Final List of Initial Pesticide Active Ingredients and Pesticide Inert Ingredients to be Screened Under the Federal Food, Drug, and Cosmetic Act, 17579-17585 [E9-8709]

Download as PDF Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices respondent burden is 1,003 hours, and the cost is $70,790. The total annualized estimated paperwork burden for this ICR is 108,364 hours, with an estimated total annual cost of $7,478,116 million. Although individual respondent burden varies based on their individual activities, this estimate assumes that the respondent actively participates in all potential activities, including developing consortia, generating all of the potential data, submitting a progress report, requesting an extension, and submitting the data. Pursuant to 5 CFR 1320.12, the submission of the ICR to OMB, along with a solicitation of comments on that ICR, is addressed in a separate document published elsewhere in today’s Federal Register. Please follow the instructions in that document to view the ICR and submit comments on the revised ICR. VI. References The following is a list of the documents that are specifically referenced in this document and placed in the docket that was established under Docket ID number EPA–HQ–OPPT– 2007–1080. For information on accessing the docket, refer to the ADDRESSES unit at the beginning of this document. 1. EPA. Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) Final Report. August 1998. http://www.epa.gov/ scipoly/oscpendo/pubs/edspoverview/ finalrpt.htm. 2. Organization for Economic Cooperation and Development (OECD). Final Report of the OECD Workshop on Harmonization of Validation and Acceptance Criteria for Alternative Toxicological Test Methods. August 1996. 3. EPA. Response to Comments on the Endocrine Disruptor Screening Program: Draft Policies and Procedures for Initial Screening and Testing. March 2009. 4. EPA. EPA’s Approach for Considering Other Scientifically Relevant Information (OSRI) under the Endocrine Disruptor Screening Program. March 17, 2009. List of Subjects rwilkins on PROD1PC63 with PROPOSALS Environmental protection, Chemicals, Endocrine disruptors, Pesticides and pests, Reporting and recordkeeping. Dated: April 3, 2009. James Jones, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances. [FR Doc. E9–8706 Filed 4–14–09; 8:45 am] BILLING CODE 6560–50–S VerDate Nov<24>2008 16:46 Apr 14, 2009 Jkt 217001 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2004–0109; FRL–8399–7] Final List of Initial Pesticide Active Ingredients and Pesticide Inert Ingredients to be Screened Under the Federal Food, Drug, and Cosmetic Act Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA) directs EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have hormonal effects. In September 2005, EPA published its approach for selecting the initial list of chemicals for which testing will be required under the Endocrine Disruptor Screening Program (EDSP) and in June 2007, EPA published the draft list of the first group of chemicals proposed for screening in the Agency’s EDSP. This document presents the final list of the first group of chemicals that will be screened in the Agency’s EDSP. The list was produced using the approach described in the September 2005 notice and considers comments received in response to the June 2007 draft list. The list includes chemicals that the Agency, in its discretion, has decided should be tested first, based upon exposure potential. The Agency deleted 6 chemicals from the original list of 73 based upon recent information showing that the chemicals are no longer expected to be found in 3 exposure pathways. The first group of 67 chemicals identified for testing includes pesticide active ingredients and High Production Volume (HPV) chemicals used as pesticide inert ingredients (also known as other ingredients). This list should not be construed as a list of known or likely endocrine disruptors. Nothing in the approach for generating the initial list provides a basis to infer that by simply being on this list these chemicals are suspected to interfere with the endocrine systems of humans or other species, and it would be inappropriate to do so. This document does not describe other aspects of the EDSP such as the administrative procedures EPA will use to require testing, which is addressed in a separate notice published in today’s Federal Register. FOR FURTHER INFORMATION CONTACT: Linda Phillips, Office of Science Coordination and Policy (7203M), PO 00000 Frm 00021 Fmt 4701 Sfmt 4703 17579 Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (202) 564–1264; e-mail address: phillips.linda@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. You may be potentially affected by this action if you produce, manufacture, use, consume, work with, or import pesticide chemicals. To determine whether you or your business may be affected by this action, you should carefully examine section 408(p) of FFDCA, 21 U.S.C. 346a(p). Potentially affected entities, using the North American Industrial Classification System (NAICS) codes to assist you and others in determining whether this action might apply to certain entities, may include, but are not limited to: • Chemical manufacturers, importers and processors (NAICS code 325), e.g., persons who manufacture, import or process chemical substances. • Pesticide, fertilizer, and other agricultural chemical manufacturers (NAICS code 3253), e.g., persons who manufacture, import or process pesticide, fertilizer and agricultural chemicals. • Scientific research and development services (NAICS code 5417), e.g., persons who conduct testing of chemical substances for endocrine effects. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPPT–2004–0109. All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is E:\FR\FM\15APN2.SGM 15APN2 17580 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the Federal Register listings at http://www.epa.gov/fedrgstr. You may access information about the EDSP at http://www.epa.gov/scipoly/oscpendo/ index.htm. rwilkins on PROD1PC63 with PROPOSALS II. Introduction A. What Action is the Agency Taking? EPA is announcing the final list of the first group of chemicals that will be screened in the Agency’s Endocrine Disruptor Screening Program (EDSP) based on the approach described in the Federal Register notice of September 27, 2005 (70 FR 56449) (FRL–7716–9), and consideration of comments received on the draft list of chemicals published in the Federal Register notice of June 18, 2007 (72 FR 33486) (FRL–8129–3). The approach focused on human exposure-related factors rather than a combination of exposure- and effectsrelated factors. The approach did not include a literature search for or consideration of any data on potential endocrine effects. Because EPA developed this list of chemicals based upon exposure potential, it should not be construed as a list of known or likely endocrine disruptors, and it would be inappropriate to do so. Nothing in the approach for generating the initial list provides a basis to infer that by simply being on this list these chemicals are suspected to interfere with the VerDate Nov<24>2008 16:46 Apr 14, 2009 Jkt 217001 endocrine systems of humans or other species. The first group of chemicals to be tested consists of chemicals that section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires be screened, i.e., pesticide active ingredients and chemicals used as pesticide inert ingredients (also known as other ingredients) that are also HPV chemicals. EPA anticipates that it may, in the future, modify its approach to selecting chemicals for screening. Information and factors that EPA may consider in selecting chemicals could include: Public input; the results of testing chemicals on the initial list; management considerations to increase the integration of screening with other regulatory activities within the Agency; implementation considerations flowing from a decision to extend screening to additional categories of chemicals (e.g., non-pesticide chemical substances); and the availability of new priority setting tools (e.g., High Throughput Prescreening or Quantitative Structure Activity Relationships models). More information on EPA’s priority setting approach is available at http:// www.epa.gov/scipoly/oscpendo/pubs/ prioritysetting. EPA’s general focus in the approach for the initial list was on pesticide active ingredients and inert ingredients with relatively greater potential for human exposure. The emphasis on human exposure does not necessarily mean that the list will not contain substances that may not also have potentially high levels of environmental exposure to ecological receptors. This Federal Register document identifies the chemicals that were removed from the draft list and presents the final list of the first group of chemicals that will be screened in the Agency’s EDSP in alphabetical order. This document does not describe other aspects of the EDSP such as the administrative procedures EPA will use to require testing, the validated tests and battery that will be included in the EDSP, or the timeframe for requiring the testing or receiving the data. These topics will be addressed in separate notices published in the Federal Register, with the administrative procedures described in a separate notice published in today’s Federal Register. B. What is the Agency’s Authority for Taking this Action? Section 408(p) of FFDCA requires EPA to ‘‘develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in PO 00000 Frm 00022 Fmt 4701 Sfmt 4703 humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as [EPA] may designate.’’ (21 U.S.C. 346a(p)). The statute generally requires EPA to ‘‘provide for the testing of all pesticide chemicals.’’ (21 U.S.C. 346a(p)(3)). However, EPA is authorized to exempt a chemical, by order upon a determination that ‘‘the substance is anticipated not to produce any effect in humans similar to an effect produced by a naturally occurring estrogen.’’ (21 U.S.C. 346a(p)(4)). ‘‘Pesticide chemical’’ is defined as ‘‘any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including all active and inert ingredients of such pesticide.’’ (21 U.S.C. 321(q)(1)). III. Background EPA developed its EDSP in response to the Congressional mandate in section 408(p) of FFDCA to ‘‘develop a screening program. . .to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effects as [EPA] may designate’’ (21 U.S.C. 346a(p)). When carrying out the program, the statute requires EPA to ‘‘provide for the testing of all pesticide chemicals.’’ The statute also provides EPA with discretionary authority to ‘‘provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such a substance.’’ In addition, section 1457 of the Safe Drinking Water Act (SDWA) provides EPA with discretionary authority to provide for testing, under the FFDCA section 408(p) screening program, ‘‘of any other substances that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.’’ EPA initially set forth the EDSP in the August 11, 1998 Federal Register notice (63 FR 42852) (FRL–6021–3), and solicited public comment on the program in the December 28, 1998 Federal Register notice (63 FR 71542) (FRL–6052–9). The program set forth in these notices was based on the recommendations of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), which was chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C. App.2, section 9(c). The EDSTAC was comprised of members representing the commercial chemical and pesticides industries, Federal and State agencies, E:\FR\FM\15APN2.SGM 15APN2 rwilkins on PROD1PC63 with PROPOSALS Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices worker protection and labor organizations, environmental and public health groups, and research scientists. EDSTAC recommended that EPA’s program address both potential human and ecological effects; examine effects on estrogen, androgen, and thyroid hormone-related processes; and include non-pesticide chemicals, contaminants, and mixtures in addition to pesticides (Ref. 1). Based on these recommendations, EPA developed a two-tiered approach, referred to as the EDSP. The purpose of Tier 1 screening (referred to as ‘‘screening’’) is to identify substances that have the potential to interact with the estrogen, androgen, or thyroid hormone systems using a battery of assays. The purpose of Tier 2 testing (referred to as ‘‘testing’’) is to identify and establish a dose-response relationship for any adverse effects that might result from the interactions identified through the Tier 1 assays. EDSTAC also recommended that EPA establish a priority-setting approach for choosing chemicals to undergo Tier 1 screening. EPA described this approach in the Federal Register of September 2005. More information on EPA’s priority setting approach for the EDSP is available at http://www.epa.gov/scipoly/ oscpendo/prioritysetting. EPA currently is implementing its EDSP in three major parts that are being developed in parallel. 1. Assay validation. Under FFDCA section 408(p), EPA is required to use ‘‘appropriate validated test systems and other scientifically relevant information’’ to determine whether substances may have estrogenic effects in humans or other endocrine effects as the Administrator may designate. Validation is defined as the process by which the reliability and relevance of test methods are evaluated for the purpose of supporting a specific use. The proposed EDSP Tier 1 screening battery of assays was presented to the FIFRA Scientific Advisory Panel (SAP) during a public meeting on March 25– 27, 2008. The FIFRA SAP report covering the meeting is available at http://www.epa.gov/scipoly/sap/ meetings/2008/march/minutes2008-0325.pdf. The final Tier 1 battery will be announced in a separate Federal Register document that the Agency anticipates issuing in spring 2009. EPA is also in the process of developing and validating Tier 2 tests. The status of each assay can be viewed on the EDSP website in the Assay Status table: http:// www.epa.gov/scipoly/oscpendo/pubs/ assayvalidation/status.htm. 2. Priority setting. EPA described its priority setting approach for the first group of pesticide chemicals to be tested VerDate Nov<24>2008 16:46 Apr 14, 2009 Jkt 217001 in the Federal Register of September 2005, and proposed the draft list of initial chemicals for review and public comment in the Federal Register notice of June 18, 2007 (72 FR 33486) (FRL– 8129–3). The Agency is responding to the public comments in a separate document (Ref. 2) posted in the docket that was established for this action (EPA–HQ–OPPT–2004–0109). This document today announces the final list of initial chemicals to undergo Tier 1 screening. More information on EPA’s priority setting approach for the EDSP is available at http:/ /www.epa.gov/ scipoly/oscpendo/prioritysetting. 3. Procedures. EPA intends to commence Tier 1 screening of the first group of pesticide chemicals by issuing test orders under FFDCA section 408(p) to chemical companies identified as the manufacturer or processor of the identified chemicals and/or the pesticide registrants. EPA published draft policies and procedures in the Federal Register notice of December 13, 2007 (72 FR 70842) (FRL–8340–3), that describes the procedures that EPA will use to issue orders, the procedures that Order recipients would use to respond to the order, how data protection and compensation will be addressed in the test orders, and other related procedures or policies. In addition, EPA developed a draft template for the test order and a draft information collection request (ICR) to obtain the necessary clearances under the Paperwork Reduction Act (PRA). Elsewhere is this issue of the Federal Register, the Agency is publishing the final policies and procedures, and the announcement of the ICR’s submission to OMB. Based on the current timing for each of the three major parts of the EDSP, the Agency intends to initiate the EDSP Tier 1 screening for the first group of pesticide chemicals by issuing test orders in 2009. This document deals only with the final list of chemicals initially selected to go through screening in the Tier 1 assays. IV. Development of the Initial List of Chemicals The development of the initial list of chemicals is described in detail in the September 2005 and the June 2007 Federal Register notices. Comments on the Final List EPA received comments on the proposed initial list including suggestions for additional chemicals, questions regarding the need for Tier 1 screening data, the future chemical selection approach, and claims for removal of chemicals from the list. One of the main concerns was whether and how EPA would consider existing data PO 00000 Frm 00023 Fmt 4701 Sfmt 4703 17581 in determining what screening assays were necessary. Although EPA does not currently intend to tailor test orders based on existing information, as articulated in the Reponse to Comments on the Draft List of Initial Pesticide Active Ingredients and Pesticide Inert Ingredients to be Screened under the Federal Food, Drug, and Cosmetic Act (Ref. 2), EPA will provide a mechanism whereby test order recipients and the public can provide information on specific chemicals for which test orders are issued. A test order recipient can elect to cite or submit existing data the recipient believes can be used to satisfy part or all of the Tier 1 Order and/or otherwise inform the determination as to whether the substance may have an effect that is similar to an effect produced by a substance that interacts with the estrogen, androgen and/or thyroid hormonal systems. In order for EPA to review the submission in a timely manner, in submitting or citing existing data, the order recipient should consider providing an explanation of the relevance of the data to the order, including, where appropriate, a cogent and complete rationale for why it believes the information is sufficient to satisfy part or all of the Tier 1 Order. The recipient’s response to test orders for Tier 1 assays will be evaluated by EPA to determine whether the cited data can be used to satisfy the order and/or otherwise inform the Tier 1 determination. This will require a caseby-case determination of whether the information submitted is of high quality and achieves the objective of Tier 1. This approach is consistent with ensuring effective and efficient use of societal and government resources in generating and reviewing data, as well as minimizing the use of animals in regulatory testing, to achieve the information base needed to support a specified objective. These comments have been addressed in a document, entitled Reponse to Comments on the Draft List of Initial Pesticide Active Ingredients and Pesticide Inert Ingredients to be Screened under the Federal Food, Drug, and Cosmetic Act (Ref. 2), available in the docket for this action under docket ID number EPA–HQ–OPPT–2004–0109. In addition, the Agency has written a paper entitled EPA’s Approach for Considering Other Scientifically Relevant Information (OSRI) under the Endocrine Disruptor Screening Program. This paper was developed by EPA to provide guidance to EPA staff and managers who will be reviewing the responses to Tier 1 Orders issued under the EDSP, and may also be of interest to E:\FR\FM\15APN2.SGM 15APN2 17582 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices parties considering whether to submit other scientically relevant information to EPA. This paper provides general guidance and is not binding on either EPA or any outside parties. Anyone may provide other scientifically relevant information, and the Agency will assess the information for appropriateness on a case-by-case basis, responding to the submitter in writing, and making EPA’s determination publicly available. A copy of this paper has been placed in the Docket for the Policies and Procedures for the Initial EDSP Screening (Docket ID number EPA–HQ– OPPT–2007–1080). V. The Final List of Initial Pesticide Active Ingredients and Pesticide Inert Ingredients (also known as other ingredients) to be Considered for Screening under the FFDCA A. Chemicals Removed from the Draft List of Proposed Chemicals for Initial Screening No HPV pesticide inert ingredients were removed. Six pesticide active chemicals were removed from the draft list of proposed chemicals for