*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 1 of 17

1 i

2 

3 Revised DRAFT (04-1as of 10-18-2010)

4 BILLING CODE 6560–50–P

5 

6 ENVIRONMENTAL PROTECTION AGENCY 

7 

8 40 CFR Part 152.5 

9 

10 i[EPA–HQ–OPP–2010-XX0427; FRL–XXXX–X] 

11 

12 i RIN 2070–[–AJ26]

13 

14 i

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

16 Definition of Pests to Include Prion

17 

18 AGENCY: Environmental Protection Agency (EPA). 

19 ACTION: Proposed rule. 

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

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

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

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

24 reduce the infectivity of any prion on inanimate surfaces (i.e., a “prion-related product”) 

25 is considered to be a pesticide and regulated as such. Any company seeking to distribute 

26 or sell a pesticide product regulated under FIFRA must obtain EPA approvala Section 3 

27 registration, Section 24(c) registration or a Section 18 emergency exemption 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 provides 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 declaration that a prion is a pest, will eliminate any 

32 confusion about the status of prion-related products under FIFRA. Codifying the 

33 Agency’s current interpretation of FIFRA will not change the manner in which EPA 

34 currently regulates prion-related products under FIFRA Sections 3, 24(c) and 18. 

35 Regulating prion-related products under FIFRA is appropriate for protecting human 

36 health and the environment against unreasonable adverse effects and ensuring that such 

37 products are effective. 

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

39 publication in the Federal Register]. 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 2 of 17

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

2 EPA–HQ–OPP–2010–XX0427, by one of the following methods: 

3 • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line 

4 instructions for submitting comments. 

5 

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

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

8 20460–0001. 

9 

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

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

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

13 (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special 

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

15 telephone number is (703) 305–5805. 

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

17 XX0427. EPA's policy is that all comments received will be included in the docket 

18 without change and may be made available on-line at http://www.regulations.gov, 

19 including any personal information provided, unless the comment includes information 

20 claimed to be Confidential Business Information (CBI) or other information whose 

21 disclosure is restricted by statute. Do not submit information that you consider to be CBI 

22 or otherwise protected through regulations.gov or e-mail. The regulations.gov website is 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

42 legal holidays. The Docket Facility telephone number is (703) 305–5805. 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 3 of 17

1 FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials 

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

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

4 5448; fax number: 703-308-6467; e-mail address: kempter.carlton@epa.gov. 

5 SUPPLEMENTARY INFORMATION: 

6 

7 I. General Information 

8 A. Does this Action Apply to Me? 

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

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

11  Producers of pesticide products (NAICS 32532 

12  Producers of antimicrobial pesticides (NAICS 32561) 

13  Veterinary testing laboratories (NAICS 541940) 

14  Medical pathology laboratories (NAICS 621511) 

15  Taxidermists, independent (NAICS 711510) 

16  Surgeons (NAICS 621111) 

17  Dental surgeons (NAICS 621210) 

18  Mortician Services (NAICS 812210)

19  Manufacturers of medical tissue devices of human and animal origin (NAICS 

20 code undetermined)

21  Manufacturers of other human cellular and tissue products (NAICS code 

22 undetermined)

23  Organ banks, body (NAICS 621991)

24  Plasma, blood, merchant wholesalers (NAICS 424210)

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

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

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

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

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

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

31 FURTHER INFORMATION CONTACT. 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 4 of 17

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

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

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

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

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

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

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

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

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

10 procedures set forth in 40 CFR Part 2. 

11 

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

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

14 (subject heading, Federal Register date and page number). 

15 ii. Follow directions. The Agency may ask you to respond to specific questions or 

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

17 number. 

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

19 language for your requested changes. 

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

21 that you used. 

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

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

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

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

26 personal threats. 

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

28 identified. 

