteritidis (SE) prevention ...
Tags:
On December 22, and without announcement on its website, the FDA published in the Federal Register the “Withdrawal of Notice and Opportunity for Hearing; Penicillin and Tetracycline Used in Animal Feed”. We, of course, express no opinion on this FDA decision which is likely to bring forth sharp criticism from consumer and science public interest groups. However, in addition to the Federal Register Notice, we also post below the June 28, 2011 Draft Guidance, “The Judicious Use ...
Tags:
The December 2011 Progress Report of the Federal Food Safety Working Group is posted below. This document is a useful summary of progress to date on the implementation of the Food Safety Modernization Act.
Tags:
In the December 23 issue of MMWR (Morbidity and Mortality Weekly Report), the CDC has published a report which evaluates the challenges facing state Food Safety Epidemiology systems in an era of severe budgetary constraints. The Report is posted below:
Tags:
The Final Weatherill Report on the 2008 Toronto Listeriosis outbreak is posted below. Our readers who are Regulatory Food Science professionals are not well served by summaries prepared by "journalists" who are not credentialed scientists. Therefore, we post the full document for our readers to review in its entirety.
Tags:
The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is proposing a new rule that will allow establishments to label a broader range of products without first submitting the label to FSIS for approval. Under the proposal, FSIS will continue to verify that labels are accurate, not misleading, and in compliance with all labeling features. This rule is expected to benefit consumers because it will get new products into the marketplace sooner while still ...
Tags:
On November 23, 2011, the European Commission Health and Consumers Directorate-General (DG-SANCO) issued EU Guidance to the Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food. It is useful to review the EC’s definitions of active and intelligent materials: ACTIVE MATERIALS: ‘active materials and articles’ means materials and articles that are intended to extend the shelf-life or to ...
Tags:
As molecular biology techniques improve, the ability to rapidly, and at comparative low-cost, establish etiologies of foodborne illness may soon reduce the importance of traditional PFGE analysis. Because of copyright restrictions, we will only post the abstract of the study published in the December 2011 issue of Applied and Environmental Microbiology. The citation for this important article is: Bakker, Switt, et al., A Whole-Genome Single Nucleotide Polymorphism-Based Approach To Trace and ...
Tags:
The long-awaited EU recommended definition of Nanomaterials was published on October 20 in the Official Journal (OJ L 275/38-40). The definition reads (in part): Nanomaterial means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. In specific cases and where warranted by ...
Tags:
In September, USDA / FSIS announced that it intends to carry out verification procedures, including sampling and testing of manufacturing trim and other raw ground beef components, to ensure control of both E.coli O157:H7 and six other serogroups of STEC E. coli (O26, O45, O103, O111, O121, and O145). FSIS has determined that they, as well as O157:H7, are adulterants of non-intact raw beef products and product components within the meaning of the Federal Meat Inspection Act. Beginning March 5, ...
Tags:
On November 25, the UK’s Health Protection Agency (HPA), together with other professional bodies from the Norovirus Working Party, issued an updated set of Guidelines for the Management of Norovirus Outbreaks. The document is posted below along with a copy of the current CDC recommendations for Norovirus management which were published in MMWR on March 4, 2011. For additional information ...
Tags:
The long awaited Food Information Regulation was published in the Official Journal (L) of the European Union on November 22. The citation is Reg. (EU) 1169/2011. OJ(L) 304/18, 22 Nov 2011. The full text of the Regulation (66 pages) is posted below:
Tags:
The American Society for Microbiology’s journal, Clinical Microbiology Reviews has published a major review article on the current state of the “science” on antimicrobial use in the production of food animals. We post the abstract below and provide the citation to the full article. ABSTRACT: Antimicrobials are valuable therapeutics whose efficacy is seriously compromised by the emergence and spread of antimicrobial resistance. The provision of antibiotics to food animals ...
Tags:
In the weeks ahead, students and practitioners of food labeling will be studying the WTO Panel’s decision on the consolidated cases WT/DS 384 (Canada) and WT/DS 386 (Mexico). In 2008, Canada and Mexico independently requested consultations with the United States, pursuant to Articles 1 and 4 of the Understanding on Rules and Procedures Governing the Settlement of Disputes (DSU), Article XXII of the General Agreement on Tariffs and Trade (GATT 1994), Article 14 of the Agreement on ...
Tags:
FSIS is delaying the effective date of the final rule that will require nutrition labeling of the major cuts of single-ingredient, raw meat and poultry products and ground or chopped meat and poultry products. The original effective date of the final rule was January 1, 2012, and it is now being delayed until March 1, 2012. The announcement appears in the Nov. 10 issue of Constituent Update: http://www.fsis.usda.gov/PDF/Const_Update_111011.pdf
Tags:
A study at Johns Hopkins University details findings regarding veterinary drug residues in seafood products. Copyright restrictions prevent us from posting the study. However, we post the abstract below. Professionals with access to science electronic resources should access the full study. Love, D. C., et al., Veterinary Drug Residues in Seafood Inspected by the European Union, United States, Canada, and Japan from 2000 to 2009, Environ. Sci. Technol., vol. 45, pp. 7232–7240, ...
Tags:
Charles Woodhouse has published a White Paper on the imported food provisions of the Food Safety Modernization Act. This paper is a version of materials prepared by Mr. Woodhouse as Guest Instructor at Michigan State University in connection with completion of his MS Food Safety program. The White Paper is posted below:
Tags:
The CDC has announced that, as of November 1, 2011, a total of 139 persons have been infected with one of the four outbreak-associated strains of Listeria monocytogenes. Twenty-nine deaths and one miscarriage have been reported from 28 states. Because of the latency period of up to 70 days, more illnesses and deaths are possible. The Listeriosis outbreak may be followed in detail at the CDC website: http://www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/110211/index.html The ...
Tags:
FDA has announced a national testing program to assess risk of Salmonella transmission to humans through pet food, pet treats, and pet supplements. Details of the announcement are posted below:
Tags:
The Institute of Medicine (IOM) of the National Academies has issued a report entitled "Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices". The report supports a three point rating system which, in addition to requiring calorie count in reasonable household measure, awards points for not exceeding maximum levels of saturated and trans fats, sodium, and added sugars. Pre-publication copies of the entire report may be downloaded from the IOM ...
Tags:
We have previously posted (October 8) the Court of Justice of the European Union (ECJ) decision in Bablok v. Freistaat Bayern noting that it has created considerable confusion and controversy among students and practitioners who follow European GMO regulation and GMO food labeling. We now post the October 18 decision of the ECJ in Brustle v. Greenpeace as a further example of the increasingly active role which the ECJ, the European Union’s highest court, is playing in deciding cases which ...
Tags:
The Government Accountability Office (GAO), the investigative arm of Congress, has issued a report which highlights the need for FDA and the ISSC (Interstate Shellfish Sanitation Conference) to better coordinate on illness reduction goals and strategies to reduce foodborne Vibrio vulnificus illnesses. The Report is posted below.
Tags:
The Center for Science in the Public Interest (CSPI) has filed a class action suit against General Mills for allegedly deceptive advertising of "Fruit Roll-ups". The action was filed today in the US District Court for the Northern District of California and challenges nutritional claims made by General Mills in product labeling and promotional activities. We express no position on the merits of the case, but attach the filed complaint for our readers to review and reach their own ...
Tags:
The Court of Justice of the European Union (ECJ) decision in Bablok v. Freistaat Bayern has created considerable confusion and controversy among students and practitioners who follow European GMO regulation and GMO food labeling. As our regular readers know, our policy is not to comment upon the merits of issues except on our Essays Page. Rather, we post original documents (when permissible under copyright law) for our professional readers who are not permitted to base their opinions upon ...
Tags:
The Center for Food Safety, a Washington based advocacy group, has filed a Petition with USFDA to require the labeling of all foods produced with Genetic Engineering technology. We express no opinion on the merits of the Petition, but believe that practitioners and students of food safety and food labeling should read the full text of the Petition as well as the Press Release. We post below the complete text of the Petition and the Press Release.
Tags:
The Food Information Regulation (FIR) will be the most significant change in European Food Labeling in 30 years. The vote by the European Council now clears the way for publication in the Official Journal of the European Union. The Regulation will become law 20-days after publication and be phased in over 3-years. The text of the July 6 Second Reading in the European Parliament (posted below) will asset practitioners until the OJ final text is released in the near future. We will post the final ...
Tags:
FDA has released the first 2009 Food Code Supplement and has also announced its Retail Food Safety Action Plan. The Food Code Supplement is posted below as is the Press Release for the Retail Food Safety Action Plan. We have also posted the 2009 Food Code for reference.
Tags:
Charles Woodhouse comments on Produce Safety and the Food Safety Modernization Act. The attached essay provides an advanced look at the probable shape of the forthcoming Produce Safety Rule by looking back at the 1998 GAPs Guide and the Leafy Greens, Tomatoes, and Melons Draft Guidance documents of 2009. The Essay is posted below:
Tags:

