Regulatory Comments to Docket No. USDA-AMS-NOP (AMS-NOP-15-0085-0001, NOP-15-16); Department of Agriculture, Agriculture Marketing Services; Notice ofPublic Meeting for the National Organic Science Board.Regulatory Comments to Docket No. USDA-AMS-NOP (AMS-NOP-15-0085-0001, NOP-15-16); Department of Agriculture, Agriculture Marketing Services; Notice ofPublic Meeting for the National Organic Science Board.
Date: April 14, 2016
Background:
The Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501-6522) authorized establishment of the National List of Allowed and Prohibited Substances (National List). The National List, a subpart within the USDA organic regulations (7 CFR 205.600 through 205.607), identifies synthetic substances that may be used in organic production and non-synthetic (natural) substances that are prohibited in organic crop and livestock production. The exemption and prohibitions granted on the National List are required to be reviewed every 5 years under the Organic Foods Production Act of 1990 by the National Organic Standards Board (NOSB). The Secretary of Agriculture has authority under OFPA to renew such exemptions and prohibitions. If substances are not reviewed by the NOSB within 5 years of their inclusion on the National List and renewed by the Secretary, their authorized use or prohibition expires. On June 1, 2011, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) published an Advanced Notice of Proposed Rulemaking (ANPR) (76 FR 31495) in the Federal Register, announcing the NOSB’s review of exempted and prohibited substances due to sunset in 2013. AMS subsequently posted these comments for public review and provided these comments to the NOSB in advance of their review of these substances. At its November 2011 and May 2012 meetings, the NOSB reviewed a number of substances, including carrageenan, under the 2013 Sunset review. On May 3, 2013 USDA published its proposed actions in the Federal Register (78 FR 25879), pursuant to recommendations made available from the NOSB regarding the status of carrageenan as a substance allowed in organic food.
Following their 2011 and 2012 meetings, the NOSB recommended, that carrageenan be listed again as an allowed substance in foods labeled organic in the U.S.; however, the NOSB surprisingly recommended that carrageenan be excluded from use in organic infant formula. NOSB gave safety concerns as their reasoning. NOSB also recommended to indicate specific allowed forms of carrageenan by Chemical Abstract Service (CAS).
Issue:
In their proposed rule, USDA decided to accept the NOSB recommendation to continue to allow carrageenan as a non-synthetic substance permitted in organic food, but they decided to reject the NOSB recommendation to exclude carrageenan from organic infant formula.
The NOSB justification to exclude carrageenan from organic infant formula was based in part on the NOSB’s interpretation of a 2003 opinion of the European Commission’s Scientific Committee for Food (SCF). In response to NOSB’s recommendations, the NOP concluded that the NOSB erred in making its 2012 recommendation to restrict the use of carrageenan and prohibit its use in organic infant formula, a recommendation based solely on a statement about newborn infants expressed in 2003 by the EU’s SCF. The EU SCF reported the following:
“Although there is no direct evidence of harm from carrageenan in infants and no toxicologically significant effects were seen in infant baboons fed carrageenan in commercial infant formulae for 16 weeks, high levels of reassurance are needed to permit additives in infant formulae.”
SCF also concluded that “there is no evidence of any adverse effects in humans from exposure to food-grade carrageenan, or that exposure to degraded carrageenan from use of food-grade carrageenan is occurring.”
The National Organic Program (NOP), which is overseen by the Agricultural Marketing Service (AMS), an agency of the U.S. Department of Agriculture, noted these statements as well as carrageenan’s status as a direct food additive and its safety when used in the amount necessary as an emulsifier, stabilizer, or thickener in foods. Furthermore, the food safety authority here, the U.S. Food and Drug Administration (FDA) does not prohibit the use of carrageenan in infant formula under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350(a)). Therefore, the NOP’s proposed rule allowed the continued use of carrageenan without restriction.
Prior to a May 2012 NOSB meeting, the Handling Subcommittee conducted a review of past NOSB recommendations, technical reports, historical documents, and public comments and concluded that the available information indicates that the substance is:
- essential for organic production,
- compatible with organic production practices,
- does not reveal unacceptable risks to the environment, human, or animal health as a result of its use or manufacture
Neither the Handling Subcommittee proposal submitted prior to the May NOSB meeting nor the full NOSB issued a recommendation stating that carrageenan use in food should be prohibited.
NPA submits these comments to urge NOSB to continue to allow carrageenan in organic foods and in organic infant formula. Carrageenan is a non-synthetic natural substance, which fits within the scope of the National Organic Program (NOP) as a permitted organic food. Carrageenan is also permitted to be used in foods as a direct food additive. AMS conducted an independent review which included consultation with FDA to gain a detailed understanding of the relevant regulations allowing for use of carrageenan in foods or infant formula. FDA, the food safety authority in the U.S., continues to maintain that carrageenan is safe for use in foods and infant formulas as codified in the federal regulations. If in the future FDA does issue a finding supporting a prohibition of carrageenan in any or all foods, AMS has stated that it will take appropriate action to come into alignment with other federal agencies with updated findings of toxicity. NPA has no problems supporting a re-evaluation of carrageenan’s science in the future, but it has consistently demonstrated a safe profile in human foods.
One of the missions of NPA is to urge the use of natural ingredient alternatives in lieu of synthetic ones. Carrageenan is natural and reduces the need for synthetic food additives as emulsifier, stabilizers, or thickeners in foods, including infant formula. NPA urges the NOSB to evaluate carrageenan under the same lens as other venerable food safety authorities have, including USDA and USFDA, and devoid of the emotional fears which are unsupported by science. This negative rhetoric, while not based on science, has unjustly served to cloud carrageenan’s clear demonstrated safety and discourage its use as a bona fide natural and organic food additive. NPA urges the NOSB to recommend carrageenan’s current permitted use in organic foods and organic infant formula.
Action:
- Carrageenan should be permitted in organic foods and organic infant formula because it is a safe direct food additive when used at levels presently found in foods
- In the May 3, 2013 proposed rule from USDA’ Agricultural Marketing Service (AMS), carrageenan was allowed as a non-synthetic substance permitted in organic foods
- USDA AMS rejected the National Organics Standards Board’s attempt to exclude carrageenan from organic infant formula in the proposed rule
- Carrageenan has a long history of safe use in foods
- Carrageenan is allowed under 21 CFR 172.620 as a direct food additive
- Carrageenan is considered Generally Recognized As Safe (GRAS) in accordance with 21 CFR 182.7255
- The U.S. Food and Drug Administration, the nation’s leading authority on food safety issues, has never prohibited the use of carrageenan in infant formula. It is permitted for use in infant formula by FDA’s Office of Nutrition and Labeling
- The World Health Organization’s Joint Expert Committee of Food Additives (JECFA) concluded it is safe for food use and that it is not necessary to specify an acceptable daily intake (ADI) limit
- Carrageenan has received the highest rating granted by JECFA for any food ingredient
- The European Economic Community recognized carrageenan for its safety and utility as an approved emulsifier, stabilizer, thickening and gelling agent
- Carrageenan is a natural product and is not carcinogenic, inflammation-provoking, nor significantly absorbed by the gut
- Oral feeding studies using non-human primate animal models (baboons) have shown no adverse effects when raised from birth to 112 days on infant formula containing up to 5-fold the level of carrageenan typically present in human infant formula
