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Skip Navigation HomeHelpResourcesContact Us Advanced Search Start of Main Content Declaration of Prion as a Pest and Amendment of Regulatory Definition of Pests to Include Prion This Proposed Rule document was issued by the Environmental Protection Agency (EPA) For related information, Open Docket Folder Show agency attachment(s) ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2010-0427; FRL-8850-4]
SummaryEPA proposes to declare a prion (i.e., proteinaceous infectious particle) a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to amend its regulations to expressly include prion within the regulatory definition of pest. EPA currently considers a prion to be a pest under FIFRA, so a product intended to reduce the infectivity of any prion on inanimate surfaces (i.e., a “prion-related product”) is considered to be a pesticide and regulated as such. Any company seeking to distribute or sell a pesticide product regulated under FIFRA must obtain a section 3 registration, section 24(c) registration, or a section 18 emergency exemption before it can be distributed or sold in the United States. This proposed rule would codify the Agency's current interpretation of FIFRA, and provides interested parties the opportunity to comment about how it is adding prion to the list of pests in the regulatory definition of pest. This amendment, together with the formal declaration that a prion is a pest, will eliminate any confusion about the status of prion-related products under FIFRA. Codifying the Agency's current interpretation of FIFRA will not change the manner in which EPA currently regulates prion-related products under FIFRA sections 3, 24(c) and 18. Regulating prion-related products under FIFRA is appropriate for protecting human health and the environment against unreasonable adverse effects and ensuring that such products are effective.
Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805. Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2010-0427. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommendsthat you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.
For Further Information ContactJeff Kempter, Antimicrobials Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5448; fax number: (703) 308-6467; e-mail address: kempter.carlton@epa.gov. Supplementary InformationI. General InformationA. Does this action apply to me?You may be potentially affected by this action if you apply for or own pesticide registrations. Potentially affected entities may include, but are not limited to: Producers of pesticide products (NAICS code 32532).
Plasma, blood, merchant wholesalers (NAICS code 424210).This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.B. What should I consider as I prepare my comments for EPA?1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
viii. Make sure to submit your comments by the comment period deadline identified.II. BackgroundA. What action is the Agency taking?EPA has decided that under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) a prion is considered to be a pest, and proposes to declare a prion to be a pest and to explicitly include it in the lists of pests in 40 CFR 152.5. These actions would affirm the Agency's authority to regulate products distributed or sold for the purpose of reducing the infectivity of prions on inanimate surfaces (i.e., prion-related products). Prion-related products are currently regulated under FIFRA and subject to all requirements and provisions of the Act based on EPA's September 10, 2003 decision that prions share enough characteristics of an “other micro-organism” or “form of life” (as those terms are used in FIFRA) to fall within the scope of FIFRA section 2(t) and 40 CFR 152.5(d). This proposal ensures that the regulatory definition reflects the Agency's authority to regulate products distributed or sold for the purpose of reducing the infectivity of prions on inanimate surfaces (i.e., prion-related products). The primary impact of declaring that a prion is a pest and including “prion” in the regulatory definition of “pest” is to provide regulatory clarity that prion-related products must be registered or exempted under FIFRA sections 3, 24(c), or 18 before such products may be distributed or sold in the United States.
Note that not all prions and prion-related products are affected by the proposed rule. Firstly, EPA's regulations at 40 CFR 152.5(d) exclude pests “* * * in or on living man or other living animals and those on or in processed food or processed animal feed, beverages, drugs * * * and cosmetics.” Therefore, the proposed rule would not apply to those uses of prion-related products. Secondly, the definition of “pesticide” in FIFRA section 2(u) excludes new animal drugs and liquid chemical sterilants intended for use on a critical or semi-critical device. Accordingly, products which fall into those categories would not be covered by the proposed rule.B. What is the Agency's authority for taking this action?This action is issued under the authority of sections 2 through 34 of FIFRA (7 U.S.C. 136-136y).III. Prion as a Pest Under FIFRAA. What is a prion?Prions (“proteinaceous infectious particles”) may occur in the central nervous system tissues of animals as an abnormal (“misfolded”), infectious form of prion protein. Prion protein in its normal form, or conformation, can be designated PrP c (“cellular” isoform) while abnormal conformations of prion proteins are generally called prions. Different types of prions are commonly designated by the type of diseases they produce, such as PrP Sc (prions associated with scrapie) and PrP BSE (prions associated with bovine spongiform encephalopathy—mad cow disease).
