Sustained Pressure By Nonprofits Forces Change in FDA Nanotech Policy
Today several leading nonprofits working on nanotechnology oversight—Center for Food Safety (CFS), Friends of the Earth, Institute for Agriculture and Trade Policy (IATP) and the International Center for Technology Assessment—issued a statement responding to recent steps taken by the Food and Drug Administration (FDA) that represent marginal progress toward regulation of products made with this new technology.
Last week FDA released new draft guidances on the use of nanotechnology in food and cosmetics. The agency’s actions followed a lawsuit filed in December 2011 by the nonprofits regarding the agency’s failure to respond to their longstanding 2006 petition demanding oversight action. On April 20, FDA responded to the petition and released the guidances. In its formal response to the groups’ lawsuit, FDA acknowledged that there are differences between nanomaterials and their bulk counterparts, and that nanomaterials have potential new risks and may require new testing. However, the agency declined to enact mandatory regulations at this time.
“From 2006, when we filed our legal petition, to 2012, FDA has improved some,” said George Kimbrell, CFS Attorney. “As these new responses show, the agency is no longer ignoring the scientific consensus that these nanomaterials have the capacity to be fundamentally different, and can create new and novel risks, necessitating new testing. Unfortunately, the agency has thus far only taken a voluntary rather than mandatory regulatory approach, despite the failure of voluntary approaches to elicit industry cooperation to regulate nanomaterials.”
Nanotechnology is a powerful new set of technologies for observing, taking apart and reconstructing nature at the atomic and molecular level. Despite already being commercially available, nanomaterials in sunscreens, cosmetics, foods and food contact substances are unlabeled and largely untested for their human health effects. Existing research raises red flags, indicating that nanomaterials have the ability to enter the bloodstream through contact with the skin, ingestion and inhalation, as well as move in the natural environment once discarded. FDA has authority over these products under the Federal Food Drug and Cosmetic Act.
One of the leading nanomaterial product sectors is nano-sunscreens. In responding to this issue in the groups’ legal petition, the agency re-opened the over-the-counter sunscreen “monograph” (or regulation), but has yet to decide whether or not the nano-sunscreens will be regulated as “new.” Sunscreens are classified as drugs and require more rigorous review than other personal care products.
“FDA essentially punted for now on nano-sunscreens. To protect public health, FDA must require safety testing and data that addresses the novel properties and novel risks of nanomaterials. FDA has a responsibility to ensure that these potentially dangerous products are not sold in stores without more clarity about their safety and labeling,” said Ian Illuminato, health and environment campaigner at Friends of the Earth.
Another potential area of concern is nanomaterials in food and food contact substances, such as food packaging materials and food conveyor belts. Although these products are far advanced in research and development, FDA does not believe them to have been commercialized. In a guidance released last week, FDA proposed classifying these substances as food additives, which require premarket testing and approval. The guidance advised that FDA likely would not accept industry claims that nano-scale food substances could be assumed to be safe because their macro-scale counterparts were assumed to be safe. Steve Suppan, senior policy analyst, Institute for Agriculture and Trade Policy declared, “This decision is a big win for consumers and will mean that nano-food additives will for the first time require pre-market safety review and approval. It is crucial that consumer organizations comment on the draft guidance to support this FDA decision, and urge that it be a basis for mandatory regulation.”
The commercial use of nanomaterials in cosmetics is currently on the rise. However, FDA stated that it lacked statutory authority to require pre-market review of these products, meaning that without new laws FDA cannot stop a company from selling cosmetics, including nano-cosmetics, even while the safety of these products is uncertain. Congressional leaders have introduced a new bill, the Safe Cosmetics Act of 2011, to remedy this problem. “Our current cosmetics legislation is in desperate need of comprehensive reform, and the novel risks of nanomaterials just highlight that longstanding failing. The Safe Cosmetics Act of 2011 would give FDA the authority it needs to adequately regulate nano-cosmetics,” said Illuminato.
Since the 2006 petition filing, FDA has taken a number of preliminary actions, including forming a task force, which issued a report and recommendations; holding multiple public meetings and workshops; publishing a number of FDA scoping documents and guidances; and, reopening the sunscreen drug monograph for the purpose of considering whether or not nano-sunscreens should be regulated as novel sunscreens.
“FDA is finally addressing nano technology in most of the areas for which it has oversight, which is a start,” concluded Kimbrell. “Much more than voluntary guidance is needed, and we will remain vigilant in our efforts to drag the agency towards responsible regulation.”
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By Bob Jacobs
Hanako, a female Asian elephant, lived in a tiny concrete enclosure at Japan's Inokashira Park Zoo for more than 60 years, often in chains, with no stimulation. In the wild, elephants live in herds, with close family ties. Hanako was solitary for the last decade of her life.
