Tag Archives: PFAS

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PFAS Used in Grease-Proofing Agents for Food Packaging No Longer Being Sold in the U.S.

By Food Safety Tech Staff
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Woman holding hamburger

Food packaging is now safer for consumers thanks to the elimination of one of the key dietary sources of Per and Polyfluoroalkyl Substances (PFAS) exposure. On February 28, the FDA announced that grease-proofing substances containing PFAS are no longer being sold by manufacturers for food contact use in the U.S. market following the completion of the voluntary market phase-out of these substances used on food packaging paper and paperboard. These substances represent the primary source of dietary exposure to PFAS from authorized food contact uses.

In 2020, the FDA obtained commitments from manufacturers to cease sales of food contact products containing certain grease-proofing substances that contain certain types of PFAS. In addition, the FDA has confirmed that other manufacturers have voluntarily stopped sales of other food contact substances (which contain different types of PFAS) intended for use as grease-proofing agents in the U.S.

The grease-proofing substances, used to prevent the leaking of grease and oil and for their water-resistant properties, were applied to fast-food wrappers, microwave popcorn bags, take-out paperboard containers, pet food bags, as well as other similar types of packaging.

While the original commitment letters received by the FDA from the manufacturers stated that the phase out could take 18 months to exhaust the market supply from the last date of sale, most of the companies exited the market prior to their original phase-out date. In addition, the FDA is working towards a validated analytical method that would allow the agency to monitor the market for these food contact substances in food packaging.

Craig Butt

Preparing for the Proposed EU Ban on PFAS

By Food Safety Tech Staff
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Craig Butt

In February, the European Union (EU) announced a proposed ban on the production, use, and sale of about 10,000 per- and polyfluoroalkyl substances (PFAS). We spoke with Craig Butt, Ph.D., Senior Staff Scientist for Food/Environmental Science at SCIEX to learn more about the proposal, how it may affect the food industry and how companies can begin preparing for more stringent regulations both in the EU and the U.S.

What do food companies need to know about the EU’s proposed ban on PFAS?

Butt: First, it is a proposal at this point and it is open to six-month commentary. About a year from now they will make an official decision. Whatever they decide will slowly be rolled out, but it is a huge and very comprehensive proposed ban that will impact people globally.

We live in an environment of global trade, so this will impact those that manufacture food packaging as well as any food products that might be coming across EU lines. What’s most interesting to me about this is the idea that, in the U.S. there’s a lot of attention on drinking water and drinking water regulations, but to propose banning PFAS in products, that takes the regulations further up the chain.

Is this a true ban on PFAS in the products or are they lowering the threshold from current levels?

Butt: There are two aspects to it. It would set lower limits, but they are also seeking more comprehensive monitoring. Typically, regulation and detection of PFAS has involved specific, targeted sets of compounds.

The problem with PFAS is, it is not like banning or reducing use of a single pesticide, you’re talking about potentially 5,000 different chemicals—depending on how you define them—and maybe even 12,000 different chemicals. So how do you address PFAS as a group? This proposal is trying to address that by looking at not only targeted compounds, but PFAS as a class and trying to understand the control of those compounds as a group.

There is still a lot of work to be done before we see where it falls out. The devil is always in the details, and I know there’s going to be pressure on multiple sides. You’re going to have pressure from one group saying this isn’t strict enough and the other side saying this is too strict and everyone’s going to go bankrupt.

But when you read it and you see the ban on products and certain thresholds in those products, I’m pretty sure that’s going to stay, particularly where they’re looking at total PFAS or total fluorine content. That tells us that we’re going to have to go beyond just looking for a targeted list of compounds and do a better job of characterizing all the fluorine compounds that are in there.

Does the proposal primarily focus on food contact packaging or the food products themselves?

Butt: There is still some clarity needed in terms of what the regulations will look like in the final document, but it seems to be focused more on the source, which would be the food packaging paper and products, rather than the food itself.

Where is the industry now in terms of detection and remediation of PFAS and where will it potentially need to go to meet these new regulations, if passed?

Butt: It is important to remember that there was a time before PFAS were widespread in food packaging, and I do know that companies are making efforts to look for alternatives. Back in the early 2000s when 3M banned Scotch Guard, it wasn’t too long until suitable alternatives were found. In the U.S., some manufacturers—working with the FDA—have agreed to change what’s in their food contact materials. In terms of what the industry has in the warehouse ready to go, it is unclear, but companies have seen the writing on the wall and are taking steps to find alternatives. Still, the move totally away from fluorochemicals will likely be a bit of a shock to those who make them.