initial screening that resulted in this final list. Two of the chemicals, azinphos-methyl and fenvalerate, were removed from the list because all uses of these pesticides have ended or will end before Tier 2 data could be generated in 2012. The remaining four chemicals were removed based on a reassessment of their uses that confirmed that they would only be expected to be present in two, instead of three, exposure pathways (i.e., the criterion for selecting chemicals for the initial list was the presence of the chemical in at least three of the four exposure pathways where the food and occupational exposure pathways were represented). Specifically, aldicarb, allethrin, dichlorvos, and methiocarb, were removed from the initial list because changes in their use and application methods has eliminated the potential for exposure in one or more pathways. As described in the September 2005 and June 2007 Federal Register notices, higher occupational exposure was based on the potential for agricultural workers to come into contact with a pesticide residue after its application (e.g., a worker pruning fruit trees or harvesting a crop). For occupational exposure, EPA relied on databases that assessed the exposure potential for workers who might enter a field or orchard after treatment with pesticides. In two cases (aldicarb and methiocarb), EPA regulation has either eliminated specific uses or changed the method of application which has eliminated or reduced the potential for post-application exposure below the threshold described in the previous Federal Register notices (September 2005 and June 2007) where EPA identified 14 work activities/crop categories (e.g., tree fruit crops) having the highest transfer coefficients. In the case of aldicarb, the pesticide can only be applied by soil incorporation while in the case of methiocarb, the remaining agricultural uses are granular applications in nurseries and greenhouses. There are currently no registered uses of dichlorvos that will result in occupational exposure pathways associated with the selected 14 work activities/crop categories having the highest transfer coefficients. Finally, current registrations for allethrin and methiocarb no longer include uses on food crops. Since these four chemicals no longer meet the listing criteria, they are being deleted from the initial list of chemicals to be screened. However, it should be noted that all pesticidal chemicals will eventually be screened for their potential to interact with the endocrine system as required by the statute. (21 U.S.C. 346a(p)(3)). Table 1 presents an alphabetized list of the six pesticide active ingredients that were removed from the original list of 73 chemicals recommended for Tier 1 screening in the EDSP and provides the rationale for their removal from the list. TABLE 1.—CHEMICALS REMOVED FROM THE INITIAL LIST OF CHEMICALS FOR TIER 1 SCREENING IN THE EDSP (THESE ARE ALL PESTICIDE ACTIVE INGREDIENTS) Chemical Name CAS Number Reason for Removal from Testing List 116063 The initial analysis using the exposure based criteria for chemical selection found aldicarb in three exposure pathways: Food, water, and occupational. Due to changes in the use pattern, aldicarb is only present in two exposure pathways (food and water) and will not be tested at this time. Allethrin 584792 The initial analysis using the exposure based criteria for chemical selection found allethrin in three exposure pathways: Food, residential, and occupational. There are currently no registered food uses for this chemical. Allethrin is only present in two exposure pathways (occupational and residential) and will not be tested at this time. Azinphos–Methyl 86500 The initial analysis using the exposure based criteria for chemical selection found azinphos-methyl in three exposure pathways: Food, water, and occupational. All uses of azinphos-methyl will cease by 2012. For this reason azinphos-methyl will not be tested. Dichlorvos rwilkins on PROD1PC63 with PROPOSALS Aldicarb 62737 The initial analysis using the exposure based criteria for chemical selection found dichlorvos in three exposure pathways: Food, residential, and occupational. There are currently no registered uses of dichlorvos that will result in occupational exposure pathways associated with the selected 14 work activities/crop categories having the highest transfer coefficients. Dichlorvos is only present in two exposure pathways (food and residential) and will not be tested at this time. VerDate Nov<24>2008 16:46 Apr 14, 2009 Jkt 217001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4703 E:\FR\FM\15APN2.SGM 15APN2 17583 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices TABLE 1.—CHEMICALS REMOVED FROM THE INITIAL LIST OF CHEMICALS FOR TIER 1 SCREENING IN THE EDSP (THESE ARE ALL PESTICIDE ACTIVE INGREDIENTS)—Continued Chemical Name CAS Number Reason for Removal from Testing List Fenvalerate 51630581 The initial analysis using the exposure based criteria for chemical selection found fenvalerate in three exposure pathways: Food, residential, and occupational. There are currently no registered food uses for this chemical. In addition, the registrant voluntarily ceased production of fenvalerate. As of the August 2007 deadline, no end use registrants have indicated a source of the technical grade active ingredient. The few remaining products under existing stocks are primarily for residential use with a few labeled for commercial use in food handling establishments. For this reason, fenvalerate will not be tested. Methiocarb 2032657 The initial analysis using the exposure based criteria for chemical selection found methiocarb in four exposure pathways: Food, water, residential, and occupational. Due to changes in the use pattern, methiocarb is only present in two exposure pathways (water and residential) and will not be tested at this time. B. The Final List of Pesticide Chemicals for Initial Screening Table 2 presents an alphabetized list of the 67 pesticide active ingredients and HPV/pesticide inert chemicals for screening in the EDSP. Because this list of chemicals was selected on the basis of exposure potential only, it should neither be construed as a list of known or likely endocrine disruptors nor characterized as such. TABLE 2.—FINAL LIST OF CHEMICALS FOR TIER 1 SCREENING IN THE EDSP Chemical Name CAS Number 2,4-D Pesticide Active Ingredient HPV/Inert 94757 x 113484 x Abamectin 71751412 x Acephate 30560191 x 4,7–Methano–1H–isoindole–1,3(2H)–dione, tetrahydro– 2–(2–ethylhexyl)–3a,4,7,7a– Acetone 67641 Atrazine 1912249 x Benfluralin 1861401 x Bifenthrin 82657043 x Butyl benzyl phthalate x 85687 x Captan 133062 x Carbamothioic acid, dipropyl–, S–ethyl ester 759944 x 63252 x Carbofuran 1563662 x Chlorothalonil 1897456 x Chlorpyrifos 2921882 x Cyfluthrin 68359375 x Cypermethrin 52315078 x 1861321 x 333415 x rwilkins on PROD1PC63 with PROPOSALS Carbaryl DCPA (or chlorthal–dimethyl) Diazinon Dibutyl phthalate 84742 Dichlobenil VerDate Nov<24>2008 x 1194656 16:46 Apr 14, 2009 Jkt 217001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4703 E:\FR\FM\15APN2.SGM x 15APN2 17584 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices TABLE 2.—FINAL LIST OF CHEMICALS FOR TIER 1 SCREENING IN THE EDSP—Continued Chemical Name CAS Number Dicofol Pesticide Active Ingredient 115322 Diethyl phthalate x 84662 Dimethoate HPV/Inert x 60515 x Dimethyl phthalate 131113 x Di–sec–octyl phthalate 117817 x Disulfoton 298044 x Endosulfan 115297 x Esfenvalerate 66230044 x Ethoprop 13194484 x Fenbutatin oxide 13356086 x Flutolanil 66332965 x 133073 x 22248799 x Glyphosate 1071836 x Imidacloprid 138261413 x 36734197 x Folpet Gardona (cis–isomer) Iprodione Isophorone 78591 x Linuron 330552 x Malathion 121755 x Metalaxyl 57837191 x Methamidophos 10265926 x 950378 x 16752775 x Methidathion Methomyl Methyl ethyl ketone 78933 Methyl parathion x 298000 x Metolachlor 51218452 x Metribuzin 21087649 x Myclobutanil 88671890 x Norflurazon 27314132 x 90437 x Oxamyl 23135220 x Permethrin 52645531 x 732116 x 51036 x Propachlor 1918167 x Propargite 2312358 x o–Phenylphenol rwilkins on PROD1PC63 with PROPOSALS Phosmet Piperonyl butoxide VerDate Nov<24>2008 16:46 Apr 14, 2009 Jkt 217001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4703 E:\FR\FM\15APN2.SGM 15APN2 17585 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices TABLE 2.—FINAL LIST OF CHEMICALS FOR TIER 1 SCREENING IN THE EDSP—Continued Chemical Name CAS Number Pesticide Active Ingredient HPV/Inert Propiconazole 60207901 x Propyzamide 23950585 x Pyridine, 2-(1-methyl-2-(4-phenoxyphenoxy)ethoxy)- 95737681 x Quintozene 82688 x Resmethrin 10453868 x 122349 x 107534963 x Simazine Tebuconazole Toluene 108883 Triadimefon 43121433 rwilkins on PROD1PC63 with PROPOSALS VI. References These references are available in the docket as identified under ADDRESSES, under Docket ID No. EPA–HQ–OPPT– 2004–0109, which is the docket for the chemicals selected for the initial round of screening under the EDSP. In addition, the first document referenced is available in Docket ID No. EPA–HQ– OPPT–2002–0066, which is the docket used for the proposed chemical selection approach described in the Federal Register notice of December 30, 2002 (67 FR 79611) (FRL–7286–6). 16:46 Apr 14, 2009 Jkt 217001 x 1582098 Trifluralin VerDate Nov<24>2008 x x 1. U.S. EPA. Endocrine Disruptor Screening and Testing Advisory Committee Final Report. August 1998. Available at: http:// www.epa.gov/ scipoly/oscpendo/edspoverview/ finalrpt.htm. (Document ID No. EPA– HQ–OPPT–2002–0066–0003). 2. U.S. EPA. ‘‘Reponse to Comments on the Draft List of Initial Pesticide Active Ingredients and Pesticide Inert Ingredients to be Screened under the Federal Food, Drug, and Cosmetic Act.’’ August 2008. Available at: http:// www.epa.gov/scipoly/oscpendo/pubs/ PO 00000 Frm 00027 Fmt 4701 Sfmt 4703 prioritysetting/. (Docket ID No. EPA– HQ–OPPT–2004–0109). List of Subjects Environmental protection, Chemicals, Endocrine disruptors, Pesticides. Dated: April 3, 2009. James Jones, Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. E9–8709 Filed 4–14–09; 8:45 am] BILLING CODE 6560–50–S E:\FR\FM\15APN2.SGM 15APN2

