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1 i

2 

3 DRAFT (04-1-2010) 

4 

5 

6 ENVIRONMENTAL PROTECTION AGENCY 

7 

8 40 CFR Part 152.5 

9 

10 i

11 [EPA–HQ–OPP–2010-XX; FRL–XXXX–X] 

12 

13 i

14 RIN 2070–[AJ26]

15 

16 i

17 Declaration of Prion as a Pest under FIFRA and Amendment of EPA’s Regulatory 

18 Definition of Pests to Include Prion

19 

20 AGENCY: Environmental Protection Agency (EPA). 

21 ACTION: Proposed rule. 

22 SUMMARY: EPA proposes to declare a prion (i.e., proteinaceous infectious particle) a 

23 “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to 

24 amend its regulations to expressly include prion within the regulatory definition of pest. 

25 EPA currently considers a prion to be a pest under FIFRA, so a product intended to 

26 reduce the infectivity of any prion on inanimate surfaces (i.e., a “prion product”) is 

27 considered to be a pesticide and regulated as such. Any company seeking to distribute or 

28 sell a pesticide product regulated under FIFRA must obtain EPA approval before it can 

29 be distributed or sold in the United States. This proposed rule would codify the Agency’s 

30 current interpretation of FIFRA, and provides interested parties the opportunity to 

31 comment about how it is adding prion to the list of pests in 40 CFR Part 152.5. This 

32 amendment, together with the formal declaration that a prion is a pest, will eliminate any 

33 confusion about the status of prion products under FIFRA. Regulating prion products 

34 under FIFRA is appropriate for protecting human health and the environment against 

35 unreasonable adverse effects and ensuring that such products are effective. 

36 DATES: Comments must be received on or before [insert date 60 days after date of 

37 publication in the Federal Register]. 

38 ADDRESSES: Submit your comments, identified by docket identification (ID) number 

39 EPA–HQ–OPP–2010–XX, by one of the following methods: 
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1 • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line 

2 instructions for submitting comments. 

3 

4 • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), 

5 Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

6 20460–0001. 

7 

8 • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection 

9 Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, 

10 VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation 

11 (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special 

12 arrangements should be made for deliveries of boxed information. The Docket Facility 

13 telephone number is (703) 305–5805. 

14 Instructions: Direct your comments to docket ID number EPA–HQ–OPP–2010-

15 XX. EPA's policy is that all comments received will be included in the docket without 

16 change and may be made available on-line at http://www.regulations.gov, including any 

17 personal information provided, unless the comment includes information claimed to be 

18 Confidential Business Information (CBI) or other information whose disclosure is 

19 restricted by statute. Do not submit information that you consider to be CBI or otherwise 

20 protected through regulations.gov or e-mail. The regulations.gov website is an 

21 “anonymous access” system, which means EPA will not know your identity or contact 

22 information unless you provide it in the body of your comment. If you send an e-mail 

23 comment directly to EPA without going through regulations.gov, your e-mail address 

24 will be automatically captured and included as part of the comment that is placed in the 

25 docket and made available on the Internet. If you submit an electronic comment, EPA 

26 recommends that you include your name and other contact information in the body of 

27 your comment and with any disk or CD-ROM you submit. If EPA cannot read your 

28 comment due to technical difficulties and cannot contact you for clarification, EPA may 

29 not be able to consider your comment. Electronic files should avoid the use of special 

30 characters, any form of encryption, and be free of any defects or viruses. 

31 Docket: All documents in the docket are listed in the docket index available at 

32 http://www.regulations.gov. Although listed in the index, some information is not 

33 publicly available, e.g., CBI or other information whose disclosure is restricted by statute. 

34 Certain other material, such as copyrighted material, is not placed on the Internet and will 

35 be publicly available only in hard copy form. Publicly available docket materials are 

36 available either in the electronic docket at http://www.regulations.gov, or, if only 

37 available in hard copy, at the OPP Regulatory Public Docket in Rm. S–4400, One 

38 Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation 

39 of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 

40 legal holidays. The Docket Facility telephone number is (703) 305–5805. 

41 FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials 

42 Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 

43 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 703-305-

44 5448; fax number: 703-308-6467; e-mail address: kempter.carlton@epa.gov. 
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1 SUPPLEMENTARY INFORMATION: 

2 

3 I. General Information 

4 A. Does this Action Apply to Me? 

5 You may be potentially affected by this action if you apply for or own pesticide 

6 registrations. Potentially affected entities may include, but are not limited to:

7 • Producers of pesticide products (NAICS 32532 

8 • Producers of antimicrobial pesticides (NAICS 32561) 

9 • Veterinary testing laboratories (NAICS 541940) 

10 • Medical pathology laboratories (NAICS 621511) 

11 • Taxidermists, independent (NAICS 711510) 

12 • Surgeons (NAICS 621111) 

13 • Dental surgeons (NAICS 621210) 

14 This listing is not intended to be exhaustive, but rather provides a guide for 

15 readers regarding entities likely to be affected by this action. Other types of entities not 

16 listed in this unit could also be affected. The North American Industrial Classification 

17 System (NAICS) codes have been provided to assist you and others in determining 

18 whether this action might apply to certain entities. If you have any questions regarding 

19 the applicability of this action to a particular entity, consult the person listed under FOR 

20 FURTHER INFORMATION CONTACT. 

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

22 1. Submitting CBI. Do not submit this information to EPA through 

23 regulations.gov or e-mail. Clearly mark the part or all of the information that you claim 

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

25 outside of the disk or CD-ROM as CBI and then identify electronically within the disk or 

26 CD-ROM the specific information that is claimed as CBI. In addition to one complete 

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

28 that does not contain the information claimed as CBI must be submitted for inclusion in 

29 the public docket. Information so marked will not be disclosed except in accordance with 

30 procedures set forth in 40 CFR Part 2. 

31 

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

33 i. Identify the document by docket ID number and other identifying information 

34 (subject heading, Federal Register date and page number). 
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1 ii. Follow directions. The Agency may ask you to respond to specific questions or 

2 organize comments by referencing a Code of Federal Regulations (CFR) part or section 

3 number. 

4 iii. Explain why you agree or disagree; suggest alternatives and substitute 

5 language for your requested changes. 

6 iv. Describe any assumptions and provide any technical information and/or data 

7 that you used. 

8 v. If you estimate potential costs or burdens, explain how you arrived at your 

9 estimate in sufficient detail to allow for it to be reproduced. 

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

11 vii. Explain your views as clearly as possible, avoiding the use of profanity or 

12 personal threats. 

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

14 identified. 

15 II. Background 

16 A. What Action is the Agency Taking? 

17 The Environmental Protection Agency (EPA or the Agency) has decided that 

18 under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) a prion is 

19 considered to be a pest, and proposes to declare a prion to be a pest and to explicitly 

20 include them in the lists of pests in 40 CFR Part 152.5. These actions would affirm the 

21 Agency’s authority to regulate products distributed or sold for the purpose of reducing 

22 the infectivity of prions on inanimate surfaces (i.e., prion products). Prion products are 

23 currently regulated under FIFRA and subject to all requirements and provisions of the 

24 Act based on EPA’s September 10, 2003 decision that prions share enough characteristics 

25 of an “other micro-organism” or “form of life” (as those terms are used in FIFRA) to fall 

26 within the scope of FIFRA section 2(t) and 40 CFR 152.5(d). This proposal ensures that 

27 the regulatory definition reflects the Agency’s authority to regulate products distributed 

28 or sold for the purpose of reducing the infectivity of prions on inanimate surfaces (i.e., 

29 prion products). The primary impact of declaring that a prion is a pest and including 

30 “prion” in the regulatory definition of “pest” is to provide regulatory clarity that prion 

31 products must be registered or exempted under FIFRA sections 3 or 18, respectively, 

32 before such products may be distributed or sold in the United States. 

33 

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

35 This action is issued under the authority of sections 2 through 34 of FIFRA (7 

36 U.S.C. 136-136y). 

37 III.Prion As Pest under FIFRA
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1 A. What is a Prion?

2 Prions (“proteinaceous infectious particles”) may occur in the central nervous 

3 system tissues of animals as an abnormal (“misfolded”), infectious form of prion protein. 

Prion protein in its normal form, or conformation, can be designated PrPc 4 (“cellular” 

5 isoform) while abnormal conformations of prion proteins are generally called prions. 

6 Different types of prions are designated by the type of diseases they produce, such as 

PrPSc (prions associated with scrapie) and PrPBSE 7 (prions associated with bovine 

8 spongiform encephalopathy—mad cow disease). 

In the disease process, prions (such as PrPsc) recruit normal prion proteins (PrPc 9 )

and convert them into prions (e.g., another copy of PrPSc 10 ). This recruitment and 

11 conversion process results in the progressive accumulation of disease-producing prions. 

12 When this process takes place in the brain, it causes disease that slowly progresses from 

13 neuronal dysfunction and degeneration to death. These neurodegenerative prion diseases 

14 are known collectively as transmissible spongiform encephalopathies (TSEs). TSEs 

15 include scrapie disease in sheep, bovine spongiform encephalopathy (BSE) in cattle, 

16 chronic wasting disease (CWD) in deer and elk, kuru and variant Creutzfeld-Jakob 

17 Disease (vCJD) in humans, and similar diseases in other animals. The EPA and other 

18 agencies are concerned that prions from animal species may infect humans (e.g., BSE 

19 from cattle converting to vCJD in humans), or that prions of human origin may spread. 

20 These diseases are always fatal in humans and animals alike, and there are no known 

21 treatments or cures. 

22 B. Legal/Regulatory Background

23 Under section 25(c)(1) of FIFRA, the Administrator, after notice and opportunity 

24 for hearing, is authorized “to declare a pest any form of plant or animal life (other than 

25 man and other than bacteria, virus, and other micro-organisms on or in living man or 

26 other living animals) which is injurious to health or the environment.” Therefore, the 

27 Agency has the authority to decide whether or not a prion should be considered to be a 

28 pest under FIFRA and whether to issue a regulation implementing that decision. 

29 

30 On September 10, 2003, the EPA decided that a prion should be considered to be 

31 a “pest” under FIFRA and that products intended to inactivate prions (i.e., “prion 

32 products”) should be regulated under FIFRA (Ref. 1). This decision was made partly in 

33 connection with the widespread occurrence of chronic wasting disease (CWD) among 

34 deer and elk in a number of states, particularly in the Rocky Mountain region. Although 

35 CWD had been endemic to that region for a long time, concerns were growing inside and 

36 outside of EPA as to how to prevent or minimize the movement of what is believed to be 

37 the causative agent for CWD—prions—through the environment. 

38 

39 At the same time, EPA was receiving inquiries from states about obtaining FIFRA 

40 Section 18 exemptions to allow use of a disinfectant against prions on inanimate surfaces 

41 in government and commercial laboratories. EPA was also aware that the Centers for 

42 Disease Control and Prevention (CDC) and the World Health Organization (WHO) were 

43 recommending the use of certain chemicals for treating surfaces and items potentially 
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1 contaminated with prions even though those chemicals were not registered by EPA for 

2 that specific purpose. Subsequent to the September 2003 decision, the EPA granted 

3 quarantine exemptions under FIFRA Section 18 to numerous states (California, Colorado, 

4 Montana, North Dakota, South Dakota, Utah, Wyoming and Maine) for the use of a 

5 commercial aqueous acid phenolic product, Environ LpH, for treatment on hard, 

6 nonporous surfaces in government and commercial laboratories contaminated with CWD 

7 and other kinds of prions. 

8 

9 C. EPA’s Interpretation of FIFRA 

10 1. Applicable FIFRA Provisions 

11 

12 FIFRA Section 25(c)(1) authorizes the Administrator “to declare a pest any form 

13 of plant or animal life (other than man and other than bacteria, virus, and other micro14 organisms on or in living man or other living animals) which is injurious to health or the 

15 environment.” FIFRA Section 2(t) defines a pest, in part, as “... any other form of 

16 terrestrial or aquatic plant or animal life or virus, bacteria or other micro17 organism...which the Administrator declares to be a pest under section 25(c)(1).” These 

18 FIFRA sections provide EPA the authority to declare something to be a “pest” if it meets 

19 these statutory provisions. 

20 

21 2. EPA’s Interpretation of FIFRA 

22 

23 EPA’s decision to declare a prion to be a pest under FIFRA rests on its statutory 

24 interpretation of FIFRA Sections 25(c)(1) and 2(t). EPA believes that Congress intended 

25 that the phrases “any other form of plant or animal life” and “other micro-organism” be 

26 broadly interpreted to include biological entities that are injurious to humans or the 

27 environment. The following points provide EPA’s rationale for this interpretation. 

28 

29 • In FIFRA, Congress has over the years used the term “other micro-organism” 

30 more broadly than most microbiologists currently would define the term because, 

31 as used in FIFRA, the term “micro-organism” includes viruses, which many 

32 microbiologists do not consider to be microorganisms. Therefore, the term 

33 “micro-organism,” as currently defined by many microbiologists, is narrower than 

34 the potential scope of the term “other micro-organism” in FIFRA. 

35 

36 • As used in FIFRA, the term “other micro-organism” includes entities other than 

37 viruses and bacteria, but it is unclear which entities. It is reasonable to assume 

38 that it includes those entities that most microbiologists currently recognize as 

39 microorganisms (i.e., microfungi, yeasts, and protists). Because the statutory 

40 language explicitly includes viruses among micro-organisms in the definition of 

41 “pest,” the term "other micro-organism" in its statutory context reasonably may be 

42 interpreted to include some other entities that many microbiologists may not 

43 categorize as microorganisms. 

44 
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1 • Today, microbiologists do not generally classify viruses as microorganisms 

2 because they are not alive (i.e., they cannot reproduce, grow or perform self3 maintenance). Therefore, the term “other micro-organism” as used in FIFRA 

4 appears broad enough to include some entities that are not alive. 

5 

6 • Congress’ rationale for including viruses within the FIFRA definition of “pest” is 

7 not known as there is no available legislative history on this issue. However, it is 

8 reasonable to infer that Congress included viruses within the FIFRA definition of 

9 “pest” and within the scope of the meaning of “micro-organism” because viruses 

10 share important characteristics of other pests. The characteristics of a virus that 

11 make it resemble a micro-organism in the context of “pest” are pathogenicity, 

12 infectivity, transmissibility, the ability to increase in number and the ability to 

13 evolve. EPA believes that Congress intended the terms “pest” and “other micro14 organism” as used in FIFRA to be broadly inclusive. 

15 

16 • One entity that shares the characteristics of pathogenicity, infectivity, 

17 transmissibility, the ability to increase in number and the ability to evolve (but 

18 which, like viruses, is not alive) is the prion, which is an infectious conformation 

19 of misfolded prion protein that causes TSE diseases in humans and animals. 

20 Prions are also unquestionably injurious to the health of humans and other 

21 animals. They cause TSE diseases that attack the nervous system, inflict 

22 irreversible damage, and are always fatal to infected animals and humans. These 

23 infectious particles, once introduced into an animal or human, can induce 

24 neuronal cells to change into prions that in turn attack other neuronal cells, 

25 primarily in the central nervous system. Finally, prions are considered among the 

26 most difficult of all biological entities to mitigate and few methods are available 

27 for effectively doing so. For these reasons, EPA believes that the public needs 

28 assurance of the safety and efficacy of products intended to reduce the infectivity 

29 of prions. 

30 

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

32 in the Animal Health Protection Act of 2002. 

33 

34 For these reasons, EPA concluded that a prion is appropriately included in the 

35 phrase “other micro-organism.” Because prions are also severely injurious to human and 

36 animal health, EPA has also concluded that a prions is appropriately included in the 

37 FIFRA definition of “pest.” 

38 

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

40 To assure that this rulemaking is based on the best available scientific 

41 information, EPA reviewed and summarized the most relevant scientific studies and 

42 publications related to the issue of whether a prion is a pest in a “white paper” (Ref. 2). 

43 EPA presented the draft white paper to the FIFRA Scientific Advisory Panel (SAP) for 

44 peer review and comment on March 31 and April 1, 2009. The SAP provided comments 

45 to EPA on the draft white paper on June 29, 2009 (Ref. 3). EPA subsequently responded 
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1 to the SAP’s comments (Ref. 4) and made revisions to the white paper in response to the 

2 SAP comments (Ref. 5). All of these referenced documents are available in the docket 

3 for this declaration and proposed rule. 

4 IV. FIFRA Review Requirements

5 

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

7 

8 In accordance with FIFRA section 25(a), EPA has submitted a draft of the 

9 proposed rule to the FIFRA SAP, the Secretary of Agriculture (USDA), and appropriate 

10 Congressional Committees. 

11 

12 The FIFRA SAP waived its review of this proposal on [insert date], because the 

13 significant scientific issues involved have already been reviewed by the SAP and 

14 additional review isn’t necessary. 

15 

16 Comments on the draft proposal received from USDA have been addressed [or 

17 revise say they did not comment. Or say...USDA participated fully in the interagency 

18 review process under Executive Order 12866, during which EPA and USDA discussed 

19 [enter major topic areas that were raised and resolved]. 

20 

21 In addition, pursuant to FIFRA section 21(b), EPA submitted a draft of the 

22 proposed rule to the Secretary of Health and Human Services (HHS). [Did they comment 

23 or not? If we got comments, include]. Comments on the draft proposal received from 

24 HHS have been addressed [or revise say they did not comment. Or say...HHS 

25 participated fully in the interagency review process under Executive Order 12866, during 

26 which EPA and HHS discussed [enter major topic areas that were raised and resolved]. 

27 

28 V. Statutory and Executive Order Reviews 

29 

30 A. Regulatory Review 

31 

32 Pursuant to Executive Order 12866, entitled Regulatory Planning and Review (58 

33 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has 

34 determined that this proposed rule is a "significant regulatory action" because this action 

35 might raise novel legal or policy issues arising out of legal mandates, the President’s 

36 priorities, or the principles set forth in the Executive Order. Accordingly, as a result of 

37 this OMB determination, EPA submitted this proposed rulemaking to OMB for review 

38 under Executive Order 12866. Any changes made in response to OMB comments have 

39 been documented in the public docket for this rulemaking as required by sec. 6(a)(3)(E) 

40 of the Executive Order. 

41 

42 EPA has prepared an economic analysis of the potential costs associated with this 

43 proposed action, entitled “Economic Analysis of the Notice of Proposed Rulemaking 

44 Concerning the Status of Prion as a Pest under the Federal Insecticide, Fungicide, and 

45 Rodenticide Act (FIFRA)” (Ref. 8). A copy of this document is available in the docket 

46 for this rulemaking, and is briefly summarized here. 
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1 

2 The Economic Analysis (EA) presents the Agency’s assessment of the potential 

3 costs and benefits expected to result from the proposed rule. In terms of benefits, the 

4 proposed rule will ensure that EPA can protect human health and the environment by 

5 subjecting prion products to regulation under FIFRA, including all data and labeling 

6 requirements. In terms of costs, using pre-2003 costs as the baseline, the incremental 

7 costs of the proposed rule per registration action range from $424 thousand to $4.72 

8 million. 

9 The EA presents the costs of various types of registrations under the proposed 

10 rule and presents expected incremental costs for three product registration types. The 

11 three types of registration actions which are possible under the proposed rule are the 

12 registration of (1) a new active ingredient, (2) a new use product, or (3) a new use 

13 amendment registration. 

14 The EA estimates that three firms may seek registrations for major new use 

15 products in the first year. If all uses are high exposure (e.g., indirect food uses), the 

16 maximum potential total cost to industry in the first year would be approximately $7.05 

17 million, and costs per firm would be approximately $2.35 million. Given the uncertainty 

18 that characterizes the market for prion products at this time, the Agency did not speculate 

19 further on the expected number of registrations in subsequent years. However, 

20 registrations that occur after the initial major new use product registrations would 

21 probably be major new use amendments. Data requirements would entail only product22 specific efficacy data for major new use amendments at a cost of approximately $431,000 

23 per registration action. 

24 

25 The EA identifies three categories of persons who could be affected by the 

26 proposed rule—pesticide registrants, users of prion products and researchers. The 

27 registration related requirements under FIFRA, however, are imposed on the entity that 

28 registers the prion product. Users of prion products and researchers are affected 

29 indirectly. The EA summarizes potential qualitative impacts of regulating prion products 

30 that were expressed by product users to EPA during its outreach efforts to these users. 

31 The EA evaluates the impacts of the data required to support the registration of a 

32 prion product, specifically the need for a product performance test that will measure the 

33 ability of an individual product to reduce the infectivity of prions. The Agency has 

34 developed draft test guidelines for prions which will ensure that the Agency receives the 

35 data needed to make objective and reliable determinations as to whether a prion product 

36 meets the Agency’s efficacy data requirements for registration. Providing clear guidance 

37 on EPA’s efficacy data requirements for prion products will benefit registrants by 

38 enabling them to submit relevant, correct and complete data submissions in support of 

39 applications for registration to the Agency. 

40 B. Paperwork Activities 

41 
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1 The information collection requirements, i.e., the paperwork collection activities, 

2 contained in this proposal are already approved by OMB under the Paperwork Reduction 

3 Act (PRA), 44 U.S.C. 3501 et seq. Specifically, the activities contained in this proposed 

4 rule are already addressed in the following information collection requests (ICRs): 

5 

6 1. The activities associated with the establishment of a tolerance are currently 

7 approved under OMB Control No. 2070-0024 (EPA ICR No. 0597); 

8 

9 2. The activities associated with the application for a new or amended registration 

10 of a pesticide are currently approved under OMB Control No. 2070-0060 (EPA ICR No. 

11 0277); and 

12 

13 3. The activities associated with the generation of data in response to a Data-Call14 In issued subsequent to registration (e.g., as part of the review of an existing registration), 

15 are currently approved under OMB Control No. 2070-0174 (EPA ICR No. 2288). 

16 

17 The existing ICRs cover the paperwork activities contained in this proposal 

18 because the activities already occur as part of existing program activities. These program 

19 activities are an integral part of the Agency pesticide program and the corresponding 

20 ICRs are regularly renewed. Although this proposal involves already approved activities, 

21 the estimated frequency of those activities may increase as a result of this proposal. The 

22 total estimated average annual public reporting burden currently approved by OMB for 

23 these various activities ranges from approximately 8 hours to 3,000 hours per respondent, 

24 depending on the activity and other factors surrounding the particular pesticide product. 

25 According to EPA’s Economic Analysis for this proposed rule (Ref. 8), using the 

26 estimate of three major new use product registrations in the first year, the additional 

27 registration of three antimicrobial products making prion related claims will result in an 

28 increase in new registration applications for the Agency from 140 to 143 and an increase 

29 in tolerance petitions of from 64 to 67. The increase in paperwork burden for the 

30 registrant will be nearly $38,000 (600 hours for three registrations) for registration 

31 activities and a little more than $423,000 (5,200 hours for three registrations) for 

32 paperwork for tolerance petitions. (Ref. 8) 

33 

34 An agency may not conduct or sponsor, and a person is not required to respond to 

35 an information collection request unless it displays a currently valid OMB control 

36 number, or is otherwise required to submit the specific information by a statute. The 

37 OMB control numbers for EPA’s regulations, after appearing in the preamble of the final 

38 rule, are listed in 40 CFR part 9 and 48 CFR chapter 15, and included on the related 

39 collection instrument (e.g., form or survey). 

40 

41 Under the PRA, "burden" means the total time, effort, or financial resources 

42 expended by persons to generate, maintain, retain, or disclose or provide information to 

43 or for a Federal agency. This includes the time needed to review instructions; develop, 

44 acquire, install, and utilize technology and systems for the purposes of collecting, 

45 validating, and verifying information, processing and maintaining information, and 

46 disclosing and providing information; adjust the existing ways to comply with any 
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1 previously applicable instructions and requirements; train personnel to be able to respond 

2 to a collection of information; search data sources; complete and review the collection of 

3 information; and transmit or otherwise disclose the information. 

4 

5 Comments are requested on the Agency’s need for this information, the accuracy 

6 of the burden estimates, and any suggested methods for minimizing respondent burden, 

7 including through the use of automated collection techniques. Send comments to EPA as 

8 part of your overall comments on this proposed action in the manner specified under 

9 ADDRESSES. In the final rule, the Agency will address any comments received 

10 regarding the information collection requirements contained in this proposal. 

11 C. Small Entity Impacts 

12 

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

14 et seq., after considering the potential economic impacts of this proposed rule on small 

15 entities, I hereby certify that this proposed rule would not have a significant adverse 

16 economic impact on a substantial number of small entities. This determination is based 

17 on the Agency’s economic analysis (Ref. 8), and is briefly summarized here. 

18 

19 Under the RFA, small entities include small businesses, small organizations, and 

20 small governmental jurisdictions. For purposes of assessing the impacts of today's rule 

21 on small entities, small entity is defined as: (1) a small business as defined by the Small 

22 Business Administration’s (SBA) regulations at 13 CFR 121.201 (in this case based on 

23 maximum number of employees or sales for small businesses in each industry sector, as 

24 defined by a 6-digit NAICS code); (2) a small governmental jurisdiction that is a 

25 government of a city, county, town, school district or special district with a population of 

26 less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is 

27 independently owned and operated and is not dominant in its field. Since the regulated 

28 community does not include small governmental jurisdictions or small not-for-profit 

29 organizations, the analysis focuses on small businesses. 

30 

31 According to the Agency’s economic analysis (Ref. 8), only three firms are 

32 expected to apply for registrations of prion products. One of these firms is known to be a 

33 large firm. Given that approximately 79% of the firms in the antimicrobial industry are 

34 small firms, it is possible that any or all of the remaining two other firms could qualify as 

35 a small entity under the SBA definition. 

36 

37 The incremental costs of the proposed rule could represent from 2-11% of the 

38 average annual revenues of a small firm. In general, the Agency does not believe that 

39 prion products are an important market segment for sodium hydroxide or sodium 

40 hypochlorite producing firms and does not anticipate a large number of product 

41 registrations beyond the first year the final rule would take effect. If small entities apply 

42 to register products for prion control, they would likely pursue a registration where they 

43 could likely cite a substantial amount of data and not incur 100% of the initial costs of 

44 testing. (Ref. 8). 

45 
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1 EPA continues to be interested in the potential impacts of this proposed rule on 

2 small entities and welcomes comments on issues related to such impacts. 

3 

4 D. Unfunded Mandates 

5 

6 This action does not contain any Federal mandates for State, local, or tribal 

7 governments or the private sector under the provisions of Title II of the Unfunded 

8 Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this 

9 regulatory action will not result in annual expenditures of $100 million or more for State, 

10 local, and tribal governments, in the aggregate, or for the private sector. As described in 

11 Unit IV.A., the incremental costs for the proposed rule are estimated from $424 thousand 

12 to $4.72 million. Since State, local, and tribal governments are rarely pesticide 

13 applicants, the proposed rule is not expected to significantly or uniquely affect small 

14 governments. As such, EPA has determined that this action does not impose any 

15 enforceable duty, contain any unfunded mandate, or otherwise have any affect on small 

16 governments. Accordingly, this action is not subject to the requirements of sections 202, 

17 203 or 205 of UMRA. 

18 

19 E. Federalism Implications 

20 

21 Pursuant to Executive Order 13132, entitled Federalism (64 FR 43255, August 

22 10, 1999), EPA has determined that this proposed rule does not have “federalism 

23 implications” because it will not have substantial direct effects on the states, on the 

24 relationship between the national government and the states, or on the distribution of 

25 power and responsibilities among the various levels of government, as specified in the 

26 Order. As indicated previously, instances where a state is a registrant are extremely rare. 

27 Therefore, this proposed rule may seldom affect a state government. Thus, Executive 

28 Order 13132 does not apply to this proposed rule. 

29 

30 In the spirit of the Order, and consistent with EPA policy to promote 

31 communications between the Agency and State and local governments, EPA specifically 

32 solicits comment on this proposed rule from State and local officials. 

33 

34 F. Tribal Implications

35 

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

37 with Indian Tribal Governments (65 FR 67249, November 6, 2000), EPA has determined 

38 that this proposed rule does not have “tribal implications” because it will not have 

39 substantial direct effects on tribal governments, on the relationship between the Federal 

40 government and the Indian tribes, or on the distribution of power and responsibilities 

41 between the Federal government and Indian tribes, as specified in the Order. As 

42 indicated previously, at present, no tribal governments hold, or have applied for, a 

43 pesticide registration. Thus, Executive Order 13175 does not apply to this proposed rule. 

44 
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Page 13 of 15

1 In the spirit of the Order, and consistent with EPA policy to promote 

2 communications between the Agency and State and local governments, EPA specifically 

3 solicits comment on this proposed rule from tribal officials. 

4 

5 G. Children’s Health

6 

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

8 Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying 

9 only to those regulatory actions that concern health or safety risks, such that the analysis 

10 required under section 5-501 of Executive Order 13045 has the potential to influence the 

11 regulation. This action is not subject to Executive Order 13045 because it does not 

12 establish an environmental standard intended to mitigate health or safety risks, and it is 

13 not designated as an “economically significant” regulatory action as defined by Executive 

14 Order 12866 (see Unit V.A.). To the contrary, this action will provide added protection 

15 for children from pesticide risk. 

16 

17 H. Energy Effects

18 

19 This action is not a “significant energy action” as defined in Executive Order 

20 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, 

21 Distribution, or Use (66 FR 28355, May 22, 2001), because it is not likely to have an 

22 effect on the supply, distribution, or use of energy as described in the Order. 

