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2 DRAFT (04-1-2010) 3

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ENVIRONMENTAL PR OTECTION AGENCY 6

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40 CFR Part 152.5 8

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[EPA–HQ–OPP–2010-XX; FRL– XXXX

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RIN 2070– [AJ26] 14

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Declaration of Prion as a Pest under FI FRA and Amendment of EPA’s Regulatory 17
Definition of Pests to Include Prion 18

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AGENCY: Environmental Protection Agency (EPA). 20

ACTION: Proposed rule. 21

SUMMARY: EPA proposes to declare a prion (i.e., pr oteinaceous in fectious particle) a 22 “pest” under the Federal Ins ecticide, Fungicide, and Roden ticide Act (FIFRA), and to 23 amend its regulations to expres sly include prion with in the regulatory definition of pest. 24 EPA currently considers a pr ion to be a pest under FIFR A, so a product intended to 25 reduce the infectivity of any prion on inan imate surfaces (i.e., a “prion product”) is 26 considered to be a pesticide a nd regulated as such. Any comp any seeking to distribute or 27 sell a pesticide product regulated under FIFR A must obtain EPA appr oval before it can 28

be distributed or sold in the United States. This proposed rule would codify the Agency’s 29 current interpretation of FIFRA, and provi des interested parties the opportunity to 30 comment about how it is adding prion to the list of pests in 40 CFR Part 152.5. This 31 amendment, together with the formal declarati on that a prion is a pest, will eliminate any 32 confusion about the status of prion products under FIFRA. Regul ating prion products 33 under FIFRA is appropriate for protecting hum an health and the environment against 34 unreasonable adverse effects and ensuring that such products are effective. 35

DATES: Comments must be recei ved on or before [ insert date 60 days after date of 36 publication in the Federal Register ]. 37

ADDRESSES: Submit your comments, identified by docket identification (ID) number 38 EPA–HQ–OPP–2010–XX, by one of the following methods: 39*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 2 of 15

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line 1 instructions for submitting comments. 2

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• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), 4 Environmental Protection Agency, 1200 Pe nnsylvania Ave., NW., Washington, DC 5

20460–0001. 6

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• Delivery : OPP Regulatory Public Docket ( 7502P), Environmental Protection 8 Agency, Rm. S–4400, One Potomac Yard (S outh Bldg.), 2777 S. Crystal Dr., Arlington, 9 VA. Deliveries are only accepted during the Do cket Facility’s normal hours of operation 10 (8:30 a.m. to 4 p.m., Monday through Fr iday, excluding legal holidays). Special 11 arrangements should be made for deliveries of boxed information. The Docket Facility 12 telephone number is (703) 305–5805. 13

Instructions : Direct your comments to doc ket ID number EPA–HQ–OPP–2010- 14 XX. EPA's policy is that all comments receiv ed will be included in the docket without 15 change and may be made available on-line at http://www.regulations.gov , including any 16 personal information provided, unless the comme nt includes information claimed to be 17 Confidential Business Information (CBI) or other information whose disclosure is 18 restricted by statute. Do not submit informa tion that you consider to be CBI or otherwise 19 protected through regulations.gov or e-mail. The regulations.gov website is an 20 “anonymous access” system, which means EPA will not know your identity or contact 21 information unless you provide it in the body of your comment. If you send an e-mail 22 comment directly to EPA without going through regulations.gov, your e-mail address 23 will be automatically captured and included as part of the comment that is placed in the 24

docket and made available on the Internet. If you submit an electronic comment, EPA 25 recommends that you include your name and other contact information in the body of 26 your comment and with any disk or CD-ROM you submit. If EPA cannot read your 27

comment due to technical difficulties and cannot contact you for clarification, EPA may 28 not be able to consider your comment. El ectronic files should a void the use of special 29 characters, any form of encryption, and be free of any defects or viruses. 30

Docket : All documents in the docket are list ed in the docket index available at 31 http://www.regulations.gov . Although listed in the index, some information is not 32 publicly available, e.g., CBI or other information whose disclosure is re stricted by statute. 33 Certain other material, such as copyrighted ma terial, is not placed on the Internet and will 34 be publicly available only in hard copy form. Publicly av ailable docket materials are 35

available either in the electronic docket at http://www.regulations.gov , or, if only 36 available in hard copy, at the OPP Regul atory Public Docket in Rm. S–4400, One 37 Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Th e hours of operation 38 of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 39 legal holidays. The Docket Facili ty telephone number is (703) 305–5805. 40

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials 41 Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 42 Pennsylvania Ave., NW., Washingto n, DC 20460–0001; telephone number: 703-305- 43 5448; fax number: 703-308-6467; e-mail address: kempter.carlton@epa.gov