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[Federal Register Volume 74, Number 71 (Wednesday, April 15, 2009)]
[Notices]
[Pages 17579-17585]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8709]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2004-0109; FRL-8399-7]


Final List of Initial Pesticide Active Ingredients and Pesticide 
Inert Ingredients to be Screened Under the Federal Food, Drug, and 
Cosmetic Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 408(p) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA) directs EPA to develop a chemical screening program using 
appropriate validated test systems and other scientifically relevant 
information to determine whether certain substances may have hormonal 
effects. In September 2005, EPA published its approach for selecting 
the initial list of chemicals for which testing will be required under 
the Endocrine Disruptor Screening Program (EDSP) and in June 2007, EPA 
published the draft list of the first group of chemicals proposed for 
screening in the Agency's EDSP. This document presents the final list 
of the first group of chemicals that will be screened in the Agency's 
EDSP. The list was produced using the approach described in the 
September 2005 notice and considers comments received in response to 
the June 2007 draft list. The list includes chemicals that the Agency, 
in its discretion, has decided should be tested first, based upon 
exposure potential. The Agency deleted 6 chemicals from the original 
list of 73 based upon recent information showing that the chemicals are 
no longer expected to be found in 3 exposure pathways. The first group 
of 67 chemicals identified for testing includes pesticide active 
ingredients and High Production Volume (HPV) chemicals used as 
pesticide inert ingredients (also known as other ingredients). This 
list should not be construed as a list of known or likely endocrine 
disruptors. Nothing in the approach for generating the initial list 
provides a basis to infer that by simply being on this list these 
chemicals are suspected to interfere with the endocrine systems of 
humans or other species, and it would be inappropriate to do so. This 
document does not describe other aspects of the EDSP such as the 
administrative procedures EPA will use to require testing, which is 
addressed in a separate notice published in today's Federal Register.