29 II. Background 

30 A. What Action is the Agency Taking? 

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

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

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

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

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

36 the infectivity of prions on inanimate surfaces (i.e., prion-related products). Prion-related
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 5 of 17

1 products are currently regulated under FIFRA and subject to all requirements and 

2 provisions of the Act based on EPA’s September 10, 2003 decision that prions share 

3 enough characteristics of an “other micro-organism” or “form of life” (as those terms are 

4 used in FIFRA) to fall within the scope of FIFRA section 2(t) and 40 CFR 152.5(d). 

5 This proposal ensures that the regulatory definition reflects the Agency’s authority to 

6 regulate products distributed or sold for the purpose of reducing the infectivity of prions 

7 on inanimate surfaces (i.e., prion-related products). The primary impact of declaring that 

8 a prion is a pest and including “prion” in the regulatory definition of “pest” is to provide 

9 regulatory clarity that prion-related products must be registered or exempted under 

10 FIFRA sections 3 or 18, respectively, before such products may be distributed or sold in 

11 the United States. 

12 

13 Note that not all prions and prion-related products are affected by the proposed 

14 rule. Firstly, EPA’s regulations at 40 CFR 152.5(d) exclude pests “...in or on living man 

15 or other living animals and those on or in processed food or processed animal feed, 

16 beverages, drugs...and cosmetics.” Therefore, the proposed rule would not apply to 

17 those uses of prion-related products. Secondly, the definition of “pesticide” in FIFRA 

18 Section 2(u) excludes new animal drugs and liquid chemical sterilants intended for use on 

19 a critical or semi-critical device. Accordingly, products which fall into those categories 

20 would not be covered by the proposed rule.

21 

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

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

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

25 III.Prion As Pest under FIFRA

26 A. What is a Prion?

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

28 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 29 (“cellular” 

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

31 Different types of prions are commonly designated by the type of diseases they produce, 

such as PrPSc (prions associated with scrapie) and PrPBSE 32 (prions associated with bovine 

33 spongiform encephalopathy—mad cow disease). 

In the disease process, prions (such as PrPsc) recruit normal prion proteins (PrPc 34 )

and convert them into prions (e.g., another copy of PrPSc 35 ). This recruitment and 

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

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

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

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

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

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

42 Disease (vCJD) in humans, and similar diseases in other animals. The EPA and other 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 6 of 17

1 agencies are concerned that animal-related prions from animal species may infectmay 

2 spread to other animals (e.g., scrapie to sheep, CWD to cervids) or to humans (e.g., BSE

3 from cattle converting to vCJD in humans), or ), and that human-related prions of human 

4 origin may spread.may be passed to other humans (e.g., kuru or CJD). These diseases are 

5 always fatal in humans and animals alike, and there are no known treatments or cures. 

6 B. Legal/Regulatory Background

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

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

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

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

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

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

13 

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

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

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

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

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

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

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

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

22 

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

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

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

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

27 recommendingrecommended the use of certain chemicalssodium hydroxide or sodium 

28 hypochlorite for treating surfaces and items potentially contaminated with prions even 

29 though those chemicals were not registered by EPA for that specific purpose. Subsequent 

30 to the September 2003 decision, the EPA has granted a total of 19 quarantine exemptions 

31 under FIFRA Section 18 to numerous states (California, Colorado, Maine, Minnesota, 

32 Montana, North Dakota, South Dakota, Utah, Wyoming and Maine) and USDA for the 

33 use of a commercial aqueous acid phenolic product, Environ LpH, for treatment on hard, 

34 nonporous surfaces in government and commercial laboratories contaminated with CWD 

35 and other kinds of prions. 