Hanako, an Asian elephant kept at Japan's Inokashira Park Zoo; and Kiska, an orca that lives at Marineland Canada. One image depicts Kiska's damaged teeth. Elephants in Japan (left image), Ontario Captive Animal Watch (right image), CC BY-ND
Affecting Health and Altering Behavior<p>It is easy to observe the overall health and psychological consequences of life in captivity for these animals. Many captive elephants suffer from arthritis, obesity or skin problems. Both <a href="https://doi.org/10.11609/JoTT.o2620.1826-36" target="_blank">elephants</a> and orcas often have severe dental problems. Captive orcas are plagued by <a href="https://doi.org/10.1016/j.jveb.2019.05.005" target="_blank">pneumonia, kidney disease, gastrointestinal illnesses and infections</a>.</p><p>Many animals <a href="https://doi.org/10.1016/j.neubiorev.2017.09.010" target="_blank">try to cope</a> with captivity by adopting abnormal behaviors. Some develop "<a href="https://doi.org/10.1016/j.applanim.2017.05.003" target="_blank" rel="noopener noreferrer">stereotypies</a>," which are repetitive, purposeless habits such as constantly bobbing their heads, swaying incessantly or chewing on the bars of their cages. Others, especially big cats, pace their enclosures. Elephants rub or break their tusks.</p>
Changing Brain Structure<p>Neuroscientific research indicates that living in an impoverished, stressful captive environment <a href="https://doi.org/10.1016/j.jveb.2019.05.005" target="_blank" rel="noopener noreferrer">physically damages the brain</a>. These changes have been documented in many <a href="https://doi.org/10.1002/cne.903270108" target="_blank" rel="noopener noreferrer">species</a>, including rodents, rabbits, cats and <a href="https://doi.org/10.1006/nimg.2001.0917" target="_blank" rel="noopener noreferrer">humans</a>.</p><p>Although researchers have directly studied some animal brains, most of what we know comes from observing animal behavior, analyzing stress hormone levels in the blood and applying knowledge gained from a half-century of neuroscience research. Laboratory research also suggests that mammals in a zoo or aquarium have compromised brain function.</p>
This illustration shows differences in the brain's cerebral cortex in animals held in impoverished (captive) and enriched (natural) environments. Impoverishment results in thinning of the cortex, a decreased blood supply, less support for neurons and decreased connectivity among neurons. Arnold B. Scheibel, CC BY-ND<p>Subsisting in confined, barren quarters that lack intellectual stimulation or appropriate social contact seems to <a href="https://doi.org/10.1590/S0001-37652001000200006" target="_blank" rel="noopener noreferrer">thin the cerebral cortex</a> – the part of the brain involved in voluntary movement and higher cognitive function, including memory, planning and decision-making.</p><p>There are other consequences. Capillaries shrink, depriving the brain of the oxygen-rich blood it needs to survive. Neurons become smaller, and their dendrites – the branches that form connections with other neurons – become less complex, impairing communication within the brain. As a result, the cortical neurons in captive animals <a href="https://doi.org/10.1002/cne.901230110" target="_blank">process information less efficiently</a> than those living in <a href="https://doi.org/10.1002/dev.420020208" target="_blank">enriched, more natural environments</a>.</p>
An actual cortical neuron in a wild African elephant living in its natural habitat compared with a hypothesized cortical neuron from a captive elephant. Bob Jacobs, CC BY-ND<p>Brain health is also affected by living in small quarters that <a href="https://doi.org/10.3233/BPL-160040" target="_blank">don't allow for needed exercise</a>. Physical activity increases the flow of blood to the brain, which requires large amounts of oxygen. Exercise increases the production of new connections and <a href="http://dx.doi.org/10.1126/science.aaw2622" target="_blank">enhances cognitive abilities</a>.</p><p>In their native habits these animals must move to survive, covering great distances to forage or find a mate. Elephants typically travel anywhere from <a href="https://www.elephantsforafrica.org/elephant-facts/#:%7E:text=How%20far%20do%20elephants%20walk,km%20on%20a%20daily%20basis." target="_blank">15 to 120 miles per day</a>. In a zoo, they average <a href="https://doi.org/10.1371/journal.pone.0150331" target="_blank" rel="noopener noreferrer">three miles daily</a>, often walking back and forth in small enclosures. One free orca studied in Canada swam <a href="https://doi.org/10.1007/s00300-010-0958-x" target="_blank" rel="noopener noreferrer">up to 156 miles a day</a>; meanwhile, an average orca tank is about 10,000 times smaller than its <a href="https://www.cascadiaresearch.org/projects/killer-whales/using-dtags-study-acoustics-and-behavior-southern" target="_blank" rel="noopener noreferrer">natural home range</a>.</p>