23 

24 I. Technical Standards

25 

26 Section 12(d) of the National Technology Transfer and Advancement Act of 1995 

27 (NTTAA), 15 U.S.C. 272 note, directs EPA to use voluntary consensus standards in its 

28 regulatory activities unless to do so would be inconsistent with applicable law or 

29 impractical. Voluntary consensus standards are technical standards (e.g., materials 

30 specifications, test methods, sampling procedures, etc.) that are developed or adopted by 

31 voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, 

32 through OMB, explanations when the Agency decides not to use available and applicable 

33 voluntary consensus standards. 

34 

35 This action does not propose to require any technical standards that would require 

36 Agency consideration of voluntary consensus standards. This action proposes the types 

37 of data to be required to support the registration of antimicrobial pesticide products with 

38 prion-related claims but does not propose to require specific methods or standards to 

39 generate those data. 

40 

41 The Agency invites comment on its conclusion regarding the applicability of 

42 voluntary consensus standards to this rulemaking. 

43 

44 J. Executive Order 12898 

45 
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Page 14 of 15

1 This proposed rule does not have an adverse impact on the environmental and 

2 health conditions in low-income and minority communities. Therefore, under Executive 

3 Order 12898, entitled Federal Actions to Address Environmental Justice in Minority 

4 Populations and Low- Income Populations (59 FR 7629, February 16, 1994), the Agency 

5 does not need to consider environmental justice-related issues. 

6 

7 VI. References

8 

9 As indicated under ADDRESSES, a docket has been established for this 

10 rulemaking under docket ID number EPA-HQ-OPP-2010-____. The following is a 

11 listing of the documents that are specifically referenced in this document. The docket 

12 includes these documents and other information considered by EPA in developing this 

13 proposed rule, including documents that are referenced within the documents that are 

14 included in the docket, even if the referenced document is not physically located in the 

15 docket. For assistance in locating these other documents, please consult the technical 

16 contact listed under FOR FURTHER INFORMATION CONTACT. 

17 

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

19 under FIFRA. Memorandum to The Record from Susan B. Hazen, Principal Deputy 

20 Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances. April 

21 29, 2004. 

22 

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

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

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

26 

27 3. U.S. Environmental Protection Agency. 2009. Transmittal of Meeting Minutes of the 

28 FIFRA Scientific Advisory Panel Meeting Held March 31 - April 1, 2009 on Scientific 

29 Issues Associated with Designating a Prion as a ‘Pest’ under the Federal Insecticide, 

30 Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods. 

31 Memorandum from Myrta R. Christian, Designated Federal Official, FIFRA Scientific 

32 Advisory Panel, Office of Science Coordination and Policy, to Debbie Edwards, Ph.D., 

33 Director, Office of Pesticide Programs. June 29, 2009. 

34 

35 4. U.S. Environmental Protection Agency. 2010. EPA Responses to Comments by the 

36 FIFRA Scientific Advisory Panel Concerning “Scientific Information Concerning the 

37 Issue of Whether Prions Are a ’Pest’ under the Federal Insecticide, Fungicide, and 

38 Rodenticide Act (FIFRA).” 2-17-10.

39 

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

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

42 Rodenticide Act. 2-17-10. 

43 

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

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

46 
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Page 15 of 15

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

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

3 

4 8. U.S. Environmental Protection Agency. 2010. Economic Analysis of the Notice of 

5 Proposed Rulemaking Concerning that Status of a Prion as a Pest under the Federal 

6 Insecticide, Fungicide, and Rodenticide Act (FIFRA). 2-17-10. 

7 

8 List of Subjects in 40 CFR Part 152.5

9 

10 Environmental protection, antimicrobial pesticides, prion. 

11 

12 Dated: ________ 

13 

14 ________________ 

15 Administrator 

16 

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

18 

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

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

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

22 § 152.5 Pests. 

23 * * * * * 

24 (a) * * * 

25 (b) * * * 

26 (c) * * * 

27 (d) Any fungus, bacterium, virus, prion, or other microorganism, except for 

28 those on or in living man or other living animals and those on or in processed food or 

29 processed animal feed, beverages, drugs (as defined in FFDCA sec. 201(g)(1)) and 

30 cosmetics (as defined in FFDCA sec. 201(i)). 

31 [FR Doc. ??–????? Filed ??–??–??; 8:45 am] 

32 BILLING CODE 6560–50–S