Regulatory Issues Regarding Food Applications of Sodium Chlorite
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® Basic Chemicals Sodium Chlorite Regulatory Issues Regarding Food Applications Introduction food components and raw materials as well as food The application of sodium chlorite and chlorine dioxide in additives. All food additives must be approved prior to food processing is a complex issue. It is often difficult to use; food does not have to be. The fact that food does identify the regulatory agency that is responsible for not require prior approval is not as big a loophole as may overseeing the use of sodium chlorite and/or chlorine first appear, since food becomes a food additive if it is dioxide in a particular segment of the food processing used as a component in another food (e.g., a potato in industry. In some cases, more than one agency has stew), unless it is excluded from the food additive jurisdiction. Congress passed the Antimicrobial definition because it is GRAS--as in the case with Regulation Technical Corrections Act of 1998 1 to clarify potatoes."2 the roles of EPA and FDA in regulating antimicrobial products used on food. This Technical Data Sheet GRAS and GRAS Affirmation: attempts to provide a history of FDA opinions, policies, "Food which is generally recognized as safe (GRAS) is and regulations regarding food processing applications. excluded from the food additive definition and its accompanying strict standards. To achieve GRAS As we review the different types of Food and Drug status, several requirements must be met. First, there Administration (FDA) communications it is important to must be a general recognition of safety. To prove this, understand the relative value of each type of document. the proponent of the substance must introduce testimony A good understanding of the following terms will also be regarding the state of scientific knowledge. [21 CFR helpful: Indirect Food Additive, GRAS and GRAS 170.30(a)]. Second, it must be established that the Affirmation. These topics are covered in detail under the GRAS supporting experts are qualified to evaluate the next two headings. substances by virtue of their scientific training and experience. And third, for pre-1958 substances, general Indirect Food Additive: recognition of safety may be established through "Indirect food additives are not directly and intentionally experience based on common use in food. added to a food for some functional purpose. "GRAS status is a question of fact that exists "Two important threshold factors are: First, an additive independent of whether FDA has considered the issue. must be a 'substance.' Second, the substance must However, manufacturers that wish to claim GRAS status become a component or otherwise affect the are in a much better regulatory position with the FDA's characteristics of the food as a result of its intended use. endorsement of GRAS status."2 "If a substance is an added substance in food, a more FDA Advisory Opinions, Information Statements or stringent measure of harm is applicable than if the Letters by Agency Personnel: substance were a naturally occurring component in food. "There are many questions for which no adequate rule or precedent exists. In such a case, you may wish to "It is important to distinguish between 'food additive' and obtain an opinion from the Food and Drug 'food.' Food is an extremely broad term that includes Administration. Using the form specified in the 600-302 Sodium Chlorite 08/2018 Important: The information presented herein, while not guaranteed, was prepared by technical personnel and is true and accurate to the best of our knowledge. NO WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OR GUARANTY OF ANY OTHER KIND, EXPRESS OR IMPLIED, IS MADE REGARDING PERFORMANCE, SAFETY, SUITABILITY, STABILITY OR OTHERWISE. This information is not intended to be all-inclusive as to the manner and conditions of use, handling, storage, disposal and other factors that may involve other or additional legal, environmental, safety 14555 Dallas Parkway, Suite 400 or performance considerations, and Occidental Chemical Corporation assumes no liability Dallas, TX 75254 whatsoever for the use of or reliance upon this information. While our technical personnel will be happy to respond to questions, safe handling and use of the product remains the 800-752-5151 responsibility of the customer. No suggestions for use are intended as, and nothing herein shall be construed as, a recommendation to infringe any existing patents or to violate any Federal, State, local or foreign laws. ® Basic Chemicals regulation, the request must indicate the issue involved and guidelines might not be accepted by the Agency. together with a full statement of the facts and legal Such opinions, they argue, are intended to help industry points relative to the request. [21 CFR 10.85]. The to comply, and preambles to proposed rules are an request may be denied if, in the view of the important vehicle for announcing Agency policies. A Commissioner, the