EDF Health

EDF asks judge to rule on legality of FDA rule allowing companies to secretly decide on chemicals in our food

Tom Neltner, J.D.is Chemicals Policy Director

At the end of March, EDF, represented jointly by counsel from Earthjustice and the Center for Food Safety (CFS), asked a federal district court judge to decide as a matter of law that the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) regulation is unlawful. The GRAS Rule allows food manufacturers to make secret safety determinations for chemicals added to food without notifying FDA or the public and to use such chemicals. If the judge agrees to our request, this would vacate the rule. Two years ago, EDF and others challenged the legality of the GRAS Rule in the Federal District Court for the Southern District of New York. Last September, the court ruled that plaintiffs EDF and the CFS have standing, setting the stage for a decision on the merits of the case.

In the Motion for Summary Judgment, we identify the following four ways in which FDA violated the law in the GRAS Rule. FDA has until May 28 to respond to our motion.

  1. FDA unlawfully delegated to food manufacturers its authority to determine the safety of chemicals added to our food.

When Congress enacted the Federal Food Drug and Cosmetic Act (FFDCA) of 1938, it gave FDA the responsibility to ensure the nation’s food is safe and free from harmful substances. To implement this responsibility, it provided the agency broad authority to adopt necessary regulations.

Unfortunately, in the GRAS Rule, instead of fulfilling its responsibility to keep food safe, FDA formally and unlawfully outsourced its responsibility to the regulated entities themselves – namely, for-profit additive manufacturers – allowing them to decide for themselves, in secret, whether the chemical substances they have manufactured can be added to food. This unlawful delegation – made without express statutory authorization – makes it all but impossible for FDA to fulfill its obligations under the FFDCA.

As a result, the GRAS Rule impermissibly allows regulated, private companies with obvious conflicts of interest to self-certify the use of their chemical additives as GRAS without notifying FDA. This is not a case where FDA is seeking legitimate outside input to gather factual information or advice and make policy recommendations. Here, FDA retains no oversight over these secret GRAS determinations that directly affect the safety of our food and thus render it impossible for the agency to fulfill its statutory mandate to keep our food safe.

By delegating its authority in the GRAS Rule, the agency violated Constitutional principles, the FFDCA, and the Administrative Procedures Act (APA). The rule effectively insulates the agency from democratic accountability for food safety decisions and denies citizens their right to seek judicial review of decisions about the safety of substances that may be added to food.

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Latest available national data shows increase in blood lead levels for at least 2 million kids

Tom Neltner, J.D.Chemicals Policy Director

In February, the Centers for Disease Control and Prevention (CDC) released a report summarizing the biomonitoring data from its National Health and Nutrition Examination Survey (NHANES). Given EDF’s focus on protecting children from lead exposure, we went straight to the most recent blood lead monitoring results. The results are disturbing. As shown in Figure 1 below, after years of progress, in 2015-16 the blood lead levels (BLLs) of more than 2 million young children[1] increased:

  • Average child BLL: 48% BLL decrease from 2007-8 to 2013-14 but only a 3% decrease in 2015-16.
  • 75th percentile BLL (75% of children are below this level): 51% decrease from 2007-8 to 2013-14 but a 2% increase in 2015-16.
  • 90th percentile BLL: 51% decrease from 2007-8 to 2013-14 but an 18% increase in 2015-16.
  • 95th percentile BLL: 45% decrease from 2007-8 to 2013-14 but a 23% increase in 2015-16.

As with the smaller uptick in 2007-08 (which may have been related to the housing crises), it may only be short-term setback, nonetheless it bears careful examination.

Even more disturbing is the Trump Administration’s response to this information. The Administration:

  • Ignored the data in the rosy picture of progress it painted in its recent Lead Action Plan; and
  • Appears to be repeating mistakes of the past by proposing to slash CDC’s childhood lead poisoning prevention budget in half.

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EDF analysis: Lead service lines in Illinois communities

Tom Neltner, J.D.Chemicals Policy Director

Building statewide, comprehensive inventories of lead service lines (LSLs) in community water systems (CWSs) is a critical part of any effort to eliminate lead pipes. With a solid inventory, states can conduct a credible needs assessment and engage the public in supporting community efforts to replace LSLs.

In January 2017, the Illinois legislature passed a law designed to reduce children’s exposure to lead in drinking water. It included a requirement that CWSs submit annual reports to Illinois Environmental Protection Agency (IEPA) regarding a “water distribution system material inventory” by April of each year. EDF sees Illinois’s approach to developing an inventory as a model to be considered by other states because it:

  • Requires all CWS to report (unlike Indiana which had a well-designed one-time voluntary survey but only a 57% response);
  • Covers the entire service line (unlike California which ignored the portion of the service line on private property); and
  • Requires annual updates to track progress, especially in reducing the number of service lines with unknown materials (unlike Michigan which requires updates only every five-years).

In August 2018, IEPA released a summary of the first year submissions and has updated it several times. IEPA indicated that 95% of CWSs submitted reports and provided totals of each type of piping material reported with 414,895 LSLs and 1,504,748 of unknown material. At the time, the agency did not provide information on what each CWS reported.

Making totals public is important but does little to engage the public in understanding what the information means for their community. But earlier this week, IEPA published an online tool, which allows residents to search for their water system and download the data for individual reports of the types of materials currently reported by their water system.  EDF also received the information pursuant to a Freedom of Information request. Click here to see the data for all the CWSs in a spreadsheet. We also used an EPA database to identify the 84 CWSs that did not comply with the law.