Published on Sat, Oct 1, 2011 by Charles Woodhouse
Normal 0 false false false EN-US X-NONE X-NONE
Tags:
Thirty-six prominent American law professors have written to the heads of the FTC, the FDA, the USDA, and the CDC to express their collective judgment that the Preliminary Proposed Nutrition Principles of the IWG (Interagency Working Group) on Food Marketed to Children do not violate the First Amendment. We attach the September 6 letter addressed to the four agency chiefs as well as a copy of the Nutrition Principles.
Tags:
A GAO Report issued this week is sharply critical of the apparent lack of diligence of USFDA and USDA in addressing the problems of antimicrobial use in food animal production and the development of AMR (Antimicrobial Resistance). We also note the September 15 feature on the NPR (National Public Radio) broadcast of "Here and Now" with Robin Young. Young called attention to the famous "missing pages" that were deleted from the USDA website at the USDA Food Safety Research Information Office web ...
Tags:
Senator Kirsten Gillibrand has introduced the Foodborne Illness Reduction Act to reform USDA and FSIS Food Safety Programs. This Bill addresses issues not reached in the FSMA. As a service to our readers, professionals who do not reach conclusions by reading secondary sources such as press releases and other media products, we post the complete official text of the Bill below as released by the GPO today.
Tags:
USDA/FSIS (Food Safety Inspection Service) announced today that in addition to E. coli O157:H7, six additional serogroups of pathogenic E. coli will be declared adulterants in non-intact raw beef (ground beef and certain tenderized products). If E. coli serogroups O26, O103, O45, O111, O121 and O145 are found in raw ground beef or its precursor products, those products will be considered adulterated and will be prohibited from entering commerce. E. coli O157:H7 and these six additional ...
Tags:
Researchers at the National Institute of Health Sciences in Japan have published a paper in the current issue of Epidemiology and Infection which provides guidance for the relative risk-assessment of infective doses of common foodborne pathogens. Because of copyright restrictions, we are permitted only to provide the abstract. Researchers with access to Cambridge Journals can read the full article as cited below. Y. HARA-KUDO and K. TAKATORI (2011). Contamination level and ingestion dose of ...
Tags:
Ireland Issues Guidelines for Ready-to-Eat (RTE) Sprouted Seeds The Food Safety Authority of Ireland (FSAI) has published guidelines for the safe production of sprouted seeds to be consumed raw, following the recent outbreaks of E. coli O104:H4 in Germany and France linked to the consumption of these seeds. These guidelines introduce pathogen control measures for seed suppliers and sprouted seed producers. These include testing and certification requirements for seeds and a disinfection step ...
Tags:
We express no opinion with respect to the merits of the present matter before the US District Court for the District of Maryland in the matter of Del Monte Fresh v. USFDA. However, we post below the two relevant documents: Import Alert 22-03 issued on 7/15/11; and the Complaint for Declaratory and Injunctive Relief. It is a matter of some interest to consider whether or not this innovative legal action is the harbinger of many more legal actions to be brought by food industry stakeholders ...
Tags:
USFDA has issued a new "White Paper" titled "Advancing Regulatory Science at FDA". As used by FDA Commissioner Margaret Hamburg, the term "Regulatory Science" means the use of evidence-based science to drive public-policy decision making. For the Food Industry, two of the eight goals in the Regulatory Science Program are particularly important. The first is "modernizing toxicology to enhance product safety". The second is, of course, the implementation of the "Prevention-Focused Food Safety ...
Tags:
USFDA has announced in the Federal Register its first User Fee Schedules in connection with implementation of the Food Safety Modernization Act. The schedules cover fees for domestic and foreign facility inspections, failure to comply with recall orders, and importer reinspections. We post below the Federal Register Notice (76 FR 45820).
Tags:
Under the ongoing Article 13 process, the EU's EFSA (European Food Safety Authority) has approved its second qualified health claim. The claim related to glycaemic response effects of slowly digestible starch. We report this claim approval because of the insight provided into the Article 13 process as described in the EFSA Scientific Opinion. Serious students of EU Food law will find review of Scientific Opinion (published in EFSA Journal 2011; 9 (7): 2292) to be of considerable interest in ...
Tags:
USFDA has reopened the Comment Period on the "Gluten Free" Labeling Proposed Rule that was initially published in 2007 (see 72 FR 2795). We post the Federal Register Notice (76 FR 46671) regarding the reopening below as well as a copy of the USFDA Press Release. The FR Notice includes an updated discussion of the Proposed Rule.
Tags:
The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) has issued a proposed rule on labeling of meat and poultry containing injections, marinades, and other added solutions. The proposed rule would require that the common or usual name of these products include an accurate description of the raw meat or poultry component, the percentage of added solution, and the individual or multi-ingredient components in the added solution. The print for such labels would be ...
Tags:
EFSA has released a Scientific Opinion updating its assessment of the state of present knowledge of the etiology and control of viral foodborne illness. The text of the 91 page document is posted below.
Tags:
As discussed in our earlier post, the text of the July 6 Resolution of the European Parliament provides significant insight into the final amendments to the Food Information Regulation (FIR) that will be issued by the European Commission in October. The text of the Resolution is posted below (61 pages). As always, we remind our readers that this weblog is intended for regulatory food science professionals who are required to read and cite only original documents. Therefore, we post without ...
Tags:
On July 5, the European Parliament will vote on a wide range of proposed changes in food labeling. The full text has remained unpublished, but a preview of the changes was released on July 29 and is posted below. The contentious "Country of Origin" rules will remain, for now, on "hold" along with trans-fat labeling. FOP (Front of Package) labeling will be required for "imitation foods" whenever substituted for ingredients that would be "normally expected". Energy content, fat, saturated fat, ...
Tags:
EFSA (the European Food Safety Authority) has released an updated Risk Assessment in consideration of the HUS (Haemolytic Uremic Syndrome) cases in France. Additionally Eurosurveillance, published by ECDC (the European Centre for Disease Prevention and Control) has released its own report on the HUS outbreak. As our readers know, unlike other blogs that summarize (for general readers) legislation or scientific research, we provide original documents whenever not precluded by copyright issues. ...
Tags:
Senator Dianne Feinstein (D-CA), has reintroduced (June 15) the “Preservation of Antibiotics for Medical Treatment Act of 2011” (PAMTA) in the 112th Congress. Senators Susan Collins (R-ME), Jack Reed (D-RI) and Barbara Boxer (D-CA) were co-sponsors of the legislation. PAMTA reintroduces measures (introduced in the 111th Congress) to address what Senator Feinstein calls "the rampant overuse of antibiotics in agriculture that creates drug-resistant bacteria, an increasing threat to ...
Tags:
The Inspector General (IG) of HHS (Health and Human Services) has issued an investigative report which points to serious flaws in USFDA's administration of recalls of imported foods. The IG surveyed FDA's performance on 17 of the 40 Class I Food Recalls between July 1, 2007 and June 30, 2008. According to the Report, FDA: (1) failed to conduct inspections or obtain complete information in 14 of the 17 recalls; (2) failed to conduct audit checks in 5 of 17 and was incomplete or untimely in the ...
Tags:
The U.S. Food and Drug Administration (USFDA) has issued a new Policy Report entitled, "Pathway to Global Product Safety and Quality". The Policy Report discusses the challenges facing USFDA in the implementation of the Food Safety Modernization Act (FSMA) in a time of rapid internationalization of the country’s food and drug supply chains. The Policy Report also highlights the fact that USFDA must face these challenges in a time of severe budgetary restriction. The Policy Report should ...
Tags:
A research team, headed by Dr. Ruchi Gupta of Northwestern University, has published its findings in the July issue of Pediatrics. The report titled, “The Prevalence, Severity, and Distribution of Childhood Food Allergy in the United States”, cannot be posted here because of copyright restrictions. Students and practitioners with access to science journal services will be able to find the article on HighWire. These findings are broadly consistent with the 2010 Johns Hopkins / NIH ...
Tags:
The Food and Drug Administration (FDA) has issued a Draft Guidance for Industry document which gives nanotechnology stakeholders their first insight into FDA’s thinking about the probable scope of future regulation of nanotechnology by FDA. FDA will take “size and functionality” into account when it determines whether a product contains nanomaterials or involves nanotechnology. FDA has also carefully avoided providing a definition of nanomaterials. “The draft ...
Tags:
Senator Kirsten Gillibrand, the only trained microbiologist in Congress, has introduced strengthened meat safety legislation that targets high-risk pathogens and currently unregulated strains of E. coli found in the meat supply and which have been associated with serious food-borne illnesses. Gillibrand’s “Foodborne Illness Prevention Act of 2011” (S-1157-IS) was introduced in the US Senate on June 8. E. coli 0157:H7 is the most common strain of STEC/VTEC found in the American ...
Tags:
The European Centre for Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA) have issued a Technical Report on the recent STEC/VTEC outbreak in Germany. Citation: Shiga toxin/verotoxin-producing Escherichia coli in humans, food and animals in the EU/EEA, with special reference to the German outbreak strain STEC O104. Stockholm: ECDC; 2011. This Report summarizes the epidemiological data on the outbreak of Shiga toxin/verotoxin-producing Escherichia coli ...
Tags:
Conservation International and the WorldFish Center have issued a major report based upon Life Cycle Analysis (LCA) of Aquaculture as compared with other Center-of-the Plate animal protein production industries. Citation: Hall, S.J., A. Delaporte, M. J. Phillips, M. Beveridge and M. O’Keefe. 2011. Blue Frontiers: Managing the Environmental Costs of Aquaculture. The WorldFish Center, Penang, Malaysia. The complete report (41 MB) may be downloaded at: www.conservation.org/marine or ...
Tags:
In the June 10 issue of MMWR (Morbidity and Mortality Weekly Report), the CDC (Centers for Disease Control) has released the 2010 data from the Foodborne Illness Active Surveillance System. This is vital background data for all students of Foodborne Illness. Please see our August 14, 2010 posting to review the latest available (and more comprehensive) 5-year trend data. The June 10 MMWR article is posted below (see page 749).
Tags:
The American Society for Microbiology (ASM) has published an important review of the European experience in efforts to control the use of AGPs (Antibiotic Growth Promoters) in food animal production. This article is most timely in view of the ongoing litigation efforts of consumer protection groups in the USA to force USFDA to take proactive steps to reduce AGP use in the USA. Please see our May 27, 2011 posting regarding this litigation. The article is available on the ASM website at ...
Tags:
As background to this announcement, NOAA (National Oceanic and Atmospheric Administration) calls attention to the poor performance of US policy makers with respect to job-creation in this industry which thrives around the world, but not in the USA. Some 84% of Aquatic Food Products (AFPs) consumed in the USA are imported and aquaculture now accounts for more than 50% of all AFPs consumed worldwide. Yet, less than 5% of US consumption of AFPs is produced through domestic aquaculture. It remains ...
Tags:
The National Resources Defense Council (NRDC) and a coalition of other environmental groups including the Center for Science in the Public Interest (CPSI), and the Union of Concerned Scientists have challenged USFDA's approval of the prophylactic use of Penicillin and Tetracyclines in animal feeds. These approvals date back to the 1950's. The Complaint, posted below, was filed on May 25 in Federal District Court (SDNY) and requests: 1. That FDA withdraw approvals for Penicillin as an animal ...
Tags:
In response to recent communications from readers, we are providing an update on the status of NOP (National Organic Program) progress towards the implementation of the Organic Apiculture Standard. The October 2010 NOSB (National Organic Standards Board) recommendation has not yet been acted upon by USDA/NOP. Interested readers should review the Draft 2001 Proposed Standard and the changes envisioned in the October 2010 NOSB recommendation. Both documents are posted below. For completness we ...
Tags:
The GAO (Government Accountability Office), the investigative arm of the US Congress, has issued another report in its series of analyses of the performance of USFDA and USDA in the protection of US consumers with respect to Food Safety risks. The report is sharply critical of FDA's performance in making the key decisions need to deploy limited resources in the most effective manner. This report should cause FDA to re-evaluate its priorities in the implementation of the Food Safety ...
Tags:
The first issuance of rules under the Food Safety Modernization Act (FSMA) were released by USFDA on May 5. The Press Release is attached as well as the two Federal Register Notices. Effective July 3, 2011, FDA will have the authority to Administratively Detain any food product without a showing that the product is Misbranded or Adulterated under the Federal Food, Drug, and Cosmetic Act. Additionally, Prior Notice Requirements for food imports are significantly expanded. Please see our article ...
Tags:
Following up on our October 2010 posting, Health Canada has released updated Rules for Control of Listeria monocytogenes in Ready-to-Eat foods. We post the new Guidelines below:
Tags:
On April 28, the Interagency Working Group on Food Marketed to Children - consisting of the Federal Trade Commission (FTC), the Centers for Disease Control (CDC), the Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA) – released its report, Preliminary Proposed Nutrition Principles to Guide Industry Self-Regulatory Efforts with suggested voluntary standards for marketing foods to children 2 – 11 and teens 12 – 17. The proposed ...
Tags:
On April 28, USFDA issued the 4th edition of "Fish and Fishery Products Hazards and Controls Guidance” as required by the Food Safety Modernization Act (FSMA), which President Obama signed into law in January. Major changes in the 4th edition include: (1) Updating post-harvest treatment for pathogens and toxins in shellfish - including Vibrio vulnificus and Vibrio parahaemolyticus; (2) revised time and temperature parameters to better control both scombrotoxin (histamine) formation and ...
Tags:
Food industry readers will want to review the FDA's newly released "Strategic Priorities 2011-2015" document. 2011 and 2012 will be the critical years for the most sweeping changes in food regulation in more than 70 years. However, FDA is tasked with a greatly expanded scope of responsibilities in a period of sharp budget restrictions from Congress. Numerous hard decisions on priorities will mean that there will be postponments in the implementation of some programs envisioned in the Food ...
Tags:
USFDA will fund a research study to evaluate market disruptions after major food recall-events in order to better understand the complex behavior of consumers, grocery retailers, and producers following major recall events. The study will be conducted under a FDA grant to the Joint Institute for Food Safety and Applied Nutrition and the Center for Risk Communication Research at the University of Maryland. It is hoped that the results of this study will further our understanding of post-recall ...
Tags:

