The Democratic Minority has circulated a redline version of the April 22, 2014, discussion draft of the Chemicals in Commerce Act (CICA2). A copy of the redline version of CICA2 is available online. The redline version is an interesting mix of substantial rewrites, deletions, and additions. The redline version, which we will refer to as CICA2-D to distinguish it from CICA2 and the original discussion draft, CICA1, proposes changes that favorably respond to numerous non-governmental organization (NGO) issues and concerns while potentially disappointing them in other areas specifically regarding animal welfare considerations. The redline is likely to be of significant concern to industry in some areas, while other changes appear to be more comforting. CICA2-D proposes important changes from a legal and/or policy perspective in the following sections (using the Toxic Substances Control Act (TSCA) numbering):
Section 3 on definitions;
Section 4 on testing;
Section 5 on new chemicals;
Section 6 on existing chemicals;
Section 8 on information gathering;
Section 14 on Confidential Business Information (CBI);
Section 18 on preemption;
Section 19 on judicial review;
Section 26 concerning policies, procedures, and guidance; and
Section 29 concerning appropriations.
All of the other sections included in CICA2 were either largely retained intact or with relatively minor changes, or were proposed to return to the TSCA formulation. In the discussion below, we summarize and discuss the major changes proposed.
Section 3: Definitions
CICA2-D proposes to broaden the definition of "intended conditions of use" to include "reasonably foreseeable unintended exposure conditions ... which may foreseeably occur as a result" (emphasis added) of manufacture, processing, etc.; include a definition of "unreasonable risk," which would include the concepts of "significant risk," "aggregate exposure" (an undefined term), and "vulnerable population" and specifies that "unreasonable risk" does not include "consideration of the availability of substitutes or cost"; and replace the term "potentially exposed subpopulation" with the term "vulnerable population."
Section 4: Testing
CICA2-D retains much of CICA2's approach to this section with important changes that would increase the U.S. Environmental Protection Agency's (EPA) discretion in some areas (including the purposes for which testing could be required and by softening the requirement that EPA "shall minimize" the use of vertebrate animals in testing) and reduce the need for certain EPA determinations.
CICA2-D broadens EPA's discretion by allowing EPA to require testing or compel information development as "needed to implement this Act" and proposes to remove certain EPA determinations and limit judicial review. These would have required that EPA determine that the "available information" is not sufficient and that additional "higher tier" testing is "necessary." Concerning "available information," CICA2-D states that EPA "shall consider reasonably available information" (emphasis added to show addition) before taking a Section 4 action. The term is new to TSCA and is not further defined. CICA2-D specifies that the "statement of need" that EPA is required to issue in taking an action under Section 4 is not judicially reviewable, which means that stakeholders will not be able to challenge this aspect in any decisions made by EPA in requiring testing. A question arises as to whether these revisions provide EPA too much discretion in not requiring that it provide a reasonable explanation for why the available information was not sufficient and that testing (which involves economic and other costs) was required.
CICA2-D proposes interesting and important changes to the approach relating to animal welfare consideration and the reduction of testing on vertebrate animals. CICA2 had required at Section 4(c)(1) that EPA "shall minimize the use of vertebrate animals in testing"; CICA2-D would soften this requirement by specifying that EPA "shall minimize to the extent practicable and consistent with the purposes of this title, the use of vertebrate animals in testing" (emphasis added to show additions). Also, CICA2 had required that EPA "before adopting a requirement for testing using vertebrate animals, consider the sufficiency" of available information, Structure Activity Relationship (SAR), and related models. CICA2-D softens this by specifying that EPA "may consider" the sufficiency of this additional information.
Section 5: New Chemicals
CICA2 had returned to an approach similar to that in TSCA; CICA2-D proposes changes to Section 5 that would substantially and materially change the approach to new chemicals. Under CICA2-D's approach, notifiers (of both new chemicals and Significant New Uses (SNU)) would be precluded from commencing manufacture until they receive the results of EPA's risk determination, EPA would be required to make multiple unreasonable risk determinations on new chemicals/SNUs, and the regulatory exemption provision under TSCA Section 5(h)(4) (these currently include low volume and polymer exemptions) would be deleted. In addition, certain provisions proposed in CICA2 relating to the handling of articles and byproducts under Section 5 would be deleted. Interestingly, while earlier TSCA reform legislative texts developed by the Democrats had included a requirement for a "minimum data set" of testing on new chemicals, this provision does not appear in CICA2-D.
