Product Exemption

Consumer products, as defined in the Consumer Product Safety Act (15 DSC 2051 et seq.), are exempt from coverage under the HazCom standard if  

---

The first experiments reported here lead us to think that the impregnation of porous supports by drugs can be achieved by means of supercritical fluids. This one-step method yields a final product exempt from any residual trace of toxic solvent. The kinetics of the mass transfer is faster, besides the thermodynamics of the adsorption seems more favourable here. The main problem encountered up to now is the weak solubility of many active molecules in pure C02, which induces a limitation of the percentage of deposited product. However, this difficulty can be overcome by the use of few amount of an entrainer. In particular, ethanol which does not show any toxicity, would greatly extend the range of active substances which could be used. 

Certain products exempt from registration include those whose composition is duly recorded in the Brazilian Pharmacopeia, Codex or National Formulary accepted by Brazilian health authorities as well as formulas of easy mcmipulation in pharmacies or chemists. 

In order to fall under the consumer product exemption the duration and frequency of use would have to be the same as that of a normal consumer using that product. 

Equipment leaks (Serving liquid or gas S10 percent by weight benzene facilities handling 1000 Mg/year and coke oven by-product exempt)... 

You ll note the exception for 261.4(b)(5), the exclusion for oil, gas, and geothermal wastes, or the Bensten Amendment. In 1988, EPA specifically exempted wastes from oil and gas exploration and production operations from the hazardous waste regrdations at Subtitle C (exploration and production exemption). This does not mean these wastes are always exempted from state regulations, however. 

A. No. Custody transfer is used to define the endpoint of production operations for crude oil and applies only to the change in ownership of the product. Exempt wastes maintain their exempt status even if they undergo custody transfer and are transported offsite for disposal or treatment. 

Regardless of quantities, if a consumer product is used in the workplace for the purpose intended by the chemical manufacturer, and the use is similar to the duration and frequency that could reasonably be expected by consumers when used in a household, then it falls under the consumer product exemption under the HazCom standard. 

The regulations, referred to as Safer Consumer Products, apply to all consumer products that contain a CoC and are sold, offered for sale, suppUed, distributed, or manufactured in California. There are several exemptions, such as dangerous prescription dmgs and devices and their associated packaging, dental restorative materials, medical devices, food, pesticides, and products used solely to manufacture a product exempted by law. Also exempted are products to be used solely out-of-state and those that are regulated by other regulatory bodies with the same ultimate purpose of safeguarding public health. 

The Fair Packaging and Labeling Act, which uses the same definitions for dmgs and cosmetics as the Food, Dmg and Cosmetic Act, only has jurisdiction over retail products sold to the consumer for use at home. This condition exempts free samples and professional use products not sold to a consumer for personal use. 

Unless otherwise exempt, a firm must submit a premarket notification, also called a 510(k), to the PDA 90 days before it intends to market a device for the first time (17). The 510(k) submission must contain sufficient information to show that the device in question is substantially equivalent to a legally marketed device for a particular intended use. This notification is also required for a product when there is a change or modification to a product that may significantly affect the safety or effectiveness of the device, or when there is a significant change or modification to the intended use of the device. 

FDA s medical device regulations relating to adulteration and misbranding generally apply to devices intended for use on animals. These devices, however, are exempt from the 510(k) and PMA requirements. FDA has viewed animal grooming products as being outside of its purview. 

In general, exempt colorants have less coloring power than certified colorants and thus have to be used at higher concentrations. Some, particularly those of plant origin, tend to be less stable, more variable in shade, and therefore more compHcated to use than certified colorants, and are more likely to introduce undeskable flavors and odors into the products in which they are incorporated. Also, depending on thek nature and origin, exempt colorants can vary substantially in composition from batch to batch, are more likely to be contaminated with undeskable trace metals, insecticides, herbicides, and bacteria such as Salmonella and can be more difficult to obtain in steady supply compared with certified colorants. 

Exempt colorants are inherently neither more nor less safe than certified colorants. However, they are viewed as having been obtained from nature (natural) (43—45) and thus imagined as less of a health ha2ard than certified colorants. In fact, like all color additives, they are fabricated products. 

The law requires nonessential products releasing Class 1 chemicals to be banned within 2 years of enactment. In 1994 a ban wiU go into effect for aerosols and non-insulating foam using Class II chemicals, with exemptions for flammability and safety. Regulations for this purpose will be required within one year of enactment, to become effective tv o vears afterwards. 

The agricultural and forest products industries are dependent on renewable resources for their existence. They are also acutely aware that air pollution can damage vegetation and, therefore, threaten their existence. Both industries have been exempt from many air pollution regulations in the past, but now they are finding these exemptions questioned and in some cases withdrawn (15). 

Consumption and production of methyl bromide will end in 2005 in industrial countries (subject to phase-out stages and exemptions) and in 2015 in developing countries. 

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. 

Use Exemptions. Certain uses of listed chemicals are specifically exempted use as a structural component of the facility use in routine janitorial or facility grounds maintenance personal uses by employees or other persons use of products containing toxic chemicals for the purpose of maintaining motor vehicles operated by the facility or use of toxic chemicals contained in intake water (used for processing or noncontactcooling) or in Intake air (used eitheras compressed air or for combustion). 

De Minimis Limitation. A listed toxic chemical does not have to be considered if it Is present in a mixture at a concentration below a specified de nvnimis level. The de minimis level is 1.0%, or 0.1% if the chemical meets the OSHA carcinogen standard. See Table II for the de minimis value associated with each listed toxic chemical. For mixtures that contain more than one member of a listed chemical category, the de minimis level applies to the aggregate concentration of all such members and not to each individually. EPA included the de minimis exemption In the njle as a burden reducing step, primarily because facilities are not likely to have information on the presence of a chemical in a mixture or trade name product beyond that available in the product s MSDS. The de minimis levels are consistent with OSHA requirements lor development of MSDS information concerning composition. 

FTC added requirements for the disclosure of water use for certain plumbing products, the disclosure of energy-related information for light bulbs and fluorescent lighting products, and the disclosure of energy-efficiency information for pool heaters. The FTC exempted other products listed in EPCA from label-... 

The advent of competition has virtually transformed the industry in evei y aspect, including its name. In the not too recent past, the industry was referred to as the electric utility industry. Today, given its significantly wide and numerous participants, it is more appropriate to refer to the industry as the electric power industry. This new power industry has new power generation and sales participants with names such as qualifying facilities, exempt wholesale generators, merchant facilities, small power production facilities, power marketers, and sales aggregators. 

A waste product, whether exempt or not, should always be recycled if economically possible. Oil-based drilling mud typically is purchased back by the vendor for reuse. Unused chemicals are similarly taken back for resale. Arrangements should be made with the mud company for similar arrange for partial drums/sacks of chemical. Muds also may be used on more than one hole. With the advent of closed system drilling, the mud must be moved off location in the event of a producing well. 

BS W and other tank bottom material from storage facilities that hold product and exempt waste... 

Spent filters, filter media, and backwash involved in the treatment of the product or an exempt waste... 

Light organics volatilized from exempt wastes in reserve pits, impoundments, or production equipment... 

Fitzpatrick, M., Common Misconceptions About the RCRA Subtitle C Exemption from Crude Oil and Natural Gas Exploration, Development and Production, Proceedings from the First International Symposium on Oil and Gas Exploration Waste Management Practices, pp. 169-179, 1990. 

---