Ecotopia

 11 December 2012

This week on Ecotopia, we’ll be interviewing BRITA BELLI, who is the editor of E -the Environmental Magazine, the largest independent magazine dedicated to green issues. She is the author of The Autism Puzzle: Connecting the Dots Between Environmental Toxins and Rising Autism Rates (Seven Stories Press) and blogs about autism and toxins at <autismandtoxins.com>.

Her magazine recently ran a feature on “nanoparticles,” tiny chemical molecules that are added to processed food for various reasons and are virtually unregulated by the Food and Drug Administration. We’ll ask her to tell us about nanonparticles and what we need to know about their effects on our health.

We’ll also ask her about a recent series of articles in E-Magazine concerning ocean acidification, how it is happening, what its effects are on marine life.

Listen to the Program

Our Conversation with Brita Belli

About E-Magazine

–E-The Environmental Magazine covers an incredible range of topics on the environment, health and nutrition, economics, and ethics. Could you tell us a little about the mission and history of the magazine? Who is your audience? (Who are your advertisers?) <www.emagazine.com>

–You also write a good number of the articles for the magazine, blog regularly, and write books. Please tell us something of your personal background and how you came to be such a passionate writer on so many environmental and health issues.

About Nanoparticles

Scroll Down to Read Brita’s Article and the FDA “Fact Sheet” on NanoParticles

–In the current issue of the magazine, you’ve written and article titled “We Know Nanoparticles Are in Our Food, But It’s Still Unclear What Harms They Pose to Our Health.” What are “nanoparticles” anyway? Where do they come from? How do they get into food? What are they designed to do? [“deliver vitamins and nutrients, alter consistency, and preserve freshness”]

–Please give us some examples of foods in which they are used. [“A lot of white processed foods contain nano-sized titanium dioxide for pigment purposes—including Mentos, Trident gum, M&Ms and Nestle Original Coffee Creamer. “]

[Our personal experience is not great, but includes a discussion with a university “human ecology” professor, whose research had included adding dessicants to chocolate chip cookies, thus making them absorb water and remain soft.]

–E-Magazine contacted the Food and Drug Administration and “an FDA spokesperson admitted that the agency does not track which foods contain the particles, but relies on companies to voluntarily offer information.” What information do the companies offer voluntarily? What–in your judgement–is not being revealed?

–You note that “The FDA has thus far preferred a hands-off approach, treating nanoparticles as equivalent to their larger-scale counterparts.” How does the FDA treat the larger additives? Why do you think the FDA is taking this approach? Shouldn’t all food ingredients be made public–except, maybe, the “secret” formula of Coke?

[Quote from the FDA Nanotechnology Fact Sheets: “The very changes in biological, chemical and other properties that can make nanotechnology applications so exciting also may merit examination to determine any effects on product safety, effectiveness, or other attributes.” Our italics added–this quote shows a bias toward nanoparticles and a casual attitude toward taking action. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm300914.htm?source=govdelivery]

–You refer to the Woodrow Wilson International Center for Scholars which is taking up the problem of nanoparticles. What are they examining? What kinds of issues are they raising? <http://www.nanotechproject.org/>

–You mention as well that nanotechnology is not limited to food, but is used in food packaging and plastics as well. What kind of research is being done on these nonfood uses?

[“In 2011, researchers found that inhaled carbon nanotubes (used in plastics and computer chips) can damage the lungs similar to asbestos, giving rise to cancer.”]

–What additional kind of science is under way and what research ought to be required on the use of nanotechnology in both food and nonfood products? And how should this be included in the regulatory process?

[“Each nanoparticle reacts differently with the human body and each needs thorough testing before it can be considered safe for consumption.”]

–How can interested listeners learn more about nanoparticles and voice their concerns?  [Check
As You Sow:  www.asyousow.org/ , National Resources Defence Council <nrdc.org>, Friends of the Earth <www.foe.org/>g

About Ocean Acidification

A couple of weeks ago on this program we talked with Robert Wintner, “Snorkel Bob,” about some of the dangers to the coral reefs due to extraction of the fish. In an article in the May/June issue of E-Magazine, Brita discusses another threat, not only to the coral reefs, but to “the entire ocean food web.” In this segment, we’ll ask her about that article: “This is your ocean on acid.”

–You begin that article with stories about the decline of the shellfish industry–clams, oysters, and others. What is happening to these fisheries, and how is it tied to ocean acidification? What are the specific effects on shellfish?

–You also write about the coral reefs, which are not only threatened, but according to many experts, may collapse completely within our lifetime. How are the reefs affected by acidification?