CICA2-D would require that EPA conduct an initial determination "whether exposure to the chemical" under intended conditions of use "may present an unreasonable risk," and then to provide that determination to the notifier in writing. Under the TSCA new chemicals program, EPA was under no obligation to explain its risk assessment and its risk management decisions to notifiers in writing or otherwise.
This proposed change is important and consequential. While there is clear value in a requirement that EPA explain its thinking, in writing, to notifiers, this will impose a significant additional burden and responsibility on EPA, which typically receives over 1,000 new chemical notifications each year. Industry may be sensitive to the additional burdens imposed on EPA by this requirement; industry likely would welcome an ability to obtain from EPA a clearer explanation of the basis for EPA new chemicals' risk assessment and risk management determinations. The fee for the service proposal envisioned by Section 26 may strengthen this expectation.
For the "may present" cases, under current TSCA, EPA could proceed to regulate the new chemicals/SNUs using Section 5(e) after which the notifier could commence manufacture; CICA2-D would require EPA to conduct a second determination whether there is a "reasonable basis to conclude [that manufacture, processing, etc.] present or will present an unreasonable risk" or that the new chemical "does not and will not present an unreasonable risk" (emphasis added). This second determination is to be completed within one year, extendable with cause for an additional two years.
As defined, "unreasonable risk" would require EPA to include consideration of aggregate exposures and vulnerable populations in evaluating Section 5 notifications. While the full effect of this change on new chemical reviews is unknown, the significance of aggregate exposure may be somewhat limited due to the fact that these are chemicals new to commerce where generally only the manufacturer/importer and its downstream customers are involved in processing/using the chemical (thus potentially limiting the scope and complexity of aggregate exposure considerations).
As redefined, "unreasonable risk" does not include consideration of the availability of substitutes or costs. CICA2-D at Section 5(c)(6) states that if EPA makes a determination that the new chemical "presents or will present an unreasonable risk," it shall impose any of a number of possible restrictions "to the extent necessary to protect adequately against such risk in a cost effective manner" (emphasis added). These appear to be the only considerations required of EPA in taking control actions on such new chemicals.
The new requirement for a second more rigorous determination before "may present" chemicals can enter commerce seems very likely to contribute to a substantially increased delay in the commercialization of such new chemicals. Questions are raised, given the limited hazard and exposure information that is typically available on new chemicals, whether EPA would be able to make and support either of the rigorous and demanding second determinations.
In this regard, it is instructive that in only one instance over TSCA's history did EPA use its Section 5(f) "will present" authority to regulate a set of related new chemicals. For the "does not and will not" standard, one might ask whether this determination is even possible for more than a handful of even well characterized chemicals, let alone after considering "reasonably foreseeable unintended exposure conditions" that "may foreseeably occur." Given the pace of innovation and new product development in the chemical industry, the delay and uncertainty provoked by the second determination could potentially drive commercial development of such "may present" cases offshore.
The approach under CICA2-D would also appear to preclude use of several of the approaches relied upon by EPA under TSCA to impose controls needed to manage risks pending the development of needed test data (this was known as "regulation pending development of data" and a related approach involved "triggered testing," wherein EPA would allow a new chemical to enter commerce subject to any needed controls but require testing requirements to be satisfied when and if certain production volume or use triggers were met). Since "may present" cases cannot enter commerce until EPA has concluded the second risk evaluation, this seems to prevent EPA and industry from applying these "interim" regulatory approaches that were of considerable value to both EPA and industry in providing a means to allow responsible commercialization to occur while also providing an assurance that needed testing would be developed.
Several witnesses before the Subcommittee have testified that new chemicals are generally "safer and greener" than their existing chemical competitors and also often provide greater energy efficiency or product efficiency, and that through improvements over time, new chemicals have been an important contributor to innovation in the chemical industry and to improved environmental performance. As drafted, CICA2-D would not allow EPA to consider and value these benefits of new chemicals in determining the need for and nature of control actions. This failing strikes us as a step in the wrong direction and, if implemented, is likely to have a significant future detrimental effect that could undo the "safer and greener" and "continuous improvement" history of innovation under the TSCA new chemicals program over the past almost 40 years.
