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November 18, 2010

EPA Proposes EDSP Policies and Procedures for SDWA Chemicals and Issues Second List of Chemicals for EDSP Tier 1 Screening

The ACTA Group

On November 17, 2010, the U.S. Environmental Protection Agency (EPA) published draft policies and procedures for screening Safe Drinking Water Act (SDWA) chemicals under the Endocrine Disruptor Screening Program (EDSP). 75 Fed. Reg. 70558. “SDWA chemicals” are substances which “may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed” (SDWA Section 1457). In the notice, EPA divided SDWA chemicals into two groups: those that are Pesticide Active Ingredients (PAI) and those that are “Other SDWA chemicals.” The latter category includes Toxic Substances Control Act (TSCA) chemicals, pharmaceuticals, and personal care product chemicals, and others. EPA also issued a second Federal Register notice that includes its second list of over 130 chemicals for which EPA is considering issuing testing orders for Tier 1 screening under the EDSP. The notice also describes how the list was created. 75 Fed. Reg. 70248. For more information, please see our November 17, 2010, memorandum regarding the Second List of Chemicals for EDSP Screening and Publication of Proposed Policies and Procedures for Requiring EDSP Testing of the Listed Chemicals online.

Policies and Procedures for SDWA Chemicals

EPA intends these draft policies and procedures to supplement the April 15, 2009, EDSP policies and procedures that were focused primarily on considerations applicable to pesticide active and inert ingredients, which compromised the first list of chemicals for Tier 1 screening. In the November 17, 2010, notice, EPA states that it “believes that some significant modifications are needed because the existing policies were designed to address screening of pesticide chemicals which are regulated under [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)], a statute that does not apply to nonpesticides.” Thus, the current notice is intended to address issues specific to “Other SDWA chemicals,” i.e., SDWA chemicals that are not PAIs.

Among the issues that are considered in the November 17, 2010, draft policies and procedures are EPA’s rationale and statutory authority for listing “Other SDWA chemicals,” how will recipients of testing orders for such chemicals be identified (i.e., EPA’s ability to identify manufacturers and importers of these chemicals), approaches to joint data development and cost sharing, procedures for handling Confidential Business Information (CBI), and related issues. Comments on the draft policies and procedures are due January 18, 2011. According to the November 17, 2010, Federal Register notice, more information regarding the draft policies and procedures is available in the docket online. Below is a summary of the policy considerations for SDWA chemicals and the procedural modifications and clarifications EPA is considering.

Who Would Receive EDSP Test Orders on SDWA Chemicals?

According to EPA, the process for issuing test orders for SDWA chemicals depends on whether the chemical is a SDWA PAI or an “Other SDWA chemical.” EPA intends to use internal databases to identify technical registrants with a current pesticide registration containing a SDWA chemical as the active ingredient, and anticipates issuing FIFRA/Federal Food, Drug, and Cosmetic Act (FFDCA) test orders to all identified technical registrants. For other SDWA chemicals, EPA intends to issue SDWA/FFDCA test orders primarily through the procedures described in the November 17, 2010, notice. EPA expects to rely primarily on information reported under the TSCA Inventory Update Reporting (IUR) Rule to identify the initial SDWA/FFDCA test order recipients. If there are no companies reporting under the IUR Rule, EPA will use other publicly available databases, such as the Toxics Release Inventory (TRI). For other SDWA chemicals that are also regulated or tracked by another agency, such as pharmaceuticals and the Food and Drug Administration (FDA), EPA may also consult with that agency to identify main manufacturers and importers.

EPA intends follow up on any new information it receives, and to issue test orders to “all significant” manufacturers or importers who are subsequently identified as such. EPA states that, of particular interest, are companies whose production or import of a listed chemical fluctuates year-by-year, or who otherwise can be considered current manufacturers or importers even though they did not report under the most recent IUR. EPA stated it does not intend to issue orders to companies that manufacture or import a chemical for research and development purposes only or only in “grams (as opposed to thousands of pounds)” (this is described as a “de minimus exemption”). At the same time, EPA clarified that companies that manufacture SDWA chemicals for export only can also receive test orders (such chemicals are not subject to testing under TSCA or FIFRA).