36 

37 Other Federal agencies are responsible for implementing controls to prevent the 

38 spread of prion diseases to animals and humans. For example, to eliminate scrapie within 

39 the United States, USDA's APHIS administers the national scrapie eradication program 

40 (9 CFR parts 54 and 79). APHIS also intends to establish a herd certification program to 

41 prevent and control CWD from farmed or captive cervids in the United States (9 CFR 

42 parts 55 and 81). In addition, APHIS regulates the importation of animals and animal 

43 products into the United States to guard against the introduction of various animal 

44 diseases, including BSE (9 CFR parts 92, 93, 94 and 95). To prevent the spread of BSE 

45 through animal feed, the FDA prohibits the use of most mammalian protein in the 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 7 of 17

1 manufacture of animal feed used for ruminants and prohibits high risk cattle materials 

2 from all animal feed (21 CFR part 589). To prevent potential human exposure to the 

3 BSE agent, USDA's FSIS prohibits for use as human food cattle materials that could 

4 potentially contain the BSE agent (9 CFR 310.22). FDA has also issued an interim final 

5 rule (69 FR 42256, July 14, 2004) prohibiting the use of certain cattle materials in human 

6 food and cosmetics to address the potential risk of BSE (21 CFR 189.5 and 700.27). 

7 

8 C. EPA’s Interpretation of FIFRA 

9 1. Applicable FIFRA Provisions 

10 

11 FIFRA Section 25(c)(1) authorizes 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 section 25(c)(1).” These 

17 FIFRA sections provide EPA the authority to declare somethingan entity to be a “pest” if 

18 it meets these statutory provisions. 

19 

20 2. EPA’s Interpretation of FIFRA 

21 

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

23 interpretation of FIFRA Sections 25(c)(1) and 2(t). EPA believes 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 are injurious to humans or the 

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

27 

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

29 more broadly than most microbiologists currently 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 microorganisms. Therefore, the term 

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

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

34 

35  As used in FIFRA, the term “other micro-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, and 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 entities that many microbiologists may not 

42 categorize as microorganisms. 

43 

44  Today, microbiologists do not generally classify viruses as microorganisms 

45 because they are not alive (i.e., they cannot reproduce sexually or asexually, 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 8 of 17

1 grow or perform self-maintenance). Therefore, the term “other micro-organism” 

2 as used in FIFRA appears broad enough to include some entities that are not alive. 

3 

4  Congress’ rationale for including viruses within the FIFRA definition of “pest” is 

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

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

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

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

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

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

11 evolve. EPA believes that Congress intended the terms “pest” and “other micro12 organism” as used in FIFRA to be broadly inclusive. 

13 

14  One entity that shares the characteristics of pathogenicity, infectivity, 

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

16 which, like viruses, is not alive) is the prion, which. A prion is an infectious 

17 conformationagent occurring in the tissues of animals that is widely, though not 

18 universally, believed to be composed of an abnormal (misfolded prion) protein 

19 that causes TSE diseases in humans and animals. without nucleic acid. Prions are 

20 also unquestionably injurious to the health of humans and other animals. They 

21 cause TSE diseases that attack the nervous system, inflict irreversible damage, 

22 and are always fatal to infected animals and humans. These infectious particles, 

23 onceOnce introduced into an animal or human, host, prions can induce neuronal 

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

25 central nervous system. Finally,formation of new prions in the animal or human 

26 host. Prions are considered among the most difficult of all biological entities to 

27 mitigate and few methods are available for effectively doing so. Moreover, 

28 current test methods cannot demonstrate complete destruction or inactivation of 

29 prions. For these reasons, EPA believes that the public needs assurance of the 

30 safety and efficacy of products intended to reduce the infectivity of prions. 

31 

32  Congress expressly included “prion” within another statute’s definition of “pest” 

33 in the Animal Health Protection Act of 2002. 

34 

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

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

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

38 FIFRA definition of “pest.” 

39 

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

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

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

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

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

45 peer review and comment on March 31 and April 1, 2009. The SAP provided comments 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 9 of 17

1 to EPA on the draft white paper on June 29, 2009 (Ref. 3). EPA subsequently responded 

2 to the SAP’s comments (Ref. 4) and made revisions to the white paper in response to the 

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

4 for this declaration and proposed rule. 

5 IV. FIFRA Review Requirements

6 

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

8 

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

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

11 Congressional Committees. 

12 

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

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

15 additional review isn’t necessary. 