The authority and ability to require testing and control measures on new chemicals was contained within TSCA Section 5 and this approach was applied in CICA2; for reasons that are difficult to discern, CICA2-D appears to require use of Section 4 to obtain needed testing. While there is at least theoretical merit in consolidating testing authority in one section, the change presents uncertain legal and policy issues and will require close analysis to understand the full effect of the approach.
Finally, the proposal to delete the regulatory exemption procedure used for low volume chemicals and polymers strikes us as both poor policy and poor execution. While the deletion was included in earlier Democratic legislative texts, this deletion would affect about 25 percent of all new chemical notices currently received by EPA. It is not at all clear, given the finding required in CICA2-D's second determination, why there is an objection to the regulatory exemption provision that as contained in TSCA and CICA2 involves a conclusion that the new chemical "will not present an unreasonable risk." This change strikes us as another step in the wrong direction.
Section 6: Existing Chemicals
CICA2-D proposes almost a complete rewrite of Section 6 as it appeared in CICA2. One of the criticisms of CICA2 was its general absence of deadlines for completing reviews or actions on existing chemicals. CICA2-D proposes a comprehensive series of deadlines to be met by EPA, including:
Establishing an initial priority list six months after the date of enactment and adding chemicals every two years thereafter until "all" chemicals have been reviewed.
Completing risk evaluations within three years after the chemical is added to the priority list.
Furthermore, EPA is directed to conduct expeditiously risk evaluations for all Inventory chemicals with 33 percent completed within six years, 66 percent within 11 years, and 100 percent of the risk evaluations completed within 16 years of enactment of CICA. EPA is also required to reevaluate chemicals no later than 15 years after completing the previous risk evaluation.
Imposing risk management control measures within one year after completing the risk evaluation step as needed to protect against unreasonable risks.
The deadlines for risk evaluation and risk management can be extended by EPA as necessary but not to exceed a cumulative period of two years.
Under CICA2-D Section 6(a), EPA is given six months after enactment to establish and publish the first priority list. While this may appear to be too short a deadline, the text specifies the chemicals that shall be included: all EPA work plan chemicals and chemicals listed in the Protocol on Persistent Organic Pollutants to the Convention on Long-Range Transboundary Air Pollution and the Stockholm Convention on Persistent Organic Pollutants (many of which are pesticides). EPA is then required to add additional chemicals to the priority list every two years "until all chemical substances subject to the risk evaluation requirement in subsection (b) have been listed."
The text specifies that the additions "should first include" chemicals detected in biomonitoring studies, those that have a high hazard, or those that are produced in large volumes. In an important change, which, by virtue of the explicit reference expands the scope of the assessment and management task, EPA is authorized to add mixtures to the priority list any time it "finds a reasonable basis to suspect that the [manufacture, etc.]...of a mixture... may present an unreasonable risk" (emphasis added), after which such mixtures are required to go through the same risk evaluation/management requirements and deadlines as individual chemicals.
CICA2 had proposed a risk evaluation standard involving a determination whether a chemical "presents or will present" or "will not present" a significant risk of harm under the intended conditions of use; CICA2-D proposes to change the risk evaluation standard to the following:
...whether there is a reasonable basis to conclude that the [manufacture, etc.] of the chemical substance or mixture...does not present and will not present an unreasonable risk.
As defined, "unreasonable risk" includes consideration of aggregate exposures and vulnerable populations. While the full effect of the changes on existing chemical reviews and actions is unknown, they would appear to present significant issues and challenges, especially for chemicals having multiple manufacturers/importers/processors and multiple TSCA uses involving some or all of industrial, commercial, and consumer users.
Reporting available to EPA under the Toxics Release Inventory, any exposures relevant to other environmental statutes (such as the Clean Air Act), and/or any use in pesticides (as an active or inert ingredient), cosmetics, and drugs would also need to be factored into the aggregate exposure assessment. Given the breadth of these possible considerations, EPA's task to consider aggregate exposures from widely or broadly used chemicals, including exposures to vulnerable populations, is likely to be difficult and complicated. Beyond this, the proposed change in the standard to "does not present and will not present an unreasonable risk" strikes us as a difficult standard to satisfy ("daunting" comes to mind), with the possible result that many/most existing chemicals may be pushed into the risk management step.