FDA Updates RPM Chapter 7 - Recalls

Published on Mon, Apr 4, 2011 by Charles Woodhouse
FDA has updated Chapter 7 (Recalls) of the Regulatory Procedures Manual. We attach a PDF of the revised Chapter 7 below as well as updated copies of Industry Guidance on Recalls and 21 CFR Part 7. We note that Sec. 206 of the FSMA amended the FDCA by adding Mandatory Recall Authority as Sec. 423.
Tags:
We have posted below advance copies of proposed FDA rules on Restaurant and Vending Machine nutrition labeling rules as mandated by the Affordable Care Act of 2010. The final text will be published in the Federal Register on April 6. Readers should of course download the final definitive text when available. These rules will apply to chain restaurants with 20 or more units and operators of 20 or more vending machines.
Tags:
On March 30, USFDA released a "Background Document" reviewing health and labeling issues related to Certified Color Additives. The document reviews the "Southampton Study" commissioned by the United Kingdom's Food Standards Agency (FSA). We point out that our readers should review the original Southampton Study document (The Lancet, vol. 370, no. 9598, pp. 1560-1567, 3 Nov. 2007). The FDA document then reviews FDA's current regulation of Certified Color Additives, the historical background for ...
Tags:
The Governmental Accountability Office (GAO), the investigative arm of Congress, has issued a report on "Federal Food Safety Oversight" which is critical of the continuing fragmentation of agency responsibilities for food safety. The Report highlights the failure of Congress to address the problem of divided and contradictory authorities in the recently enacted Food Safety Modernization Act. In this analysis, the GAO again suggests that Congress should mandate a unified food safety agency ...
Tags:
The USDA's Food Safety Inspection Service ("FSIS") has issued new standards for control of Salmonella and Campylobacter in poultry. Attached below is the March 16 Press Release as well as an Advance Copy of the Federal Register Notice which will issue later this week. Additionally, we have posted a January 18 letter from the Centers of Disease Control ("CDC") which provides estimates of the prevalence of Salmonella and Campylobacter illnesses with poultry related etiologies.
Tags:
With the publication of two Federal Register Notices today, the FDA has taken the first administrative steps in the implementation process for the Food Safety Modernization Act ("FSMA"). Today's Notices begin the implementation of the Importer Provisions of the FSMA. The two Notices are posted below:
Tags:
Congresswoman Louise Slaughter has introduced H.R. 965, the Preservation of Antibiotics for Medical Treatment Act (“PAMTA”). Her legislation would limit the use of seven classes of antibiotics currently used to treat animals, most of which are already healthy, and preserve their use for humans. Louise Slaughter is unique among Members of Congress as the only serving member with a degree in microbiology (she also earned a MPH at University of Kentucky). First elected to Congress in ...
Tags:
On March 3, the Government Accountability Office issued a new Report titled “Opportunities to Reduce Potential Duplication in Government Programs” highlighting Food Safety programs among some 34 duplicative governmental programs in which inefficiencies are created through fragmentation of responsibility and unnecessary duplication of programs. The Government Accountability Office is the audit, evaluation, and investigative arm of Congress. The report (page 3) states that the ...
Tags:
Senators Begich, Murkowski, Murray, and Wyden have introduced two bills in the opening days of the 112th Congress. S-230 would prohibit USFDA from approving the marketing of genetically-engineered fish. S-229 would, in event of approval, require that genetically - engineered fish be labeled as such. The complete texts of both bills are posted below:
Tags:
On January 31, USDA released the 2010 update of "Dietary Guidelines for Americans", 7th Edition. This document, issued every 5-years, and from an inherently cautious governmental agency, remains an important benchmark for the "general consensus" on nutritional priorities for the consuming public. It may, as has been normal for past editions, receive considerable criticism from nutrition and consumer activists, but is, nevertheless, an important point of reference for students of food policy, ...
Tags:
FDA has issued the first Annual Report on the initial 12-months of operation of the Reportable Food Registry (September 2009 to September 2010). Participants in the farm-to-market value chain filed some 2,600 reports in the RFR system and the four most important causes which triggered mandatory reporting were: (1) Salmonella - 37.6%; (2) Undeclared Allergens - 34.9%; (3) Listeria monocytogenes - 14.4%; (4) E. Coli O157:H7 - 2.6%. A copy of the report is posted below:
Tags:
The GMA (Grocery Manufacturers Association) has made public a second FOP (Front of Package) labeling scheme which is called "Nutrition Keys". In 2010 the previous "Smart Choices" GMA initiative was dismissed by USFDA. It remains to be seen what position FDA Commissioner Margaret Hamburg will take on "Nutrition Keys". Readers who follow the work of nutritionist Marion Nestle should read her 2010 Commentary on this issue published by JAMA. Nestle, Marion, Front of Package Food Labels: Public ...
Tags:
The Government Accountability Office (the "investigative arm" of the US Congress) has issued another of its series of reports on Food Labeling issues. The report is titled "Food Labeling: FDA Needs to Reassess its Approach to Protecting Consumers from False or Misleading Claims" and takes aim at Health Claims, Qualified Health Claims, and Structure / Function Claims. The full report is posted below. The report presents, as Appendix I, an analysis of FDA's handling of Health Claims in response ...
Tags:
THIS IS THE FIRST OF A SERIES OF ESSAYS ON THE FSMA WRITTEN BY CHARLES WOODHOUSE THESE ESSAYS ARE DRAWN FROM THE MONTHLY FOOD SAFETY COLUMN WRITTEN BY CHARLES WOODHOUSE IN THE AMERICAN AGRICULTURAL LAW ASSOCIATION'S PUBLICATION AGRICULTURAL LAW UPDATE January 4, 2011 – President Obama Signs the FSMA With the Senate vote of December 22, the 111th Congress passed the Food Safety Modernization Act of 2010. This legislation will be signed into law by President Obama as PL 111-322 and in due ...
Tags:
The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced on December 29 that, effective January 1, 2012, it will require nutritional information panels for 40 of the most popular cuts of meat and poultry products. Under the new rule, packages of ground or chopped meat and poultry will feature nutrition information panels on their labels. Additionally, whole, raw cuts of meat and poultry will also have nutrition facts panels either on their package labels or ...
Tags:
The Food Safety Modernization Act has now passed both the House and Senate in the final days of the 111th Congress and heads for the desk of President Obama. Posted below is the latest available GPO version of the text - this is not final - the final text will be posted on this Weblog in a few more days after signature by the President and GPO release of the final text. This provisional text (240 pages) was extracted from the 2,000 pages of HR 3082
Tags:
In three new documents released (pre-publication) to support testimony before Congress, the CDC estimates that each year 1 out of 6 Americans (or 48 million people) experiences a foodborne illness, 138,000 are hospitalized, and over 3,000 die from foodborne diseases. Norovirus is identified as the most common enteric pathogen, accounting for an estimated 5.5 million infections a year, or 58 percent of documented and diagnosed illnesses requiring clinical treatment. Salmonella was second, ...
Tags:
On December 15, as part of its ongoing enforcement offensive to police the dietary supplements industry, the FDA issued a broad new warning about some dietary supplements, body-building products, and purported sexual enhancement products in a “Dear Manufacturer Letter” to manufacturers and trade groups. The FDA has issued nearly 300 alerts about dietary supplements in recent years. “These tainted products can cause serious adverse effects, including strokes, organ failure, and ...
Tags:
On December 13, President Obama signed the Healthy, Hunger Free Kids Act of 2010. The Act includes significant Food Safety program requirements for School Lunch Programs, recall provisions, and mandates Food Safety education, training, and certification for program managers and staff. Additionally, the Act introduces a Pilot Program for the inclusion of Organic Foods in School Lunch Programs. The White House Fact Sheet on the Act is attached below as well as the full text of the Act.
