Burdensome Requirement

Sections 6(a) and (c) refer to particular chemical substances or mixtures, rather than to chemicals in general. Thus, except in unusual circumstances. Section 6 labeling rules would be limited to individual chemicals or mixtures which pose a specified risk. 

Because Section 6 is intended to apply primarily to individual chemical substances, regulation of entire categories should be limited to situations where EPA demonstrates that the categorization involved is appropriate to fulfill the objectives of Section 6. Under this approach, EPA s definition of a category will not be suitable to achieve the purpose of the Act imless EPA proves that the definition constitutes a rational grouping of chemicals under the Section 6 criteria for determining unreasonable risk.  

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In choosing among these regulatory measures. Section 6(a) directs EPA to restrict the chemical only to the extent necessary to protect adequately against [the] risk it poses and to impose the least burdensome requirements. This emphasis on minimizing the burdens of regulation is also reflected in Section 2(b)(3) of TSCA, under which EPA must exercise its authority in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation. ... 

The Agency is specifically required by the statute to use the least burdensome requirements to protect adequately against a risk of injury to health or the environment. Further, if EPA finds that the risk of injury to health or the environment could be eliminated or reduced to a sufficient extent by actions taken under another federal law or laws administered in whole or in part by EPA, such as the Clean Water Act or the Clean Air Act, ° the Agency may not issue rules under TSCA 6(a) unless it determines that it is in the public interest to protect against such risk under TSCA 6." Under TSCA s judicial review provisions, a reviewing court is required to set aside rulemaking under TSCA 6(a) if a rule is not supported by substantial evidence in the rulemaking record... taken as a whole. ... 

If the Administrator finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment, the Administrator shall by rule apply one or more of the following requirements to such substance or mixture to the extent necessary to protect adequately against such risk using the least burdensome requirements ... 

The key to the process is that the CPSC must select the least burdensome requirement to prevent or adequately reduce the specific, targeted risk of injury. Beyond rule making power, the CPSC also has the legal authority... 

Heat for soldering is usually obtained from torches. The high conductivity of copper makes it necessary to use large flames for the larger sizes, and for this reason the location in which the joint will be made must be carefully considered. Soldered joints are most widely used in sizes 2 in and smaller for which heat requirements are less burdensome. Soldered joints should not be used in areas where plant fires are hkely because exposure to fires resiilts in rapid and complete failure of the joints. Properly made, the joints are completely impervious. The code permits the use of soldered joints only for Category D fluid service and then only if the system is not subject to severe cychc condions. 

The generality of this strategy was investigated by the preparation of a small carbohydrate library of tri-, tetra-, and pentasaccharides (Table 11.1). This protocol quickly becomes burdensome if libraries (rather than single targets) are desired since it requires isolation of every intermediate. We pursued one-pot methods as a practical and more efficient alternative. (See Scheme 11.11.)... 

Raman spectroscopy s sensitivity to the local molecular enviromnent means that it can be correlated to other material properties besides concentration, such as polymorph form, particle size, or polymer crystallinity. This is a powerful advantage, but it can complicate the development and interpretation of calibration models. For example, if a model is built to predict composition, it can appear to fail if the sample particle size distribution does not match what was used in the calibration set. Some models that appear to fail in the field may actually reflect a change in some aspect of the sample that was not sufficiently varied or represented in the calibration set. It is important to identify any differences between laboratory and plant conditions and perform a series of experiments to test the impact of those factors on the spectra and thus the field robustness of any models. This applies not only to physical parameters like flow rate, turbulence, particulates, temperature, crystal size and shape, and pressure, but also to the presence and concentration of minor constituents and expected contaminants. The significance of some of these parameters may be related to the volume of material probed, so factors that are significant in a microspectroscopy mode may not be when using a WAl probe or transmission mode. Regardless, the large calibration data sets required to address these variables can be burdensome. 

Although the GLP revisions of 1987 excluded animal feed and water from the definition of control article, it would appear that such common vehicles as saline solutions and carboxymethylcellulose solutions still fall within the definition. Such a strict definition of the term for such innocuous vehicles as saline solutions is quite burdensome when one considers the requirements for control articles that are found in other sections of the GLPs characterization [ 58.105(a)], stability testing [ 58.105(b)], sample retention [ 58.105(d)], and inventory [ 58.107(d)]. It does not appear that this comprehensive definition is enforced by FDA field investigators in the course of GLP inspections. 

The fluid nature of this broad range of risks and the nonspecific relationship to the depth or extent of gathering proof argues further for the expert nature of the process. Only the combination of experience and training that qualifies a true expert will allow consistently appropriate decisions with such inconsistent and murky criteria. The alternative, defining all systems in terms of the most rigid requirements, is an expensive and unnecessarily burdensome alternative. 

Machinists have learned through experience, and are certainly well aware, that machining plastics is profitable. While machining plastics is not particularly burdensome, there are specific considerations that must be followed when machining plastics. Because plastics have a much lower deflection temperature than metals if too great a heat build up is allowed, the plastic may tend to gum tooling. Plastics are more resilient than metals when close tolerance is required. The operator must compensate for the resilience effect of plastic. 

A second aspect of this method, which specifications alone would not have addressed, is the issue of sample preparation. The method-development chemist purposefully developed a sample preparation procedure that did not require a sample dilution step. Although this resulted in a 1000-ml sample flask, the development chemist thought the absence of a dilution step would be appreciated by the QC chemist who would be using the method. In the QC environment, however, the use of such a large sample flask was seen as a burdensome inconvenience. A 1000-ml volumetric sample flask made for slow sample preparation. Over 12 liters of sample diluent were needed to test... 

Once an author has identified the tables, figures, and text that require permission, the next step is for the author to write to the copyright owner to request permission. This is not a difficult task, but it requires some organization and attention to detail, and it may take several months for permission to be granted. Fortunately, the Internet has made the task less burdensome than it used to be because most publishers post their permission policy, forms, and contact information on the Web. Some publishers now have Web-based permission systems. 

The government provides all the personnel for the review process for submitted research access requests these are typically staff from INRENA. With respect to the review process, it depends on the access requested. If access to traditional knowledge is involved then it becomes a burdensome process. This is because prior negotiations with the communities involved are needed to generate a written permission for access this document is required by INRENA in order to review the application. If the papers conform perfectly with what is requested, the review process can last one month if not, it can take up to three months. Obtaining exportation permits has a similar timeframe. 

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