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SUPPLEMENTARY INFORMATION: 1

2

I. General Information 3

A. Does this Action Apply to Me? 4

You may be potentially affected by this action if you apply fo r or own pesticide 5 registrations. Potentially affected entities may include, but are not limited to: 6

• Producers of pesticide products (NAICS 32532 7

• Producers of antimicrobial pesticides (NAICS 32561) 8

• Veterinary testing la boratories (NAICS 541940) 9

• Medical pathology laboratories (NAICS 621511) 10

• Taxidermists, independent (NAICS 711510) 11

• Surgeons (NAICS 621111) 12

• Dental surgeons (NAICS 621210) 13

This listing is not intended to be exha ustive, but rather provides a guide for 14 readers regarding entities likely to be affected by this action. Other types of entities not 15

listed in this unit could also be affected. The North American I ndustrial Classification 16 System (NAICS) codes have been provided to assist you and others in determining 17 whether this action might apply to certain en tities. If you have a ny questions regarding 18 the applicability of this ac tion to a particular entity, consult the person listed under FOR 19
FURTHER INFORMATION CONTACT

. 20

B. What Should I Consider as I Prepare My Comments for EPA? 21

1. Submitting CBI . Do not submit this information to EPA through 22 regulations.gov or e-mail. Clearly mark the pa rt or all of the information that you claim 23

to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the 24

outside of the disk or CD-ROM as CBI and then identify electronically within the disk or 25 CD-ROM the specific information that is clai med as CBI. In addition to one complete 26

version of the comment that includes inform ation claimed as CBI, a copy of the comment 27

that does not contain the information claimed as CBI must be submitted for inclusion in 28 the public docket. Information so marked will not be disclosed except in accordance with 29 procedures set forth in 40 CFR Part 2. 30

31

2. Tips for preparing your comments . When submitting comments, remember to: 32

i. Identify the document by docket ID nu mber and other identifying information 33 (subject heading, Federal Register date and page number). 34*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 4 of 15

ii. Follow directions. The Agency may ask you to respond to specific questions or 1 organize comments by referencing a Code of Federal Regulations (C FR) part or section 2

number. 3

iii. Explain why you agree or disagree; suggest alternatives and substitute 4 language for your requested changes. 5

iv. Describe any assumptions and provid e any technical information and/or data 6 that you used. 7

v. If you estimate potential costs or bu rdens, explain how you arrived at your 8 estimate in sufficient detail to allow for it to be reproduced. 9

vi. Provide specific examples to illustra te your concerns and suggest alternatives. 10

vii. Explain your views as clearly as possible, avoidi ng the use of profanity or 11 personal threats. 12

viii. Make sure to submit your comments by the comment period deadline 13

identified. 14

II. Background 15

A. What Action is the Agency Taking? 16

The Environmental Protection Agency (EPA or the Agency) has decided that 17 under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) a prion is 18 considered to be a pest, and proposes to decl are a prion to be a pe st and to explicitly 19 include them in the lists of pests in 40 CF R Part 152.5. These actions would affirm the 20 Agency’s authority to regulat e products distributed or sold for the purpose of reducing 21 the infectivity of prions on in animate surfaces (i.e., prion pr oducts). Prion products are 22 currently regulated under FIFRA and subject to all requirements and provisions of the 23 Act based on EPA’s September 10, 2003 decision that prions share e nough characteristics 24 of an “other micro-organism” or “form of life” (as those terms are used in FIFRA) to fall 25 within the scope of FIFRA section 2(t) a nd 40 CFR 152.5(d). This proposal ensures that 26 the regulatory definition reflects the Agency’s authority to regulat e products distributed 27 or sold for the purpose of reducing the infec tivity of prions on inanimate surfaces (i.e., 28 prion products). The primary impact of decl aring that a prion is a pest and including 29 “prion” in the regulatory defin ition of “pest” is to provide regulatory clarity that prion 30 products must be registered or exempted under FIFRA sections 3 or 18, respectively, 31 before such products may be distribu ted or sold in the United States. 32

33 B. What is the Agency's Aut hority for Taking this Action? 34

This action is issued under the authority of sections 2 through 34 of FIFRA (7 35 U.S.C. 136-136y). 36

III. Prion As Pest under FIFRA 37*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 5 of 15

A. What is a Prion? 1

Prions (“ pr oteinaceous in fectious particles”) may o ccur in the central nervous 2 system tissues of animals as an abnormal (“mi sfolded”), infectious form of prion protein. 3 Prion protein in its normal form, or conformation, can be designated PrP c (“cellular” 4 isoform) while abnormal conformations of pr ion proteins are generally called prions. 5 Different types of prions are designated by th e type of diseases they produce, such as 6

