Action
Final Rule.
Summary
With
this final rule EPA declares a prion (i.e., proteinaceous
infectious particle) to be a “pest” under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) and amends the regulations to expressly include
prion within the regulatory definition of pest. This final rule also amends
existing pesticide product performance data requirements to clarify that
efficacy data are required for pesticide products with prion-related claims. In
addition, EPA is announcing the availability of final test guidelines on
generating the product performance data for prion-related pesticide
products.
Unified Agenda
Prions; Amendment of EPA?s Regulatory Definition of Pests to Include Prion
4 actions from January 26th,
2011 to November 2012
- DATES:
- ADDRESSES:
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- I. Executive Summary
- A. Does this action apply to me?
- B. What is the agency's authority for taking this action?
- C. What action is the agency taking?
- D. What are the incremental costs and benefits of this action?
- II. Background
- A. What is a prion?
- B. Regulatory History of Products With Prion-Related Claims
- C. Data Requirements for Pesticides
- D. Test Guidelines Used To Develop Data for Submission to EPA
- III. Public Comments on the Proposed Rules
- A. Public Comments on the January 2011 Proposal
- B. Public Comments on the November 2011 Supplemental Proposed Rule
- IV. The Final Rule
- V. FIFRA Mandated Reviews
- VI. Statutory and Executive Order Reviews
- A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
- B. Paperwork Reduction Act (PRA)
- C. Regulatory Flexibility Act (RFA)
- D. Unfunded Mandates Reform Act (UMRA)
- E. Executive Order 13132: Federalism
- F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
- G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
- H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use
- I. National Technology Transfer and Advancement Act (NTTAA)
- J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations
- VII. Congressional Review Act
- VIII. References
- List of Subjects in 40 CFR Parts 152, 158 and 161
- PART 152—[AMENDED]
- PART 158—[AMENDED]
- PART 161—[AMENDED]
This final rule is
effective April 29, 2013.
ADDRESSES: Back to Top
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2010-0427, is available at http://www.regulations.gov or at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in the EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. In addition to being available in the docket, a copy of the final test guidelines titled “Product Performance Test Guidelines, OCSPP 810.2700: Products with Prion-Related Claims” is available online at http://epa.gov/ocspp/pubs/frs/home/testmeth.htm.
Melba
Morrow, Antimicrobials Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;
telephone number: (703) 308-2716; fax number: (703) 308-6467; email address: morrow.melba@epa.gov.
A. Does this action apply to me?
You may be potentially
affected by this action if you apply for or own pesticide registrations. The
following list of North American Industrial Classification System (NAICS) codes
is not intended to be exhaustive, but rather provides a guide to help readers
determine whether this document might apply to them. Potentially affected
entities may include, but are not limited to:
- Producers of pesticide products (NAICS code 32532).
- Producers of antimicrobial pesticides (NAICS code 32561).
- Veterinary testing laboratories (NAICS code 541940).
- Medical pathology laboratories (NAICS code 621511).
- Taxidermists, independent (NAICS code 711510).
- Surgeons (NAICS code 621111).
- Dental surgeons (NAICS code 621210).
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). In particular, the final rule is issued pursuant
to FIFRA section 25(a) (7 U.S.C. 136w(a)).
C. What action is the agency taking?
EPA declares a prion (i.e., proteinaceous infectious particle) to be a “pest” under
FIFRA, and amends its regulations to expressly include prion within the
regulatory definition of pest. Since 2003, EPA has considered 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, subject to
some possible exceptions, 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 rule codifies the Agency's current
interpretation of FIFRA with respect to prions. The amendment of the definition
of “pest” in EPA's regulations, together with the formal declaration under FIFRA
section 25(c)(1) that a prion is a pest, eliminates any confusion about the
status of prion-related products under FIFRA. 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.
EPA is also amending
its product performance data requirements to clarify that efficacy data are
required for all products with prion-related claims. The existing product
performance data requirements already require efficacy data to be submitted when
the “pesticide product bears a claim to control pest microorganisms that pose a
threat to human health and whose presence cannot readily be observed by the user
including, but not limited to, microorganisms infectious to man in any area of
the inanimate environment * * * .” Since this general product performance data
requirement applies to products with prion-related claims, EPA is amending the
regulation to specifically identify the efficacy data that are required for
products with prion-related claims. In addition, EPA is announcing the
availability of final test guidelines concerning the generation of product
performance data for prion-related products.
D. What are the incremental costs and benefits of this action?
This final rule will:
(a) Codify the Agency's current interpretation of FIFRA by adding “prion” to the
list of pests in 40 CFR 152.5, and
(b) amend the pesticide data requirement regulations to clarify that efficacy
data are required to support the registration of all end-use products which bear
label claims to reduce the infectivity of prions. The qualitative benefits of
this final rule relate to the protection of human health and the environment by
subjecting prion-related products to regulation under FIFRA, including all data
and labeling requirements. The incremental costs of this rule are estimated to
range from $424,000 to $4.72 million per pesticide registration action. See also
Unit VI.A.
A. What is a prion?
snip...
snip...see full text ;
Tuesday, February 14, 2012
White House budget proposes cuts to ag programs including
TSE PRION disease aka mad cow type disease
Wednesday, January 26, 2011
Declaration of Prion as a Pest Under FIFRA and Amendment
of EPA's Regulatory Definition of Pests To Include Prion EPA-HQ-OPP-2010-0427
EPA-HQ-OPP-2010-0427
Friday, March 27, 2009
Scientific Issues Associated with Designating a Prion as
a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
and Related E March 31 - April 1, 2009
Friday, February 08, 2013
*** Behavior of Prions in the Environment: Implications for Prion Biology
Wednesday, February 20, 2013
World Organization for Animal Health Recommends United
States' BSE Risk Status Be Upgraded
Statement from Agriculture Secretary Tom Vilsack:
Thursday, February 14, 2013
The Many Faces of Mad Cow Disease Bovine Spongiform
Encephalopathy BSE and TSE prion disease
Thursday, February 21, 2013
National Prion Disease Pathology Surveillance Center
Cases Examined January 16, 2013
TSS
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