In the disease process, prions (such as PrP sc) recruit normal prion proteins (PrP c) and convert them into prions (e.g., another copy of PrP Sc). This recruitment and conversion process results in the progressive accumulation of disease-producing prions. When this process takes place in the brain, it causes disease that slowly progresses from neuronal dysfunction and degeneration to death. These neurodegenerative prion diseases are known collectively as transmissible spongiform encephalopathies (TSEs). TSEs include scrapie disease in sheep, bovine spongiform encephalopathy (BSE) in cattle, chronic wasting disease (CWD) in deer and elk, kuru and variant Creutzfeld-Jakob Disease (vCJD) in humans, and similar diseases in other animals. EPA and other agencies are concerned that animal-related prions may spread to other animals (e.g., scrapie to sheep, CWD to cervids) or to humans (e.g., BSE), and that human-related prions may be passed to other humans (e.g., kuru or CJD). These diseases are always fatal in humans and animals alike, and there are no known treatments or cures.B. Legal/Regulatory BackgroundUnder section 25(c)(1) of FIFRA, the Administrator, after notice and opportunity for hearing, is authorized “to declare a pest any form of plant or animal life (other than man and other than bacteria, virus, and other micro-organisms on or in living man or other living animals) which is injurious to health or the environment.” Therefore, the Agency has the authority to decide whether or not a prion should be considered to be a pest under FIFRA and whether to issue a regulation implementing that decision.
Other Federal agencies are responsible for implementing controls to prevent the spread of prion diseases to animals and humans. For example, to eliminate scrapie within the United States, USDA's Animal and Plant Health Inspection Service (APHIS) administers the national scrapie eradication program (9 CFR parts 54 and 79). APHIS also intends to establish a herd certification program to prevent and control CWD from farmed or captive cervids in the United States (9 CFR parts 55 and 81). In addition, APHIS regulates the importation of animals and animal products into the United States to guard against the introduction of various animal diseases, including BSE (9 CFR parts 92, 93, 94, and 95). To prevent the spread of BSE through animal feed, the Food & Drug Administration (FDA) prohibits the use of most mammalian protein in the manufacture of animal feed used for ruminants and prohibits high risk cattle materials from all animal feed (21 CFR part 589). To prevent potential human exposure to the BSE agent, USDA's Food Safety and Inspection Service prohibits for use as human food cattle materials that could potentially contain the BSE agent (9 CFR 310.22). FDA has also issued an interim final rule (69 FR 42256, July 14, 2004) prohibiting the use of certain cattle materials in human food and cosmetics to address the potential risk of BSE (21 CFR 189.5 and 700.27).C. EPA's Interpretation of FIFRA1. Applicable FIFRA provisions. FIFRA section 25(c)(1) authorizes the Administrator “to declare a pest any form of plant or animal life (other than man and other than bacteria, virus, and other micro-organisms on or in living man or other living animals) which is injurious to health or the environment.” FIFRA section 2(t) defines a pest, in part, as “* * * any other form of terrestrial or aquatic plant or animal life or virus, bacteria or other micro-organism * * * which the Administrator declares to be a pest under section 25(c)(1).” These FIFRA sections provide EPA the authority to declare an entity to be a “pest” if it meets these statutory provisions.
2. EPA's interpretation of FIFRA. EPA's decision to declare a prion to be a pest under FIFRA rests on its statutory interpretation of FIFRA sections 25(c)(1) and 2(t). EPA believes that Congress intended that the phrases “any other form of plant or animal life” and “other micro-organism” be broadly interpreted to include biological entities that are injurious to humans or the environment. The following points provide EPA's rationale for this interpretation. In FIFRA, Congress has over the years used the term “other micro-organism” more broadly than most microbiologists currently would define the term because, as used in FIFRA, the term “micro-organism” includes viruses, which many microbiologists do not consider to be microorganisms. Therefore, the term “micro-organism,” as currently defined by many microbiologists, is narrower than the potential scope of the term “other micro-organism” in FIFRA.
As used in FIFRA, the term “other micro-organism” includes entities other than viruses and bacteria, but it is unclear which entities. It is reasonable to assume that it includes those entities that most microbiologists currently recognize as microorganisms (i.e., microfungi, yeasts, and protists).Because the statutory language explicitly includes viruses among micro-organisms in the definition of “pest,” the term “other micro-organism” in its statutory context reasonably may be interpreted to include some other entities that many microbiologists may not categorize as microorganisms.
