This year, the Atlantic basin had eight consecutive storms develop—the first time in 124 years. The storms—and by storms I mean big storms—have had catastrophic effects on families, communities and the economy at large. Millions of people were left powerless, access to clean drinking water was compromised and homes were destroyed. It will take decades […]

This year, the Atlantic basin had eight consecutive storms develop—the first time in 124 years. The storms—and by storms I mean big storms—have had catastrophic effects on families, communities and the economy at large. Millions of people were left powerless, access to clean drinking water was compromised and homes were destroyed. It will take decades […]

Tom Neltner, J.D., is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant [pullquote]FDA’s apparent lack of follow-up when faced with jaw-dropping levels of a toxic chemical in food is disturbing.[/pullquote] For more than 40 years, the Food and Drug Administration (FDA) has conducted the Total Diet Study (TDS) to monitor levels of approximately 800 pesticides, metals, […]

The post Little follow-up when FDA finds high levels of perchlorate in food first appeared on EDF Health.

By Tom Neltner

Tom Neltner, J.D., is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

FDA’s apparent lack of follow-up when faced with jaw-dropping levels of a toxic chemical in food is disturbing.

For more than 40 years, the Food and Drug Administration (FDA) has conducted the Total Diet Study (TDS) to monitor levels of approximately 800 pesticides, metals, and other contaminants, as well as nutrients in food. The TDS’s purposes are to “track trends in the average American diet and inform the development of interventions to reduce or minimize risks, when needed.” By combining levels of chemicals in food with food consumption surveys, the TDS data serve a critical role in estimating consumers’ exposure to chemicals.

From 2004 to 2012 (except for 2007), FDA collects and tests about 280 food types for perchlorate, a chemical known to disrupt thyroid hormone production. This information is very important, because for the many pregnant women and children with low iodine intake, even transient exposure to high levels of perchlorate can impair brain development.

The agency published updates on food contamination and consumers’ exposure to perchlorate in 2008 (covering years 2004-2006) and in 2016 (covering 2008-2012). On its Perchlorate Questions and Answers webpage, FDA says it found “no overall change in perchlorate levels across foods” in samples collected between 2008 and 2012 compared to those collected between 2005 and 2006. It also notes that there were higher average levels in some food and lower in others between the time periods and suggests that a larger sampling size or variances in the region or season when the samples were collected may account for the differences.

FDA’s Q&A webpage masks the most disturbing part of the story

FDA’s attempt at providing consumers with information about the presence of a toxic chemical in food and what it means for their health falls short. By focusing on the similar average level of perchlorate across foods, FDA masks the disturbing fact that children are consuming increasing amounts of perchlorate: 35% for infants, 23% for toddlers and 12% for children between 2 and 6 from 2004-2006 to 2008-2012. The agency’s webpage notes the exposures in 2008-2012 but fails to mention the increase reported by its own scientists.

FDA’s webpage also fails to mention that the perchlorate Reference Dose (RfD), the amount of exposure unlikely to result in an adverse health effect, was set more than a decade ago and does not reflect the latest research. In 2013, the Environmental Protection Agency (EPA)’s Science Advisory Board indicated that the RfD may not sufficiently protect pregnant women and young children. As a result, EPA, with FDA’s support, is in the final stages of updating that number. FDA’s estimated average exposures to perchlorate by infants and toddlers was very close to the RfD, and many children may well exceed the outdated RfD.

FDA failed to investigate extraordinarily high levels of perchlorate

In the 2016 update, we noticed that some foods, such as bologna, salami and rice cereal, had very high levels, far greater than in 2004-2006. In May 2017, FDA provided more data that enabled us to learn what region and year the samples were collected.

We knew from FDA’s Compliance Program Guidance Manual that staff are asked to follow-up on any unusual analytical findings in the TDS samples (Figure 1). So in June 2017, we filed a Freedom of Information Act (FOIA) request seeking details for 47 composite samples (18 baby foods and 29 other foods) that, in our view, had unusually high levels of perchlorate. We asked for any information regarding:

• Test results for composite and individual samples (Figure 2);
• Product details on the individual foods; and
• Any follow-up testing or investigations.

FDA’s response to the FOIA raises concerns. First, the agency did not have criteria for following up on perchlorate. Specifically, staff requested guidance “on cut-off value of perchlorate in the composite that would trigger analysis of individual foods,” but we didn’t find any in the documents provided to us. Without this guidance, some staff listed composite samples with at least 20 ppb as “noteworthy;” others used 15 ppb as the trigger for re-testing and confirmation. All 47 samples we asked FDA about were above these levels. Yet, there was no retesting of the composite for 27 of them.