EPA is also considering issuing catch-up orders for manufacturers and importers who are indentified as beginning manufacture or import within five years of the issuance of the SDWA/FFDCA test order. EPA would expect a recipient of a catch-up order to participate in the cost sharing if it relies on data developed or submitted by another recipient or consortia to satisfy its test order obligation. EPA stated that it intends to “rely on the public to identify such manufacturers.” If after considering these steps no manufacturers or importers are identified, or all test order recipients have ceased manufacture of a chemical and EPA has not received the required information, the SDWA chemical would be considered an “orphan.” EPA is requesting comment on how it should approach such chemicals.

How Will Recipients of Orders on SDWA Chemicals Be Notified?

EPA would notify test order recipients by registered mail or electronically, once it establishes a process. EPA asks that commenters include some discussion of the mechanisms by which EPA can ensure that accurate records documenting that the individual has received the order, as well as the date of receipt of the order, can be obtained through the use of electronic reporting mechanisms.

How Will the Public Know Who Has Received a Test Order on a SDWA Chemical or Who Has Supplied the Needed Data?

According to the draft policies and procedures, EPA intends to publish the list of “all test order recipients” on the EDSP website. The notice does not discuss how EPA intends to handle confidential company identity information received under the IUR, although it goes on and “invites the submission of information (with proper substantiation) identifying additional entities — including entities who manufacture for export only — who should have received a test order.” EPA suggests that commenters could either identify themselves or another person as additional candidates for the receipt of an order.

How Will EPA Minimize Duplicative Testing?

EPA intends to post the status of test orders, including recipients’ responses, on the EDSP website so that both order recipients and the public can determine the status of responses. According to EPA, making this information available will enable test order recipients to identify and join other recipients to develop the data, thereby minimizing duplicative testing and promoting fair and equitable sharing of test costs.

What Are the Potential Responses to Test Orders on SDWA Chemicals?

The basis for a SDWA/FFDCA order is that a chemical may be found in sources of drinking water to which substantial populations may be exposed. EPA states that exiting any given market (e.g., the pesticide market) is not sufficient if the SDWA chemical is manufactured or imported for other uses because the chemical may still be found in sources of drinking water. If sufficient data on a SDWA chemical are not generated in response to a FIFRA/FFDCA order (e.g., all FIFRA/FFDCA order recipients exit the market or otherwise indicate that they are not providing data), EPA may issue a subsequent SDWA/FFDCA order. Order recipients provide their initial responses on an “Initial Response Form for Individual Order Recipients.” EPA anticipates including in SDWA/FFDCA test orders the following response options:

  • Option 1: Recipient indicates that it intends to generate data;
  • Option 2: Recipient indicates that it is submitting or citing existing data or other scientifically relevant information (OSRI);
  • Option 3: Recipient indicates that it intends to enter (or offer to enter) into an agreement to form a consortium to provide the data;
  • Option 4: Recipient claims that it is not subject to the test order;
  • Option 5: Recipient intends to discontinue the manufacture or import of the chemical; or
  • Option 6: Recipient responds according to one of three other response options. As part of the Initial Response, a recipient may also ask EPA to reconsider some or all of the testing specified in the order if:
    • 6a. The recipient can demonstrate that the chemical is an endocrine disruptor and that additional EDSP Tier 1 screening is unnecessary;
    • 6b. The recipient can demonstrate that the chemical meets the standard for an exemption under FFDCA Section 408(p)(4) (i.e., “that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogen”); or
    • 6c. The chemical was used by EPA as a “positive control” to validate one or more of the screening assays. EPA generally expects that if the chemical was used by EPA as a “positive control” to validate one or more of the screening assays, only the data submitted related to those assays for which the chemical was used to complete the testing as part of the validation effort would be sufficient to satisfy the Tier 1 Order.

EPA intends to make a determination on any claim and respond to the recipient in writing within 90 days of receipt. If EPA cannot verify the claim, the original requirements and deadlines in the order would remain. If EPA could verify the claim, EPA would consider the response to satisfy the order fully and no further response would be required.

How Can Order Responses and Data Be Submitted Electronically?

EPA states that it is developing a new electronic submission system for data submitted in response to SDWA/FFDCA test orders following the general process established for TSCA Section 5 Premanufacture Notices and under development for other TSCA reporting. The order electronic reporting system will take advantage of EPA’s Central Data Exchange (CDX) to allow order recipients to respond to an order and to submit test data via the Internet. Recipients, if not already registered with CDX, will need to complete the registration process, thereby establishing a secure log-on to CDX.