FOR FURTHER INFORMATION CONTACT: Linda Phillips, Office of Science 
Coordination and Policy (7203M), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-1264; e-mail address: phillips.linda@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. You may be 
potentially affected by this action if you produce, manufacture, use, 
consume, work with, or import pesticide chemicals. To determine whether 
you or your business may be affected by this action, you should 
carefully examine section 408(p) of FFDCA, 21 U.S.C. 346a(p). 
Potentially affected entities, using the North American Industrial 
Classification System (NAICS) codes to assist you and others in 
determining whether this action might apply to certain entities, may 
include, but are not limited to:
     Chemical manufacturers, importers and processors (NAICS 
code 325), e.g., persons who manufacture, import or process chemical 
substances.
     Pesticide, fertilizer, and other agricultural chemical 
manufacturers (NAICS code 3253), e.g., persons who manufacture, import 
or process pesticide, fertilizer and agricultural chemicals.
     Scientific research and development services (NAICS code 
5417), e.g., persons who conduct testing of chemical substances for 
endocrine effects.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPPT-2004-0109. All documents 
in the docket are listed in the docket index available in 
regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
Although listed in the index, some information is

[[Page 17580]]

not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, will be publicly 
available only in hard copy. Publicly available docket materials are 
available electronically at http://www.regulations.gov, or, if only 
available in hard copy, at the OPPT Docket. The OPPT Docket is located 
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room 
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding Federal holidays. The telephone number of the EPA/DC Public 
Reading Room is (202) 566-1744, and the telephone number for the OPPT 
Docket is (202) 566-0280. Docket visitors are required to show 
photographic identification, pass through a metal detector, and sign 
the EPA visitor log. All visitor bags are processed through an X-ray 
machine and subject to search. Visitors will be provided an EPA/DC 
badge that must be visible at all times in the building and returned 
upon departure.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the Federal Register 
listings at http://www.epa.gov/fedrgstr. You may access information 
about the EDSP at http://www.epa.gov/scipoly/oscpendo/index.htm.

II. Introduction

A. What Action is the Agency Taking?

    EPA is announcing the final list of the first group of chemicals 
that will be screened in the Agency's Endocrine Disruptor Screening 
Program (EDSP) based on the approach described in the Federal Register 
notice of September 27, 2005 (70 FR 56449) (FRL-7716-9), and 
consideration of comments received on the draft list of chemicals 
published in the Federal Register notice of June 18, 2007 (72 FR 33486) 
(FRL-8129-3). The approach focused on human exposure-related factors 
rather than a combination of exposure- and effects-related factors. The 
approach did not include a literature search for or consideration of 
any data on potential endocrine effects. Because EPA developed this 
list of chemicals based upon exposure potential, it should not be 
construed as a list of known or likely endocrine disruptors, and it 
would be inappropriate to do so. Nothing in the approach for generating 
the initial list provides a basis to infer that by simply being on this 
list these chemicals are suspected to interfere with the endocrine 
systems of humans or other species.
    The first group of chemicals to be tested consists of chemicals 
that section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA) 
requires be screened, i.e., pesticide active ingredients and chemicals 
used as pesticide inert ingredients (also known as other ingredients) 
that are also HPV chemicals. EPA anticipates that it may, in the 
future, modify its approach to selecting chemicals for screening. 
Information and factors that EPA may consider in selecting chemicals 
could include: Public input; the results of testing chemicals on the 
initial list; management considerations to increase the integration of 
screening with other regulatory activities within the Agency; 
implementation considerations flowing from a decision to extend 
screening to additional categories of chemicals (e.g., non-pesticide 
chemical substances); and the availability of new priority setting 
tools (e.g., High Throughput Pre-screening or Quantitative Structure 
Activity Relationships models). More information on EPA's priority 
setting approach is available at http://www.epa.gov/scipoly/oscpendo/pubs/prioritysetting.
    EPA's general focus in the approach for the initial list was on 
pesticide active ingredients and inert ingredients with relatively 
greater potential for human exposure. The emphasis on human exposure 
does not necessarily mean that the list will not contain substances 
that may not also have potentially high levels of environmental 
exposure to ecological receptors. This Federal Register document 
identifies the chemicals that were removed from the draft list and 
presents the final list of the first group of chemicals that will be 
screened in the Agency's EDSP in alphabetical order. This document does 
not describe other aspects of the EDSP such as the administrative 
procedures EPA will use to require testing, the validated tests and 
battery that will be included in the EDSP, or the timeframe for 
requiring the testing or receiving the data. These topics will be 
addressed in separate notices published in the Federal Register, with 
the administrative procedures described in a separate notice published 
in today's Federal Register.

B. What is the Agency's Authority for Taking this Action?

    Section 408(p) of FFDCA requires EPA to ``develop a screening 
program, using appropriate validated test systems and other 
scientifically relevant information, to determine whether certain 
substances may have an effect in humans that is similar to an effect 
produced by a naturally occurring estrogen, or such other endocrine 
effect as [EPA] may designate.'' (21 U.S.C. 346a(p)). The statute 
generally requires EPA to ``provide for the testing of all pesticide 
chemicals.'' (21 U.S.C. 346a(p)(3)). However, EPA is authorized to 
exempt a chemical, by order upon a determination that ``the substance 
is anticipated not to produce any effect in humans similar to an effect 
produced by a naturally occurring estrogen.'' (21 U.S.C. 346a(p)(4)). 
``Pesticide chemical'' is defined as ``any substance that is a 
pesticide within the meaning of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), including all active and inert ingredients of 
such pesticide.'' (21 U.S.C. 321(q)(1)).

III. Background

    EPA developed its EDSP in response to the Congressional mandate in 
section 408(p) of FFDCA to ``develop a screening program. . .to 
determine whether certain substances may have an effect in humans that 
is similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effects as [EPA] may designate'' (21 U.S.C. 
346a(p)). When carrying out the program, the statute requires EPA to 
``provide for the testing of all pesticide chemicals.'' The statute 
also provides EPA with discretionary authority to ``provide for the 
testing of any other substance that may have an effect that is 
cumulative to an effect of a pesticide chemical if the Administrator 
determines that a substantial population may be exposed to such a 
substance.'' In addition, section 1457 of the Safe Drinking Water Act 
(SDWA) provides EPA with discretionary authority to provide for 
testing, under the FFDCA section 408(p) screening program, ``of any 
other substances that may be found in sources of drinking water if the 
Administrator determines that a substantial population may be exposed 
to such substance.''
    EPA initially set forth the EDSP in the August 11, 1998 Federal 
Register notice (63 FR 42852) (FRL-6021-3), and solicited public 
comment on the program in the December 28, 1998 Federal Register notice 
(63 FR 71542) (FRL-6052-9). The program set forth in these notices was 
based on the recommendations of the Endocrine Disruptor Screening and 
Testing Advisory Committee (EDSTAC), which was chartered under the 
Federal Advisory Committee Act (FACA), 5 U.S.C. App.2, section 9(c). 
The EDSTAC was comprised of members representing the commercial 
chemical and pesticides industries, Federal and State agencies,

