Essays

May 15, 2021 - Charles Woodhouse is the author of the Book Chapter on "International Food Law" to appear in the forthcoming American Bar Association "Practitioner's Guide to Food Law". This new ABA publication is in final preparation at the American Bar Association and will be available later in 2021.

June 14, 2020 - We particularly note two recent additions to our Book List. The first is the important contribution to Process Engineering and Systems Analysis by the UK's Trevor Kletz. Things can and do go catastrophically wrong in the processing of agricultural commodities since we are dealing with Heat and Pressure in industral processes as well as hazardous biocides in the fumigation processes. As Professor Gordon has taught us in his classic "Structures", in the context of failures in ...

DECEMBER 17, 2018 - We add 7 new books to our science reaing list for 2018. Blum, Deborah, The Poison Squad: One Chemist’s Single-Minded Crusade for Food Safety at the Turn of the Twentieth Century, Penguin, 2018. Quammen, David, The Tangled Tree: A Radical New History of Life, Simon & Schuster, 2018. Doudna, Jennifer, A Crack in Creation: Gene Editing and the Unthinkable Power to Control Evolution, Houghton Mifflin Harcourt, 2017. Jones, Lucy, Big Ones: How Natural Disasters ...

PLEASE CLICK ON THE HEADLINE ABOVE TO SEE PHOTO June 12, 2017 - This magnificent mosaic depicts Roman grain inspectors MISURATORI analyzing arriving grain shipments in the customs area of the Imperial Roman port of Ostia Antica. The inspector on the left is holding a RUTELLIUM for drawing samples from within the MODIUS holding a specific quantity of grain. This mosaic decorates the floor of the Grande Aula of the Collegio dei Mensores.

JUNE 30, 2016 - We cannot offer any advice to our readers on the current crop of “two-day seminars” that are proliferating and that claim that they will produce qualified food “experts” for the new FSMA compliance and food liability litigation environment. We offer only these comments and a strong “caveat emptor”: There are hard choices in front of food company CEOs in choosing their commitment level to Food Safety. We believe that sending an employee to ...

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 ...

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 ...

In our current national atmosphere of “anti-science denialism”, even the established statistical tenets of epidemiology are under attack. It has become clear to this author that the general public (and perhaps the legal profession and judiciary as well) is unaware that the role of the epidemiologist is to establish “association”, not “causation”. In the interest of facilitating understanding of this issue, we post below the famous 1965 discussion of this ...

February 7, 2014 - President Obama traveled to Michigan State University today to sign the Agricultural Act of 2014 ("The Farm Bill"). Please note our previous posts below on various issues related to this important legislation. Following the final 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 ...

Charles Woodhouse's article on "Preparing for the Food Safety Modernization Act" appears in the Fall 2013 issue of Food, Cosmetics, and Nutraceuticals News. A PDF of the article is posted below:

July 26, 2013 - FDA has released the preliminary texts of two important Proposed Rules issued pursuant to the Food Safety Modernization Act (FSMA). Today the Proposed Rules for the Foreign Supplier Verification Program (FSVP) and for Third-Party Audits were released in preliminary form. Publication in the Federal Register will follow next week. We continue to wait for the release of the Voluntary Qualified Importer Program (VQIP) Proposed Rule. Todays texts are posted below:

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 ...

FDA Food Recalls are now running at the rate of four per day *, but Recall Insurance is highly problematical in that it provides minimal, and often illusory, protection. The only real option for protection is advance planning and a program of proactive compliance. This is particularly important with the ongoing, and now, after the Presidential Election, certain, implementation of the Food Safety Modernization Act (FSMA). In July, I gave a lecture at Michigan State University on Recall ...

www.PACAreform.com The website www.PACAreform.com is being hosted by Woodhouse Shanahan PA as a pro bono service to Florida Growers. This website will host a Members-Only discussion group of Florida Growers who will develop suggestions and recommendations to the Secretary of Agriculture with respect to PACA procedures and policies that directly impact the interests of Florida Growers of Perishable Agricultural Commodities. Perishable Agricultural Commodities Act (PACA) of 1930 The PACA ...

Note - the 11 photos in this article take some time to download. Many of our readers know that the author spends several months each year in Firenze. Therefore, the author dedicates this "photo essay" to the Mercato Centrale di Firenze and the people who make the Mercato Centrale the "temple" of Italian Cuisine. In Italy, the author enjoys the daily pleasure of spending each morning at the Mercato, speaking Italian, shopping for the perfect ingredients, and learning from the masters of ...

Reporters for the mainstream media are focusing intensely on the reintroduction of products that were formerly, in some cases, considered processing waste into food products intended for human consumption. Because these reprocessed elements are, in fact, a portion of the stated original product, clear labeling disclosure, to highlight their reintroduction, has not normally been required by FDA or USDA. Unlike LFTB and Dairy Product Solids, the current supply of Raw Scraped Ground Tuna has not, ...

The public reaction to the “Green Slime” story in Australia is bringing unwanted attention to the use of permeate or “dairy product solids” in fluid milk. In due course, reporters from the popular media will, no doubt, investigate permeate use in the United States. The US food industry does not need another episode of the Pink Slime controversy. Once again, the food industry’s, perhaps understandable, desire to avoid meaningful labeling disclosure will provide an ...

Since our posting of March 23 (below), the Pink Slime "Perfect Storm" has continued unabated with industry executives and legislators continuing to attract more attention to this unfortunate story with their bumbling over-reactions. As we pointed out in our previous Essay – there is no “science” whatsoever to indicate that FTLB is harmful to human health. When will industry executives learn what I learned as a farm-boy growing up in New Hampshire? “The more you stir it, ...

