Re: Objections and Request for Formal Evidentiary Public Hearing Regarding FDA’s Denial of Perchlorate Food Additive Petition

June 4, 2017

ENVIRONMENTAL DEFENSE FUND, NATURAL RESOURCES DEFENSE COUNCIL, BREAST CANCER PREVENTION PARTNERS, CENTER FOR ENVIRONMENTAL HEALTH, CENTER FOR FOOD SAFETY, CENTER FOR SCIENCE IN THE PUBLIC INTEREST, CLEAN WATER ACTION, ENVIRONMENTAL WORKING GROUP, AND IMPROVING KIDS’ ENVIRONMENT

June 4, 2017 Commissioner Gottlieb

Food and Drug Administration

Division of Dockets Management (HFA–305) Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

Re:       Objections and Request for Formal Evidentiary Public Hearing Regarding FDA’s Denial of Perchlorate Food Additive Petition No. 4B4808, at Docket No. FDA-2015-F-537

Dear Commissioner:

The Food and Drug Administration’s (FDA) May 4, 2017 denial of Food Additive Petition (FAP) No. 4B4808 is based on a flawed interpretation of the law and the science. This is troubling because perchlorate consumption by young children due to contamination of the food supply has demonstrably increased, threatening fetal and infant brain development.

The serious flaws in the agency’s legal and scientific approach to perchlorate are numerous. The agency’s decision and its underlying analysis grossly underestimated the extent to which perchlorate migrates from packaging and food handling equipment into dry food. In measuring this migration, FDA relied on a single study using a test designed for small packaging that was conducted by a company with a vested interest in the outcome. This migration test bears little relevance to the actual conditions of use of the perchlorate in bulk packaging allowed by FDA. It was not designed to assess the abrasive and compressive forces driving the migration of perchlorate into food from this use. It also was not relevant to the contribution of perchlorate into food from food handling equipment. Despite these serious shortcomings, the company’s test still showed that perchlorate migrates into food.

In addition, the agency ignored its own data, which shows that its November 2005 approval allowing perchlorate in dry food polymeric (plastic) packaging and other plastic surfaces of food handling equipment likely contributed to the high, even shocking, levels of perchlorate found in dry baby food cereals by FDA in its Total Diet Study (TDS) samples collected from 2008 to 2012. These rice, barley, oatmeal, and mixed grain cereals are the best measure of the impact of the agency’s decision because these foods are usually handled dry from farm to store including when shipped in bulk and are not known to be contaminated by other sources of perchlorate such as contaminated water.

Before FDA’s 2005 approval of the use of perchlorate, perchlorate concentrations in these baby food dry cereals were relatively low, with 1 of 20 samples (5%) at 11 parts per billion (ppb) and the rest below 3 ppb. In contrast, FDA’s sampling after the 2005 decision indicated that 12 of 80 samples (15%) had perchlorate concentrations of over 3 ppb, including samples with concentrations of 173, 98, 67, 37, 24, and 16 ppb. These extremely high concentrations, well in excess of pre-approval results, suggest that they may result from use of the perchlorate-laden plastic in a limited number of food contact articles resulting in contamination of the baby food products.

These results are further confirmed by FDA’s study comparing samples collected from 2008 to 2012, after FDA’s approval to those collected from 2005 to 2006. This comparison shows that mean cumulative exposures increased 36% for infants 6-11 months of age; 24% for toddlers two years of age; and 11% for six-year old children. Yet, unaccountably, the agency failed to mention these notable results in its denial of FAP No. 4B4808. Nor did FDA explain how, in light of these documented increases, the conditions of use continue to satisfy the agency’s safety standard. Under the law, additives must be reasonably certain to cause no harm under the intended conditions of use, and FDA must so demonstrate given these increases in exposure for the most vulnerable consumers: infants, toddlers, and children.

Read the full petition.

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