How to regulate nanotechnology in food?

In 1959, a Nobel Prize-winning physicist challenged his colleagues to use submicroscopic particles to manufacture a wide range of products—an idea that captivated the imagination of scientists and inspired the science fiction movies “Fantastic Voyage” and “Innerspace.”

Fifty years later, “nano” (small) technology has moved from the science fiction realm to scientific fact, and federal regulators are laying the groundwork for monitoring a new generation of medical devices, drugs, cosmetics, and other products.

The U.S. Food and Drug Administration is continuing a dialogue on nanotechnology begun in 2011 by publishing proposed guidelines on the evaluation and use of nanomaterials in FDA-regulated products.

The first draft guideline, “Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology” was published in the Federal Register in June, 2011. The FDA is still reviewing and receiving comments on this document from the public.

In April 2012 the FDA is issuing two new draft guidelines for manufacturers of food substances and cosmetics, which are also open for public comment.

FDA Commissioner Margaret A. Hamburg, M.D., says the guidelines provide a starting point for the nanotechnology discussion. “Our goal is to regulate these products using the best possible science,” Hamburg says. “Understanding nanotechnology remains a top priority within the agency’s regulatory science initiative and, in doing so, we will be prepared to usher science, public health, and FDA into a new, more innovative era.”

Nanotechnology—the science of manipulating materials on a scale so small that they can’t be seen with a regular microscope—could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or altering the look and feel of a cosmetic.

“Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes” describes factors industry should consider when determining whether a significant change in the manufacturing of a food substance affects its identity, safety or regulatory status (such as whether a substance is covered by an existing food additive regulation). A food substance is one that is added to food or to food packaging for purposes that include improving taste, texture, or shelf life.

This guidance covers “any manufacturing process change that might affect a food substance’s identity, intended uses, or the way it behaves in the body after it is eaten,” says Dennis Keefe, Ph.D., director of the Office of Food Additive Safety.

Keefe added that nanotechnology now is being studied in food packaging to combat bacteria and detect spoilage, and to improve the bioavailability (the degree and rate at which a substance is absorbed into one’s system) of nutrients, among other applications.

Pets and Service Dogs in grocery stores; the line must be drawn

I am constantly annoyed with pet owners that take their little dogs to the store, especially the grocery store. Oregon is too.  The state Department of Agriculture started a public awareness campaign last month reminding Oregonians that it’s illegal for dogs to enter grocery stores – unless it’s a service dog. Stores like Bed, Bath & Beyond and Home Depot aren’t good places to be bringing your pet, but there can be legal consequences in stores and restaurants that serve food.

There have been some arguments made for and against patrons bringing pets to stores. Some say their personal pets are like “children” to them, as if they are another family member, but bringing pets into stores is not a good idea for public safety in a microbiological sense and also a physical sense. I hate tripping over toddlers at Walmart, and I don’t want to add tripping on leashes or small dogs to this problem.

By law, grocery stores must allow service dogs into grocery stores.  According to the Americans with Disabilities Act, business owners may ask if an animal is for service, yet they cannot require a customer to show certification or other proof that an animal is certified. In fact, legitimate service animals aren’t always certified. (For more information on the law, call 1-800-514-0301.) A quick search on Google brought up Service Animal IDs for $30, no verification paperwork needed. This ID doesn’t classify the animal as a service animal, but most people aren’t able to tell the difference between the real thing and phonies. IDs such as this one could allow anyone to bring a pet into a store selling food, and most likely store managers wouldn’t do a thing about it.

Separating the true service dogs from the personal pets makes it hard for those that rely on their service animals for help with a disability.  The ADA defines a service animal as any guide dog, signal dog, or other animal individually trained to provide assistance to an individual with a disability. If they meet this definition, animals are considered service animals under the ADA regardless of whether they have been licensed or certified by a state or local government.

Most people think of service dogs as performing functions such as leading the blind and opening doors, but they are also psychiatric service dogs that help people with psychological problems. Unfortunately there is where the lines become very grey. Assistance Dogs International has three categories: guide dogs for the blind and visually impaired, hearing dogs for the deaf and hard of hearing and service dogs for people with disabilities other than those related to vision or hearing. Service dogs may be needed by people with disabilities that are not visible and perform activities such as alerting of oncoming seizures or a variety of psychiatric disabilities. While grocery store owners are allowed to ask if an animal is a service animal or pet, they are not allowed to ask what their disability is (if not visible).

This issue spins round and round. Untrained animals shouldn’t be brought into areas of food. But disabled people need service animals present to help with disabilities. But pets may not be able to be distinguished from service animals, and patrons may abuse the fact that the store owner can’t ask what their disability is. But the store owner has a right to exclude pets from areas with food for sale.

The long and the short of it is, there isn’t a federal regulatory agency that dictates how these animals are certified as service dogs. Even if we did have the regulatory agency, would that ensure resolution of all the service animal disputes? Of course not, just as the existence of the FDA and USDA doesn’t ensure the 100% safety of our food supply.


Can regulators regulate and promote? Safe food sells

I cringe when pompous professorial types begin sentences with, “Clearly …” 

It happens a lot

Over the years, I’ve repeatedly heard a variation of, “Clearly, government agencies can’t regulate and promote food at the same time.” I was on National Public Radio in Maryland a few weeks ago and the statement was repeated mantra-like by both the host and some activist dude.

Yesterday, it was Sylvain Charlebois, a business professor at the University of Regina, telling Canadian parliamentarians they should establish an independent food safety agency reporting directly to Parliament because the Canadian Food Inspection Agency is failing consumers because of its “dual mandate.”

That wasn’t so clear to Ronald Doering (right) who served as the CFIA’s president from 1997 to 2002 and practically designed the agency. He called Charlebois’s proposal to "hive off food safety" to a body reporting to Parliament instead of to a minister, “silly.”

"The principle consensus all around was if you’re going to reorganize how you’re going to do food safety, animal heath and plant protection, you’ve got to make sure you’ve got accountability right. All parties agreed that we needed to have the agency report directly to a minister in the traditional way, and there could be no doubt that the minister the agency reported to would be accountable for its work."

Sure, CFIA has problems — like staff figuring out how to subscribe to FSnet. About 400 of them got deleted last week because of repeated error messages due to changes in e-mail addresses. About 250 figured out how to resubscribe; the other 150 decided to personally e-mail and demand I play secretary. Veterinarians with entitlement issues?

Back to the issue. I’ve always thought it’s easier to market safe food and never had much time for the armchair conspiracy theorists.

Doering also said it’s "simplistic" to argue the CFIA’s dual mandate presents a problem for consumers. Rather, he said Canadians are well-served by putting "the whole food chain in a single enforcement agency, so the CFIA is responsible for seeds, feed, fertilizers, all plant health, all animal health, all food, all commodities because they are all connected."

"The Canadian food, animal health and plant regulatory system is admired around the world. The idea we can export to a 100 countries food, animal or plants without inspection has to say something about the credibility of the regulatory agency."