Disrupting Brain Chemistry and Killing Cells<p>Living in enclosures that restrict or prevent normal behavior creates chronic frustration and boredom. In the wild, an animal's stress-response system helps it escape from danger. But captivity traps animals with <a href="https://doi.org/10.1073/pnas.1215502109" target="_blank">almost no control</a> over their environment.</p><p>These situations foster <a href="https://doi.org/10.1037/rev0000033" target="_blank">learned helplessness</a>, negatively impacting the <a href="https://doi.org/10.1155/2016/6391686" target="_blank" rel="noopener noreferrer">hippocampus</a>, which handles memory functions, and the <a href="https://doi.org/10.1016/j.neuropharm.2011.02.024" target="_blank" rel="noopener noreferrer">amygdala</a>, which processes emotions. Prolonged stress <a href="https://doi.org/10.3109/10253899609001092" target="_blank" rel="noopener noreferrer">elevates stress hormones</a> and <a href="https://doi.org/10.1523/JNEUROSCI.10-09-02897.1990" target="_blank" rel="noopener noreferrer">damages or even kills neurons</a> in both brain regions. It also disrupts the <a href="https://doi.org/10.1016/j.neubiorev.2005.03.021" target="_blank" rel="noopener noreferrer">delicate balance of serotonin</a>, a neurotransmitter that stabilizes mood, among other functions.</p><p>In humans, <a href="https://doi.org/10.1006/nimg.2001.0917" target="_blank" rel="noopener noreferrer">deprivation</a> can trigger <a href="https://doi.org/10.3389/fnins.2018.00367" target="_blank" rel="noopener noreferrer">psychiatric issues</a>, including depression, anxiety, <a href="https://doi.org/10.3389/fnins.2018.00367" target="_blank" rel="noopener noreferrer">mood disorders</a> or <a href="https://doi.org/10.1177/1073858409333072" target="_blank" rel="noopener noreferrer">post-traumatic stress disorder</a>. <a href="https://doi.org/10.1007/s00429-010-0288-3" target="_blank" rel="noopener noreferrer">Elephants</a>, <a href="https://doi.org/10.1371/journal.pbio.0050139" target="_blank" rel="noopener noreferrer">orcas</a> and other animals with large brains are likely to react in similar ways to life in a severely stressful environment.</p>
Damaged Wiring<p>Captivity can damage the brain's complex circuitry, including the basal ganglia. This group of neurons communicates with the cerebral cortex along two networks: a direct pathway that enhances movement and behavior, and an indirect pathway that inhibits them.</p><p>The repetitive, <a href="http://dx.doi.org/10.1016/j.bbr.2014.05.057" target="_blank">stereotypic behaviors</a> that many animals adopt in captivity are caused by an imbalance of two neurotransmitters, dopamine and <a href="https://doi.org/10.1016/j.neubiorev.2010.02.004" target="_blank" rel="noopener noreferrer">serotonin</a>. This impairs the indirect pathway's ability to modulate movement, a condition documented in species from chickens, cows, sheep and horses to primates and big cats.</p>
The cerebral cortex, hippocampus and amygdala are physically altered by captivity, along with brain circuitry that involves the basal ganglia. Bob Jacobs, CC BY-ND<p>Evolution has constructed animal brains to be exquisitely responsive to their environment. Those reactions can affect neural function by <a href="https://www.penguinrandomhouse.com/books/311787/behave-by-robert-m-sapolsky/" target="_blank">turning different genes on or off</a>. Living in inappropriate or abusive circumstance alters biochemical processes: It disrupts the synthesis of proteins that build connections between brain cells and the neurotransmitters that facilitate communication among them.</p><p>There is strong evidence that <a href="https://doi.org/10.1523/JNEUROSCI.0577-11.2011" target="_blank">enrichment</a>, social contact and appropriate space in more natural habitats are <a href="https://doi.org/10.1111/j.1748-1090.2003.tb02071.x" target="_blank" rel="noopener noreferrer">necessary</a> for long-lived animals with large brains such as <a href="https://doi.org/10.1371/journal.pone.0152490" target="_blank" rel="noopener noreferrer">elephants</a> and <a href="https://doi.org/10.1080/13880292.2017.1309858" target="_blank" rel="noopener noreferrer">cetaceans</a>. Better conditions <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543669/" target="_blank" rel="noopener noreferrer">reduce disturbing sterotypical behaviors</a>, improve connections in the brain, and <a href="https://doi.org/10.1038/cdd.2009.193" target="_blank" rel="noopener noreferrer">trigger neurochemical changes</a> that enhance learning and memory.</p>