PrP Sc (prions associated with scrapie) and PrP BSE (prions associated with bovine 7 spongiform encephalopathy—mad cow disease). 8

In the disease process, prions (such as PrP sc ) recruit normal prion proteins (PrP c ) 9 and convert them into pri ons (e.g., another copy of PrP Sc ). This recruitment and 10 conversion process results in the progressive accumulation of disease-producing prions. 11 When this process takes place in the brain, it causes disease that slowly progresses from 12 neuronal dysfunction and degenera tion to death. These neurodegenerative prion diseases 13 are known collectively as transmissible s pongiform encephalopathies (TSEs). TSEs 14 include scrapie disease in sheep, bovine spongiform encepha lopathy (BSE) in cattle, 15 chronic wasting disease (CWD) in deer a nd elk, kuru and variant Creutzfeld-Jakob 16 Disease (vCJD) in humans, and similar diseas es in other animals. The EPA and other 17 agencies are concerned that prions from animal species may infect humans (e.g., BSE 18 from cattle converting to vCJD in humans), or that prions of human origin may spread. 19 These diseases are always fatal in humans and animals alike, and there are no known 20

treatments or cures. 21

B. Legal/Regulatory Background 22

Under section 25(c)(1) of FIFRA, the Ad ministrator, after notice and opportunity 23 for hearing, is authorized “to de clare a pest any form of plant or animal life (other than 24 man and other than bacteria, virus, and ot her micro-organisms on or in living man or 25 other living animals) which is injurious to he alth or the environment.” Therefore, the 26 Agency has the authority to decide whether or not a prion should be considered to be a 27 pest under FIFRA and whether to issue a regulation implementing that decision. 28

29 On September 10, 2003, the EPA decided that a prion should be considered to be 30 a “pest” under FIFRA and that products in tended to inactivate prions (i.e., “prion 31 products”) should be regulated under FIFRA (Ref . 1). This decision was made partly in 32 connection with the widespread occurrence of chronic wasting disease (CWD) among 33 deer and elk in a number of states, particul arly in the Rocky M ountain region. Although 34 CWD had been endemic to that region for a long time, concerns were growing inside and 35 outside of EPA as to how to prevent or minimize the movement of what is believed to be 36 the causative agent for CWD—prions —through the environment. 37

38 At the same time, EPA was receiving inqui ries from states about obtaining FIFRA 39 Section 18 exemptions to allow use of a disi nfectant against prions on inanimate surfaces 40 in government and commercial laboratories. EPA was also aware that the Centers for 41 Disease Control and Prevention (CDC) and th e World Health Organization (WHO) were 42 recommending the use of certain chemicals fo r treating surfaces a nd items potentially 43*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 6 of 15

contaminated with prions even though thos e chemicals were not registered by EPA for 1 that specific purpose. Subsequent to the September 2003 decision, the EPA granted 2 quarantine exemptions under FIFRA Section 18 to numerous states (California, Colorado, 3 Montana, North Dakota, South Dakota, Uta h, Wyoming and Maine) for the use of a 4 commercial aqueous acid phenolic product, Environ LpH, for treatment on hard, 5 nonporous surfaces in government and commercial laboratories contaminated with CWD 6 and other kinds of prions. 7

8

C. EPA’s Interpretation of FIFRA 9

1. Applicable FIFRA Provisions 10

11 FIFRA Section 25(c)(1) author izes the Administrator “to declare a pest any form 12 of plant or animal life (other than man and other than bacteria, virus, and other micro13 organisms on or in living man or other living animals) which is injurious to health or the 14 environment.” FIFRA Section 2(t) defines a pest, in part, as “... any other form of 15 terrestrial or aquatic plant or animal life or virus, bacteria or other micro16 organism...which the Administrator declares to be a pest under sec tion 25(c)(1).” These 17 FIFRA sections provide EPA the authority to declare something to be a “pest” if it meets 18 these statutory provisions. 19

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2. EPA’s Interpretation of FIFRA 21

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EPA’s decision to declare a prion to be a pest under FIFRA rests on its statutory 23 interpretation of FIFRA Secti ons 25(c)(1) and 2(t). EPA beli eves that Congress intended 24 that the phrases “any other form of plant or animal life” and “other micro-organism” be 25 broadly interpreted to include biological entities that ar e injurious to humans or the 26 environment. The following points provide EPA’s rationale for this interpretation. 27