Tags:
The Enrolled Senate version of the Food Safety Modernization Act (S-510 ES) is back in play. Please see our post of December 7 for a discussion of the constitutional error made in the Senate on voting out S-510 ES. The House has now accepted (by a vote of 212-206) a Continuing Resolution which funds the federal government through September 2011. The Enrolled Senate version has been attached to the Continuing Resolution, thus curing the constitutional violation of the requirement that all ...
Tags:
The final Enrolled Senate (ES) version of S-510 (the Food Safety Modernization Act) has now been released by the Government Printing Office. Readers are referred to our previous post on the constitutional violation contained in the ES version of S-510. This drafting error has probably precluded the passage of Food Safety legislation in the 11th Congress. With the days counting down to Recess, it now looks increasingly unlikely that the 111th Congress will complete work on a Food Safety Bill. In ...
Tags:
On November 30, with a vote of 73 to 25, the US Senate passed an amended version of S-510, the Food Safety Modernization Act. The action now moves to the House of Representatives in the final days of the First Session of the 11th Congress. It is possible, but not certain that the House will accept S-510 as passed by the Senate, but there are substantial differences between S-510 as passed by the Senate and the House's HR-2749, the Food Safety Enhancement Act. There is also a major “blue ...
Tags:
The European Food Safety Authority (EFSA) has published its 2010 Eurobarometer Survey Report on consumer perceptions of food related risks. Contamination of food with industrial chemicals is perceived as the greatest public concern. Other major areas of concern are pesticide residues on fruit and vegetables, the presence of antibiotic and hormone residues in meat, bacterial pathogens such as Salmonella in eggs and Listeria in cheese, and the use of GE animals for human food. This document, with ...
Tags:
A team of researchers at Duke University has published an article criticizing the FDA methodology for the approval of GE (Genetically Engineered) Atlantic Salmon. The article was published in the November 19 issue of Science. Due to copyright restrictions we cannot attach the full text of the article. However, we include the summary below. Readers with university or other institutional affiliations can obtain copies on the HighWire Press electronic journals service. Genetically Modified Salmon ...
Tags:
Students of Food Labeling will wish to note that the debate on labeling of GE (Genetically Engineered) Foods has now reached Australia and New Zealand. Australian Senator Nick Xenophon has introduced legislation to require retail level labeling of foods containing GE derived ingredients. The Food Standards Amendment (Truth in Labeling - Genetically Modified Material) Bill 2010 would amend the Food Standards Australia New Zealand Act 1991. Three documents are attached: (1) the text of the ...
Tags:
The 2008 Listeria monocytogenes outbreak in Canada claimed 22 lives and caused a major review of the 2004 Health Canada guidelines for contorl of L. monocytogenes in Ready-to-Eat (RTE) foods. Readers can review the Weatherill Report (9/14/09 posting on this weblog). Health Canada has now issued its revised Policy on Listeria monocytogenes in Ready-to-Eat Foods (Nov. 3, 2010) The policy document is posted below.
Tags:
The Yale University Rudd Center on Food Policy & Obesity has issued a major report entitled Evaluating Fast Food Nutrition and Marketing to Youth. Our readers with interests in Food Labeling and Food Advertising will want to review the policy implications of this important report. The text of the report is attached below in two sections because of the large size of the files.
Tags:
The US Department of Justice has filed an amicus brief in a case before the US Court of Appeals for the Federal Circuit (“CAFC”) opposing the issuance of gene patents to naturally occurring DNA sequences that are merely isolated from existing organisms without additional alterations or manipulations. With the possible approval of the first Genetically Engineered (“GE”) animal being approved by USFDA for human food and the controversial labeling issues surrounding this ...
Tags:
On October 22, USFDA released a new 10-year Survey tracking food retail, restaurant, and food service industry efforts to control and reduce key food safety risk factors. In addition, USFDA has identified the need for trained and credentialed food safety managers in a separate Report which documents the effect of the presence of such credentialed managers on food safety compliance. In comments announcing the release of these reports, the FDA Deputy Commissioner for Foods, Michael R. Taylor, ...
Tags:
The US Department of Agriculture Foreign Agricultural Service has issued a review of FY 2010 agricultural export programs. This document is a valuable reference and review and is posted below. Additional information is available at the FAS Market Development website http://www.fas.usda.gov/mos/marketdev.asp
Tags:
Funded by a grant from the National Institutes of Health (National Institute of Environmental Health Sciences), researchers at Johns Hopkins University have completed the largest study ever conducted on the prevalence of food allergies in the US population. Because of copyright restrictions, we cannot provide the text of the article which is published in the October issue of the Journal of Allergy and Clinical Immunology. We are able to provide an abstract and we also attach the NIEHS Press ...
Tags:
The UK Food Standards Agency has issued warnings to importers on produce coated with wax containing morpholine as a carrier for glazing agents. The warning is primarily directed at apples since apples are most often consumed without peeling. Attached below is a file of FSA documents on the morpholine warning. The Material Safety Data Sheet (MSDS) for morpholine is available at: http://www.sciencelab.com/msds.php?msdsId=9927366
Tags:
On October 13, the Canada Gazette published an Official Notice listing bisphenol A as a Schedule-1 Toxic Substance under the Canadian Environmental Protection Act, 1999. This Notice will pave the way for possible upcoming restrictions on the use of BPA in food contact applications for food sold in Canada. It remains to be seen what possible effect this development will have upon the policies of the European Food Safety Authority and the US Food and Drug Administration. The Official Notice from ...
Tags:
Congresswoman Rosa DeLauro (D-CT), Chair of the Appropriations Agriculture Subcommittee (controlling the budget of USFDA and USDA) has issued what some may view as a direct challenge to USFDA Commissioner Margaret Hamburg over approval of trans-genic salmon. Readers who are following the AquaAdvantage Salmon matter will understand the intent of this legislation. The text of HR-6325 - Consumer Right to Know Food Labeling Act of 2010 - is attached below. It was released by the GPO today October ...
Tags:
The Institute of Medicine of the National Academies of Sciences has issued the first of two reports on Front-of-Package (FOP) Food Labeling Examination of Front-of-Package Nutrition Rating Systems and Symbols: Phase 1 Report The federal government requires that most packaged foods carry a standardized label—the Nutrition Facts panel—that provides nutrition information intended to help consumers make healthful choices. In recent years, manufacturers have begun to include additional ...
Tags:
With an increasingly activist Federal Trade Commission (FTC) taking a more aggressive posture with regard to food label claims of an environmental nature, readers should note the first update of the FTC Green Guides in 11 years is now in its Rulemaking / Comment phase. We have attached the Press Release, the Summary, and the full text of proposed changes. For comparison we also attach the 2000 Green Guide (note the legislative section at the end of the 2000 edition).
Tags:
Lawyers who are also trained and credentialed in the biological sciences will play a vital role in the development of the new field of Regulatory Food Science. In an important report, issued today, USFDA outlines the agenda for the development of the Regulatory Sciences. The report - Advancing Regulatory Science for Public Health - is attached below. The Regulatory Food Science agenda section of the report is on pages 13 and 14. As Food Science moves from the 20th Century level of the organism ...
Tags:

