How and when will FDA rule on ortho-phthalates in food? It’s anyone’s guess.

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

The Food and Drug Administration (FDA) has yet to decide three overlapping petitions requesting the agency take action on uses of ortho-phthalates in contact with food. Two of the petitions—a food additive petition and a citizen petition—were submitted by EDF, Earthjustice and nine other public health allies. In those petitions, we requested the revocation of all uses of this class of chemicals in food because the agency can no longer conclude that such use is safe. The law required FDA to make a decision by no later than September 2018; that deadline has long since come and gone, and the agency hasn’t acted.

The third petition was submitted by the Flexible Vinyl Alliance, an industry group. It requested that the agency revoke the food additive uses of 26 ortho-phthalates because, according to FDA’s notice, they had been abandoned. The agency agreed to review the petition in July 2018 and invited public comment on it in November 2018.  Public comments were due on January 14, 2019.

In a press release about its petition, the industry group announced that only four ortho-phthalates “remain relevant in food contact applications”:  di(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), dicyclohexyl phthalate (DCHP) and diisodecyl phthalate (DIDP).  It also stated that it confidentially provided the agency with exposure and safety data on these four substances. The agency has made neither the industry’s petition nor the safety data on the four ortho-phthalates publicly available. We submitted a Freedom of Information Act (FOIA) request seeking industry’s “confidential” report and more information on the petition.  We await a response.

What do the petitions from EDF and other public health advocates request?

In our petitions, we showed that ortho-phthalates are a class of chemically- and pharmacologically-related substances associated with reproductive, developmental, and endocrine health effects. We demonstrated that, when the cumulative effect of these chemicals in the diet are considered as required by law, the FDA cannot conclude their use as food contact substances (FCS) is safe. Given these health risks, we asked FDA to remove all food uses it had previously approved including those for paper, plastic, adhesives, coatings, and metal lubricants.

We also asked that FDA explicitly prohibit use of eight ortho-phthalates that an expert panel convened by the Consumer Product Safety Commission concluded were not safe to use in toys that children put in their mouths, reasoning that if the chemicals are not safe in such toys, they have no place in children’s food.

What does the industry claim in its petition?

The Flexible Vinyl Alliance’s food additive petition claims that some or all of the uses of 26 ortho-phthalates were permanently abandoned. If accepted by FDA, the petition would necessarily affect the cumulative risk assessment necessary to decide our pending food additive petition and our citizen petition. While it is a positive step that industry is abandoning uses of some of these endocrine disrupting chemicals, it was not a surprise.

Industry has taken a similar approach to our previous food additive petitions, seeking to moot parts of our petition and narrow the scope of the discussion. For instance, FDA accepted an abandonment petition on the use of styrene as a flavor while reviewing our carcinogenic flavors petition, enabling the industry to avoid a declaration by the agency that styrene was a carcinogen. For our perchlorate petition, FDA accepted another industry abandonment petition to narrow the focus of the exposure assessment.

Nine, not four, ortho-phthalates remain allowed for use in food contact materials

As we reviewed the FDA summary of the industry petition, we struggled to clearly understand what uses were covered. By comparing the list of ortho-phthalates in our petition to those the industry claimed were abandoned, we found that nine – not four – remain allowed for use. The nine are in the table below.

We were also disappointed to see that industry is actively using in food contact materials three ortho-phthalates banned from use in children’s toys by CPSC. It is a good example of regulatory dysfunction since CPSC’s expert panel determined that most of children’s exposure was from food.

Phthalate Name and CASRNFDA approved uses not covered by industry petitionIndustry claimCPSC action
Dicyclohexyl phthalate (DCHP)
(84-61-7)
Adhesives, paper, paperboard, plastics, polymersIndustry acknowledged use as FCS is active.CPSC banned from children’s toys.
Di(2-ethylhexyl) phthalate (DEHP)
(117-81-7)
Adhesives, coatings, resins, paper, paperboard, sealing gaskets, metal lubricants, defoaming agents, plastics, and polymersIndustry acknowledged use as FCS is active.CPSC banned from children’s toys.
Diisononyl phthalate (DINP)
(28553-12-0)
Plastics and polymersIndustry acknowledged use as FCS is active.CPSC banned from children’s toys.
Diisodecyl phthalate (DIDP)
(26761-40-0)
Adhesives, coatings; sealing gaskets, rubber, metal lubricantsIndustry acknowledged use as FCS is active.--
Diallyl phthalate (DAP)
(131-17-9)
Reactant in paper and paperboardIndustry did not address this use.--
Diethyl phthalate (DEP)
(84-66-2)
Plastics and polymersIndustry did not address this use.--
Diisooctyl phthalate (DIOP)
(27554-26-3)
Plastics and polymersIndustry did not address this use.--
Ethyl phthalyl ethyl glycolate (EPEG)
(84-72-0)
Plastics and polymersIndustry did not address this use.--
Butyl phthalyl butyl glycolate (BPBG)
(85-70-1)
Plastics and polymersIndustry did not address this use.--