[[Page 17581]]

worker protection and labor organizations, environmental and public 
health groups, and research scientists.
    EDSTAC recommended that EPA's program address both potential human 
and ecological effects; examine effects on estrogen, androgen, and 
thyroid hormone-related processes; and include non-pesticide chemicals, 
contaminants, and mixtures in addition to pesticides (Ref. 1). Based on 
these recommendations, EPA developed a two-tiered approach, referred to 
as the EDSP. The purpose of Tier 1 screening (referred to as 
``screening'') is to identify substances that have the potential to 
interact with the estrogen, androgen, or thyroid hormone systems using 
a battery of assays. The purpose of Tier 2 testing (referred to as 
``testing'') is to identify and establish a dose-response relationship 
for any adverse effects that might result from the interactions 
identified through the Tier 1 assays. EDSTAC also recommended that EPA 
establish a priority-setting approach for choosing chemicals to undergo 
Tier 1 screening. EPA described this approach in the Federal Register 
of September 2005. More information on EPA's priority setting approach 
for the EDSP is available at http://www.epa.gov/scipoly/oscpendo/prioritysetting.
    EPA currently is implementing its EDSP in three major parts that 
are being developed in parallel.
    1. Assay validation. Under FFDCA section 408(p), EPA is required to 
use ``appropriate validated test systems and other scientifically 
relevant information'' to determine whether substances may have 
estrogenic effects in humans or other endocrine effects as the 
Administrator may designate. Validation is defined as the process by 
which the reliability and relevance of test methods are evaluated for 
the purpose of supporting a specific use. The proposed EDSP Tier 1 
screening battery of assays was presented to the FIFRA Scientific 
Advisory Panel (SAP) during a public meeting on March 25-27, 2008. The 
FIFRA SAP report covering the meeting is available at http://www.epa.gov/scipoly/sap/meetings/2008/march/minutes2008-03-25.pdf. The 
final Tier 1 battery will be announced in a separate Federal Register 
document that the Agency anticipates issuing in spring 2009. EPA is 
also in the process of developing and validating Tier 2 tests. The 
status of each assay can be viewed on the EDSP website in the Assay 
Status table: http://www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/status.htm.
    2. Priority setting. EPA described its priority setting approach 
for the first group of pesticide chemicals to be tested in the Federal 
Register of September 2005, and proposed the draft list of initial 
chemicals for review and public comment in the Federal Register notice 
of June 18, 2007 (72 FR 33486) (FRL-8129-3). The Agency is responding 
to the public comments in a separate document (Ref. 2) posted in the 
docket that was established for this action (EPA-HQ-OPPT-2004-0109). 
This document today announces the final list of initial chemicals to 
undergo Tier 1 screening. More information on EPA's priority setting 
approach for the EDSP is available at http://www.epa.gov/scipoly/oscpendo/prioritysetting.
    3. Procedures. EPA intends to commence Tier 1 screening of the 
first group of pesticide chemicals by issuing test orders under FFDCA 
section 408(p) to chemical companies identified as the manufacturer or 
processor of the identified chemicals and/or the pesticide registrants. 
EPA published draft policies and procedures in the Federal Register 
notice of December 13, 2007 (72 FR 70842) (FRL-8340-3), that describes 
the procedures that EPA will use to issue orders, the procedures that 
Order recipients would use to respond to the order, how data protection 
and compensation will be addressed in the test orders, and other 
related procedures or policies. In addition, EPA developed a draft 
template for the test order and a draft information collection request 
(ICR) to obtain the necessary clearances under the Paperwork Reduction 
Act (PRA). Elsewhere is this issue of the Federal Register, the Agency 
is publishing the final policies and procedures, and the announcement 
of the ICR's submission to OMB.
    Based on the current timing for each of the three major parts of 
the EDSP, the Agency intends to initiate the EDSP Tier 1 screening for 
the first group of pesticide chemicals by issuing test orders in 2009. 
This document deals only with the final list of chemicals initially 
selected to go through screening in the Tier 1 assays.

IV. Development of the Initial List of Chemicals

    The development of the initial list of chemicals is described in 
detail in the September 2005 and the June 2007 Federal Register 
notices.
Comments on the Final List
    EPA received comments on the proposed initial list including 
suggestions for additional chemicals, questions regarding the need for 
Tier 1 screening data, the future chemical selection approach, and 
claims for removal of chemicals from the list. One of the main concerns 
was whether and how EPA would consider existing data in determining 
what screening assays were necessary. Although EPA does not currently 
intend to tailor test orders based on existing information, as 
articulated in the Reponse to Comments on the Draft List of Initial 
Pesticide Active Ingredients and Pesticide Inert Ingredients to be 
Screened under the Federal Food, Drug, and Cosmetic Act (Ref. 2), EPA 
will provide a mechanism whereby test order recipients and the public 
can provide information on specific chemicals for which test orders are 
issued. A test order recipient can elect to cite or submit existing 
data the recipient believes can be used to satisfy part or all of the 
Tier 1 Order and/or otherwise inform the determination as to whether 
the substance may have an effect that is similar to an effect produced 
by a substance that interacts with the estrogen, androgen and/or 
thyroid hormonal systems. In order for EPA to review the submission in 
a timely manner, in submitting or citing existing data, the order 
recipient should consider providing an explanation of the relevance of 
the data to the order, including, where appropriate, a cogent and 
complete rationale for why it believes the information is sufficient to 
satisfy part or all of the Tier 1 Order. The recipient's response to 
test orders for Tier 1 assays will be evaluated by EPA to determine 
whether the cited data can be used to satisfy the order and/or 
otherwise inform the Tier 1 determination. This will require a case-by-
case determination of whether the information submitted is of high 
quality and achieves the objective of Tier 1. This approach is 
consistent with ensuring effective and efficient use of societal and 
government resources in generating and reviewing data, as well as 
minimizing the use of animals in regulatory testing, to achieve the 
information base needed to support a specified objective.
    These comments have been addressed in a document, entitled Reponse 
to Comments on the Draft List of Initial Pesticide Active Ingredients 
and Pesticide Inert Ingredients to be Screened under the Federal Food, 
Drug, and Cosmetic Act (Ref. 2), available in the docket for this 
action under docket ID number EPA-HQ-OPPT-2004-0109. In addition, the 
Agency has written a paper entitled EPA's Approach for Considering 
Other Scientifically Relevant Information (OSRI) under the Endocrine 
Disruptor Screening Program. This paper was developed by EPA to provide 
guidance to EPA staff and managers who will be reviewing the responses 
to Tier 1 Orders issued under the EDSP, and may also be of interest to

[[Page 17582]]

parties considering whether to submit other scientically relevant 
information to EPA. This paper provides general guidance and is not 
binding on either EPA or any outside parties. Anyone may provide other 
scientifically relevant information, and the Agency will assess the 
information for appropriateness on a case-by-case basis, responding to 
the submitter in writing, and making EPA's determination publicly 
available. A copy of this paper has been placed in the Docket for the 
Policies and Procedures for the Initial EDSP Screening (Docket ID 
number EPA-HQ-OPPT-2007-1080).

V. The Final List of Initial Pesticide Active Ingredients and Pesticide 
Inert Ingredients (also known as other ingredients) to be Considered 
for Screening under the FFDCA