Second, staff confirmed the results for 20 composite samples which should have triggered tests on the three individual samples that made up the composite.

But FDA only provided information for four individual foods:

• Baby food rice cereal (173 ppb in composite in summer of 2008): Newark sample had 252 ppb; New York City had 112 ppb; and Philadelphia had 3 ppb.
• Baby food carrots (74 ppb in composite in winter of 2011): Denver sample had 163 ppb; Los Angeles sample had 111 ppb; and Seattle sample had 0 ppb.
• Baby food barley cereal (67 ppb in composite in spring of 2008): Dallas had 182 ppb; and Tampa and Baltimore had 1 ppb.
• Baby food oatmeal with fruit (42 ppb in composite in summer of 2008): New York City had 82 ppb; Newark had 3 ppb; and Philadelphia had 0 ppb.

Even more disturbing is that, despite confirming the results in the composite samples, FDA could find no records that the individual samples in the highest levels, bologna with 1557 ppb, 1,090 and 686 ppb for collard greens and 686 ppb for salami lunchmeat, were ever tested.

Similarly, the agency could not find any records of the TDS coordinator investigating the possible cause of the high levels of contamination or any communication between the coordinator and others in the Center for Food Science and Applied Nutrition that oversees the TDS. Also not available were the receipts essential to identifying the brand and lot of the samples with unusual high levels of perchlorate; therefore EDF was unable to follow-up.

Conclusion

The agency’s apparent lack of follow-up when faced with jaw-dropping levels of a toxic chemical in food is disturbing. While testing the products is a critical first step, FDA needs to investigate the reasons for the high levels so that it can protect the food supply. Identifying the cause and crafting interventions to reduce or minimize risks, as stated in the TDS purpose statement, is especially important for toxics like perchlorate, where even short exposures during critical life stages may cause lasting harm to a child’s developing brain. But for this to happen, FDA needs to acknowledge the evidence on sources of perchlorate in food, such as its use in packaging or from degraded bleach, and clearly explain what the implications are for the health of children and pregnant women, especially those with low iodine intake.

Update on related perchlorate issue: FDA has not yet responded to EDF’s and eight other public interest organizations’ objection to the agency’s May 4, 2017 decision to reject a petition to ban perchlorate from uses in contact with food. The objection and request for evidentiary hearing were filed on June 4, 2017.

Tom Neltner, J.D., is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant For more than 40 years, the Food and Drug Administration (FDA) has conducted the Total Diet Study (TDS) to monitor levels of approximately 800 pesticides, metals, and other contaminants, as well as nutrients in food. The TDS’s purposes are to “track trends in the […]

This year’s global climate conference (COP23) is upon us. This blog post lays out what will be happening during the COP related to REDD+ in the negotiations and what we can hear about in the hallways and many side events.

By Chris Meyer

The 2017 UN climate talks will take place from November 6 to 17 in Bonn, Germany | Photo: Pixabay

This year’s global climate conference (COP23) is upon us and will be an interesting mix of Fijian diplomacy and Kölsch beer. As I do every year, in this year’s pre-COP blog I lay out what will be happening during the COP related to REDD+ in the negotiations and what I hope to hear about in the hallways and many side events.

The COP23 conference is expected to be a working COP as parties make the necessary progress in rule writing to meet the 2018 deadline of a final rulebook. There will also be a lot of news about non-state actors – the private sector, states like California, and other non-federal entities – being discussed as a reaction to Trump’s reckless decision to leave the Paris Agreement.

For a good overview of how we are doing in with respect to the climate change and forest sector, I suggest reading this year’s New York Declaration on Forests report. It includes a good review on progress in the private sector (or lack thereof) and funding for forest conservation – and activities causing deforestation.

But, back to the UNFCCC …

REDD+ in the negotiation agenda

After a year’s hiatus from the COP agenda, REDD+ will make an expected brief appearance in the Subsidiary Body for Implementation (SBI) agenda the first week during discussions about the “coordination of REDD+ finance”. This is a leftover item from the Warsaw REDD+ Framework decision, when parties agreed to not create a “REDD+ Committee” to coordinate REDD+ finance as some parties wished, but rather annual informal and voluntary meetings during the mid-year subsidiary body negotiations (SBs) for 4 years to share experiences about REDD+ financing. Many of the attendees from parties to observers would agree that these informal meetings were of little value.

In this COP, negotiators are scheduled to reevaluate whether to continue the SBs or create the REDD+ Committee. I doubt there will be interest in either of them. However, the agenda item could be used as an opening to push a party’s or coalition’s not completely related proposal for financing REDD+, such as a centralized registry for REDD+ transactions.

