Activity exemptions

SI 1986/1002 Radioactive Substances (Substances of Low Activity) Exemption Order... 

Laboratories Listed toxic chemicals that are manufactured, processed, or otherwise used in laboratory activities at a covered facility under the direct supervision of a technically qualified individual do not have to be factored into the threshold and release calculations. However, pilot plant scale and specialty chemical production do not qualify for this laboratory activities exemption. 

Step 2 allows you to identify uses of the chemical or chemical category that were included In Step 1 but that are exempt under section 313. Do not include In Step 2 exempt forms of the chemical not included in the calculations in Step 1. For example. If you did not report the freon contained in the building s air conditioners in Step 1, you would not include the amount as exempt in Step 2. Step 2 is intended for use when one form or use of the chemical is exempt while others forms require reporting. Note the type of exemption for future reference. Also identify, if applicable, the fraction or percentage of the chemical present that Is exempt. Add the amounts in each activity to obtain a subtotal for exempted amounts of the chemical or chemical categories at the facility. 

You must submit a report If you exceed any threshold for any listed chemical or chemical category. For example, if vour facility processes 22.000 pounds of a listed chemical and also otherwise uses 16,000 pounds of that same chemical, although you do not exceed the process threshold, you do exceed the othenwise used threshold (10,000 pounds) and you therefore must report. However, in preparing your reports, you must consider all non-exempted activities and all releases of that chemical from your facility, not just the releases from the otherwise use activity. 

Since your facility employs more than 10 people and falls withinSIC codes 20-39, yourfacilitymust reporl under section 313. [Note Once any of the applicable thresholds for lead compounds are exceeded, you are required to idenlify all manufacturing, processing, and use activities. You must report all releases of all lead compounds present at your facility, regardless of the activity from which they originate unless there Is a specifically exempted use, such as the use of an article or use of intake water naturally containing lead.]... 

This study has found that dmg regulation does not meet these requirements in all the countries studied. In some countries, legislation omits or exempts certain areas of pharmaceutical activity from the scope of control. In Australia, Malaysia and the Netherlands, legislation requires traditional/herbal medicines to be assessed and registered. But this is not the case in Cypms, Uganda or Zimbabwe. As a result of such gaps, dmg regulation provides only partial protection for consumers. 

For an active ingredient in an OTC drug product that is exempt from bearing an expiration date under 211.137, the reserve sample shall be retained for 3 years after distribution of the last lot of the drug product containing the active ingredient. 

A joint EPA-industry program is proposed to make it easier for the chemical industry to comply with the PMN requirements of TSCA and hopefully encourage more new product development activity. This program includes a simplified reporting form promulgating exemptions for those classes of new chemicals... 

Because the Sixth Amendment itself exempts most of the chemicals that are subject to EPA s current rulemaking, In general the Commission does not need to commence any exemption activities analogous to EPA s efforts. Thus, the EEC s premarket program covers only those new polymers that contain 2% or more of a monomer(s). (Any new monomer iis subject to the notification requirements.) Further, because PMN s must be submitted only for new substances that are "placed on the [Community] market," the EEC s PMN requirements generally do not apply to the manufacture and use of intermediates (or of any other new substances, for that matter) by one company at one site.(13)... 

Article 8(1) of the Sixth Amendment specifies three different types of exemptions for R D substances. The third appears to be analogous to the TSCA 5(h)(1) exemption for test marketing activities. 

F. Premarket Notification, Investigational Device exemptions including Humanitarian Exemptions, Premarket Approval, Product Development Protocols, Classification, Device Tracking, Petitions for Reclassification, postmarket surveillance under Sections 510(k), 513, 515, 519, 520(g) and (m), and 522, and the advisory committees necessary to support these activities. 

Petroleum, natural gas, and synthetic fuels are excluded from the definition of a hazardous substance, and the definitions of pollutants and contaminants under CERCLA this is known as the Petroleum Exclusion. Although the EPA has the authority to regulate the release or threatened release of a hazardous substance, pollutant, or contaminant, the release of petroleum, natural gas, and synthetic fuels from active or abandoned pits or other land disposal units is currently exempt from CERCLA. Such sites cannot use Superfund dollars for cleanup, nor can the EPA enforce an oil and gas operator, landowner, or other individual to clean up a release under CERCLA. Substances exempt include such materials as brine, crude oil, and refined products (i.e., gasoline and diesel fuel) and fractions. 

Furthermore, the employee can be fired at any time, for any reason, except for those situations covered by law—discrimination based on race, sex, age, religion, or union activity. Indeed, since most chemists are exempt employees under the Fair Labor Standards Act, the employer does not even have to pay them for overtime work. 

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. ... 

The schedule only provides exemptions from the requirement to hold a marketing authorisation. Other activities involved in the supply of medicines on a particular patient basis need to be carried out under the appropriate authorisations. 

As a matter of law, activities that fall within the exemptions and comply with aU the criteria and conditions upon which the exemptions operate will be lawful, but as a matter of pohcy, there are certain circles of thought which believe that to utilise available exemption provisions for large-scale supply is not within the spirit of the exemptions. There is certainly a strong argument that exemption provisions are to allow manufacture and supply in response to needs that are special in that they cannot be met through the use of products already authorised and available on the market. 

The provisions of Article 23(a) require the MAH to inform the competent authority about various activities associated with the availability of the product on the market. Under Article 24 of the revised legislation only a single renewal is required when the product has been authorised for 5 years. A second renewal may take place after a further 5 years if there are justified pharmacovi-gilance groimds. In addition, any authorisation, which is not followed by placing the product on the market within 3 years (or which is not present on the market for 3 years), shall cease to be valid. Member States may grant exemptions from the 3-year rule, if justified on public health grounds. 

A Clinical Trial Exemption (CTX) Scheme was introduced in Australia in 1987, with the intention of encouraging clinical trial activity. However, in addition to the aforementioned TGA restrictions, which required all clinical trials of an active substance underway in Australia to be completed before the review of a general marketing application relating to that substance, the specified data package included requirements unique to Australia, and the 60 working day review period compared with a 35 calendar day review imder the UK CTX Scheme. 

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