16 

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

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

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

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

21 

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

23 to the Secretary of Health and Human Services (HHS). [Did they comment or not? If 

24 we got comments, include]. Comments on the draft proposal received from HHS have 

25 been addressed [or revise say they did not comment. Or say...HHS participated fully in 

26 the interagency review process under Executive Order 12866, during which EPA and 

27 HHS discussed [enter major topic areas that were raised and resolved].

28 

29 The FIFRA SAP waived its review of this proposal on June 1, 2010, because the 

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

31 additional review isn’t necessary. A copy of this waiver is available in the docket.

32 

33 As required by FIFRA section 25(a), the written comments on the draft proposal 

34 received from USDA and HHS, along with EPA responses, are available in the docket. 

35 EPA addressed these comments as part of the interagency review process under 

36 Executive Order 12866, and changes made to the proposed rule in response to all 

37 comments received during that interagency review are documented in the docket as 

38 required by Executive Order 12866. 

39 

40 V. Statutory and Executive Order Reviews 

41 

42 A. Regulatory Review 

43 

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

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

46 determined that this proposed rule is a "significant regulatory action" because this action 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 10 of 17

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

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

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

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

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

6 of the Executive Order. 

7 

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

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

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

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

12 for this rulemaking, and is briefly summarized here. 

13 

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

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

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

17 subjecting prion-related products to regulation under FIFRA, including all data and 

18 labeling requirements. In terms of costs, using pre-2003 costs as the baseline, the 

19 incremental costs of the proposed rule per registration action range from $424 thousand 

20 to $4.72 million. 

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

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

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

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

25 amendment registration. 

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

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

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

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

30 that characterizes the market for prion-related products at this time, the Agency did not 

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

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

33 probably be major new use amendments. Data requirements would entail only product34 specific efficacy data for major new use amendments at a cost of approximately $431,000 

35 per registration action. Approximately 80% of the firms in the pesticide manufacturing 

36 industry are small firms with revenues of $22 million, on average. A cost of $7.05 

37 million suggests that the incremental cost per firm of $2.35 million dollars would equal 

38 nearly 11% of annual revenues. However, after the initial three registrations, a major 

39 new use amendment at a cost of $431,000 would represent fewer than 2% of average 

40 annual revenues. 

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

42 proposed rule—pesticide registrants, users of prion-related products and researchers. The 

43 registration related requirements under FIFRA, however, are imposed on the entity that 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 11 of 17

1 registers the prion-related product. Users of prion-related products and researchers are 

2 affected indirectly. The EA summarizes potential qualitative impacts of regulating prion3 related products that were expressed by product users to EPA during its outreach efforts 

4 to these users. 

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

6 prion-related product, specifically the need for a product performance test that will 

7 measure the ability of an individual product to reduce the infectivity of prions. The 

8 Agency has developed draft test guidelines for prions which will ensure that the Agency 

9 receives the data needed to make objective and reliable determinations as to whether a 

10 prion-related product meets the Agency’s efficacy data requirements for registration. 

11 Providing clear guidance on EPA’s efficacy data requirements for prion-related products 

12 will benefit registrants by enabling them to submit relevant, correct and complete data 

13 submissions in support of applications for registration to the Agency. 

14 One unintended consequence of using products approved for use under FIFRA 

15 Section 18 exemptions is that at least one state, California, requires that such products be 

16 applied only by certified applicators. EPA further understands, however, that California 

17 has no such requirement for pesticide products that are registered under FIFRA Section 3 

18 or 24(c) that are not classified for restricted use. Hence, laboratories in CA that use 

19 prion-related products registered under Section 3 or 24(c) would not be subject to a 

20 certified applicator requirement. The initial cost of obtaining the certified applicator’s 

21 license in California is $140, and the renewal fee is $60 every two years (see 

22 http://www.cdpr.ca.gov/docs/license/qac.htm). In addition, 20 hours of continuing 

23 education is required to obtain renewal. If a similar requirement is imposed by other 

24 states, the cost to laboratories for obtaining applicator licenses would probably be about 

25 the same. No such cost is associated with products registered under Section 3 or 24(c).