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• In FIFRA, Congress has over the years us ed the term “other micro-organism” 29 more broadly than most microbiologists cu rrently would define the term because, 30 as used in FIFRA, the term “micro-organism” includes viruses, which many 31 microbiologists do not consider to be mi croorganisms. Therefore, the term 32 “micro-organism,” as currently defined by many microbiologists, is narrower than 33 the potential scope of the term “o ther micro-organism” in FIFRA. 34

35

• As used in FIFRA, the term “other mi cro-organism” includes entities other than 36 viruses and bacteria, but it is unclear which entities. It is reasonable to assume 37 that it includes those entities that most microbiologists currently recognize as 38 microorganisms (i.e., microfungi, yeasts, a nd protists). Because the statutory 39 language explicitly includes viruses among micro-organisms in the definition of 40 “pest,” the term "other micro-organism" in its statutory context reasonably may be 41 interpreted to include some other en tities that many microbiologists may not 42 categorize as microorganisms. 43

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• Today, microbiologists do not generally classify viruses as microorganisms 1 because they are not alive (i.e., they cannot reproduce, grow or perform self2 maintenance). Therefore, the term “other micro-organism” as used in FIFRA 3 appears broad enough to include some entities that are not alive. 4

5

• Congress’ rationale for including viruses w ithin the FIFRA definition of “pest” is 6 not known as there is no available legislativ e history on this issue. However, it is 7 reasonable to infer that Congress included viruses within the FIFRA definition of 8 “pest” and within the scope of the meaning of “micro-organism” because viruses 9 share important characteristics of other pest s. The characteristics of a virus that 10 make it resemble a micro-organism in th e context of “pest” are pathogenicity, 11 infectivity, transmissibility, the ability to increase in number and the ability to 12 evolve. EPA believes that Congress intend ed the terms “pest” and “other micro13 organism” as used in FIFRA to be broadly inclusive. 14

15

• One entity that shares the characteristics of pathogenicity, infectivity, 16 transmissibility, the ability to increase in number and the ability to evolve (but 17 which, like viruses, is not alive) is the prion, which is an infectious conformation 18 of misfolded prion protein that causes TSE diseases in humans and animals. 19 Prions are also unquestionably injurious to the health of humans and other 20 animals. They cause TSE diseases th at attack the nervous system, inflict 21 irreversible damage, and are always fatal to infected animals and humans. These 22 infectious particles, once introduced into an animal or human, can induce 23 neuronal cells to change into prions that in turn attack other neuronal cells, 24 primarily in the central nervous system. Finally, prions are considered among the 25 most difficult of all biological entities to mitigate and few methods are available 26 for effectively doing so. For these reas ons, EPA believes that the public needs 27 assurance of the safety and efficacy of products intended to reduce the infectivity 28 of prions. 29

30

• Congress expressly included “prion” within another statute’s definition of “pest” 31

in the Animal Health Protection Act of 2002. 32

33 For these reasons, EPA concluded that a prion is appropriately included in the 34 phrase “other micro-organism.” Because prions are also severely injurious to human and 35 animal health, EPA has also concluded that a prions is appropriately included in the 36 FIFRA definition of “pest .” 37

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D. EPA’s Prion Science Evaluation and Efficacy Test Guidance Documents 39

To assure that this rulemaking is based on the best available scientific 40 information, EPA reviewed and summarized th e most relevant scie ntific studies and 41 publications related to the issue of whether a prion is a pest in a “white paper” (Ref. 2). 42 EPA presented the draft white paper to the FIFRA Scientific Advisory Panel (SAP) for 43 peer review and comment on March 31 and April 1, 2009. The SAP provided comments 44 to EPA on the draft white paper on June 29, 2009 (Ref. 3). EPA subsequently responded 45*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 8 of 15

to the SAP’s comments (Ref. 4) and made revi sions to the white paper in response to the 1 SAP comments (Ref. 5). All of these refere nced documents are available in the docket 2 for this declaration and proposed rule. 3

IV. FIFRA Review Requirements 4

5 [ Note to reviewers: this section will be filled in once FIFRA review is completed. ] 6

7 In accordance with FIFRA section 25(a), EPA has submitted a draft of the 8 proposed rule to the FIFRA SAP, the Secret ary of Agriculture (USDA), and appropriate 9 Congressional Committees. 10

11 The FIFRA SAP waived its review of this proposal on [ insert date ], because the 12 significant scientific issues involved have already been reviewed by the SAP and 13

additional review is n’t necessary. 14

15 Comments on the draft proposal receiv ed from USDA have been addressed [ or 16 revise say they did not comment . Or say...USDA participated fully in the interagency 17 review process under Executive Order 12866, during which EPA and USDA discussed 18 [ enter major topic areas that were raised and resolved ]. 19