A. Chemicals Removed from the Draft List of Proposed Chemicals for 
Initial Screening

    No HPV pesticide inert ingredients were removed. Six pesticide 
active chemicals were removed from the draft list of proposed chemicals 
for initial screening that resulted in this final list. Two of the 
chemicals, azinphos-methyl and fenvalerate, were removed from the list 
because all uses of these pesticides have ended or will end before Tier 
2 data could be generated in 2012. The remaining four chemicals were 
removed based on a reassessment of their uses that confirmed that they 
would only be expected to be present in two, instead of three, exposure 
pathways (i.e., the criterion for selecting chemicals for the initial 
list was the presence of the chemical in at least three of the four 
exposure pathways where the food and occupational exposure pathways 
were represented). Specifically, aldicarb, allethrin, dichlorvos, and 
methiocarb, were removed from the initial list because changes in their 
use and application methods has eliminated the potential for exposure 
in one or more pathways. As described in the September 2005 and June 
2007 Federal Register notices, higher occupational exposure was based 
on the potential for agricultural workers to come into contact with a 
pesticide residue after its application (e.g., a worker pruning fruit 
trees or harvesting a crop). For occupational exposure, EPA relied on 
databases that assessed the exposure potential for workers who might 
enter a field or orchard after treatment with pesticides. In two cases 
(aldicarb and methiocarb), EPA regulation has either eliminated 
specific uses or changed the method of application which has eliminated 
or reduced the potential for post-application exposure below the 
threshold described in the previous Federal Register notices (September 
2005 and June 2007) where EPA identified 14 work activities/crop 
categories (e.g., tree fruit crops) having the highest transfer 
coefficients. In the case of aldicarb, the pesticide can only be 
applied by soil incorporation while in the case of methiocarb, the 
remaining agricultural uses are granular applications in nurseries and 
greenhouses. There are currently no registered uses of dichlorvos that 
will result in occupational exposure pathways associated with the 
selected 14 work activities/crop categories having the highest transfer 
coefficients. Finally, current registrations for allethrin and 
methiocarb no longer include uses on food crops. Since these four 
chemicals no longer meet the listing criteria, they are being deleted 
from the initial list of chemicals to be screened. However, it should 
be noted that all pesticidal chemicals will eventually be screened for 
their potential to interact with the endocrine system as required by 
the statute. (21 U.S.C. 346a(p)(3)).
    Table 1 presents an alphabetized list of the six pesticide active 
ingredients that were removed from the original list of 73 chemicals 
recommended for Tier 1 screening in the EDSP and provides the rationale 
for their removal from the list.

 Table 1.--Chemicals Removed From the Initial List of Chemicals for Tier
  1 Screening in the EDSP (These are all pesticide active ingredients)
------------------------------------------------------------------------
                                                      Reason for Removal
          Chemical Name               CAS Number      from Testing List
------------------------------------------------------------------------
Aldicarb                                     116063   The initial
                                                      analysis using the
                                                      exposure based
                                                      criteria for
                                                      chemical selection
                                                      found aldicarb in
                                                      three exposure
                                                      pathways: Food,
                                                      water, and
                                                      occupational. Due
                                                      to changes in the
                                                      use pattern,
                                                      aldicarb is only
                                                      present in two
                                                      exposure pathways
                                                      (food and water)
                                                      and will not be
                                                      tested at this
                                                      time.
------------------------------------------------------------------------
Allethrin                                    584792  The initial
                                                      analysis using the
                                                      exposure based
                                                      criteria for
                                                      chemical selection
                                                      found allethrin in
                                                      three exposure
                                                      pathways: Food,
                                                      residential, and
                                                      occupational.
                                                      There are
                                                      currently no
                                                      registered food
                                                      uses for this
                                                      chemical.
                                                      Allethrin is only
                                                      present in two
                                                      exposure pathways
                                                      (occupational and
                                                      residential) and
                                                      will not be tested
                                                      at this time.
------------------------------------------------------------------------
Azinphos-Methyl                               86500  The initial
                                                      analysis using the
                                                      exposure based
                                                      criteria for
                                                      chemical selection
                                                      found azinphos-
                                                      methyl in three
                                                      exposure pathways:
                                                      Food, water, and
                                                      occupational. All
                                                      uses of azinphos-
                                                      methyl will cease
                                                      by 2012. For this
                                                      reason azinphos-
                                                      methyl will not be
                                                      tested.
------------------------------------------------------------------------
Dichlorvos                                    62737  The initial
                                                      analysis using the
                                                      exposure based
                                                      criteria for
                                                      chemical selection
                                                      found dichlorvos
                                                      in three exposure
                                                      pathways: Food,
                                                      residential, and
                                                      occupational.
                                                      There are
                                                      currently no
                                                      registered uses of
                                                      dichlorvos that
                                                      will result in
                                                      occupational
                                                      exposure pathways
                                                      associated with
                                                      the selected 14
                                                      work activities/
                                                      crop categories
                                                      having the highest
                                                      transfer
                                                      coefficients.
                                                      Dichlorvos is only
                                                      present in two
                                                      exposure pathways
                                                      (food and
                                                      residential) and
                                                      will not be tested
                                                      at this time.
------------------------------------------------------------------------

[[Page 17583]]

 
Fenvalerate                                51630581  The initial
                                                      analysis using the
                                                      exposure based
                                                      criteria for
                                                      chemical selection
                                                      found fenvalerate
                                                      in three exposure
                                                      pathways: Food,
                                                      residential, and
                                                      occupational.
                                                      There are
                                                      currently no
                                                      registered food
                                                      uses for this
                                                      chemical. In
                                                      addition, the
                                                      registrant
                                                      voluntarily ceased
                                                      production of
                                                      fenvalerate. As of
                                                      the August 2007
                                                      deadline, no end
                                                      use registrants
                                                      have indicated a
                                                      source of the
                                                      technical grade
                                                      active ingredient.
                                                      The few remaining
                                                      products under
                                                      existing stocks
                                                      are primarily for
                                                      residential use
                                                      with a few labeled
                                                      for commercial use
                                                      in food handling
                                                      establishments.
                                                      For this reason,
                                                      fenvalerate will
                                                      not be tested.
------------------------------------------------------------------------
Methiocarb                                  2032657  The initial
                                                      analysis using the
                                                      exposure based
                                                      criteria for
                                                      chemical selection
                                                      found methiocarb
                                                      in four exposure
                                                      pathways: Food,
                                                      water,
                                                      residential, and
                                                      occupational. Due
                                                      to changes in the
                                                      use pattern,
                                                      methiocarb is only
                                                      present in two
                                                      exposure pathways
                                                      (water and
                                                      residential) and
                                                      will not be tested
                                                      at this time.
------------------------------------------------------------------------

B. The Final List of Pesticide Chemicals for Initial Screening

    Table 2 presents an alphabetized list of the 67 pesticide active 
ingredients and HPV/pesticide inert chemicals for screening in the 
EDSP. Because this list of chemicals was selected on the basis of 
exposure potential only, it should neither be construed as a list of 
known or likely endocrine disruptors nor characterized as such.

                       Table 2.--Final List of Chemicals for Tier 1 Screening in the EDSP
----------------------------------------------------------------------------------------------------------------
                                                                             Pesticide Active
                     Chemical Name                           CAS Number         Ingredient         HPV/Inert
----------------------------------------------------------------------------------------------------------------
2,4-D                                                                94757                  x  .................
----------------------------------------------------------------------------------------------------------------
4,7-Methano-1H-isoindole-1,3(2H)-dione, 2-(2-                       113484                  x  .................
 ethylhexyl)-3a,4,7,7a-tetrahydro-
----------------------------------------------------------------------------------------------------------------
Abamectin                                                         71751412                  x  .................
----------------------------------------------------------------------------------------------------------------
Acephate                                                          30560191                  x  .................
----------------------------------------------------------------------------------------------------------------
Acetone                                                              67641                                     x
----------------------------------------------------------------------------------------------------------------
Atrazine                                                           1912249                  x  .................
----------------------------------------------------------------------------------------------------------------
Benfluralin                                                        1861401                  x  .................
----------------------------------------------------------------------------------------------------------------
Bifenthrin                                                        82657043                  x  .................
----------------------------------------------------------------------------------------------------------------
Butyl benzyl phthalate                                               85687                                     x
----------------------------------------------------------------------------------------------------------------
Captan                                                              133062                  x  .................
----------------------------------------------------------------------------------------------------------------
Carbamothioic acid, dipropyl-, S-ethyl ester                        759944                  x  .................
----------------------------------------------------------------------------------------------------------------
Carbaryl                                                             63252                  x  .................
----------------------------------------------------------------------------------------------------------------
Carbofuran                                                         1563662                  x  .................
----------------------------------------------------------------------------------------------------------------
Chlorothalonil                                                     1897456                  x  .................
----------------------------------------------------------------------------------------------------------------
Chlorpyrifos                                                       2921882                  x  .................
----------------------------------------------------------------------------------------------------------------
Cyfluthrin                                                        68359375                  x  .................
----------------------------------------------------------------------------------------------------------------
Cypermethrin                                                      52315078                  x  .................
----------------------------------------------------------------------------------------------------------------
DCPA (or chlorthal-dimethyl)                                       1861321                  x  .................
----------------------------------------------------------------------------------------------------------------
Diazinon                                                            333415                  x  .................
----------------------------------------------------------------------------------------------------------------
Dibutyl phthalate                                                    84742                                     x
----------------------------------------------------------------------------------------------------------------
Dichlobenil                                                        1194656                  x  .................
----------------------------------------------------------------------------------------------------------------