How Will EPA Facilitate Joint Data Development and Cost Sharing for SDWA Chemicals?

EPA states that while FFDCA Section 408(p) does not allow it to impose binding arbitration requirements identical to those authorized by FIFRA Section 3, EPA believes it has the authority under FFDCA Section 408(p) to develop procedures that would facilitate joint data generation. Specifically, EPA has discretion to determine what actions constitute compliance with a FFDCA Section 408(p) test order, and EPA intends to apply this discretion in a manner that creates strong incentives for companies to develop data jointly voluntarily. EPA states that “each recipient” of a Section 408(p) order has a “separate obligation” to satisfy the order and EPA will consider a recipient’s obligation to provide data fulfilled if the recipient jointly or individually submits results from the required assays, or “EPA judges that it would be equitable to allow the recipient to rely on, or cite, results of studies submitted by another person.” According to the draft policies and procedures, EPA believes that it would generally be equitable to allow a recipient of a FFDCA Section 408(p) test order to rely on the results of studies submitted by another person where: (1) the data generator has given permission to the recipient to cite the results; or (2) within a reasonable period after receiving the FFDCA Section 408(p) test order, the recipient has made an offer to commence negotiations regarding the amount and terms of paying a reasonable share of the cost of testing; has included an offer to resolve any dispute over the recipients’ shares of the test costs by submitting the dispute to a neutral third party with authority to bind the parties; and, if arbitration is requested, participates in the arbitration proceeding and complies with the terms of any arbitration award. EPA intends this approach to parallel that used under FIFRA Section 3(c)(2)(B).

What Procedures Can EPA Apply for Handling CBI for SDWA Chemicals?

With regard to other SDWA chemicals, the draft policies and procedures note that SDWA has no provisions that authorize EPA to extend protections for handling CBI beyond those established by the Trade Secret Act (TSA). EPA states that, “[f]or chemicals on the non-confidential TSCA Inventory? health and safety data may not be claimed as CBI when it is submitted to EPA.” Further, because the chemical identity is public for all SDWA chemicals on this second EDSP chemical list, “EPA expects that there would be no need to claim submitted information as confidential.”

As stated in the April 15, 2009, notice, data submitted in response to SDWA/FFDCA orders would only be subject to the protections under FIFRA, the Freedom of Information Act (FOIA), and TSA, with the notable possible exception of data for pesticide food-use inert chemicals. Registrants of a food-use inert ingredient that is also identified as a SDWA chemical should expect to receive SDWA/FFDCA test orders; all CBI and data compensation provisions established in FIFRA would still apply, however. When the identity of a company subject to a SDWA/FFDCA test order is claimed as CBI, EPA “intends to offer the company an opportunity to identify an agent who would act on their behalf in all matters” related to the EDSP. For any company that chooses to designate an agent, EPA intends to make the name of the agent (instead of the company) public by including it on the list of recipients of SDWA/FFDCA test orders.

What Is the Process for Contesting a Test Order or Consequences for Failure to Respond or Comply with a Test Order?

EPA states that its interpretation is that a test order is final agency action subject to review by all order recipients, including non-registrants. If anyone potentially subject to an order wishes to challenge the validity of the factual predicate for issuance of the order, specifically EPA’s determination that the chemical or substance for which testing is required by the order is a “substance that may occur in sources of drinking water” and/or that “a substantial population may be exposed to such substance,” that person would only be able to do so under SDWA Section 1448 by filing a petition for review in the U.S. Court of Appeals for the circuit in which the recipient resides or transacts business within 45 days of the date of the SDWA determination, plus 14 days provided under 40 C.F.R. Section 23.7. EPA interprets the date of the determination to be the date that EPA publishes the final EDSP list along with the Schedule for Issuance of Orders. If the order recipient wishes to challenge the validity of any other provisions of the order, including the requirement to conduct any test or use the specific test protocols required by the order, it must submit to EPA a detailed explanation of the basis for its challenge that provides sufficient information for EPA to evaluate the issue. While EPA is considering the submission, the original deadline would remain. EPA states that it intends to respond to a request in writing within 90 days of receipt. If EPA does not grant the recipient’s request, the original deadline remains.