20 In addition, pursuant to FIFRA secti on 21(b), EPA submitted a draft of the 21 proposed rule to the Secretary of He alth and Human Services (HHS). [ Did they comment 22 or not? If we got comments, include ]. Comments on the draft proposal received from 23 HHS have been addressed [ or revise say they did not comment . Or say...HHS 24 participated fully in the interagency re view process under Executive Order 12866, during 25 which EPA and HHS discussed [ enter major topic areas that were raised and resolved ]. 26

27 V. Statutory and Executive Order Reviews 28

29 A. Regulatory Review 30

31 Pursuant to Executive Order 12866, entitled Regulatory Planning and Review (58 32 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has 33 determined that this proposed rule is a "significant regulatory action" because this action 34 might raise novel legal or policy issues aris ing out of legal mandates, the President’s 35 priorities, or the principles set forth in th e Executive Order. Accordingly, as a result of 36 this OMB determination, EPA submitted this proposed rulemaking to OMB for review 37 under Executive Order 12866. Any changes made in response to OMB comments have 38 been documented in the public docket for this rulemaking as required by sec. 6(a)(3)(E) 39

of the Executive Order. 40

41 EPA has prepared an economic analysis of the potential costs associated with this 42 proposed action, entitled “Economic Analys is of the Notice of Proposed Rulemaking 43 Concerning the Status of Prion as a Pest under the Federal Insecticide, Fungicide, and 44 Rodenticide Act (FIFRA)” (Ref . 8). A copy of this document is available in the docket 45 for this rulemaking, and is briefly summarized here. 46*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 9 of 15

1

The Economic Analysis (EA) presents the Agency’s assessment of the potential 2 costs and benefits expected to result from th e proposed rule. In terms of benefits, the 3 proposed rule will ensure that EPA can pr otect human health and the environment by 4 subjecting prion products to regulation unde r FIFRA, including all data and labeling 5 requirements. In terms of costs, using pr e-2003 costs as the baseline, the incremental 6 costs of the proposed rule per registra tion action range from $424 thousand to $4.72 7

million. 8

The EA presents the costs of various t ypes of registrations under the proposed 9 rule and presents expected incremental cost s for three product registration types. The 10 three types of registration actions which are possible under the pr oposed rule are the 11 registration of (1) a new activ e ingredient, (2) a new use product, or (3) a new use 12 amendment registration. 13

The EA estimates that three firms may seek registrations for major new use 14 products in the first year. If all uses are high exposure (e.g., indirect food uses), the 15 maximum potential total cost to industry in the first ye ar would be approximately $7.05 16 million, and costs per firm would be approxi mately $2.35 million. Given the uncertainty 17

that characterizes the market for prion products at this time, the Agency did not speculate 18 further on the expected number of registra tions in subsequent years. However, 19 registrations that occur af ter the initial major new use product registrations would 20 probably be major new use amendments. Data requirements would entail only product21 specific efficacy data for major new use amendments at a cost of approximately $431,000 22 per registration action. 23

24

The EA identifies three categories of persons who could be affected by the 25 proposed rule—pesticide regist rants, users of prion produc ts and researchers. The 26 registration related requirements under FIFRA, however, are imposed on the entity that 27 registers the prion product. Users of prion products a nd researchers are affected 28 indirectly. The EA summarizes potential qualitative impacts of regulating prion products 29 that were expressed by product users to EPA duri ng its outreach efforts to these users. 30

The EA evaluates the impacts of the data required to support the registration of a 31 prion product, specifically the need for a product performance test that will measure the 32 ability of an individual pr oduct to reduce the infectivity of prions. The Agency has 33 developed draft test guidelines for prions whic h will ensure that the Agency receives the 34 data needed to make objective and reliable de terminations as to whether a prion product 35 meets the Agency’s efficacy data requirement s for registration. Providing clear guidance 36 on EPA’s efficacy data requirements for pr ion products will benefit registrants by 37 enabling them to submit relevant, correct a nd complete data submissions in support of 38 applications for registration to the Agency. 39

B. Paperwork Activities 40

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The information collection requirements, i.e., the paperwork collection activities, 1 contained in this proposal are already a pproved by OMB under the Paperwork Reduction 2 Act (PRA), 44 U.S.C. 3501 et seq . Specifically, the activities contained in this proposed 3 rule are already addressed in the followi ng information collection requests (ICRs): 4

5

1. The activities associated with the es tablishment of a tolerance are currently 6 approved under OMB Control No. 2070-0024 (EPA ICR No. 0597); 7