Regarding risk management, if EPA determines there is not a reasonable basis for concluding the risk evaluation standard can be met for a given chemical, EPA is required to implement restrictions that EPA "determines are cost-effective and necessary to protect adequately against an unreasonable risk of harm...under [the chemical's] intended conditions of use" (emphasis added). EPA may have great difficulty determining the restrictions "necessary to protect adequately" against an unreasonable risk insofar as this determination would require that the aggregated exposures that remain, including "reasonably foreseeable unintended exposure conditions" that "may foreseeably occur," "do not and will not present an unreasonable risk."
Socioeconomic considerations and the availability of alternatives are not otherwise considered in determining the need for and nature of any control actions to be taken. Earlier Democratic legislative texts had included "exemption provisions," which, although narrowly drawn, did allow for some consideration of the availability of substitutes, including for "critical or essential uses" or where use of the chemical at issue provides a "net benefit." CICA2-D's proposal not to consider such issues at all in taking control measures strikes us as ill-considered and perhaps a bit extreme, recognizing that even the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) in the European Union (EU) includes an authorization procedure whereby substitute issues can be carefully considered and such use authorized when the case is made.
CICA2-D also expands the scope of entities for which manufacturers and processors must give notice of unreasonable risk determinations. CICA2 had limited this to entities in the chain of commerce; CICA2-D would expand the provision to include "other persons...exposed to such substance or mixture," to give public notice of such risks, and to replace or repurchase such substance or mixture "as elected by the person to which the requirement is directed."
Section 8: Information Gathering
CICA2-D proposes to delete many of the Section 8 provisions in CICA2, including requirements to develop and utilize an "active" versus "inactive" Inventory, several provisions otherwise requiring continued use of various chemical nomenclatures, a provision otherwise specifying that "statutory mixtures" are treated as being included on the Inventory, provisions regarding byproducts and recycling/reclamation activities, and a requirement that EPA develop and maintain a confidential and a non-confidential portion of the Inventory; specifies that EPA shall include "chemical identity
generic name" (redlining added to show specific changes) in the Inventory information published; and also deletes other CBI provisions in this section. CICA2-D would retain the approach in CICA2 concerning promulgation within two years of enactment of "separate reporting requirements for manufacturers and processors as necessary to carry out sections 4 and 6."
CICA2-D would also allow EPA to use order authority. This would be in addition to EPA's existing authority to issue rules to obtain information under Section 8.
Finally, CICA2-D proposes an interesting new provision at Section 8(d)(3) that gives EPA authority to promulgate rules or orders under Section 8(d) to require companies to submit "copies of any studies or summaries of studies submitted to other governments by or for such person." This provision seems useful particularly in light of the activities under REACH in the EU, although it could also present conflicts with data sharing contracts entered into by companies as part of REACH compliance efforts.
In lieu of the active/inactive Inventory, CICA2-D would require EPA to remove from the Inventory any chemical for which "each manufacturer or processor" (emphasis added) has submitted a certification that they no longer manufacture or process such chemical. The effect of this change would be to require that any chemicals removed from the Inventory would need to go through the new chemicals process before re-entering commerce, which is a major change from the approach proposed in CICA2. While the certification process by which EPA would remove chemicals from the Inventory would seem to present some challenges (particularly the "each" manufacturer or processor requirement), when considered in a broader context, the approach could be workable.
As discussed in more detail below under Section 26, CICA2-D would require that EPA impose an annual "maintenance fee" on "each manufacturer or processor" unless the entity submits to EPA a certification under Section 8 that it no longer manufactures or processes such chemical. The combination of this fee requirement along with the "no longer" certification would provide EPA with the information needed to determine the chemicals that should be removed from the Inventory, although, as written, the proposed approach allows EPA to remove chemicals based only on the certifications (i.e., the fact of any fees paid in a given year is not considered), which might result in a gap, for example, in the case of companies that are new manufacturers or processors of the chemical in a given year.
While CICA2's active/inactive Inventory listing process had involved consideration of chemicals manufactured/processed during the five-year period prior to enactment of the Act, CICA2-D would limit this consideration to chemicals that are manufactured or processed during the year following enactment of the Act. The approach under CICA2-D plus the "annual" operation of the fees provision could adversely impact chemicals that have in the past been or in the future are periodically manufactured or processed (i.e., "batch chemicals") and perhaps put such companies into the position of paying the annual fee each year (including in the first year), regardless.