request: is incomplete, 'cannot question of fairness is raised if the Agency seeks to reasonably be given on the matter involved,' a prior make advisory opinions immune from judicial review. advisory opinion or regulation adequately covers the The Agency has yet to issue a final rule on this subject. matter, the request does not raise a policy issue of broad applicability, or the 'Commissioner otherwise concludes "An advisory opinion represents FDA's formal position. that an advisory opinion would not be in the public It obligates the Agency to act in conformity until the interest.' [21 CFR 10.85(a)]. opinion is amended or revoked. Except in unusual situations involving an immediate and significant danger "Formerly, advisory opinions were binding. In 1992, to health, FDA may not recommend legal action against however, FDA proposed to revise its advisory a person or product with respect to an action taken in opinion rules, [57 FR 47314, October 15, 1992 , conformity with an unrevoked advisory opinion. listed at 21 CFR 10.85 and 10.90], to indicate that advisory opinions would no longer be binding "Amendment or revocation of an advisory opinion may but 'simply represent the Agency's best advice be affected at any time. Federal Register publication is on the matter at issue at the time they are adequate notice of the revocation or amendment of an rendered.' advisory opinion. As an alternative to the Federal Register publication, the regulations provide for Guidelines would have the same status as opinions, amendment or revocation 'in the same manner as the providing 'useful information' about Agency practices notice of the advisory opinion was originally given.' [21 and procedures. The proposal includes, in its definition CFR 10.85(g)]. of an advisory opinion, what would not be binding not only statements in preambles to proposed regulations "Care should be taken to distinguish between formal but also preambles to final regulations. The only advisory opinions and informal statements or letters by documents that would not be deemed advisory Agency personnel. An informal opinion, whether written opinions would be codified regulations and final or oral, does not bind the Agency. (FDA letter to the orders issued through formal rulemaking contrary does not bar enforcement proceedings.) procedures. "Advisory opinions often take a year or more from the "The Agency proposed taking these steps on grounds time the opinion is initially requested. Often the that: (1) the courts have found that advisory opinions Agency's decision does not provide the clear-cut are not generally binding; (2) obliging FDA to follow guidance the request sought to evoke. advisory opinions and guidelines may limit the Agency's ability to respond to specific situations; (3) finally, the "The majority of FDA advisory opinions are not proposed regulations respond to the case Community denominated as such. Trade Correspondence (only Nutrition Institute v. Young 818 F.2d 943 (DC. Cir. 1987) issued between 1938 and 1946), compliance policy which called into question FDA's procedures for issuing guides, and guidelines (relating to test procedures, advisory opinions and guidelines that purposed to be protocols, ingredient specifications, labeling or other binding. technical or policy criteria) are advisory opinions. Any portion of the Federal Register notice -- other than the "Industry groups have opposed this change on the text of a final rule -- is also an advisory opinion. These grounds that good faith efforts to comply with what opinions are readily revoked or amended by inconsistent appears to be regulatory requirements in formal opinions statements in later Federal Register issues, so extreme 600-302 Sodium Chlorite 08/2018 Important: The information presented herein, while not guaranteed, was prepared by technical personnel and is true and accurate to the best of our knowledge. NO WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OR GUARANTY OF ANY OTHER KIND, EXPRESS OR IMPLIED, IS MADE REGARDING PERFORMANCE, SAFETY, SUITABILITY, STABILITY OR OTHERWISE. This information is not intended to be all-inclusive as to the manner and conditions of use, handling, storage, disposal and other factors that may involve other or additional legal, environmental, safety 14555 Dallas Parkway, Suite 400 or performance considerations, and Occidental Chemical Corporation assumes no liability Dallas, TX 75254 whatsoever for the use of or reliance upon this information. While our technical personnel will be happy to respond to questions, safe handling and use of the product remains the 800-752-5151 responsibility of the customer. No suggestions for use are intended as, and nothing herein shall be construed as, a recommendation to infringe any existing patents or to violate any Federal, State, local or foreign laws. ® Basic Chemicals caution must be exercised in relying upon a statement in Federal Food, Drug, and Cosmetic Act to grant any the preamble of a proposed or final rule as an advisory exemption for the illegal use of a food additive.