–What is the magnitude of ocean acidification? How is it caused? [A huge question, we realize, since so many variables are involved.]

–OK, we and most of our listeners are totally convinced about the dangers and causes of ocean acidification (along with climate change and other virulent effects of human presence on the planet). What is being done? One of your interviewees, Rob Jackson, referred to “piecemeal solutions”–What are they and why won’t they work?

–Are there some success stories in reef and shellfish restoration that point the way to larger, more comprehensive solutions?

–A global solution to ocean acidification would involve a world wide effort to reduce of greenhouse gas emissions. Given the very mixed results of Kyoto, Copenhagen, Rio 20, what do you see as the probability of reform? Can/will the US take a leadership role? [Several of the people we’ve interviewed on the program have said flatly that we can’t depend on governments and legislation to accomplish environmental reform. Do you agree?]

About Ecoethics

–We’d like to ask you about the topic of one other issue of E-Magazine (December 2010), which raised the question, “Do we have a moral obligation to save the planet?” What is your degree of optimism that the earth’s 7.3 billion people (and growing) will answer that question affirmatively?

–What topics are you writing and thinking about next?

This has been Ecotopia on KZFR, and we have been talking with Brita Belli, editor, writer, and activist on environmental issues. We strongly encourage listeners to check out E-The Environmental Magazine <www.emagazine.com/> and her blog <www.autismandtoxins.com>. Thank you for taking time to be with us tonight.

 

Brita's Article on Nanoparticles 

It’s uncomfortable to acknowledge that not only are we largely unaware of nanoparticles in our food supply, but that the U.S. Food and Drug Administration (FDA) can offer little in the way of specifics. Contacted for this issue’s cover story on the use of nanoparticles in food—microscopic particles used to deliver vitamins and nutrients, alter food consistency and preserve freshness—an FDA spokesperson admitted that the agency does not track which foods contain the particles, but relies on companies to voluntarily offer information.

 

As such, comprehensive information about which particular foods contain nanoparticles is hard to come by. Groups that are attempting to provide a go-to guide, particularly the Woodrow Wilson International Center for Scholars, have captured just a sliver of products. In some cases, particularly when it comes to supplements, packaging will tout the inclusion of nanosilver or nanoiron. But in most cases, consumers have no idea if a food product or its packaging contains nanomaterials. What’s worse, scientists are still uncovering the possible health impacts of ingesting nanoparticles and discovering that these tiny particles could cause harm when they enter the bloodstream through the digestive tract and accumulate in organs

 

The FDA has thus far preferred a hands-off approach, treating nanoparticles as equivalent to their larger-scale counterparts. But science shows us that the particles’ small size makes them capable of bypassing the blood-brain barrier and lodging in lungs, bringing unintended consequences. In 2011, researchers found that inhaled carbon nanotubes (used in plastics and computer chips) can damage the lungs similar to asbestos, giving rise to cancer. Ingested nanoparticles may have more subtly damaging effects—including inducing over-absorption of a particular vitamin or mineral to a toxic level. Each nanoparticle reacts differently with the human body and each needs thorough testing before it can be considered safe for consumption; but there’s been no such cautionary delay in bringing these products to market.

 

What do we know about where nanoparticles are found? A lot of white processed foods contain nano-sized titanium dioxide for pigment purposes—including Mentos, Trident gum, M&Ms and Nestle Original Coffee Creamer. Food packaging is another route of exposure, though it’s nearly impossible to determine which contain nanoaluminum and nanosilver, used for its antibacterial properties. What’s needed—with nanoparticles and all chemicals—is a precautionary approach that safety tests firsts and approves second. Instead, researchers are scrambling to determine adverse health outcomes, industry is keeping quiet, the FDA is avoiding the issue and consumers are left in the dark.

 

The FDA “Fact Sheet” on Nanotechnology

 

Fact Sheet: Nanotechnology

April 2012

 

Nanotechnology Overview

 

Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated products, including medical products, foods and cosmetics. Nanomaterials, developed using nanotechnology, are measured in nanometers — equal to about one-billionth of a meter — so small that they can’t be seen with a regu­lar microscope. These nanomaterials can have different chemical, physical, or biological properties than their conventionally-scaled counterpart materials used in many products regulated by FDA.

 

FDA has long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies. Nanotechnology is not unique in this regard. The very changes in biological, chemical and other properties that can make nanotechnology applications so exciting also may merit examination to determine any effects on product safety, effectiveness, or other attributes. Understanding nanotechnol­ogy remains a top FDA priority. FDA is monitoring the evolving science and has a robust research agenda to help assess the safety and effectiveness of products using nanotechnology.