Section 14: CBI
Further detailed analysis would be needed to comprehend the full effect of the proposed changes to Section 14. At a minimum, the changes would seem to reduce the ability to protect chemical identity, particularly in a health and safety study submitted to EPA. Among the changes proposed in CICA2-D are the following:
CICA2 Section 14(a) had included cross references to both subsections (b) and (d); CICA2-D would retain a cross reference to (d) only.
CICA2 Section 14(b) had created a presumption of confidentiality for the information types in Section 14(a) other than chemical identity; these included marketing and sales information, identity of constituents in a mixture, specific volume information, and related information. CICA2-D removes this presumption and would require that companies justify all CBI claims made.
CICA2-D proposes to delete the statement at CICA2 Section 14(d)(5), which states that health and safety information does not include chemical identity information.
CICA2-D proposes to delete the provision at CICA2 Section 14(f)(2), which has the effect of removing disclosure protections for CBI claims made prior to the date of enactment of the Act.
Section 18: Preemption
CICA2-D strikes the preemption language in CICA2 and notes "replacement to be discussed." Preemption has been and continues to be one of the major issues to be resolved in reforming TSCA.
Section 19: Judicial Review
CICA2-D, in an important change from TSCA, proposes to apply the "arbitrary and capricious" standard for judicial review in lieu of the "substantial evidence" standard that had otherwise applied under TSCA. The substantial evidence standard, in other environmental statutes, had been identified by some stakeholders as part of the problem in TSCA's inability to deal with existing chemicals. This change had been proposed in earlier Democratic TSCA reform legislative texts.
Section 26: Policies, Procedures, and Guidance
CICA2-D proposes important changes to this Section, relative to the approach in the current TSCA and with regard to the CICA2 proposals regarding scientific standards and guidance. CICA2 did not propose any changes to the fees approach in TSCA Section 26.
CICA2-D proposes significant and important changes to the fee authority provision in TSCA, including creating several categories of fees applicable to both manufacturers and processors and requiring that EPA deposit the fees collected in a "TSCA Implementation Fund" from which EPA can draw amounts appropriated by Congress to support administering the Act. If implemented, such an approach could go a long way to providing the resources needed by EPA to meet its responsibilities under the Act.
Regarding fees, EPA currently requires a $2,500 fee for submission of a premanufacture notice (PMN) for a new chemical substance. Reduced fees are available for qualifying small businesses, and intermediate and consolidated PMNs. Fees collected go to the U.S. Treasury and are not available for EPA's use as such.
CICA2-D requires payment of "one or more reasonable service fees" from "any person required to submit information under this Act" and would also require payment of an annual "maintenance fee" by each manufacturer and processor of a chemical substance on the TSCA Inventory or alternatively, if such entity no longer manufactures or processes a chemical, they are required by CICA2-D to provide a certification to this effect to EPA per Section 8(b)(4). As discussed above under Section 8, this certification is tied to the requirement that EPA remove from the Inventory chemicals for which "each" manufacturer or processor has submitted the certification. As proposed, the approach could have the effect of ensuring that entities either pay the fee or provide the certification required by EPA lest they be in violation of one or the other requirement, although, as noted above, there may be gaps in the approach.
CICA2-D does not specify fee amounts and states that in setting fees, EPA must consider "the ability to pay of covered persons, the costs of administering the Act, and expected appropriations." It thus appears that CICA2-D would allow EPA to impose reduced fees on small businesses, for example, though the text does not direct EPA specifically to do so.
By comparison, the Pesticide Registration Improvement Extension Act (PRIA3) updated in 2012 EPA's now ten-year-old fee-for-service program for pesticide product registration. Under PRIA3, EPA may charge a fee for new product registration and amendment applications and select related submissions. The fee varies across a range of 189 submission categories. EPA states the fee size corresponds with the amount of data and EPA analysis required to assess the submission. Fees range from $1,217 for a registration application for a new biopesticide product that is the same or substantially similar to one already on the market, to $597,683 for a new conventional pesticide active ingredient intended for a food use.
