Environmental Protection Agency (EPA).
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.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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 Start Printed Page 17580not 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.
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)).
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, Start Printed Page 17581worker 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 Start Printed Page 17582parties 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.
|Chemical Name||CAS Number||Reason for Removal 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.|
|Start Printed 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.
|Chemical Name||CAS Number||Pesticide Active Ingredient||HPV/Inert|
|Butyl benzyl phthalate||85687||x|
|Carbamothioic acid, dipropyl-, S-ethyl ester||759944||x|
|DCPA (or chlorthal-dimethyl)||1861321||x|
|Start Printed Page 17584|
|Methyl ethyl ketone||78933||x|
|Start Printed Page 17585|
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).Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: April 3, 2009.
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