 

Strong science is critical to FDA’s ongoing review of the products it regulates. FDA is investing in an FDA-wide nanotechnology regulatory science program to further enhance FDA’s scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products. In general, FDA considers the current framework for safety assessments sufficiently robust and flexible to be appropriate for a variety of materials, including nanomaterials.

FDA is maintaining a product-focused and science-based regulatory policy to appropriately regulate products using this emerging technology. Legal standards vary among various product-classes that FDA regulates. FDA will regulate nanotechnology products under existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction. The agency is taking a prudent scientific approach to assess each product on its own merits, and does not make broad, general assumptions about the safety of nanotechnology products.

 

FDA’s Action on Nanotechnology

In June 2011, FDA issued a draft guidance a Draft Guidance for Industry entitled, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology” to present its thinking on considerations related to nanotechnology.[1] In that draft guidance, FDA indicated that the Agency would issue product-specific guidances in the future, as appropriate.

 

Accordingly, FDA is issuing for public comment two product-specific draft guidance documents to address the use of nanotechnology by the foods and cosmetics industries. Both guidance documents are being issued as part of FDA’s ongoing implementation of recommendations from FDA’s 2007 Nanotechnology Task Force Report. They are:

 

Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives1

 

Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products2

The draft foods guidance alerts manufacturers to the potential impact of any significant manufacturing process change, including those involving nanotechnology, on the safety and regulatory status of food substances. This guidance describes the factors manufacturers should consider when determining whether a significant change in manufacturing process for a food substance already in the market:

 

Affects the identity of the food substance;

Affects the safety of the use of the food substance;

Affects the regulatory status of the use of the food substance; and

Warrants a regulatory submission to FDA.

The draft foods guidance also recommends manufacturers consult with FDA regarding a significant change in manufacturing process for a food substance already in the market.

 

The draft cosmetics guidance, describes FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products.

Cosmetics are not subject to premarket approval; however, they must be safe for consumers under labeled or customary conditions use, and they must be properly labeled.

 

Cosmetics manufactured using nanomaterials are subject to the same legal requirements as any other cosmetics. Companies and individuals who market cosmetics are legally responsible for the safety of their products.

In general, the processes currently in use for assessing safety are appropriate for cosmetics containing nanomaterials. However, data needs and testing methods should be evaluated in light of the properties or functions that may be exhibited by nanomaterials used in cosmetic products

 

FDA’s Approach to Regulation of Nanotechnology Products

 

FDA will continue to regulate nanotechnology products under its existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction. FDA intends to ensure transparent and predictable regulatory pathways grounded in the best available science.

 

One size does not fit all. We intend our regulatory approach to be adaptive and flexible. It is necessary for technical assessments to be product-specific, taking into account the effects of nanomaterials in the particular biological and mechanical context of each product and its intended use.

Particular approaches for each product area will vary according to the statutory authorities. The scope and issues covered in the two draft guidance documents released today – one for foods and one for cosmetics – reflect this approach.

FDA’s regulatory policy approach is consistent with relevant overarching U.S. government policy principles, and supports innovation under appropriate oversight.

 

Industry remains responsible for ensuring that its products meet all applicable legal requirements, including standards for safety — regardless of the emerging nature of a technology involved in the manufacturing a product. FDA encourages industry to consult early with the agency to address any questions related to the safety, effectiveness, or other attributes of products that contain nanomaterials, or about the regulatory status of such products.

 

Comments on the Draft Guidance Documents

 

Anyone may comment on any guidance at any time. In order to ensure that FDA considers comments on these draft guidance documents in developing the final guidances, electronic or written comments on these draft guidances should be submitted within 90 days of the publication of the notice of availability in the Federal Register. Electronic comments should be submitted to http://www.regulations.gov/3. Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For More Information

 

Draft Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology4, June 2011

 

Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives5, April 2012

 

Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products6, April 2012

 

 

 

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[1] Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; Availability7. 76 FR 34715; June 14, 2011.

 

 

 

 

KZFR Community Radio 90.1 FM

Record of Public Discussion:

 

Program: Ecotopia on KZFR, Tuesday, 6-7 pm

Programmers: Susan and Stephen Tchudi

 

Date: 11 December 2012

 

Guest(s), Issues Discussed, and Length of Discussion(s):

Brita Belli, Editor, E-The Environmental Magazine. Topics include “nanoparticles,” small molecules being placed in food products that may be harmful to your health, but are largely unregulated by the FDA; ocean acidification and its effects on shellfish; the general state of the enviornmental movement and the odds favoring or disfavoring its ultimate triumph.

 

 

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