Congress expressly included “prion” within another statute's definition of “pest,” namely in the Animal Health Protection Act of 2002.For these reasons, EPA concluded that a prion is appropriately included in the phrase “other micro-organism.” Because prions are also severely injurious to human and animal health, EPA has also concluded that a prion is appropriately included in the FIFRA definition of “pest.”D. EPA's Prion Science Evaluation and Efficacy Test Guidance DocumentsTo assure that this rulemaking is based on the best available scientific information, EPA reviewed and summarized the most relevant scientific studies and publications related to the issue of whether a prion is a pest in a “white paper” (Ref. 2). EPA presented the draft white paper to the FIFRA Scientific Advisory Panel (SAP) for peer review and comment on March 31 and April 1, 2009. The SAP provided comments to EPA on the draft white paper on June 29, 2009 (Ref. 3). EPA subsequently responded to the SAP's comments (Ref. 4) and made revisions to the white paper in response to the SAP comments (Ref. 5). All of these referenced documents are available in the docket for this declaration and proposed rule.IV. FIFRA Review RequirementsIn accordance with FIFRA section 25(a), EPA has submitted a draft of the proposed rule to the FIFRA SAP, the Secretary of Agriculture (USDA), and appropriate Congressional Committees. In addition, pursuant to FIFRA section 21(b), EPA submitted a draft of the proposed rule to the Secretary of Health and Human Services (HHS).
As required by FIFRA section 25(a), the written comments on the draft proposal received from USDA and HHS, along with EPA responses, are available in the docket. EPA addressed these comments as part of the interagency review process under Executive Order 12866, and changes made to the proposed rule in response to all comments received during that interagency review are documented in the docket as required by Executive Order 12866.V. Statutory and Executive Order ReviewsA. Regulatory ReviewPursuant to Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that this proposed rule is a “significant regulatory action” because this action might raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Accordingly, EPA submitted this proposed rulemaking to OMB for review under Executive Order 12866. Any changes made in response to OMB comments have been documented in the docket for this rulemaking as required by the Executive Order.
The EA estimates that three firms may seek registrations for major new use products in the first year. If all uses are high exposure (e.g., indirect food uses), the maximum potential total cost to industry in the first year would be approximately $7.05 million, and costs per firm would be approximately $2.35 million. Given the uncertainty that characterizes the market for prion-related products at this time, the Agency did not speculate further on theexpected number of registrations in subsequent years. However, registrations that occur after the initial major new use product registrations would probably be major new use amendments. Data requirements would entail only product-specific efficacy data for major new use amendments at a cost of approximately $431,000 per registration action. Approximately 80% of the firms in the pesticide manufacturing industry are small firms with revenues of $22 million, on average. A cost of $7.05 million suggests that the incremental cost per firm of $2.35 million dollars would equal nearly 11% of annual revenues. However, after the initial three registrations, a major new use amendment at a cost of $431,000 would represent fewer than 2% of average annual revenues.
One unintended consequence of using products approved for use under FIFRA section 18 exemptions is that at least one state, California, requires that such products be applied only by certified applicators. EPA further understands, however, that California has no such requirement for pesticide products that are registered under FIFRA section 3 or 24(c) that are not classified for restricted use. Hence, laboratories in California that use prion-related products registered under section 3 or 24(c) would not be subject to a certified applicator requirement. The initial cost of obtaining the certified applicator's license in California is $140, and the renewal fee is $60 every 2 years (see http://www.cdpr.ca.gov/docs/license/qac.htm). In addition, 20 hours of continuing education is required to obtain renewal. If a similar requirement is imposed by other states, the cost to laboratories for obtaining applicator licenses would probably be about the same. No such cost is associated with products registered under section 3 or 24(c).B. Paperwork ActivitiesThe information collection requirements, i.e., the paperwork collection activities, contained in this proposal are already approved by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. Specifically, the activities contained in this proposed rule are already addressed in the following information collection requests (ICRs):
Comments are requested on the Agency's need for this information, the accuracy of the burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques. Send comments to EPA as part of your overall comments on this proposed action in the manner specified underADDRESSES. In the final rule, the Agency will address any comments received regarding the information collection requirements contained in this proposed rule.C. Small Entity ImpactsPursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., after considering the potential economic impacts of this proposed rule on small entities, I hereby certify that this proposed rule would not have a significant adverse economic impact on a substantial number of smallentities. This determination is based on the Agency's economic analysis (Ref. 8), and is briefly summarized here.