Under FFDCA Section 408(p)(5)(D), non-registrants who fail to comply with a test order are liable for the same penalties and sanctions as are provided for under TSCA Section 16, which provides that after notice and an administrative hearing held on the record, civil penalties may be assessed. Additionally, for EDSP test orders issued under the authorities of FIFRA/FFDCA or SDWA/FFDCA, the enforcement responses described in the FIFRA policies and procedures apply.

What Is the Informal Administrative Review Procedure?

According to the draft policies and procedures, EPA generally intends to include a provision in test orders issued under FFDCA Section 408(p) by which recipients could raise any questions or challenges concerning the issuance of the order. EPA expects order recipients who file a challenge to present their objections with sufficient specificity and detail to allow EPA to evaluate effectively the issue(s) presented. Filing a challenge would not extend the test order timeline, and EPA recommends that order recipients who respond with a challenge do so in a timely manner, and with adequate detail.

Request for Comment

EPA requests comment on the following issues:

  • Response Option to Cease Manufacture: EPA seeks comment on the option for test order recipients of a SDWA/FFDCA order to comply with the order by ceasing to manufacture or import the chemical. Under SDWA, EPA issues a test order based upon a finding that a chemical “may be found in sources of drinking water” and “that a substantial population may be exposed.” The chemical’s current presence in sources of drinking water and the corresponding potential for public exposure is not altered by a company’s subsequent choice to cease manufacture or import of the chemical, and the potential for continued exposure exists. Moreover, according to EPA, given that past actions contributed to the source of the current exposure, the company should remain responsible for generating the data to allow EPA to characterize the significance of that exposure. On the other hand, if the test order recipient stops manufacturing and importing a chemical, it will lead to less exposure to the chemical in sources of drinking water. EPA notes further that an order recipient who ceases to manufacture or import a chemical that is subject to EDSP screening will no longer receive any economic benefit from the sale of the chemical with which to defray the cost of testing. Finally, according to EPA, requiring a company to provide EDSP data on a chemical, even if it ceases manufacture and import of the chemical, “removes a major incentive for companies to stop producing chemicals for which test orders are issued.” Comment: This statement telegraphs quite a bit about the way EPA defines the purpose of the “testing” under this program. Consequently, EPA seeks comment on whether it is generally inappropriate to allow companies to comply with an order by agreeing to cease manufacture or import of a SDWA chemical.
    • Comment: This section seems not to recognize that FFDCA Section 408(p)(5)(A) states that orders should go to “a person who manufactures or imports” a substance subject to testing.
  • Persistence: Despite the fact that the term “persistence” does not appear in the relevant statutory provisions, EPA seeks comment on whether and how to factor a chemical’s persistence in the environment into EDSP policies and procedures. EPA generally intends FFDCA Section 408(p) as giving it authority to issue orders to current registrants, manufacturers, and importers of a chemical. For persistent chemicals, past registrants, manufacturers, and importers (as well as processors and users) are likely to have contributed to current and ongoing contamination. EPA requests comment on how this could be taken into account. According to EPA, one option would be to issue orders to such manufacturers, to ensure that they share in the costs of generating the data. Another option would be for EPA to issue orders to such parties only where the chemical is no longer manufactured or imported in the U.S.
    • Comment: This section is also instructive regarding the scope of authority that EPA may believe it has despite the absence of relevant statutory provisions.
  • Catch-Up Orders and Data Compensation: EPA seeks comment on whether five years is the appropriate length of time that it should continue to issue SDWA/FFDCA catch-up orders as a means to ensure equitable sharing of test costs. Under FIFRA, new pesticide registrants who did not generate data on an EDSP pesticide chemical are required to pay data compensation to the registrant who sponsored the testing. Test data are compensable for a 15-year period. For this reason, EPA stated in the existing policies and procedures that it intends to issue catch-up orders for 15 years after the initial data were submitted. FIFRA requirements ensure that any new manufacturer of a pesticide chemical registers with EPA, thus enabling EPA to identify test order recipients and issue orders accordingly. Neither SDWA nor FFDCA enable EPA to identify manufacturers or importers of SDWA chemicals so readily, and EPA would bear a substantial burden if it were to issue SDWA catch-up orders on every chemical for 15 years following issuance of the first order(s) (or receipt of the data), simply based on the effort required to identify new manufacturers and importers. Data compensation requirements are also established in TSCA for data generated in response to Section 4 test rules. The reimbursement period for TSCA test data ends “after an amount of time equal to that which had been required to develop data or after five years, whichever is later.” EPA seeks comment regarding the appropriate amount of time to require data compensation for EDSP data generated in response to SDWA/FFDCA orders. This data will be made public after EPA has received it, and data compensation measures exist “solely to maintain fair and equitable sharing of test costs.” EPA also notes that a five-year window for issuing catch-up orders would include the next IUR collection.
  • Orphan Chemicals: EPA seeks comment on the value of testing orphan chemicals (those for which test orders do not generate the necessary data). EPA is interested in strategies for obtaining the data or sources of funding to conduct EDSP screening.
  • Electronic Notification: EPA seeks comment as to whether companies who already have a CDX account would prefer to receive the notification electronically, either as a standard procedure or upon request. EPA requests that commenters include some discussion of the mechanisms by which EPA can ensure that accurate records documenting that the individual has received the order, as well as the date of receipt of the test order, can be obtained through the use of electronic reporting mechanisms.