The industry’s petition most likely did not address the use of DEP, DIOP, EPEG, and BPBG, and DEHP in plastics and polymers because the uses were sanctioned prior to 1958 and, therefore, technically they are not food additives due to a quirk in the law. The DAP use was most likely not addressed because the approval is for a chemical reacted to make another chemical and not added directly to food contact articles. However, as all of these uses remain approved, the agency must assume that they are ongoing. We made this point clear in our comments.

Furthermore, as we demonstrate in our petitions, exposure to any one of three of the ortho-phthalates that industry has not claimed to have abandoned (DEHP, DINP, or DIDP) is estimated to exceed the acceptable daily intake for ortho-phthalates.  Logically, cumulative exposure to all nine ortho-phthalates exceeds this limit even if industry abandons some uses. The industry petition in no way lets FDA off the hook.

Ortho-phthalates in food handling equipment not clearly explained in industry petition

Many of the FDA-approved uses of ortho-phthalates involve food handling equipment such as conveyors, tubing, pumps, meters, tanks, chutes, and other equipment installed in facilities. Each of these uses may release ortho-phthalates into the food.

For a chemical use to qualify as abandoned, industry must not only cease to manufacture or sell the equipment containing it, but also no longer use any such existing equipment in contact with food. However, based on FDA’s Federal Register notice, the Flexible Vinyl Alliance appears not to have clearly demonstrated that the installed equipment containing ortho-phthalate-laden plastic was abandoned. This is important given the long life-expectancy of some types of food handling equipment.

In our comments, we raised this concern and advised FDA that if it accepts the abandonment claim, then any company using installed equipment containing ortho-phthalates that come in contact with food would be violating the law. We therefore requested that when publishing the final rule, FDA explicitly state that continued use of installed equipment with abandoned ortho-phthalates that come into contact with food is unlawful and the food processed with such equipment would be adulterated.

Alternately, FDA could narrow the abandonment claim to only future equipment. However, the agency must then continue to count the estimated migration of ortho-phthalates into food from each and every contact with the installed equipment as part of its evaluation of the safety of the remaining ortho-phthalates. This would mean that FDA cannot consider these uses to be abandoned.

FDA’s failure to share relevant documents with the public

FDA did not publish a copy of the Flexible Vinyl Alliance’s petition when it requested comment, most likely because the industry did not grant permission. This decision made it difficult to clearly understand how thorough or rigorous industry efforts were to confirm that uses were actually abandoned as it claimed.

In addition, FDA has not yet responded to our FOIA request for the industry’s “confidential” exposure and safety data that it submitted regarding the use of the four ortho-phthalates it considers relevant. Without that information, we are unable to evaluate the relevance to our petitions and make well-informed comments. In the comments we did submit, we state that both FDA and the industry must be more transparent with their documents and their analyses.

FDA delayed publishing the public notice despite statutory mandate to act

Once FDA agrees to consider a food additive petition like the one filed by the Flexible Vinyl Alliance or by EDF and its allies, the law directs the agency to publish a Federal Register notice within 30 days[1] and make a final decision within 180 days.[2] For the industry petition, the clock started on July 3, 2018, and a final decision was due on December 31, 2018. However, despite the law, FDA did not publish the notice until November 14, 2018 and the deadline for comments was January 14, 2018 – two weeks after the statutory deadline for action by FDA.

The delay in publishing the notice raises questions about the seriousness with which FDA takes these statutory deadlines. In our comments, we encouraged FDA to make timely decisions consistent with the statute.

Summary

In our petitions, we showed that ortho-phthalates as a class are not safe for use in food. Given the risks they pose, FDA has a duty to act. The first step is to make timely decisions – yet the agency is more than four months past due the September 2018 deadline.

To the extent that the Flexible Vinyl Alliance petition advances the agency’s decision on our petitions, we appreciate the effort. However, from what we can tell from the Federal Register notice, the industry appears to have underestimated the potential exposure from the remaining uses  and left unresolved whether the abandonment includes ongoing uses in installed food handling equipment, and if not, how the agency intends to handle such uses.

Regardless of the effect of the industry petition on our efforts, it is certainly time for FDA to rule on whether to revoke its approval for all food contact uses of ortho-phthalates. The clock is ticking.

[1] 21 U.S.C. §348(b)(5).

[2] 21 U.S.C. §348(c)(2).  The agency has 90 days but can grant itself a 90-day extension.

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