[[Page 17584]]

 
Dicofol                                                             115322                  x  .................
----------------------------------------------------------------------------------------------------------------
Diethyl phthalate                                                    84662                                     x
----------------------------------------------------------------------------------------------------------------
Dimethoate                                                           60515                  x  .................
----------------------------------------------------------------------------------------------------------------
Dimethyl phthalate                                                  131113                                     x
----------------------------------------------------------------------------------------------------------------
Di-sec-octyl phthalate                                              117817                                     x
----------------------------------------------------------------------------------------------------------------
Disulfoton                                                          298044                  x  .................
----------------------------------------------------------------------------------------------------------------
Endosulfan                                                          115297                  x  .................
----------------------------------------------------------------------------------------------------------------
Esfenvalerate                                                     66230044                  x  .................
----------------------------------------------------------------------------------------------------------------
Ethoprop                                                          13194484                  x  .................
----------------------------------------------------------------------------------------------------------------
Fenbutatin oxide                                                  13356086                  x  .................
----------------------------------------------------------------------------------------------------------------
Flutolanil                                                        66332965                  x  .................
----------------------------------------------------------------------------------------------------------------
Folpet                                                              133073                  x  .................
----------------------------------------------------------------------------------------------------------------
Gardona (cis-isomer)                                              22248799                  x  .................
----------------------------------------------------------------------------------------------------------------
Glyphosate                                                         1071836                  x  .................
----------------------------------------------------------------------------------------------------------------
Imidacloprid                                                     138261413                  x  .................
----------------------------------------------------------------------------------------------------------------
Iprodione                                                         36734197                  x  .................
----------------------------------------------------------------------------------------------------------------
Isophorone                                                           78591                                     x
----------------------------------------------------------------------------------------------------------------
Linuron                                                             330552                  x  .................
----------------------------------------------------------------------------------------------------------------
Malathion                                                           121755                  x  .................
----------------------------------------------------------------------------------------------------------------
Metalaxyl                                                         57837191                  x  .................
----------------------------------------------------------------------------------------------------------------
Methamidophos                                                     10265926                  x  .................
----------------------------------------------------------------------------------------------------------------
Methidathion                                                        950378                  x  .................
----------------------------------------------------------------------------------------------------------------
Methomyl                                                          16752775                  x  .................
----------------------------------------------------------------------------------------------------------------
Methyl ethyl ketone                                                  78933                                     x
----------------------------------------------------------------------------------------------------------------
Methyl parathion                                                    298000                  x  .................
----------------------------------------------------------------------------------------------------------------
Metolachlor                                                       51218452                  x  .................
----------------------------------------------------------------------------------------------------------------
Metribuzin                                                        21087649                  x  .................
----------------------------------------------------------------------------------------------------------------
Myclobutanil                                                      88671890                  x  .................
----------------------------------------------------------------------------------------------------------------
Norflurazon                                                       27314132                  x  .................
----------------------------------------------------------------------------------------------------------------
o-Phenylphenol                                                       90437                  x  .................
----------------------------------------------------------------------------------------------------------------
Oxamyl                                                            23135220                  x  .................
----------------------------------------------------------------------------------------------------------------
Permethrin                                                        52645531                  x  .................
----------------------------------------------------------------------------------------------------------------
Phosmet                                                             732116                  x  .................
----------------------------------------------------------------------------------------------------------------
Piperonyl butoxide                                                   51036                  x  .................
----------------------------------------------------------------------------------------------------------------
Propachlor                                                         1918167                  x  .................
----------------------------------------------------------------------------------------------------------------
Propargite                                                         2312358                  x  .................
----------------------------------------------------------------------------------------------------------------

[[Page 17585]]

 
Propiconazole                                                     60207901                  x  .................
----------------------------------------------------------------------------------------------------------------
Propyzamide                                                       23950585                  x  .................
----------------------------------------------------------------------------------------------------------------
Pyridine, 2-(1-methyl-2-(4-phenoxyphenoxy)ethoxy)-                95737681                  x  .................
----------------------------------------------------------------------------------------------------------------
Quintozene                                                           82688                  x  .................
----------------------------------------------------------------------------------------------------------------
Resmethrin                                                        10453868                  x  .................
----------------------------------------------------------------------------------------------------------------
Simazine                                                            122349                  x  .................
----------------------------------------------------------------------------------------------------------------
Tebuconazole                                                     107534963                  x  .................
----------------------------------------------------------------------------------------------------------------
Toluene                                                             108883                                     x
----------------------------------------------------------------------------------------------------------------
Triadimefon                                                       43121433                  x  .................
----------------------------------------------------------------------------------------------------------------
Trifluralin                                                        1582098                  x  .................
----------------------------------------------------------------------------------------------------------------

VI. References

    These references are available in the docket as identified under 
ADDRESSES, under Docket ID No. EPA-HQ-OPPT-2004-0109, which is the 
docket for the chemicals selected for the initial round of screening 
under the EDSP. In addition, the first document referenced is available 
in Docket ID No. EPA-HQ-OPPT-2002-0066, which is the docket used for 
the proposed chemical selection approach described in the Federal 
Register notice of December 30, 2002 (67 FR 79611) (FRL-7286-6).
    1. U.S. EPA. Endocrine Disruptor Screening and Testing Advisory 
Committee Final Report. August 1998. Available at: http:// www.epa.gov/scipoly/oscpendo/edspoverview/finalrpt.htm. (Document ID No. EPA-HQ-
OPPT-2002-0066-0003).
    2. U.S. EPA. ``Reponse to Comments on the Draft List of Initial 
Pesticide Active Ingredients and Pesticide Inert Ingredients to be 
Screened under the Federal Food, Drug, and Cosmetic Act.'' August 2008. 
Available at: http://www.epa.gov/scipoly/oscpendo/pubs/prioritysetting/. (Docket ID No. EPA-HQ-OPPT-2004-0109).

List of Subjects

    Environmental protection, Chemicals, Endocrine disruptors, 
Pesticides.


    Dated: April 3, 2009.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.

[FR Doc. E9-8709 Filed 4-14-09; 8:45 am]
BILLING CODE 6560-50-S