8

2. The activities associated with the a pplication for a new or amended registration 9 of a pesticide are current ly approved under OMB Control No. 2070-0060 (EPA ICR No. 10 0277); and 11

12

3. The activities associated with the generation of data in response to a Data-Call13 In issued subsequent to regist ration (e.g., as part of the review of an existing registration), 14 are currently approved under OMB C ontrol No. 2070-0174 (EPA ICR No. 2288). 15

16 The existing ICRs cover the paperwor k activities containe d in this proposal 17 because the activities already occur as part of existing program activities. These program 18 activities are an integral part of the Ag ency pesticide program and the corresponding 19 ICRs are regularly renewed. Although this pr oposal involves alrea dy approved activities, 20 the estimated frequency of those activities may increase as a result of this proposal. The 21 total estimated average annua l public reporting burden currently approved by OMB for 22 these various activities range s from approximately 8 hours to 3,000 hours per respondent, 23 depending on the activity and other factors su rrounding the particular pesticide product. 24 According to EPA’s Economic Analysis for this proposed rule (Ref. 8), using the 25 estimate of three major new use product registrations in the first year, the additional 26 registration of three antimicrobial products ma king prion related clai ms will result in an 27 increase in new registration applications fo r the Agency from 140 to 143 and an increase 28 in tolerance petitions of from 64 to 67. The increase in paperwork burden for the 29 registrant will be nearly $38,000 (600 hours fo r three registrations) for registration 30

activities and a littl e more than $423,000 (5,200 hours for three registrations) for 31 paperwork for toleranc e petitions. (Ref. 8) 32

33 An agency may not conduct or sponsor, and a person is not required to respond to 34 an information collection request unless it displays a currently valid OMB control 35 number, or is otherwise required to submit the specific information by a statute. The 36 OMB control numbers for EPA’s regulations, afte r appearing in the preamble of the final 37 rule, are listed in 40 CFR part 9 and 48 CFR chapter 15, and included on the related 38 collection instrument ( e.g., form or survey). 39

40 Under the PRA, "burden" means the total time, effort, or financial resources 41 expended by persons to generate, maintain, reta in, or disclose or pr ovide information to 42 or for a Federal agency. This includes the time needed to review instructions; develop, 43 acquire, install, and utilize technology and systems for the purposes of collecting, 44 validating, and verifying information, pro cessing and maintaining information, and 45 disclosing and providing information; adjust the existing ways to comply with any 46*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 11 of 15

previously applicable instruc tions and requirements; train pe rsonnel to be able to respond 1 to a collection of information; search data s ources; complete and re view the collection of 2 information; and transmit or otherw ise disclose the information. 3

4 Comments are requested on the Agency’s need for this inform ation, the accuracy 5 of the burden estimates, and any suggeste d methods for minimizing respondent burden, 6 including through the use of au tomated collection techniques. Send comments to EPA as 7 part of your overall comments on this pr oposed action in the manner specified under 8
ADDRESSES . In the final rule, the Agency will address any comments received 9 regarding the information collection requirements contained in this proposal. 10

C. Small Entity Impacts 11

12 Pursuant to section 605(b) of the Regul atory Flexibility Act (RFA), 5 U.S.C. 601 13

et seq ., after considering the potential economic impacts of this proposed rule on small 14 entities, I hereby certify that this proposed rule would not have a significant adverse 15 economic impact on a substantial number of sm all entities. This de termination is based 16 on the Agency’s economic analysis (Ref. 8), and is briefly summarized here. 17

18 Under the RFA, small entities include sm all businesses, small organizations, and 19 small governmental jurisdictions. For purposes of assessing the impacts of today's rule 20 on small entities, small entity is defined as: (1) a small business as defined by the Small 21 Business Administration’s (SBA) regulations at 13 CFR 121.201 (in th is case based on 22 maximum number of employees or sales for sm all businesses in each industry sector, as 23 defined by a 6-digit NAICS code); (2) a small governmental jurisdiction that is a 24 government of a city, county, town, school distri ct or special district with a population of 25 less than 50,000; and (3) a small organization that is any not-fo r-profit enterprise which is 26 independently owned and operated and is not do minant in its field. Since the regulated 27 community does not include small government al jurisdictions or small not-for-profit 28 organizations, the analysis focuses on small businesses. 29

30 According to the Agency’s economic an alysis (Ref. 8), only three firms are 31 expected to apply for registrati ons of prion products. One of these firms is known to be a 32 large firm. Given that approximately 79% of the firms in the antimicrobial industry are 33 small firms, it is possible that any or all of the remaining two other firms could qualify as 34 a small entity under the SBA definition. 35