The media have been enjoying the lurid and sensational characterization of LFTB (Lean Finely Trimmed Beef) as the “Dinner from Hell”. Despite the fact that there is no “science” to support public fears, across a wide political spectrum in the national media, the coverage has been uniformly negative. Beginning with the famous New York Times “expose” in 2009* and even today in The Atlantic**. Of course, as food scientists we know that LFTB treated with ammonium ...

A review and discussion article published in Annals of Internal Medicine suggests that the food industry should be cautious in the current, perhaps excessive, rush to bring out "Gluten Free" products. The citation and abstract are posted below: Di Sabatino, A., Corazza, G. R., Nonceliac Gluten Sensitivity: Sense or Sensibility?, Ann Intern Med, v.156, pp. 309-311, 21 February 2012. Abstract Recent studies support the existence of a new condition, nonceliac gluten sensitivity, which manifests as ...

United Nations Special Rapporteur Olivier De Schutter has issued a major report to the United Nations Human Rights Council on the Right to Food. This report, which suggests significant regulatory changes at both international and nation levels, will generate controversy in food industry and food regulatory circles. However, it is important reading for regulatory food science professionals as it will be often cited in discussions of food policy in the years ahead. We post the report below: Right ...

Readers should pay close attention to the “cautionary tale’ of the prosecution of the owner of a California company involved in the sale of supposedly “organic” liquid fertilizer. The United States Attorney for the Northern District of California has issued a press release detailing the guilty plea entered by the owner of California Liquid Fertilizer (CLF). Between 200 and 2006, over $6.5 million of products were falsely labeled as USDA Organic. The owner of CLF, Peter ...

We have another example of the dangers of Antiscience Denialism in the proliferation of state laws permitting intrastate sale of nonpasteurized dairy products. The March 3 issue of Emerging Infectious Diseases presents the strongest epidemiological evidence to date on the danger to public health from state laws permitting the intrastate sale of nonpasteurized dairy products. Researchers at the Centers for Disease Control present data from 30 states documenting foodborne illnesses attributed to ...

As our readers know, editorial comments on this Weblog are confined to the Essays section and very limited in scope. However, as a New Hampshire Native, a Dartmouth Graduate, and a lawyer, the author feels qualified to comment on this misguided piece of legislation. It is obvious that the sponsors of this Bill are either: (1) not trained lawyers; or (2) lawyers who perhaps skipped or slept through the law school Constitutional Law lectures on the Commerce Clause and the Supremacy Clause. We ...

Some of our readers know that the Woodhouse family owns a DOT Authorized Motor Carrier – Woodhouse Trucking LLC. Therefore we take particular interest in the highway transportation provisions of the Food Safety Modernization act (FSMA). SEC. 111. Sanitary transportation of food. (a) In general.—Not later than 18 months after the date of enactment of this Act, the Secretary shall promulgate regulations described in section 416(b) of the Federal Food, Drug, and Cosmetic Act (21 ...

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 ...

The term “Regulatory Science” has entered the vocabulary of compliance professionals in recent years. Perhaps the most generally accepted definition of this term has been offered by FDA Commissioner Margaret Hamburg. Her definition of “Regulatory Science” is this – “Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.”(1) This ...

Despite its continued refusal to define “Natural”, FDA has recently issued a Warning Letter to a New York food manufacturer. Like the famous definition of obscenity by a former US Supreme Court Justice – “I can’t define it, but I know it when I see it.” – FDA apparently “knows a violation when it sees it”. The FDA website says only this about “natural": “What is the meaning of 'natural' on the label of food? From a food science ...

All seafood importers should understand that seafood Species Substitution is not simply an Economic Crime. Seafood Species Substitution exposes the consumer to substantial health risks and the importer to civil liability and potential FDA recalls as well as to criminal liability of corporate officers. As all importers know, Fish and Crustacean Shellfish are classed as Major Allergens under the Federal Allergen Labeling and Consumer Protection Act (FALCPA). Undeclared Allergens can, of ...

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:

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:

Charles Woodhouse comments on the Regulatory Science agenda of USFDA and on the philosophy behind the implementation of the Food Safety Modernization Act. He also comments on the convergence of the concept of "causation" with respect to the etiology of foodborne illness in science and in the law.

Score: Lawyers 200; Scientists 23; in the 111th Congress We are personally somewhat dismayed by the relatively poor performance of the US Congress in formulating evidence based public policy in an increasingly technical and complex world. Furthermore, there are disappointingly few Members of Congress who are willing to take principled stands against the growing influence of what has come to be known as “anti-science denialism” [1] in the public square. Scientists & Engineers for ...

WHAT ROLE WILL TRADITIONAL HACCP PLAY IN THE FOOD SAFETY MODERNIZATION ACT? Charles F. Woodhouse, Esq. August 1, 2011 We will examine the actual provisions of the legislation in order to more fully understand the concept of Hazard Analysis and Risk-Bases Preventative Controls which are at the heart of the Food Safety Modernization Act. Note to readers on Citation: Pub. L. No. 111-353, § 103, 124 Stat. 3885, 3889-3899 (2011). Amending the FDCA and now cited as FDCA ...

Charles Woodhouse has written a recent White Paper on Wheat Gluten Allergy and Celiac Disease. In view of the strong pressure on legislators and health authorities (in the USA, the European Union, and Canada) from Allergy Awareness and Public Health interest groups to strengthen allergy labeling requirements, this is a topic of major interest to Regulatory Food Scientists who deal with labeling issues. We post the White Paper below:

Normal 0 false false false EN-US X-NONE X-NONE

Normal 0 false false false EN-US X-NONE X-NONE