The concerns will be whether the non-fluorinated chemicals are as effective as the PFAS, and if they are not will they still be satisfactory? We also need to be cautious as we investigate alternatives because we don’t want to replace these PFAS chemicals with newer chemicals that we don’t yet have knowledge about their toxicology or environmental impact on.

What should people looking at now in terms of investigating new products and understanding what they’re going to need to do in terms of detection?

Butt: Detection is the first step. Some folks may not be aware of what’s in the products they are buying in terms of raw materials. You want to know what’s in your own products and the products you are using. There is a huge risk in terms of public relations and reputation. The last thing a company wants to do is have a third party test their products and find out that there are PFAS in them and have that potential reputational damage, because there are a lot of third parties out there that do that, and they are not afraid to name names.

Are there effective tests available if you want to start checking your packaging?

Butt: Yes, we have gotten very good at measuring extremely low levels as well as reducing some of the impacts on data quality and detection in terms of confirmed detection. We can measure things at trace levels and accurately say that they are there. That’s from a targeted standpoint. But we’re also very good at doing non-targeted work to find some of those unknown PFAS that may not be on a standard monitoring list but can help improve the further characterization of what’s there.

A lot of attention has been on PFOS and PFOA, but if you are only looking at those compounds, then you are doing yourself a disservice because what we know and what we’ve seen through time is that those lists of dangerous compounds only continue to grow. As regulators become aware of their presence and their toxicology and as analytical chemists get better and publish findings of these new compounds in consumer products, then the list will continue to grow.

In terms of the regulatory climate here in the U.S., where do you think we’re headed?

Butt: Back in the late 2000s, the FDA scientists produced some really incredible work looking at PFAS in food packaging and their migration out of that packaging into foods, and we continue to work with them. They are great scientists and they published some groundbreaking research. However, these are not the same scientists who make the regulations.

There have been some voluntary agreements with some of the manufacturers to reduce the use of chemicals that are larger—the long chain compounds—which are more likely to accumulate in human blood. But these EU regulations will put a whole lot more pressure on companies to look at PFAS as a larger class of chemicals.

As companies look for alternatives that are a) effective and b) not dangerous, are leaching tests typically part of testing these new products?

Butt: The EU regulations do have a leaching component for some of the food packaging materials, particularly for plastic food packaging. You do need to assess the leaching from plasticizer compounds. I’m not sure if there’s a similar leeching test for PFAS, because PFAS are a little bit weird in the sense that, in the past, most of the chemicals that we were concerned about were those that were fat soluble. We know that fatty foods like yogurts are very good at pulling out the contaminants from the food packaging, but PFAS are a little bit odd because they like more neutral compounds, ones that have some emulsifying properties to them—not super fatty or super water soluble—so you have to be cautious that the right kind of migration tests are being used and are fully applicable for these compounds.

One of the things that makes PFAS so interesting is that they don’t behave like our traditional hydrophobic organic contaminants. They don’t build up in your fat. Years ago, when we were worried about DDT and PCBs and some of those other chlorinated pesticides it was because they build up in your fat. But PFAS build up in the blood, kidney and liver, which from a chemical standpoint is interesting but it also means that some of our tests have to be revised for them.

But the really big thing is, with all the PFAS that are out there, the onus now seems to be shifting on to the manufacturer to know what is in their products beyond just the big ones of PFOS and PFOA. I think that is where we’re going in terms of the testing market. It’s not just testing for individual compounds, but doing a total PFAS analysis at a screening level and then, if a product is above a certain threshold, we do a more targeted, specific analysis.

PFAS

Phasing Out PFAS

By Food Safety Tech Staff
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PFAS

Efforts to regulate and remediate per- and polyfluoroalkyl substances (PFAS) are picking up a steam. Earlier this month, researchers from Northwestern University published a study verifying a low-cost process that breaks the chemical bonds of two major classes of PFAS compounds—perfluoroalkyl carboxylic acids (PFCAs) and perfluoroalkyl ether carboxylic acids (PFECAs)—leaving behind only benign end products.

Last week, the EPA proposed designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), two of the most widely used PFAS, as hazardous substances. If finalized, the rule will trigger industry reporting of PFOA and PFOS releases and allow the agency to require cleanups and recover cleanup costs.