36 The incremental costs of the proposed ru le could represent from 2-11% of the 37 average annual revenues of a small firm. In general, the Agency does not believe that 38 prion products are an important market se gment for sodium hydroxide or sodium 39 hypochlorite producing firms and does not anticipate a large number of product 40 registrations beyond the first year the final rule would take ef fect. If small entities apply 41 to register products for prion control, they would likely pursue a registration where they 42 could likely cite a substantial amount of data and not incur 100% of the initial costs of 43 testing. (Ref. 8). 44

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EPA continues to be interested in the potential impacts of this proposed rule on 1 small entities and welcomes comments on issues related to such impacts. 2

3

D. Unfunded Mandates 4

5 This action does not contain any Federa l mandates for State, local, or tribal 6 governments or the private sector under th e provisions of Title II of the Unfunded 7 Mandates Reform Act (UMRA), 2 U.S.C. 1531 -1538. EPA has determined that this 8 regulatory action will not result in annual expe nditures of $100 million or more for State, 9 local, and tribal governments, in the aggregate, or for the private sect or. As described in 10 Unit IV.A., the incremental co sts for the proposed rule are estimated from $424 thousand 11 to $4.72 million. Since State, local, and tr ibal governments are rarely pesticide 12 applicants, the proposed rule is not expected to significantly or uniquely affect small 13 governments. As such, EPA has determined that this action does not impose any 14 enforceable duty, contain any unfunded mandate, or otherwise have any affect on small 15 governments. Accordingly, this action is not subject to the requireme nts of sections 202, 16

203 or 205 of UMRA. 17

18 E. Federalism Implications 19

20 Pursuant to Executive Order 13132, entitled Federalism (64 FR 43255, August 21 10, 1999), EPA has determined that this proposed rule does not have “federalism 22 implications” because it will not have substa ntial direct effects on the states, on the 23 relationship between the nati onal government and the states, or on the distribution of 24 power and responsibilities among the various le vels of government, as specified in the 25 Order. As indicated previously, instances wher e a state is a registrant are extremely rare. 26 Therefore, this proposed rule may seldom affect a state government. Thus, Executive 27 Order 13132 does not apply to this proposed rule. 28

29 In the spirit of the Order, and c onsistent with EPA policy to promote 30 communications between the Agency and Stat e and local governments, EPA specifically 31 solicits comment on this proposed rule from State and local officials. 32

33 F. Tribal Implications 34

35 As required by Executive Order 13175, entitled Consultation and Coordination 36

with Indian Tribal Governments (65 FR 67249, November 6, 2000), EPA has determined 37 that this proposed rule does not have “tri bal implications” because it will not have 38

substantial direct effects on tribal governments, on the rela tionship between the Federal 39 government and the Indian tribes, or on the distribution of power and responsibilities 40 between the Federal government and Indian tr ibes, as specified in the Order. As 41 indicated previously, at pres ent, no tribal governments hold, or have applied for, a 42 pesticide registration. Thus, Executive Order 13175 does not apply to this proposed rule. 43

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In the spirit of the Order, and c onsistent with EPA policy to promote 1 communications between the Agency and Stat e and local governments, EPA specifically 2 solicits comment on this proposed rule from tribal officials. 3

4

G. Children’s Health 5

6 EPA interprets Executive Order 13045, entitled Protection of Children from 7

Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying 8 only to those regulatory actions th at concern health or safety ri sks, such that the analysis 9 required under section 5-501 of Executive Orde r 13045 has the potential to influence the 10 regulation. This action is not subject to Executive Order 13045 because it does not 11

establish an environmental standard intended to mitigate health or safety risks, and it is 12 not designated as an “econo mically significant” regulatory action as defined by Executive 13 Order 12866 (see Unit V.A.). To the contrar y, this action will provide added protection 14 for children from pesticide risk. 15

16 H. Energy Effects 17

18 This action is not a “significant energy action” as defined in Executive Order 19 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, 20 Distribution, or Use (66 FR 28355, May 22, 2001), because it is not likely to have an 21 effect on the supply, distribut ion, or use of energy as described in the Order. 22

23
I. Technical Standards 24

25 Section 12(d) of the Na tional Technology Transfer and Advancement Act of 1995 26 (NTTAA), 15 U.S.C. 272 note, directs EPA to use voluntary consensus standards in its 27 regulatory activities unless to do so would be inconsistent with applicable law or 28 impractical. Voluntary consensus st andards are technical standards ( e.g ., materials 29 specifications, test methods, sampling procedures, etc .) that are devel oped or adopted by 30 voluntary consensus standards bodies. N TTAA directs EPA to provide Congress, 31 through OMB, explanations when the Agency de cides not to use avai lable and applicable 32 voluntary consensus standards. 33