REDD+ related negotiation items: transparency, NDCs and market

Much of the Warsaw Framework for REDD+ addressed transparency. After following initial discussions in the broader transparency agenda item that is part of the APA, many parties and negotiators are worried that those negotiations might dilute what was achieved for REDD+. Transparency in REDD+ thus far includes the Lima REDD+ Information Hub where countries submit their National REDD+ Strategies, Reference Emission Level (REL) submissions, Safeguard Information System summaries, and results. The process established for reviewing the RELs, which includes a technical assessment and publication of that assessment, is very important. The fact that the new US negotiator for transparency is the former REDD+ negotiator for the US, however, could be very helpful to ensure no dilution occurs.

Many of the party submissions on producing Nationally Determined Contributions (NDCs) mentioned the land use sector explicitly, and REDD+ implicitly. The more detail related to the inclusion of the land use sector in NDCs the better, but it might be hard for negotiators to come to agreement on the extent or nature of those details.

The market negotiations under the SBSTA will continue; those on Article 6.2 of the Paris Agreement and Internationally Transferred Mitigation Outcomes (ITMOs) are particularly relevant. More explicit guidance on no double counting/claiming is needed to ensure environmental integrity for REDD+ and ITMOs that might come from any other sector or project. REDD+ in itself, however, does not need explicit language in Article 6.2.

Other noticeable REDD+ financing developments

The Green Climate Fund recently approved guidance and $500 million for REDD+ results based payments, which I expect to be discussed substantially during the COP. Although the amount is not sufficient, the methodologies the GCF agreed upon will be relevant to other REDD+ finance decisions in the future.

Private finance for advancing deforestation free commodities is another hot topic and I expect to learn more concrete details about the andgreen.fund that was announced earlier in the year. Specifically, I’d like more clarity on how they will be defining jurisdictions advancing in becoming deforestation free, which is a requirement of the fund to determine what private sector actors will be funded.

This year’s report on New York Declaration on Forests provides extensive insight on the current state of forest finance. The report reviews the billions of pledges, commitments, and amounts spent to advance REDD+. More interesting is the amount of “grey” funding available from public subsidies and private sector investment for the land sector. The amount of “grey” funding greatly exceeds direct REDD+ funding and needs to be changed or channeled to activities that support forest conservation.

Indigenous Peoples in the negotiations

Indigenous territories have rates of deforestation eight times less than external forests.

Indigenous Peoples are hoping for a decision on the Indigenous Peoples’ traditional knowledge platform that will support the inclusion of them and their solutions to mitigating and adapting to climate change. A number of parties from Ecuador to Canada are prioritizing and supporting this platform. While interested in all agenda items, Indigenous Peoples will also probably focus on the NDC negotiation to ensure that the need to include them in the development and revision of the NDCs is explicitly mentioned. Many party submissions on the topic included the need for NDCs to discuss how they consulted Indigenous Peoples and other groups in their development.

Indigenous leaders from the Amazon basin will be promoting a new scientific analysis which found, that from a regional level, indigenous territories have rates of deforestation eight times less than external forests. Hopefully, parties will take note of this and include more overt references to the importance of supporting and including Indigenous Peoples in decisions.

Reporting on progress by countries implementing REDD+

While not formally on the negotiation agenda, I expect a number of countries at their pavilions or in other events to present the final versions of their National REDD+ Strategies. Parties have already submitted 25 Reference Emission Levels (REL) and I expect a few more to arrive during the COP or before the end of the year. Discussions around best practices in REL construction and lessons learned will be a popular topic – amongst the technical people at least.

The richest presentations and discussions related to REDD+ will likely happen on November 12th during a set of panels on forests as part of the Action Agenda, now called the Marrakech Partnership for Climate Action. During this event, I hope to hear more about how the private sector is implementing the 700+ deforestation-free related commitments they’ve taken, but largely have yet to implement.

A “working” COP

Many expect no big decisions on forests – like a Warsaw Framework for REDD+ – to be agreed upon at this COP. However, I would like to see a decision on the platform for Indigenous Peoples’ traditional knowledge, which would be helpful for REDD+.

The parties should make progress on advancing the markets, NDC, and transparency negotiations that are indirectly related, but no less important, to REDD+. Decisions on those topics at the COP next year, as mandated in the Paris Agreement, are essential for continuing the implementation of REDD+ and unlocking necessary finance.

This year’s global climate conference (COP23) is upon us. This blog post lays out what will be happening during the COP related to REDD+ in the negotiations and what we can hear about in the hallways and many side events.

This year’s global climate conference (COP23) is upon us. This blog post lays out what will be happening during the COP related to REDD+ in the negotiations and what we can hear about in the hallways and many side events.

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