GHG Emissions Embedded in Food Waste

Published on Mon, Oct 4, 2010 by Charles Woodhouse
An important study on GHG Emissions and Food Waste has been published in Environmental Science and Technology. The authors include the noted agricultural efficiency researcher, Michael D. Webber of The University of Texas at Austin. Readers with access to science databases will find the citation to the full article posted below. For other readers, we provide the abstract below. This work estimates the energy embedded in wasted food annually in the United States. We calculated the energy ...
Tags:
In an action which casts serious doubt upon the prompt approval of the first Genetically Engineered (GE) Animal by USFDA, eleven US Senators have written to FDA Commissioner Hamburg urging that the Food and Drug Administration stop moving forward with the approval process for GE Atlantic salmon. Led by Senator Mark Begich (D-Alaska), the senators complained that the FDA is incorrectly treating the request for approval of AquAdvantage salmon as if it were a new veterinary drug and not as a new ...
Tags:
Using recombinant-based in vivo expression technology (RIVET), University of Florida researchers have discovered that tomato variety and maturity may influence the growth and prevalence of Salmonella enterica bacteria within the fruit. The findings, published August 31 in Public Library of Science (PLoS) ONE, suggest researchers may be able to develop tomato cultivars more resistant to Salmonella enterica contamination. Also, by monitoring tomato ripeness, it may be possible to reduce the ...
Tags:
On September 27, European Union agricultural ministers representing Germany, France, Italy and Spain reportedly expressed strong opposition to a proposal that would decentralize Genetically Engineered (GE) crop approval decisions from the EU level to the national level. Because of weighted voting at the EU Commission, this stance taken by larger countries threatens the chances of the expected compromise agreement on the regulation of Genetically Engineered crops in the region. To assist readers ...
Tags:
United States Senators Patrick Leahy, Amy Klobuchar, and Al Franken have introduced S-3767 the FOOD SAFETY ACCOUNTABILITY ACT OF 2010. This proposed legislation would dramatically increases prison sentences for violation of the FD&C Act, by introduction of adulterated or misbranded food into interstate commerce, to up to 10 years. Readers are reminded that FD&C Act violations are classed as strict liability crimes - meaning that intent is not an element of proof for the prosecution. ...
Tags:
On September 14, the Wall Street Journal published an important review article detailing the National Institutes of Health (NIH) research program that may lead to greater restrictions on structure / function and health claims made for Dietary Supplements. Due to copyright restrictions we cannot post the Wall Street Journal article. However, interested readers are able to access the article through Lexis/Nexis or the Wall Street Journal website. The article discusses ongoing grant funding for ...
Tags:
As Food Safety legislation moves forward in Congress, Senator Kirsten Gillibrand (D-NY) has emerged as one of the foremost Food Safety advocates in Congress. In March she introduced S-3114, a bill that would require food retailers and distributors to post lists of food products that have been recalled and impose an affirmative obligation notify purchasers about such recalled products. The Consumer Recall Notification Act would require grocery retailers and distribution centers to list specific ...
Tags:
BRIEFING PACKET The USFDA Veterinary Medicine Advisory Committee has released its Briefing Packet for the September 20 meeting to review the possible approval of Genetically Engineered (GE) AquaAdvantage Atlantic Salmon for use as human food. The general media will, of course, greatly overstate the strength of the potentially favorable position taken by the Committee. However, this is a generally favorable opinion on what may become the first center-of-the-plate protein to be approved for ...
Tags:
On August 26, FDA released a Background Document discussing its current thinking on the labeling of foods derrived from Genetically Engineered Salmon. This document is of significant interest in that AquaAdvantage GE Salmon may become the first GE animal food product to be approved for sale in the US. This document should be of great interest to the food labeling community. We also attach the Notice of Public Hearings.
Tags:
On August 24, USFDA released a new Industry Guidance document on Restaurant Nutrition Food Labeling. We attach below the two Federal Register Notices and the updated Guidance Document.
Tags:
Please see our July 12 posting for discussion of the new Shell-Egg Rule (74 FR 33030) which entered into effect on July 9, 2010 for producers with 50,000 or more layers at one farm. Below we have posted the Draft Guidance document issued this week. Please note there are additional modified Rules for Small Entities. Producers with 3,000 but fewer than 50,000 layers at one farm have a July 9, 2012 Compliance Date. Producers with fewer than 3,000 layers at a single farm are exempt. A link to the ...
Tags:
In coordination with the EFSA Advisory Forum, the Belgian Federal Public Service for Health, Food Chain Safety and the Environment is hosting a series of round tables on the role of science in the formulation of food-safety policy. In most cases, EFSA (European Food Safety Authority) decisions to protect consumers from Food Safety risks are based on scientific evidence. Sometimes there is uncertainty, which leads to the precautionary principle being applied. These concepts are enshrined in ...
Tags:
The August 13 issue of MMWR (Morbidity and Mortality Weekly Report) includes the release of 2007 data on Foodborne Illiness in the United States. We attach the relevant pages below.
Tags:
On August 9, the US Senate passed the "Healthy, Hunger-Free Kids Act" (Child Nutrition Act S-3307). This legislation now will move to the House in September (after recess) where passage is also expected without major changes. This Act will significantly restrict marketing of low nutritional value food products in American schools. The full text of S-3307 is attached below.
Tags:
USFDA has issued its Review Report on the first six-months of operations of the Reportable Food Registry (RFR). We have also included below the most recent Compliance Guide for the RFR updated to June 23, 2010.
Tags:
The UK’s Food Standards Agency (FSA), Biotechnology and Biological Sciences Research Council (BBSRC), and the Department for Environment, Food and Rural Affairs (Defra) have announced a new strategy for the development of a research agenda for the reduction of Campylobacter in the UK food supply. The FSA has declared that Campylobacter is the single most important food safety issue facing the UK today. The bacteria is estimated to account for almost a third of all food poisoning cases in ...
Tags:
July 21, 2010 - USFDA today issued a Federal Register notice that explains how restaurants and similar retail food establishments not covered by the new federal menu labeling requirements, such as establishments with fewer than 20 locations, and vending machine operators with fewer than 20 vending machines, can voluntarily register to become subject to the new federal requirements. Section 4205 of the Patient Protection and Affordable Care Act sets new federal requirements for nutrition ...
Tags:
The European Food Safety Authority (EFSA) has issued a Scientific Opinion of its Scientific Committee - "Guidance on human health risk-benefit assessment of foods" The document develops the EFSA methodology for risk-benefit assessments and works through several specific examples. One of the examples is a risk-benefit assessment of methyl-mercury associated with consumption of fish.
Tags:
The new FDA regulation for prevention of Salmonella in Shell Eggs take effect this week. We attach the Guidance document as well as the Federal Register Notice of the Final Rule.
Tags:
On July 7, the Proposed Rule on Restaurant and Food Service Nutrition Information was published in the Federal Register. The Notice is attached below. We also attach Section 2572 of the Health Care legislation signed by President Obama in March.
Tags:
Scientists at the University of London’s School of Hygiene and Tropical Medicine have published a review of the nutrition-related benefits to health of consuming organic foods in the American Journal of Clinical Nutrition. We have provided the abstract below as published on the London School’s website. Due to copyright restriction we are unable to attach the complete article which is available to researchers on the HighWire Press service. Nutrition-related health effects of organic ...
Tags:
The USDA Economic Research Service has released a report on Local and Mainstream Food Supply Chains. Local, so called "Low Food Miles", food products have been rapidly gaining popularity with consumers. This report provides research and data on this important development in food production and marketing. It is suggested that interested readers also see - Weber & Mathews, "Food-Miles", Environmental Science & Technology, vol 42 no 10, 2008.
Tags:
European Union Council Regulation (EC) No 834-2007 covering the production and labelling of organic products is now in full effect. We attach the complete text below. Readers should also understand that the new rules cover imported organic products which must conform with the new Regulation as well. We note that in "EU English" the spelling "labelling" is used rather than the American "labeling". We also include Council Regulation (EC) 710-2009 covering the details of Organic Aquaculture.
Tags:
In connection with potential contamination concerns raised by the Gulf Oil Spill, USFDA has issued a Letter to Industry reviewing regulations and requirements applicable to molluscan shellfish and other seafood production. FDA has also released its Analytic Protocol for reopening of areas closed to seafood harvesting.
Tags:
Stanford University researchers have published a study in PNAS, the Proceedings of the National Academy of Sciences, documenting cumulative GHG (Greenhouse Gas) mitigation provided by agricultural intensification. Readers with access to science databases will find the citation to the full article posted below. For other readers, we provide the abstract below. Abstract - As efforts to mitigate climate change increase, there is a need to identify cost-effective ways to avoid emissions of ...
Tags:
On June 28, FDA issued a Draft Guidance Letter to Industry on Use of Antimicrobials in Food-Production Animals. We attach the Letter, the Press-Release, and the Q&A below. This Letter has attracted considerable media attention. We recommend reading the letter instead of relying on the commentary of journalists who are anxious to tell you "more than they know". We also suggest reading the New York Times Editorial of June 29 at the following ...
Tags:

EFSA Annual Report for 2009 Issued

Published on Sun, Jun 27, 2010 by Charles Woodhouse
The European Food Safety Authority has issued its 2009 Annual Report. This author believes that USFDA CFSAN should also issue a similar Annual Report to its "stakeholders".
Tags:
USDA has published a proposed modification of PACA Trust provisions which may protect post-default agreements. The Federal Register Notice is attached below.
Tags:
On June 21, the US Supreme Court issued its long-awaited decision in Monsanto Company v. Geertson Seed Farms, 561 U.S. ___ (2010). In this important decision, the Supreme Court has lifted the injunction on distribution of Genetically Engineered (GE) alfalfa. The Slip Opinion, authored by Justice Samuel Alito, is attached below.
Tags:
As the European Union prepares for adoptions of major revisions in Food Labeling Regulations we post both the current law (Directive 2000 13 EC) and the Proposed Revisions. When the final text is adopted, it will be posted on our Weblog. We also include the Q&A Sheet for the Proposed Regulations.
Tags:
Health Canada has issued a survey of BPA residual levels in common canned foods. The attached report summarizes the methodology of the survey and reports results. Health Canada has previously concluded that migration of BPA into canned foods does not pose a public health risk to the general public.
Tags:
While food safety is also regulated by the USDA, the FDA oversees approximately 80 percent of the U.S. food supply, including all produce and seafood. Food safety experts and the public have criticized the FDA food safety system and questioned whether it properly safeguards Americans from foodborne diseases. Congress asked the Institute of Medicine of the National Academy of Sciences to examine the gaps in the current food safety system under the purview of the FDA and to identify the tools ...
Tags:
The June issue of the USDA magazine "Amber Waves" presents a valuable update on the current status of organic farming in the USA and discusses challenges and opportunities for the future. We also post, for our readers convenience, EIB #55 and EIB #58. These two Economic Information Bulletins, published in 2009, contain the research data for the current update.
Tags:

FDA Files Motion to Dismiss in CFS v. Hamburg

Published on Mon, May 31, 2010 by Anonymous
Tags:
On May 24, the Government Accountability Office released the text of its April 23 letter to USFDA highlightings GAO findings that show significant gaps in FDA Food Safety Research and Programs. The text of the Report is attached below.
Tags:
The Produce Safety Project has issued another excellent report in its series. The report issued this week focuses on lessons that can be learned from the European Union’s Food Safety Policy. For copyright reasons we cannot attach the report, but it is available on the following link: http://www.producesafetyproject.org/admin/reports/files/Building_the_Science.pdf
Tags:
HHS, NIH, and the National Cancer Institute have issued the 2008-2009 report titled “Reducing Environmental Cancer Risk”. This report, see link below, contains numerous Food Safety recommendations and specifically recommends Organic Food Choices for the consumer that will reduce consumption of pesticide, antibiotic, and growth hormone residues. http://deainfo.nci.nih.gov/advisory/pcp/pcp.htm
Tags:
In “Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease” an Institute of Medicine (National Academy of Sciences) panel has recommended that FDA adopt a consistent scientific process and framework for biomarker evaluation across all regulated areas, including drugs, medical devices, biologics, foods, and dietary supplements. As evinced by recent articles in the food industry press this recommendation is creating concern in the food manufacturing sector and ...
Tags:
It is increasingly clear that the final Food Safety legislation which will emerge from the 111th Congress will be very close to the provisions of HR 2749 which passed the House and moved to House-Senate Conference in August 2009. Therefore, we are again posting the text of HR 2749 for reference and review.
Tags:
On May 6, the Government Accountability Office (GAO) issued an important update of the September 2009 Import Food Safety Report (GAO-09-873) previously posted on this Weblog. For our reader's convenience, we post both reports below.
Tags:
Normal 0 false false false EN-US X-NONE X-NONE
Tags:
USFDA has opened a comment period for FOP (Front of Pack) food labeling. We have attached below the Federal Register Notice (75 FR 22602). This document contains an excellent discussion of FOP labeling issues and also includes an extensive reference list.
Tags:
The USDA Inspector General released today a highly critical report on National Residue Program monitoring for pesticide, heavy metal, and antibiotic residues in the national meat supply. The report dated March 25 is attached below.
Tags:
On March 30, the US Department of Agriculture Economic Research Service released data updated through 2008 on organic agriculture. A remarkable 15% annual growth of acreage dedicated to organic production has been documented. The attached PDF document provides the URLs necessary to access this data.
Tags:
The Department of Health and Human Services Inspector General has issued a report on USFDA's inspection program for domestic food plants. The report documents an underfunded and under-resourced agency unable to police food manufacturers and effectively prevent food safety emergencies. This report will have a significant impact as Congress considers food safety legislation in the months ahead.
Tags:

Published on Thu, Apr 1, 2010 by Anonymous
Tags:
The Affordable Healthcare for America Act signed by President Obama on March 23 contains the Restaurant Labeling provisions that we discussed in our posting of 11/3/2010. To assist our readers we attach below pages 1527-1536. Readers should note that it is possible, but unlikely, that these provisions could be amended in Senate / House Reconciliation. Until final Reconciliation these and other provisions can be reviewed on Thomas.gov (Library of Congress) under HR-3962, Division C, Title V, ...
Tags:
The Office of Inspector General of the USDA has issued a report that is sharply critical of USDA enforcement of the National Organic Program (NOP). The OIG Report highlights lax enforcement by USDA of organic labeling rules and failures of accredited certifiers to follow-up certificatiuon with periodic re-inspections and residue testing.
Tags:
In a report released on March 18, the Government Accountability Office (GAO) was sharply critical of FDA in its handling of Food Irradiation Petitions on a timely basis. The report faults FDA for non-compliance with its own internally set processing deadlines and for needlessly delaying the application of this potentially valuable new food safety technology.
Tags:
We are posting again (a year later) a review of COOL Labeling requirements in response to continuing questions that arise in connection with COOL implementation. Country of Origin Labeling is a labeling law that requires retailers, such as full-line grocery stores, supermarkets, and club warehouse stores, notify their customers with information regarding the source of certain foods. Food products, (covered commodities) contained in the law include muscle cut and ground meats: beef, veal, pork, ...
Tags:
A February 2010 Report released by the Government Accountability Office finds significant shortcomings in USFDA's oversight of the GRAS determination process. The Report highlights significant failings in USFDA's response to new concerns about the safety of GRAS substances.
Tags:
On March 3, FDA Commissioner Hamburg issued the attached Open Letter to Industry on Food Labeling issues. Also attached is the list of Warning Letters issued in connection with this Open Letter. You may access the specific letters at this link: http://www.fda.gov/Food/LabelingNutrition/ucm202859.htm
Tags:
The European Food Safety Authority has set up an EFSA scientific cooperation (ESCO) working group to collect and analyze information on the safety of substances used in non-plastic materials which come into contact with food. This follows a number of incidents in recent years in which certain substances used in non-plastic food contact materials (such as inks and adhesives) have been found to migrate into foods. Whilst EU rules specify that all materials coming into contact with foods must be ...
Tags:
The 2008 Organic Production Survey (OPS) is a follow-on survey to the 2007 Census of Agriculture. It is the first organic production and practices survey conducted on the national level by the U.S. Department of Agriculture (USDA), National Agricultural Statistics Service (NASS). The organic industry has experienced measurable growth over the last few years. This survey responded to the intense need for detailed industry data. The 2007 Census of Agriculture reported more than 20,000 farms ...
Tags:
The European Food Safety Authority (EFSA) has issued its 2008 Statistical Report on Zoonoses and Foodborne Human Illness within the European Union. Release date 1/28/2010. Please see attached file.
Tags:
For the past year, Customs Brokers have been preparing their customers - international seafood and produce shippers should be prepared for a new phase of regulatory enforcement that will soon take effect. U.S. Customs & Border Protection (USCBP) will begin enforcing the Importer Security Filing (ISF) Rule on January 26 with substantial financial penalties for non-compliance. The ISF rule has actually been in effect since Jan. 25, 2009. But, USCBP gave international traders of all commercial ...
Tags:
The New York City Health Department announces the Natiuonal Salt Reduction Initiative on Ja. 11, 2010. The Press Release and additional background information is attached below. This program is closely related to the United Kingdom's Food Standards Agency which published Salt Reduction Goals for 80 food categories in June 2009. For more information on the FSA's Salt Reduction Targets see http://www.food.gov.uk/healthiereating/salt/
Tags:
As part of a UK Government strategy to reduce Greenhouse Gasses, Hilary Benn, the UK’s Environment Secretary has introduced the new “Carbon Footprint” labeling strategy and several mayor food marketers and processors, including Tesco and PepsiCo have adopted the voluntary program. Publicly Available Specifications (PAS) have been prepared by British Standards Institution (BSI) to specify requirements for assessing the life cycle greenhouse gas emissions (GHG) of goods and ...
Tags:
The science and technology committee of Britain's upper house of parliament said, in a report issued on January 8, that use of nanoparticles in food and food packaging is likely to grow dramatically in the next decade, but too little is known about their safety. "The technologies have the potential to deliver some significant benefits to consumers, but it is important that detailed and thorough research into potential health and safety implications ... is undertaken now to ensure that any ...
Tags:
A new review from France has concluded that there are nutritional benefits to organic produce, on the basis of data compiled for the French food agency AFSSA. The conclusion opposes that of a UK study published in July 2009 (See weblog entry posted 7/15/09) Abstract – Food security, nutritional quality and safety vary widely around the world. Reaching these three goals is one of the major challenges for the near future. Up to now, industrialized production methods have clearly shown ...
Tags:
The lack of Food Industry compliance with the Bioterrorism Preparedness and Response Act of 2002 is again in the news (See our Weblog posting of March 31, 2009). Compliance with the Food Facility Register is running at the 48% level as documented by this HHS Inspector General Report.
Tags:
In the Fall 2009 Federal Unified Agenda, FDA announced its intent to issue enforceable regulations in line with the August 2009 commodity specific guidance documents on leafy greens, tomatoes, and melons. In addition the 1998 Good Agricultural Practices (GAPs) Guide will be updated. Please find the Unified Agenda Notice below as well as a copy of the 1998 GAPs Guide. The leafy greens, tomatoes, and melons Guidance Documents are posted elsewhere on this Weblog.
Tags:
General function claims under Article 13.1 of Regulation (EC) No. 1924/2006 refer to the role of a nutrient or substance in growth, development and body functions; psychological and behavioral functions; slimming and weight control, satiety or reduction of available energy from the diet. In October 2009, EFSA published the highly controversial series of opinions which provided scientific evaluations for more than 500 “general function” health claims from a list of 4,185 claims ...
Tags:

USFDA Releases Food Traceability Study

Published on Thu, Nov 19, 2009 by Charles Woodhouse
On November13, the Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) released a report from the Institute of Food Technologists (IFT), which recommends clear objectives be set for all users of a simpler, globally accepted food supply chain that can benefit from existing commercial systems. CFSAN commissioned the IFT report in 2008 as part of the agency's ongoing examination of food product tracing practices, and its commitment to improve the ability of ...
Tags:
The Food Safety Modernization Act of 2009 will now move to Senate debate. On November 18, the Senate Committee on Health, Education, Labor, and Pensions ordered S-510 to be reported with amendments. After passage by the Senate, S-510 will move to reconciliation with HR-2749 The Food Safety Enhancement Act of 2009 passed by the House in August. Both Bills are attached below.
Tags:

USFDA Releases Updated 2009 FOOD CODE

Published on Mon, Nov 9, 2009 by Charles Woodhouse
Last updated in 2005, the USFDA today released the 2009 Food Code. There are important changes for produce food safety with newly updated instructions for handling leafy greens.
Tags:
The Federal Register Notice (FR-74-211-56843-110309) on the forthcoming FDA / FSIS meeting has been posted below. There is a good deal of useful background information in the notice so it is well worth reading. We note that the Food Safety Enhancement Act of 2009 (when passed) will have a specific traceability mandate. Of course, the Bioterrorism Act of 2002 is also relevant in that it established the basic one-up one-down system in place since 2005. The HHS Inspector General Report earlier ...
Tags:
HR 3962, entitled the "Affordable Health Care for America Act" was introduced by Representative John Dingell (D-MI) on October 29, 2009. Section 2572, entitled "Nutrition Labeling of Standard Menue Items at Chain Restaurants and of Articles of Food Sold from Vending Machines", is posted on this item.
Tags:
In a letter to Congresswoman Rosa DeLauro, important new conceptual guidance on USFDA's approach to FOP Labeling has been provided by Commissioner Margaret Hamburg. The Release, the Backgrounder, and the DeLauro letter are inclided in the attached PDF file.
Tags:
In a major policy speech on October 17, USFDA's Michael Taylor announced new food safety requirements for fresh shellfish. The attached PDF file includes the policy speech text, a Backgrounder, a letter to the shellfish industry outlining the new requirements, and background information on Michael Taylor.
Tags:
An updated version of the Agricultural Research Service's (ARS) flagship nutrient database has been launched by ARS, the principal intramural scientific research agency of the U.S. Department of Agriculture (USDA). The database is the major authoritative source of information about food composition in the United States. This year, more than 200 new entries have been added to the "USDA National Nutrient Database for Standard Reference, Release 22," or SR22 for short, which now includes a total ...
Tags:
The European Food Safety Authority - EFSA - has published its first series of opinions on the list of ‘general function’ health claims compiled by Member States and the European Commission. Experts on EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) evaluated the scientific evidence for more than 500 claims. The opinions will help inform future decisions of the European Commission and Member States concerning the authorisation of health claims. The web ...
Tags:
On October 6, the Center for Science in the Public Interest issued its Report "The Ten Riskiest Foods Regulated by USFDA". Because of copyright restrictions we refer readers to the web site below: http://cspinet.org/new/pdf/cspi_top_10_fda.pdf You may paste this address to your browser and access the report. Readers should know that Meat and Poultry are supervised by USDA rather than USFDA. Therefore, these two product categories are not included in the CSPI Report. To get a more nuanced view ...
Tags:
The NY Times article presents strong criticism of USFDA's Food Safety policy and enforcement of the Federal Meat Inspection Act. The link to the article is posted here: http://www.nytimes.com/2009/10/04/health/04meat.html?_r=1&sq=food safety&st=cse&scp=4&pagewanted=print Because of copyright restrictions we post this link which can be pasted on your browser to locate the article. In an October 5 Press Release (posted here), Secretary Vilsack responds.
Tags:

Vitter Amendment to Food Safety Enhancement Act

Published on Fri, Oct 2, 2009 by Charles Woodhouse
The Food Safety Enhancement Act of 2009 (HR 2749) went to House Senate Conference on August 3. The amendment process is underway and we note an amendment introduced by Senator David Vitter (R, LA) which is intended to increase the pressure on USFDA to increase inspections of imported seafood. The conferees direct FDA, working with appropriate Federal agencies, to conduct a study and prepare a report on the challenges associated with imported seafood. The report shall include, by product and ...
Tags:

UK Food Standards Agency issues 2008 Pesticide Residues Report for Produce

Published on Sat, Sep 26, 2009 by Charles Woodhouse
The Pesticide Residues Committee of the UK's Food Standards Agency has released its controversial 2008 Pesticide Residues Annual Report. As was the case with the July report on Organic Foods, this report will create considerable controversy in the industry and in the environmental community.
Tags:
The EU's Rapid Alert System for Food and Feed ("RASFF") has released its 2008 Annual Report on Border Refusals during 2008. For comparison purposes we also attach the September 2008 USDA-ERS EIB Report No. 39 FOOD SAFETY AND IMPORTS. It is instructive to compare USFDA and DG-SANCO Import Refusals. For both the USA and the EU, Seafood Products and Produce (Fruits and Vegetables) are the top two categories of Border Refusals.
Tags:
The Third Period of Review (POR#3) runs from 2/1/07 to 1/31/08
Tags:
In 2008, listeriosis associated with processed meat products killed 22 Canadians. We have attached both the full Investigative Report as well as the Executive Summary.
Tags:
The US Department of Labor has released its 2009 Report on Child Labor and Forced Labor. This report singles out possible abuses related to certain seafood products and producing countries.
Tags:
On September 8, USFDA initiated the active phase of the REPORTABLE FOOD REGISTRY. Industry personnel at all levels of the food industry value-chain must be familiar with the 24-hour reporting mandate for all food safety violative conditions as defined in the attached Industry Guidance Document. Criminal liability may attach to individuals for failure to advise USFDA of Reportable Events on a timely basis.
Tags:

Important Traceability Status Review published in Food Technology

Published on Mon, Aug 31, 2009 by Charles Woodhouse
Institute of Food Technologists (IFT) members should read the August 2009 Traceability Review in Food Technology. This material cannot be linked or posted here since it is copyrighted material on an IFT member-only restrited website.
Tags:

Judge Stanceu of US Court of International Trade Rules on Shrimp Bonding Case

Published on Tue, Aug 25, 2009 by Charles Woodhouse
Five years later, after great financial hardship imposed upon shrimp importers, the US Court of International Trade rules in favor of the industy and against USCBP on antidumping bonds placed to secure payments that have already been made. However, the victory is Pyrrhic at best.
Tags:

USFDA Issues Updated Industry Guidance on Seafood Glaze

Published on Fri, Aug 14, 2009 by Charles Woodhouse
Tags:

USFDA Guidance - Microbial Contamination of Leafy Greens

Published on Sat, Jul 25, 2009 by Charles Woodhouse
July 25 release of FDA Guidance on Food Safety Requirements for Leafy Greens
Tags:
On July 25 USFDA released Food Safety Guidance for Tomatoes
Tags:

USFDA Guidance - Microbial Contamination of Melons

Published on Sat, Jul 25, 2009 by Charles Woodhouse
On July 25, USFDA released Guidance for Food Safety requirements for Melon production.
Tags:
The release of the Organic Foods Health Effects Report by the UK Government (Food Standards Agency) has caused considerable consternation in the Organic Foods industry. However, I believe that most sophisticated supporters of the organic movement accept the arguments presented by Michael Pollan in "The Omnivore's Dilemma".
Tags:

USFDA Issues Industry Guidance on Seafood Names

Published on Thu, Jun 18, 2009 by Charles Woodhouse
Tags:
This article reviews the innovative Michigan State University programs - the Graduate Certificate in International Food Law and Regulation and the Professional Master of Science Food Safety program.
Tags:

Food Safety Enhancement Act of 2009

Published on Fri, May 29, 2009 by Charles Woodhouse
As Congress moves on from Food Safety to Healthcare, here is the latest version of the Food Safety Enhancement Act of 2009 as released by Henry Waxman, Chair of the House Energy and Commerce Subcommittee.
Tags:
Our May 2009 article discusses the coming USFDA crack-down on the use of unapproved veterinary drugs in aquaculture food production.
Tags:
Our April 2009 article discusses Traceability Requirements under the Bioterrorism Act of 2002 and the HHS-IG Study on the level of industry awareness of Traceability Requirements.
Tags:
The attached USDA GAIN Report discusses proposed changes to NOM-051 (Norma Oficial Mexicana) General Labeling Specifications for Pre-Packaged Foods and Non-alcoholic Beverages.
Tags:

HHS Inspector General Investigation of Food Traceability

Published on Tue, Mar 31, 2009 by Charles Woodhouse
The March 2009 release of the Food Traceability Investigative Report by the Health & Human Services Inspector General surprised both members of Congress and food industry observers by revealing the astounding lack of knowledge of existing traceability requirements on the part of industry executives. "One-up, One-down" Traceability has been mandated since 2005 under theprovisions of the Bioterrorism Act of 2002, but has been widely ignored at all levels of the food value-chain.
Tags:

USFDA Updates RPM Recall Procedures

Published on Tue, Mar 31, 2009 by Charles Woodhouse
The USFDA has published an update of the Regulatory Procedures Manual Chapter 7 - Recall Procedures.
Tags:
The Government Accountability Office report on seafood fraud highlights a serious and growing problem n which the consumer is defrauded by species substitution and short-weight hidden by excess glazing.
Tags:
Our March 2009 article discusses recent Food Recalls and the new UNFAO Global Study of Shrimp Fisheries.
Tags:

UNFAO - Global Study of Shrimp Fisheries

Published on Sat, Feb 28, 2009 by Charles Woodhouse
Tags:
A pair of excellent reviews of current agricultural biotechnology issues has been released by the Congressional Research Service - one on plant biotechnology issues and the other on agricultural animal genetic engineering. These reports provide a summary of the US agricultural biotechnology regulatory system and discuss international and trade issues as well.
Tags:
Our February 2009 article discusses the state of the seafood market in late 2008 during the world financial crisis.
Tags:

USFDA Issues Staff Guidance on Seafood Decomposition

Published on Tue, Feb 10, 2009 by Charles Woodhouse
Tags:
Our January 2009 article discusses the selection of Third Party Certification Organizations by USFDA.
Tags:

USCBP Prior Notice (10+2 Program) Documents

Published on Thu, Jan 1, 2009 by Charles Woodhouse
As a service to readers, we are keeping the background documents on USCBP 10+2 active on the Weblog
Tags:

Published on Wed, Dec 31, 2008 by Charles Woodhouse
Tags: