Statutory exemption

As virtually everyone knows, the Delaney Clause prohibits the addition to food of any additive that has been found to induce cancer upon ingestion by test animals. As very few people realize, however, that general proposition is riddled with statutory exemptions, has been subjected to constant administrative exceptions created by FDA to avoid absurd results, and thus has been invoked only twice in its 24-year existence.(25) It simply is not an important factor in FDA s decision-making on food safety. If it were repealed tomorrow, and the other food safety statutory provisions remained unchanged, not a single FDA decision during the past 24 years would be changed. 

As noted in the discussion of exports above, chemical substances, mixtures, or articles containing such substances or mixtures manufactured, processed, or distributed in commerce solely for export and labeled as for export only are generally exempt from the provisions of TSCA. This exemption does not apply to 12(b) export notification requirements, to 8 reporting and recordkeeping requirements, or to chemical substances, mixtures, or articles that the EPA determines will present an unreasonable risk of injury to health or the environment in the United States. This statutory exemption includes importation of chemical substances solely for export because the word manufacture is defined to include importation. A chemical substance that will be relabeled or processed and will not be used in the United States may be imported solely for export. ... 

While the statutory exemption noted above clearly excludes the requirement of making an import certification for chemical substances imported for export only, EPA has taken the position that the requirements of 13 do apply to chemical substances imported for export only. Although there are very good arguments based on the statute itself that these requirements cannot be enforced in the context of import for export only, it seems prudent to make import certifications in this situation. 

EPA s authority under section 404 includes veto power of Corps permits, authority to interpret statutory exemptions and jurisdiction, enforcement actions, and delegating the section 404 program to the states. 

With the help of LC-MS-MS (operating at MRM mode) technique, Lin and co-workers were able to screen through various raw materials and optimise formulations to satisfy the no migration/no food additive statutory exemption of FDA regulation. Extractable results using two of such EB curable formulas (Formula 2 and Formula 3) are listed in Table 11.7 along with those of model Formula 1 using both GC-MS and LC-MS detection methods. 

Samples made from model formula 1 were determined to be non-FDA compliant with both GC-MS and LC-MS methods in both direct and indirect extraction tests. For samples made from formula 2, the results are quite different with the different methods. With results from the GC-MS method, the sample made from formula 2 could easily be determined as FDA compliant (through the no migration exemption) for both direct and indirect applications, while results from the LC-MS method only allows its use for indirect food packaging applications under the Functional Barrier Doctrine exemption. Samples made from Formula 3, on the other hand, are determined to be FDA compliant (through the no migration statutory exemption) even with the more stringent LC-MS method. It can be seen that only with the LC-MS detection technique can one clearly determine the actual level of migration especially when there are non-volatile species involved. 

Any food additive that is not within these exclusions is required to be the subject of a FCN according to section 409 of the FDCA. However, there are other evaluation options by which food contact substances can be determined to be exempt from or compliant with FDA regulations (Statutory Exemption). Food contact substance is defined as any substance intended for use as a component of materials used in manufacturing, packaging, packing, transportation, or holding food if such use is not intended to have a technical effect in food . Provided next is a list of mechanisms by which a statutory exemption can be established (i.e., the substance is not reasonably expected to become a component of food) ... 

Among these statutory exemption mechanisms, the No Migration fNo Food Additive ... 

Statutory procedures for waste and effluent management take precedence over any other methods. However, for operations In which compliance with statutory regulations is exempt or inapplicable because of scale or other circumstances, the following suggestions may be helpful. 

Finally, both laws provided general exemptions for (commercial) R D substances. To qualify, companies must comply with certain statutory limitations concerning production volume, use, and (in the case of the EEC) numbers of customers.(12)... 

Section 409(b)(2) of the Act sets forth the statutory requirements for such a petition. These requirements are described in greater detail in 21 CFR 171.1. That section also specifies the format of the petition. Alternatively, in some cases, an exemption to regulation as a food additive may be pursued. 

The original provisions date back to the early 1970s. Under section 7(2) of the Medicines Act 1968, it was necessary to hold a product licence in order to sell, supply, export or import a medicinal product to procure those activities or for the manufacture or assembly of the product. However, various exemptions from the licensing requirements, including those relating to particular patient supply, were provided for in the act and in related statutory instruments. The most important exemptions were contained in sections 9 and 13 of the act, the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971, the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 and the Medicines (Exemptions from Licences) (Importation) Order 1984. ... 

In view of the regulatory delay that was caused by the need to apply for a CTC, a Statutory Order (SI 1974/498) was made during 1974, to provide an exemption from the need to hold a CTC in such cases, subject to certain conditions. This order applied to trials conducted by doctors and dentists on their own responsibility (DDX). The basis of the clinical trial exemption (CTX) scheme, introduced in 1981, to include studies initiated by the pharmaceutical industry, was that together with a detailed clinical trial protocol and summaries of chemical, pharmaceutical, pharmacological, pharmacokinetic, toxicological and human volunteer studies, a clinical trial in patients may proceed without the need for the additional details normally required for a CTC or Product Licence application. This exemption scheme was based on the requirements that ... 

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