34 This action does not propose to require a ny technical standards that would require 35 Agency consideration of voluntary consensus st andards. This action proposes the types 36 of data to be required to s upport the registration of antimicr obial pesticide products with 37 prion-related claims but does not propose to require specific methods or standards to 38 generate those data. 39

40 The Agency invites comment on its conclusion regarding the applicability of 41 voluntary consensus standa rds to this rulemaking. 42

43

J. Executive Order 12898 44

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This proposed rule does not have an adverse impact on the environmental and 1 health conditions in low-income and minority communities. Therefore, under Executive 2 Order 12898, entitled Federal Actions to Address Envi ronmental Justice in Minority 3 Populations and Low- Income Populations (59 FR 7629, February 16, 1994), the Agency 4

does not need to consider envir onmental justice-related issues. 5

6
VI. References 7

8

As indicated under ADDRESSES , a docket has been established for this 9 rulemaking under docket ID number EPA-HQ-OPP-2010-____. The following is a 10 listing of the documents that are specifically referenced in this document. The docket 11

includes these documents and other informati on considered by EPA in developing this 12 proposed rule, including documents that are referenced within the documents that are 13 included in the docket, even if the referenced document is not physic ally located in the 14 docket. For assistance in locating these othe r documents, please consult the technical 15

contact listed under FOR FURTHER INFORMATION CONTACT

. 16

17 1. U.S. Environmental Protection Agency. 2004. Considerations of Prions as a Pest 18

under FIFRA. Memorandum to The Record from Susan B. Hazen, Principal Deputy 19 Assistant Administrator, Office of Preventi on, Pesticides, and Toxic Substances. April 20 29, 2004. 21

22 2. U.S. Environmental Protection Agency. 2009. “Scientific Information Concerning the 23

Issue of Whether Prions Are a ‘Pest’ unde r the Federal Insecticide, Fungicide, and 24

Rodenticide Act.” Draft dated 2-23-09. 25

26 3. U.S. Environmental Protection Agency. 2009. Transmittal of Meeting Minutes of the 27 FIFRA Scientific Advisory Panel Meeting Held March 31 - April 1, 2009 on Scientific 28 Issues Associated with Designating a Prion as a ‘Pest’ under the Federal Insecticide, 29 Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods. 30 Memorandum from Myrta R. Christian, Designa ted Federal Official, FIFRA Scientific 31 Advisory Panel, Office of Science Coordi nation and Policy, to Debbie Edwards, Ph.D., 32 Director, Office of Pesticid e Programs. June 29, 2009. 33

34 4. U.S. Environmental Protection Agency. 2010. EPA Responses to Comments by the 35 FIFRA Scientific Advisory Panel Concerni ng “Scientific Information Concerning the 36

Issue of Whether Prions Are a ’Pest’ unde r the Federal Insecticide, Fungicide, and 37 Rodenticide Act (FIFRA).” 2-17-10. 38

39 5. U.S. Environmental Protection Agency. 2010. Scientific Information Concerning the 40

Issue of Whether A Prion Is a “Pest” under the Federal Insecticide, Fungicide, and 41

Rodenticide Act. 2-17-10. 42

43 6. U.S. Environmental Protection Agency. 2009. Product Performance Test Guidelines 44

OPPTS 810:XXXX Products with Prion Re lated Claims. Draft dated 2-23-09. 45

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7. U.S. Environmental Protection Agency. 2009. Product Performance Test Guidelines 1

OPPTS 810:XXXX Products with Prion Related Claims. Draft dated 12-8-09. 2

3 8. U.S. Environmental Protection Agency. 2010. Economic Analysis of the Notice of 4 Proposed Rulemaking Concerning that Status of a Prion as a Pest under the Federal 5 Insecticide, Fungicide, and Rode nticide Act (FIFRA). 2-17-10. 6

7 List of Subjects in 40 CFR Part 152.5 8

9 Environmental protection, antim icrobial pesticides, prion. 10

11 Dated: ________ 12

13

________________ 14

Administrator 15

16 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 17

18 1. The authority citation for part 152 would continue to read as follows: 19

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701. 20

2. By amending 152.5(d) to add the term “prion” as follows: 21

§ 152.5 Pests

. 22

* * * * * 23 (a) * * * 24 (b) * * * 25 (c) * * * 26 (d) Any fungus, bacterium, virus, pr ion, or other microorganism, except for 27 those on or in living man or other living an imals and those on or in processed food or 28 processed animal feed, beverages, drugs (as defined in FFDCA sec. 201(g)(1)) and 29 cosmetics (as defined in FFDCA sec. 201(i)). 30

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