EPA continues to be interested in the potential impacts of this proposed rule on small entities and welcomes comments on issues related to such impacts.D. Unfunded MandatesThis action does not contain any Federal mandates for State, local, or tribal governments or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this regulatory action will not result in annual expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or for the private sector. As described in Unit IV.A., the incremental costs for the proposed rule are estimated from $424,000 to $4.72 million. Since State, local, and tribal governments are rarely pesticide applicants, the proposed rule is not expected to significantly or uniquely affect small governments. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments. Accordingly, this action is not subject to the requirements of sections 202, 203 or 205 of UMRA.E. Federalism ImplicationsPursuant to Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), EPA has determined that this proposed rule does not have “federalism implications” because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in the Order. As indicated previously, instances where a state is a registrant are extremely rare. Therefore, this proposed rule may seldom affect a state government. Thus, Executive Order 13132 does not apply to this proposed rule.
In the spirit of the Order, and consistent with EPA policy to promote communications between the Agency and State and local governments, EPA specifically solicits comment on this proposed rule from State and local officials.F. Tribal ImplicationsAs required by Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), EPA has determined that this proposed rule does not have “tribal implications” because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in the Order. As indicated previously, at present, no tribal governments hold, or have applied for, a pesticide registration. Thus, Executive Order 13175 does not apply to this proposed rule.
In the spirit of the Order, and consistent with EPA policy to promote communications between the Agency and State and local governments, EPA specifically solicits comment on this proposed rule from tribal officials.G. Children's HealthEPA interprets Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of Executive Order 13045 has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks, and it is not designated as an “economically significant” regulatory action as defined by Executive Order 12866 (see Unit V.A.). To the contrary, this action will provide added protection for children from pesticide risk.H. Energy EffectsThis action is not a “significant energy action” as defined in Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because it is not likely to have an effect on the supply, distribution, or use of energy as described in the Order.I. Technical StandardsSection 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), 15 U.S.C. 272 note, directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, and sampling procedures) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
The Agency invites comment on its conclusion regarding the applicability ofvoluntary consensus standards to this proposed rulemaking.J. Environmental JusticeThis proposed rule does not have an adverse impact on the environmental and health conditions in low-income and minority communities. Therefore, under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), the Agency does not need to consider environmental justice-related issues.VI. ReferencesAs indicated underADDRESSES, a docket has been established for this rulemaking under docket ID number EPA-HQ-OPP-2010-0427. The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA in developing this proposed rule, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical contact listed underFOR FURTHER INFORMATION CONTACT.
3. U.S. Environmental Protection Agency. 2009. Transmittal of Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting Held March 31-April 1, 2009 on Scientific Issues Associated with Designating a Prion as a `Pest' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods. Memorandum from Myrta R. Christian, Designated Federal Official, FIFRA Scientific Advisory Panel, Office of Science Coordination and Policy, to Debbie Edwards, PhD, Director, Office of Pesticide Programs. June 29, 2009. See http://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html. 4. U.S. Environmental Protection Agency. 2010. EPA Responses to Comments by the FIFRA Scientific Advisory Panel Concerning “Scientific Information Concerning the Issue of Whether Prions Are a `Pest' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).” February 17, 2010.
List of Subjects in 40 CFR Part 152Environmental protection, Antimicrobial pesticides, Prion.
[FR Doc. 2011-1636 Filed 1-25-11; 8:45 am]BILLING CODE 6560-50-P
Attachments View All (0) View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed Mar 28 2011, at 11:59 PM ET ID: EPA-HQ-OPP-2010-0427-0002 Tracking Number: View original printed format: Document Information Date Posted: Jan 26, 2011RIN: 2070-AJ26CFR: 40 CFR Part 152Federal Register Number: 2011-01636 Show More Details Submitter Information Comments5 Comments Received* March 28, 2011
OPP Regulatory Public Docket 7502P
The following public comment... View Comment Attached are the American Chemistry Council Biocides Panel Comments on the Declaration of Prion as a Pest under FIFRA and Amendment of EPA’s Regulatory... View Comment See attached View Comment Docket Information This document is contained in EPA-HQ-OPP-2010-0427 Related Dockets: NoneRelated RINs: NoneRelated Documents: Declaration of Prion as Pest under Federal Insecticide...Declaration of Prion as a Pest Under FIFRA: Final Test...Clarification of Product Performance Data for Products with... Related Comments: View all * This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document. Document text and images courtesy of the Federal Register Home Search Advanced Search Browse By Category Learn About Us eRulemaking Program Media Toolkit Agencies Awards & Recognition Enhancements & Fixes Resources Site Data Regulatory Agenda Agency Reports Required by Statute API Overview Developers Help How to use Regulations.gov FAQs Glossary Connect With Contact Us Privacy and Security Notice User Notice Accessibility Statement Partner Sites We the People Federal Register Reginfo Congress.gov USA.gov E-Gov Opengov Participate Today!