July 23, 2016

Congressional Impasse on Zika Virus Funding Impacts Public Health Efforts in Peak Summer Months

The Zika virus outbreak is spreading in the U.S., according to local public health authorities and the federal Centers for Disease Control (CDC); international Zika virus cases are also increasing. Infection occurs because of a mosquito bite that transmits the virus, and most public health interventions to date concentrate on limiting exposure to the mosquito (Aedes aegypti). As of yet, there is no vaccine or specific treatment for the Zika virus. The discovery that Zika virus infection in pregnant women can lead to birth defects, including microcephaly, raised the alarm about the spread of the virus in this population (see earlier post here). To date, there are about 1400 reported cases in the U.S; there are about 400 cases of Zika infection in pregnant women. Most cases in the U.S. are traced to individuals traveling outside the country, returning with the infection; Puerto Rico, Brazil and other Caribbean and Latin American countries are some of the hotspots of transmission. Now, however, there  appear to be are several cases of local transmission of the Zika virus in Florida, which means that the virus is gaining a foothold in the U.S. itself. As in most public health crises, the government is tasked with providing increased support to local authorities, funding for treatment developments, and other activities. Congress has been in a stalemate over emergency Zika virus funding over the last month. President Obama sought $1.9 billion in new dedicated funding; the House of Representatives approved $1.1 billion. On to the Senate, where several provisions inserted into the funding bill encountered opposition; most notably, an explicit ban on Planned Parenthood as the recipient of any new funds. As discussed in an earlier post, because of the risk that Zika virus infection poses to pregnant women, who are at risk to give birth to babies with developmental disorders (and not all are known at this point), access to contraception and other reproductive services would appear to be a key ingredient in minimizing the birth of Zika-affected babies. That’s where the usual political conflict over reproductive and family planning funding entered the Zika funding legislation, and created an impasse. So to date, the Senate has not approved the funding that the House approved, and Congress has taken its usual lengthy summer break without acting on emergency funding for Zika virus research and support. The 7-week hiatus in the Zika funding battle has dismayed federal public health officials. The American Medical Association  (AMA) faulted Congress
At a time when concerns continue to mount about the nation's readiness to protect the public from the Zika virus, the AMA is disappointed by Congress' failure to pass legislation before adjourning for summer recess that would provide the resources necessary for our country to respond to this looming public health crisis. Without ensuring there are sufficient resources available for research, prevention, control and treatment of illnesses associated with the Zika virus, the United States will be ill-equipped to deploy the kind of public health response needed to keep our citizens safe and healthy—especially since the spread of mosquito-borne illness is accelerated during the summer months.
Editorials in some of the hardest hit areas of the country noted how the impasse would adversely affect their regions; here is the Palm Beach Post from Florida on the local impact: 
Congress has left the building. And in its dysfunctional wake, it leaves yet another failed effort at passing crucial emergency funding to fight the spread of the dreaded Zika virus. For at least the next seven weeks, Florida — which has distinguished itself as ground zero for cases of the mosquito-borne virus — will just have to hope that the worst part of the rainy storm season doesn’t translate into more infections. (Palm Beach County has seen about 12 cases of travel-related Zika.) It may be a long, hot summer. Mosquitoes that carry the Zika virus breed year-round here, and the number of infections in the continental United States is mounting. On Monday, the state Health Department reported 13 new cases of the Zika virus in Florida - the most reported cases of the virus in a single day. Moreover, federal officials say they will have to postpone a slew of anti-Zika actions. For example, the U.S. Centers for Disease Control and Prevention will have “limited capacity” to help with efforts to counter mosquito populations in the continental U.S. and territories. 
Yes, it should be noted that the CDC is now dispersing about 60 million dollars currently to localities to augment public health efforts, but these are “stopgap” awards that will not approach the scale of the demand. Congress returns on September 6th.

July 17, 2016

Congress Passes Federal Labeling Requirement for Genetically Engineered Foods; State Labeling Laws Would Be Preempted

Vermont enacted the first state law that requires the manufacturers of food products with genetically engineered (GE) ingredients to label their food products accordingly. Its Act 120 became law on July 1, 2016. However, for decades, there has been an ongoing battle at the federal level over whether a national labeling scheme should be enacted (the term GMO/genetically modified organism is also used). (See earlier posts for more background). So, after the Vermont bill became effective, there was a flurry of activity in Congress again to address the issue of a federal labeling scheme for GE food products. (The FDA has not required labels on food products with GE ingredients, in a policy that dates back to 1992). The Senate recently passed a bill, S. 764, that would mandate a particular federal labeling scheme for GE ingredients, and would also preempt any state labeling laws. The federal bill uses the term "bioengineering" to describe the products covered by the law: 
[F]ood - (A) that contains genetic material that has been modified through in vitro recombinant [DNA] techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature. 
There is an explicit statement of the preemption achieved by this legislation: 
No State or a political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food or seed in interstate commerce any requirement relating to the labeling of whether a food (including food served in a restaurant or similar establishment) or seed is genetically engineered (which  shall  include such other similar terms as determined by the Secretary of Agriculture) or was developed or produced using genetic engineering, including any requirement for claims that a food or seed is or contains an ingredient that was developed or produced using genetic engineering.
This last provision is aimed at the recent Vermont law, as well as other initiatives in Connecticut, Maine and Alaska. Since its enactment in 2014, the Vermont law had already impacted the food and restaurant industries, with some major players declaring that they would provide labels in anticipation of the law (see here). It was apparent that the Vermont law had immediate national impact, as food manufacturers faced compliance with the statute or avoidance of Vermont’s market (practically unworkable). Now, the House of Representatives has passed a version of the recent Senate bill, and it goes to President Obama for signing; it appears that he will sign it. The clear effect of the federal bill is to preempt the long-sought state labeling laws. However, does this bill actually require a label? The bill departs from other labeling proposals over the years (state and federal) in that it contains no explicit requirement to provide a “GMO” or other GE-related name on the main label of the product. The actual labeling scheme in the new federal law is quite elastic, describing the format of the labeling as follows: 
[T]he form of a food disclosure under this section be a text, symbol, or electronic or digital link. 
Thus, a consumer could use a smartphone to read a QR code, or utilize a provided link to access information, or read whatever disclosure material the manufacturer has chosen to provide. The forms of the notification could be arguably obscure, and indirect. In other words, at least so far, there will be no uniformity of disclosure. Already, there are allegations that the bill is discriminatory in that it will make it harder for some consumers to pursue the informational references; access to digitally formatted information is not universal. The USDA has two years to make the law operational, and may refine the labeling formats in that period, subject to public input.