Second List of Chemicals for EDSP Tier 1 Screening

On November 17, 2010, EPA issued a notice containing the second list of chemicals for Tier 1 screening under the EDSP. This list expands the EDSP to include additional pesticides and adds priority drinking water chemicals as authorized by SDWA Section 1457 and is intended to provide public notice of EPA’s tentative decision-making in advance of actual issuance of EDSP testing orders.

As described in the notice, EPA considered chemicals contained in priority lists developed by the Office of Pesticide Programs (OPP) and the Office of Water (OW) in EPA. The OPP candidate chemicals consisted of pesticides that were scheduled for Registration Review during fiscal years (FY) 2007 and 2008.

OW identified candidate chemicals that are either contaminants regulated with a national primary drinking water regulation (NPDWR) or are unregulated contaminants that are listed on the third Contaminant Candidate List (CCL 3). EPA thus began with 85 NPDWR regulated contaminants and 116 unregulated CCL 3 contaminants. The notice discusses how these source lists provide information that supports the listing requirements concerning the “estrogenic substances screening program” specified at SDWA Section 1457: the substance “may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.”

Consolidation of the OW and OPP lists of chemicals resulted in over 200 chemicals, which was subsequently streamlined by excluding chemicals that fell into any of the following categories:

  • Biological agent and naturally occurring chemicals (e.g., microbials, microbial toxins, inorganics, radionuclides).
  • Chemicals for which the manufacturer, importer, or registrant cannot be clearly identified (e.g., disinfection byproducts or DBPs, microbes, microbial toxins, degradate compounds with more than one possible source).
  • Chemicals already included on the first EDSP list because these chemicals have already received an EDSP order. Note, however, that if no one agreed to provide data in response to that order, additional orders may be issued under a SDWA determination.
  • Chemicals that are hormones with confirmed endocrine effects.
  • Chemicals not likely to be biologically active or which are incompatible with testing assays for various reasons due to one or more of their physiochemical properties (e.g., gases, strongly acidic or basic, solubility, vapor pressure molecular weight).
  • Pesticides that are scheduled for registration review after FY 2008.

The notice clarifies, however, that although such chemicals have been excluded from the second EDSP list, these exclusions are not intended to suggest that EPA has no interest in the chemicals’ potential for endocrine disruption.

The result is a listing of approximately 134 chemicals (“approximately” because some of the entries represent groups of related chemicals, e.g., polychlorinated biphenyls) and EPA requests information that may inform the exclusion or inclusion of chemicals on the second EDSP list. EPA notes that it does not plan to respond formally to information or comments but will add such information to the public record and will consider them before issuing the list in final and issuing orders. A quick scan of the listing indicates over 60 entries that are on the TSCA Inventory, including numerous chlorinated organics, benzene, ethyl benzene, xylenes, styrene, hexane, methanol, ethylene glycol, DEHP, BHA, TDI, 1-butanol, PFOS, and PFOA, among others. Three of the listings are pharmaceuticals (erythromycin, nitroglycerin, and quinoline). Somewhat puzzling is the inclusion of five chemicals included in the Stockholm Convention on Persistent Organic Pollutants, which are known not to be in production in the United States: chlordane, endrin, heptachlor, toxaphene, and PCBs. A full listing is available in the Federal Register notice or on EPA’s website online.