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Laws in states with the most lead service lines support using rates to fund replacement on private property: New analysis

Tom Neltner, J.D.Chemicals Policy Director

We found no explicit barriers to using rate funds to replace the lines on private property in the 13 we focused on. These states have an estimated 4.2 million LSLs, more than two-thirds of the nation’s total

Lead service lines (LSLs) – the lead pipes that connect a building’s plumbing to the water main under the street – are a significant source of lead in drinking water for those homes that have them. In light of the well-documented benefits to society from reducing children’s exposure to lead, there is a consensus that we need to replace the estimated six million LSLs remaining in the country. It will take time, but it needs to be done.

One challenge to this goal is how to fund replacement of the portion of the service line on private property. Because LSLs extend from under the street to a building, typically about half of the line is on public property and half is on private property. The perception among utilities has been that they do not have the legal authority to use rates paid by customers to cover the cost of replacing the portion on private property because it provides a benefit only to that property owner. This view was reinforced when the Wisconsin Public Service Commission blocked Madison from doing it, forcing the city to use other funds to complete the work. That decision from the early 2000s came before the risks of even low-level exposure to lead were well understood.

Many utilities have therefore taken to replacing only the portion of the LSL on public property when the property owner is unwilling or unable to pay to replace the portion on private property. The practice, often called “partial replacement,” is not only inefficient but can actually exacerbate residents’ exposure to lead. As evidence of the risks of even low-level exposure to lead—and of the society-wide benefits of reducing lead exposure—have mounted and the tragedy in Flint, Michigan made clear the need to replace LSLs, states like Indiana, Missouri, New Jersey, Pennsylvania and even Wisconsin, have adopted new laws or policies that have allowed funds from rates, with some limitations, to be used to replace the side on private property. Michigan has gone further and adopted rules mandating the practice, although some utilities have challenged the rule in court.

Given the funding challenge and the trends in the states, EDF partnered with the Emmett Environmental Law & Policy Clinic at Harvard Law School to review the state laws and policies in the 13 states with the most LSLs. Clinic Deputy Director Shaun Goho and law student Marcello Saenz conducted a state-by-state review of the laws, court decisions, and policies. The authors:

Found no explicit barriers to using rate funds to replace the lines on private property. These states have an estimated 4.2 million LSLs, more than two-thirds of the nation’s total. In these states, publicly-owned utilities can act pursuant to existing state legislation by determining that the practice serves a public purpose—protecting public health. Investor-owned utilities can do the same, but typically need approval of the state’s utility commission. While we have not reviewed the remaining states, we anticipate that the state laws and policies are similar to the ones we evaluated.

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Posted in EPA, Health Policy, lead, Public Health, States / Tagged , , , , , , , , , , , , , | Comments are closed

Toxic chemicals can enter food through packaging. We made a list.

Boma Brown-West, Senior Manager, Tom Neltner, Chemicals Policy Director, and Michelle Harvey, Consultant.

This is the second in a series evaluating the challenges in single-use food packaging waste.

See our list of key chemicals of concern in food packaging.

In the late 1980s, the Council of Northeast Governors (CONEG) was concerned that heavy metals in packaging would accumulate in recycled materials to levels that presented serious health concerns. The organization drafted model legislation that prohibited the intentional addition of mercury, lead, cadmium, and hexavalent chromium to any component of packaging, including inks. It also set a 100 parts-per-million limit on the total amount of these four heavy metals. To ensure compliance, companies making packaging materials had to provide certificates of compliance to downstream purchasers and report compliance to the states.

CONEG also established the Toxics in Packaging Clearinghouse to maintain the model legislation, coordinate implementation of state legislation, and serve as a resource for companies seeking compliance information. The Council’s hypothesis: protecting virgin material from contamination will improve the recyclability of post-consumer materials and protect public health.

Over the years, 19 states have adopted a variation of the model legislation.  In 2018, the State of Washington took an unprecedented step of expanding its version of the legislation from heavy metals to include per- and poly-fluorinated alkyl substances (PFAS). PFAS are bioaccumulating, persistent chemicals and are associated with an array of health problems including endocrine disruption and children’s developmental harm. The State was concerned that paper and cardboard food packaging treated with these chemicals may be contaminating composting and paper recycling processes post-consumer.

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Important insight from the organic certification approach to chemical additives in food

Tom Neltner, J.D.is Chemicals Policy Director

Since 2014, chemicals in food[1] have been consumers’ most important food safety issue, reaching a high of 35% in 2018, according to annual industry surveys by the International Food Information Council. For comparison, “foodborne illness from bacteria” was half that percent.

Food companies have responded to this growing consumer alarm by adopting policies banning artificial flavors, colors and other ingredients that sound like chemicals. This approach is unlikely to do more than serve as window dressing for the underlying problems since it’s not science-based – many of these additives may be safe. The Center for Science in the Public Interest called out this practice in its 2017 “Clean Label: Public Relations or Public Health?” report and pointed readers to its Chemical Cuisine system that rates common additives for health and safety.

There are some companies, like Panera Bread, that are taking a more systematic approach to the ingredients used in the food they sell, starting with the question of whether the additives used are essential and whether the ingredients pose health or safety concerns. As a result, the company worked closely with their suppliers and reformulated many of their products.

And now, thanks to a fascinating new report from the Environmental Working Group (EWG), we are learning about another structured approach that addresses health concerns with chemical additives – the Federal organic certification program for processed foods. To be honest, before reading the report, I viewed the organic program as narrowly focused on pesticides and was only vaguely aware of how it dealt with chemical additives. I was missing the bigger picture.

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