Under PRIA3, EPA also may charge a pesticide product registrant an annual maintenance fee for each registered product. The fee may change each year depending on the number of registrations and the target revenue set forth in the statute; for fiscal years (FY) 2013 through 2017, the revenue target is $27,800,000. The per-product fee usually is approximately $3,500, with a fee ceiling for registrants with 200 or more registered products. Finally, under PRIA3, fee reductions up to 75 percent are permitted for qualifying small businesses and select, special registration and amendment applications.
CICA2-D also proposes to delete several provisions in CICA2 (concerning scientific standards, weight of scientific evidence, and a requirement for EPA to publish any written guidance for notice and comment) and proposes a new provision entitled "scientific integrity." The new proposed text would require that EPA, within two years after enactment, and after public notice and comment and seeking the advice of the Science Advisory Board, "shall promulgate guidance" for evaluating the quality of scientific information submitted to or relied upon by EPA under the Act. The lack of specificity in the CICA2-D approach gives EPA greater discretion in developing its approach, although it should be noted that as proposed, it is silent on the question of future revisions to the guidance.
Section 29: Authorization of Appropriations
CICA2-D includes an important new provision that specifies that EPA should receive appropriations of $90,000,000 for each of FYs 2015 through 2017 to implement CICA. This would represent a significant increase in the resources otherwise appropriated for TSCA implementation.
The fact that the Democrats on the House Energy and Commerce Committee crafted an alternative is interesting in itself as it might be a starting point for any further negotiations between the two parties. At the same time, the draft now circulated seems to be cobbled together pieces of suggested changes driven by an attempt to be different from the majority proposal (if the Republican draft included a deadline of so many years, the Democratic draft makes it shorter); respond in some way to the criticism raised by "Democratic" witnesses who have appeared at the House hearings (include consideration of "vulnerable populations," "aggregate exposure," and the concept of "no benefits"); and provide EPA with changes it has signaled at hearings that would improve the proposal (provide EPA with a fee structure and a $90 million authorization).
The "cobbling" nature of the current Democratic draft leaves a number of issues or suggestions undefined or unclear as to how they might be readily implemented -- as outlined in the discussion above. The Democrats' draft includes new undefined terms that appear to be efforts responding to the Republican position (e.g., the term "aggregate exposure" is not defined). Some changes would greatly impact the program that may not be the intent of the sponsors (e.g., the term "does not present and will not present an unreasonable risk" could have the effect of delaying EPA action as it mulls the "will not" concept in the context of "reasonably foreseeable unintended exposure" that "may foreseeably occur"). Some suggestions are plainly contrary to each other (e.g., even though "unreasonable risk" is not to include "consideration of the availability of substitutes or cost," mitigation of risks must be "cost-effective"). Taken together, the new draft seems to be a bit of a hodgepodge of ideas attempting to meet the purpose of having something to support as an alternative.
One notable, and very important missing element is the affirmative absence of any language on the issue of preemption -- even language simply prohibiting or denying federal preemption. As preemption has been identified as the most significant stumbling block in the discussion of TSCA amendments, the lack of a Democratic alternative is a significant omission from any serious legislative formulation.
This omission is forgivable as almost anything the minority Democrats in the House fashion is mostly irrelevant given the partisan rancor and animosity between the parties in this Congress. The Republican majority can move any legislation it wishes at virtually any time in the House, and others can speculate about the wisdom of investing serious negotiating time to any effort in the House given the current dynamics. At the same time, since there is no equivalent "Democratic alternative" that has been seen from the Senate, any alternative legislative text from the House Democrats immediately carries some weight.
What is most unfortunate in general, however, is that given the lateness of the legislative calendar of this Congress, almost any proposal coming now is too late in the session to have a serious possibility of enactment this year. Congress will leave relatively early this year to allow incumbent members to engage in their re-election campaigns, and the serious partisan posturing has already begun. Even if the Democrats in the House fashioned a truly compromise proposal, and one that the House Republicans could accept (an unlikely scenario), the one most difficult issue would remain in the Senate (preemption) and then the byzantine nature of the Senate procedures would have to be untangled.
The one tantalizing speculation that could make a bill have a glimmer of hope is to ask whether the relevant players might be willing to endorse some kind of "narrow" TSCA reform bill during a lame duck session of Congress preparing for a Republican majority to hold power in the Senate next year. This parlor game will be played out on this and many other issues between now and November -- all remaining speculation until the results are in after Election Day.