26 B. Paperwork Activities 

27 

28 The information collection requirements, i.e., the paperwork collection activities, 

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

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

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

32 

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

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

35 

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

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

38 0277); and 

39 

40 3. The activities associated with the generation of data in response to a Data-Call41 In issued subsequent to registration (e.g., as part of the review of an existing registration), 

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

43 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 12 of 17

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

16 paperwork for tolerance petitions. (Ref. 8) 

17 

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

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

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

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

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

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

24 

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

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

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

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

29 validating, and verifying information, processing and maintaining information, and 

30 disclosing and providing information; adjust the existing ways to comply with any 

31 previously applicable instructions and requirements; train personnel to be able to respond 

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

33 information; and transmit or otherwise disclose the information. 

34 

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

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

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

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

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

40 regarding the information collection requirements contained in this proposal. 

41 C. Small Entity Impacts 

42 

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

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

45 entities, I hereby certify that this proposed rule would not have a significant adverse 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 13 of 17

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

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

3 

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

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

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

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

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

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

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

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

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

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

14 organizations, the analysis focuses on small businesses. 

15 

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

17 expected to apply for registrations of prion-related products. One of these firms is known 

18 to be a large firm. Given that approximately 79% of the firms in the antimicrobial 

19 industry are small firms, it is possible that any or all of the remaining two other firms 

20 could qualify as a small entity under the SBA definition. 

21 

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

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

24 prion-related products are an important market segment for sodium hydroxide or sodium 

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

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

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

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

29 testing. (Ref. 8). 

30 

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

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

33 

34 D. Unfunded Mandates 

35 

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

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

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

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

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

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

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

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

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

45 enforceable duty, contain any unfunded mandate, or otherwise have any affect on small 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 14 of 17

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

2 203 or 205 of UMRA. 

3 

4 E. Federalism Implications 

5 

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

7 10, 1999), EPA has determined that this proposed rule does not have “federalism 

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

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

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

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

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

13 Order 13132 does not apply to this proposed rule. 

14 

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

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

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

18 

19 F. Tribal Implications

20 

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

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

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

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

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

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

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

28 pesticide registration. Thus, Executive Order 13175 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 tribal officials. 

33 

34 G. Children’s Health

35 

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

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

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

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

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

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

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

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

44 for children from pesticide risk. 

45 

46 H. Energy Effects
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 15 of 17

1 

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

3 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, 

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

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

6 

7 I. Technical Standards

8 

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

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

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

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

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

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

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

16 voluntary consensus standards. 

17 

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

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

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

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

22 generate those data. 

23 

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

25 voluntary consensus standards to this rulemaking. 

26 

27 J. Executive Order 12898Environmental Justice

28 

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

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

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

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

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

34 

35 VI. References

36 

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

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

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

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

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

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

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

44 contact listed under FOR FURTHER INFORMATION CONTACT. 

45 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 16 of 17

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

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

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

4 29, 2004. 

5 

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

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

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

9 

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

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

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

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

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

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

16 Director, Office of Pesticide Programs. June 29, 2009. See 

17 http://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html

18 

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

20 FIFRA Scientific Advisory Panel Concerning “Scientific Information Concerning the 

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

22 Rodenticide Act (FIFRA).” 2-17-10. 

23 

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

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

26 Rodenticide Act. 2-17-10. 

27 

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

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

30 

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

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

33 

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

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

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

37 

38 List of Subjects in 40 CFR Part 152.5

39 

40 Environmental protection, antimicrobial pesticides, prion. 

41 

42 Dated: ________ 

43 

44 ________________

45 

46 
*** EO 12866 Review Draft – Deliberative – Do Not Cite, Quote or Release During the Review *** 

Page 17 of 17

1 _______________________

2 Administrator 

3 

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

5 

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

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

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

9 § 152.5 Pests. 

10 * * * * * 

11 (a) * * * 

12 (b) * * * 

13 (c) * * * 

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

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

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

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

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

19 BILLING CODE 6560–50–S