Section 5 e Orders

The EPA may issue an order under TSCA 5(e) if there is not enough information to evaluate the risks posed by the PMN substance and if the PMN substance either (i) may present a risk or (ii) there will be substantial 

67 Fed. Reg. 76282 (Dec. 11. 2002). This Federal Register notice states that the PMN form must be used for TMEs, and that [i]f EPA has not taken action to deny the exemption application, under section 5(h)(1) for TMEs. .. the notice submitter may manufacture or import the new chemical substance when the respective review period for those notices expires (i.e., day 45 for TME...). W. at 76284-85. This is not consistent with statements EPA has made elsewhere about TMEs. For a discussion of TMEs see Chapter 5, PMN Exclusions and Exemptions. 

Office of Prevention and Pollution Control, Accomphshments Report (Jan. 2007-June 2008), available at http //www.epa.gov/oppt/ar/2007-2008/working/sustainable.htm. 

The model risk-based ecotoxicity order includes provisions that are found in most of the model orders  

http //www.epa.gov/oppt/newchems/pubs/expbasedtesting.htin. 

---

A second approach to measuring benefits would be to look at changes that have occurred because of formal action or the threat of such action under TSCA Section 5. Of the more than 1,000 PMNs submitted since July 1979, nine have been subject to Section 5(e) orders and several others were withdrawn before a... 

As part of its premanufacture review, EPA can use Section 5(e), to require the submitter to develop data and to obtain hazards which the "new" chemical may pose, and can impose controls or restrictions on its nse. These requirements apply only to the company which submits the PMN. Once a chemical is added to the inventory, one may manufacture or use it without notifying EPA, without the same restrictions or controls. However, EPA can use its authority under Section 5 of TSCA to issue Significant New Use Rules (SNURS) which extend the limitations in Section 5(e) orders to other manufacturers, importers, and processors. This ensures that everyone is treated in essentially the same manner, and that the original PMN submitter is not put at a disadvantage compared to subsequent manufacturers, importers, and processors. 

The EPA notes in the action plan for chlorinated paraffins that some of the chemicals in this class that are currently manufactured in or imported into the United States are not on the Inventory, and their manufacturers and importers must submit premanufacture notifications (PMNs). °° Section 5(e) orders may result from the PMN process for those chemicals. EPA is considering issuing a finding under TSCA 6(a) that short-chain chlorinated paraffins present or will present an unreasonable risk, and is also considering bans or restrictions under 6 ° ... 

Each 5(e) order will, to some extent, need to be reviewed because each one will contain a unique set of requirements for handling the subject material. Section 5(e) orders trigger export notification requirements. 

Aside from the actions already initiated by EPA under Section 6 to restrict exposures to polychlorinated biphenyls and to chlorofluorocarbons in certain uses, no other actions have been taken against specific chemical substances, nor has an imminent hazard been identified for appropriate action. Less than a dozen proposed orders have been issued under Section 5(e) requesting further information to assess the risks of as many new substances. Perhaps 80 informal requests for further information on such substances have been made and satisfied voluntarily. Testing programs for a substantial number of existing substances have been started and more are planned. In addition, of course, the monumental task of creating an inventory of some 55,000 existing chemicals was completed. 

Impacts directly attributable to TSCA regulations include several proposed and final regulations directed at specific chemical substances under section 6—polychlorinated biphenyls (PCBs), dioxin, chlorofluorocarbons (CFCs), and asbestos—and orders issued under section 5(e). 

This approach is easily accommodated by the specific provisions of TSCA. Little up-front information is generally required for a PMN no specific battery of testing is mandated. Rather, in an appropriate case EPA has the authority under section 5(e) of TSCA to require by administrative order specific data needed to complete its risk assessment and to prevent commercial manufacture until this data is provided. 

There maybe significant limitations on a company s right to manufacture or import an existing chemical, as discussed in more detail in this chapter. Some of these limitations may be the result of a Significant New Use Rule, an order under Section 5(e), a consent order, or a product restriction under 6. 

Any person may petition the Administrator to initiate a proceeding for the issuance, amendment, or repeal of a rule under section 2603 [Section 4], 2605 [Section 6], or 2607 [Section 8] of this title or an order under section 2604(e) [Section 5(e)] or 2605(b)(2) [Section 6(b)(2)] of this title. 

Section 5(e) Consent Order, with or without SNUR 1,492... 

Several generalizations of the inelastic theory to large deformations are developed in Section 5.4. In one the stretching (velocity strain) tensor is substituted for the strain rate. In order to make the resulting constitutive equations objective, i.e., invariant to relative rotation between the material and the coordinate frame, the stress rate must be replaced by one of a class of indifferent (objective) stress rates, and the moduli and elastic limit functions must be isotropic. In the elastic case, the constitutive equations reduce to the equation of hypoelastidty. The corresponding inelastic equations are therefore termed hypoinelastic. 

In this section, the general inelastic theory of Section 5.2 will be specialized to a simple phenomenological theory of plasticity. The inelastic strain rate tensor e may be identified with the plastic strain rate tensor e . In order to include isotropic and kinematic hardening, the set of internal state variables, denoted collectively by k in the previous theory, is reduced to the set (k, a) where k is a scalar representing isotropic hardening and a is a symmetric second-order tensor representing kinematic hardening. The elastic limit condition in stress space (5.25), now called a yield condition, becomes... 

The theory of Section 5.2 was developed using the classical small strain tensor E, implicitly assuming that deformations are small in the sense of Section A.7. If deformations are indeed small, then the approximations in Section A.7 hold. In particular, from (A.IOO2) and (A.103), neglecting higher-order terms. 

In order to consider the inelastic stress rate relation (5.111), some assumptions must be made about the properties of the set of internal state variables k. With the back stress discussed in Section 5.3 in mind, it will be assumed that k represents a single second-order tensor which is indifferent, i.e., it transforms under (A.50) like the Cauchy stress or the Almansi strain. Like the stress, k is not indifferent, but the Jaumann rate of k, defined in a manner analogous to (A.69), is. With these assumptions, precisely the same arguments... 

The concentration-time profile for this system was calculated for a particular set of constants k = 1.00X 10 6 s k = 2.00X 10 4 molL 1,and [A]0 = 1.00xl0 3M. The concentration-time profile, obtained by the numerical integration technique explained in Section 5.6, is shown in Fig. 2-11. Consistent with the model, the variation of [A] is nearly linear (i.e., zeroth-order) in the early stages and exponential near the end. 

Section 5.1 shows how nonlinear regression analysis is used to model the temperature dependence of reaction rate constants. The functional form of the reaction rate was assumed e.g., St = kab for an irreversible, second-order reaction. The rate constant k was measured at several temperatures and was fit to an Arrhenius form, k = ko exp —Tact/T). This section expands the use of nonlinear regression to fit the compositional and temperature dependence of reaction rates. The general reaction is... 

---