For the food and beverage industry, most current regulations involve food contact packaging, with states outpacing the FDA in implementing thresholds and working toward outright bans.

“Maine has a declaration requirement for PFAS in food packaging, and eight states are in motion to completely ban PFAS in food packaging products,” says Sally Powell Price, regulatory expert for food and beverage safety, MilliporeSigma.

California, Connecticut, Maine, Minnesota, New York, Vermont and Washington are among the states that have already passed legislation limiting the use of PFAS in food packaging. Outside the U.S., the Eurpean Commissions’ Restrictions Roadmap outlines a plan to outlaw the use of PFAS in packaging by 2030.

The good news for the food and beverage industry is that non-PFAS packaging alternatives are affordable. “The alternatives are fairly priced, so if manufacturers are converting from PFAS to non-PFAS materials, it may require changing some processes, but the price will not change very much,” says Yanqi Qu, food & beverage safety and quality technology specialist, MilliporeSigma.

The area that poses a greater challenge and requires more significant investment from the public and potentially industry groups lies in the testing of actual food commodities. This is also an area of increased regulatory scrutiny.

Regulating and Detecting PFAS in Food

In July, the FDA released the results of its Total Diet Study, which included outcomes of its retail seafood products PFAS testing. “This testing actually catalyzed a recall of clam products from China,” says Price. “The FDA tested foods imported from all regions for the study, so this is something that the FDA is monitoring. I can see this recent recall driving them to do more testing at the border for products coming in to the U.S., especially seafood.”

The state of Maine has dairy testing mandates already in place. “PFAS are bio-accumulators, so it’s not just fish. Cattle and other livestock could also be an issue,” says Price. “The testing program in Maine is a regulatory model that I would use to extrapolate and look at where our future could lie.”

One of the key challenges in detecting PFAS levels in food commodities lies in the variety of matrices to be tested and the huge numbers of PFAS currently in the environment. In December 2021, the FDA published its methodology for PFAS analysis in food and beverage, which focused on fruits, vegetables and beverage samples.

“They are using an extraction method. They used a solvent to extract materials from the surface of the food and beverage samples, and then analyzed them using a liquid chromatoghraphy and mass spectrometry (LC-MS) system,” says Qu. “This method was just posted last year, and the public is not satisfied with it. There are more than 600 different types of PFAS compounds, and for this method they only focused on 16 of them. The FDA is saying, we need more time to test for all 600.”

LC-MS used to test for PFAS in food and beverages is very similar to the PFAS testing in the environment. However, testing food products is more complex than testing water or soil. “Different foods have different interferences and complications, and it is extremely difficult to account for all of the potential interferences and or complications that might arise as you move from one matrix to another,” says Taylor Reynolds, marketing manager for environmental testing and industrial chemical manufacturing, MilliporeSigma. “The science is struggling to keep up. You get into issues where you might have overlapping peaks on your chromatogram, which makes it hard to distinguish the readings. Calibration standards are not all readily available. So, even if a lab wanted to test for 600 compounds, I’m not sure they could easily get their hands on 600 compounds as a reference standard to do their calibration groups.”

What Food Manufacturers Can Do

Price encourages food manufacturers to keep an eye on their state legislatures for proposed and upcoming regulations and be aware of known concerns specific to their areas. “The FDA looks to best fit for purpose,” she says. “So if there is a known concern, for example local data shows that you have PFAS infiltration in the ground water near your livestock or your crops, having a testing plan in place or a mitigation strategy is a good idea, where possible.”

Local FDA and EPA departments can often provide mitigation support as well as guidance to ensure you are aligned with local regulations.

In the coming years, we are likely to see not only more stringent regulations, but also a better understanding of the most hazardous PFAS compounds to help target mitigation and replacement strategies. This data combined with continued efforts to neutralize PFAS, as seen in the Northwestern study, could signal a promising future.

“Our work addressed one of the largest classes of PFAS, including many we are most concerned about,” said William Dichtel, Robert L. Letsinger Professor of Chemistry in Northwestern’s Weinberg College of Arts and Sciences, and lead author of the Northwesten study. “There are other classes that don’t have the same Achilles’ heel, but each one will have its own weakness. If we can identify it, then we know how to activate it to destroy it.”

“PFAS compounds have been so incredibly useful, yet weaning ourselves off of them is not going to be terribly difficult,” says Reynolds. “As long as organizations keep their heads up and are paying at least a marginal amount of attention, it shouldn’t be a terribly difficult to transition away from them, particularly on the packaging side of things. I personally am optimistic about the ultimate resolution of this issue, because people are taking it seriously and the science is showing that we can find solutions.”

 

Image: PFAS Molecule, courtesy of NIST

Water fountain

EPA Proposes Designating Certain PFAS as Hazardous Substances

By Food Safety Tech Staff
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Water fountain

The EPA is proposing to designate two of the most widely used per- and polyfluoroalkyl substances (PFAS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as “Superfund.” In its August 26 announcement, the agency noted that this would increase transparency around releases of these harmful chemicals and help to hold polluters accountable for cleaning up their contamination.

The proposal applies to perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, and is based on significant evidence that PFOA and PFOS may present a substantial danger to human health or welfare or the environment. PFOA and PFOS can accumulate and persist in the human body for long periods of time. Evidence from laboratory animal and human epidemiology studies indicates that exposure to PFOA and/or PFOS may lead to cancer, reproductive, developmental, cardiovascular, liver and immunological effects.

“Communities have suffered far too long from exposure to these forever chemicals. The action announced today will improve transparency and advance EPA’s aggressive efforts to confront this pollution, as outlined in the Agency’s PFAS Strategic Roadmap,” said EPA Administrator Michael S. Regan.Under this proposed rule, EPA will both help protect communities from PFAS pollution and seek to hold polluters accountable for their actions.”

If finalized, the rulemaking would trigger reporting of PFOA and PFOS releases, providing the EPA with better data and the option to require cleanups and recover cleanup costs to encourage better waste management.  It would also improve EPA, state, Tribal nation and local community understanding of the extent and locations of PFOA and PFOS contamination throughout the country and help communities avoid or reduce contact with these potentially dangerous chemicals.

The EPA said that it is focused on holding responsible those who have manufactured and released significant amounts of PFOA and PFOS into the environment. It will use enforcement discretion and other approaches to ensure fairness for minor parties who may have been inadvertently impacted by the contamination.

If this designation is finalized, releases of PFOA and PFOS that meet or exceed the reportable quantity would have to be reported to the National Response Center, state or Tribal emergency response commissions, and the local or Tribal emergency planning committees.

Additionally, the proposed rule would, in certain circumstances, facilitate making the polluter pay by allowing EPA to seek to recover cleanup costs from a potentially responsible party or to require such a party to conduct the cleanup. In addition, federal entities that transfer or sell their property will be required to provide a notice about the storage, release or disposal of PFOA or PFOS on the property and a covenant warranting that it has cleaned up any resulting contamination or will do so in the future, if necessary.

EPA will be publishing the Notice of Proposed Rulemaking in the Federal Register in the next several weeks. Upon publication, EPA there will be a 60-day comment period.

 

 

Woman shopping

FDA Seeks Information on Fluorinated Polyethylene Food Contact Packaging

Woman shopping

The FDA is seeking scientific data and input from industry on current food contact uses of fluorinated polyethylene, as well as consumer dietary exposure that may result from those uses. On July 19, the agency issued a request for information due to concerns that fluorination of polyethylene may result in the formation of per- and polyfluoroalkyl substances (PFAS).

The FDA authorized fluorinated polyethylene for general use in contact with food in 1983 (21 CFR 177.1615). However, the regulation requires specific manufacturing conditions that must be in place during the fluorination process. In 2021, testing by the Environmental Protection Agency (EPA) noted the migration of perfluorooctanoic acid (PFOA), a type of PFAS, from fluorinated polyethylene containers used to hold pesticides. In response, the FDA issued a letter to food manufacturers, reminding industry that only certain fluorinated polyethylene containers are authorized for food contact use.

The July 19 call for input and data is part of the FDA’s efforts to monitor new scientific information on food contact surfaces (FCS) as it becomes available. “This includes reviewing scientific literature and studies from other regulatory and health agencies in the U. S. and in other countries. Considering recent developments, the FDA is seeking additional information on current practices to ensure the safe use of fluorinated polyethylene in contact with food,” said the FDA in its letter to industry.

Those interested in providing information can submit comments electronically on Regulations.gov to docket number FDA-2022-N-1526.

Submit written/paper submissions with Docket No. FDA-2022-N-1526 for “Fluorinated Polyethylene Containers for Food Contact Use; Request for Information” to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852