HomeMy WebLinkAboutF&G - Notice of Proposed Changes in Regulations - Commercial Use and Possession of Native Rattlesnakes for Biomedical and Therapeutic Purposes i
Commissioners STATE OF CALIFORNIA Valerie Termini,Executive Director
Eric Sklar,President Edmund G.Brown Jr.,Governor 1.416 Ninth Street, Room 1320
Saint Helena Sacramento,CA 95814
Jacque Hostler-Carmesin,Vice President (916)653-4899
McKinleyville Fish and Game Commission www.fgc.ca.gov
Anthony C.Williams,Member
Huntington Beach BUT113UAI Ni'. 1
Russell E.Burns,Member '4VIXAUON
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Peter S.Silva,Member 45 04 2017
EI Cajon
1U1WV11J: CAL,FOR'qA
Wildlife Heritage and Conservation
Since 9870
August 1, 2017
This is to provide you with a copy of the notice of proposed regulatory action relative to
adding Section 42, and subsection (a)(2) of Section 703, and amend subsection (c) of
Section 43 and subsection (a) of Section 651, Title 14, California Code of Regulations,
relating to commercial use and possession of native rattlesnakes for biomedical and
therapeutic purposes, which will be published in the California Regulatory Notice
Register on August 4, 2017.
Please note the date of the public hearing related to this matter and associated
deadlines for receipt of written comments.
Additional information and all associated documents may be found on the Fish and
Game Commission website at.hftp://www.fgc.ca.gov/regulations/2017/index.asp .
Laura Patterson, Senior Environmental Scientist Specialist, Department of Fish
and Wildlife, (916) 445-6456, has been designated to respond to questions on the
substance of the proposed regulations.
Sincerely,
berrii iemann
Associate Governmental Program Analyst
Attachment
TITLE 14. Fish and Game Commission
Notice of Proposed Changes in.Regulations
NOTICE IS HEREBY GIVEN that the Fish and Game Commission (Commission),
pursuant to the authority vested by Section 5061 of the Fish and Game Code,
Section 597 of the Penal Code, Sections 11503 and 11506 of the Government Code
and to implement, interpret or make specific Sections 5060 and 5061 of the Fish and
Game Code, Section 597, of the Penal Code; Sections 11503 and 11506 of the
Government Code, proposes to add Section 42 and subsection (a)(2) of Section 703,
and amend subsection (c) of Section 43 and subsection (a) of Section 651,-relating to
Commercial Use and Possession of Native Rattlesnakes for Biomedical and
Therapeutic Purposes
Informative DigestlPolicy Statement Overview
The Fish and Game Commission (Commission) received a petition in 2015 to amend
existing regulations or adopt new regulations that would allow for the commercial use of
native rattlesnakes to develop antivenom, vaccines, and other therapeutic agents. The'
Commission approved the petition request at its February 11, 2016 meeting in
Sacramento and forwarded it to the Department of Fish and wildlife (Department) for
evaluation. Department staff met with the petitioners during 2016 to gather additional'
information. The petitioners had initially proposed using "nuisance" snakes collected by
rattlesnake removal businesses for this purpose, as well as raising the possession limit
on native rattlesnakes for aversion trainers. However, those proposals would have
required additional public outreach and scoping of affected businesses that would have
greatly delayed the development of the new regulations. Therefore, with the petitioners'
consent, the Department narrowed the scope of the regulatory proposal to address only
commercialized use of native rattlesnakes for venom extraction in conjunction with
research and development of biomedical and therapeutic agents. In addition,.the
Department added propagation of native rattlesnakes at the request of the petitioners.
The Commission has the statutory authority to adopt regulations for the commercial use
of native reptiles pursuant to Fish and Game Code Section 5061. Currently, there are
only two authorized commercial activities in California: captive propagation and-sale of
three species of snakes, which is allowed under Section 43, and wild collection and sale
of native reptiles by Biological Supply Houses,which is allowed under Section 651.
Venom from rattlesnakes differs by species, and in some cases by location within the
species. For example, Southern Pacific Rattlesnake (Crotalus oreganus hellen) venom
has unique properties that differ across its range. Antivenom and vaccines that are.
derived from different species of rattlesnakes than the species that inflicted the bite are
less effective, and sometimes not effective at all, in treatment of the bite. Currently, the
only way antivenom, vaccines, and therapeutic agents can be derived from native
rattlesnakes in California is through non-commercial research and development through
a valid Scientific Collecting Permit pursuant to Section 650. However, Biological Supply
Houses can collect native rattlesnakes and sell them to out-of-state scientific and
educational facilities that develop and sell these products.
Existing Regulations
The text of Section 42 was repealed in January 2002, but the title and note are still
listed in Title 14, Code of Regulations.(CCR). Section 43 contains regulations for the
..captive propagation of native reptiles and sale of three species of native snakes.
Section 651 regulations specify the wild collection and sale of native reptiles by
Biological Supply Houses,
Proposed Regulations
The proposed Section 42 regulation will allow California businesses to develop and sell
regionally specific antivenom, vaccines, and therapeutic agents derived from native
rattlesnake venom that would benefit human, pet, and livestock health. The new permit
is structured to allow for:
1. Businesses which seek to maintain live native rattlesnake species for venom
extraction and develop and sell therapeutic products from the native rattlesnake
venom, or
2. Businesses which only intend to develop and sell therapeutic products from the .
native rattlesnake venom.
In addition, it is necessary to make minor amendments to Sections 43, 651, and 703 to
provide consistency and clarity with the proposed Section 42.
Subsection (a) of Section 42 details the activities.that the activities that allowed with a
commercial native rattlesnake permit issued by the Department.
Subsection (b) of Section 42 specifies that this regulation does not supersede any other
federal, state, or local laws regulating or prohibiting possession of native rattlesnakes or
the activities authorized under.a commercial native rattlesnake permit.
Subsection (c) of Section 42 lists the species of native rattlesnakes that may be used
under this regulation.
'Subsection (d)of Section 42 specifies regulations for the permit application, fees,
duration of permit, and qualification requirements, such as minimum qualifications, letter
of reference, statement of purpose, an emergency action plan, an initial inspection and
minimum age. A separate permit is proposed for each facility housing native rattlesnake
species or creating products from venom extracted from native rattlesnake species.
The proposed regulation establishes a new 2018 Commercial Native Rattlesnake
Permit Application (Form DFW 1044 (New 412017)), which is incorporated by reference
herein.
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Subsection (e) of.Section 42 describes the general conditions associated with
possessing a permit pursuant to this section, including agreeing to random inspections,
ability to transfer or exchange rattlesnakes among permittees, prohibition of-release into
the wild, and conditions under which applications will be denied or permits will be
revoked.
Subsection (f) of Section 42 describes the humane care and treatment that permittees
must provide to native rattlesnakes possessed under this regulation. It includes
requirements on enclosure size, substrate, and cleanliness; appropriate food and water;
pest control; and observation and handling.
Subsection (g) of Section 42 describes the requirement for each facility to maintain an
Emergency Action Plan and the minimum contents of that plan in the event of a bite,
escape, or emergency evacuation.
Subsection (h) of Section 42 describes the records a permittee must maintain while.
operating under a permit pursuant*to this section and the duration the records must be
kept and made available to the department. The proposed regulation establishes a new
Commercial Native Rattlesnake Permit Record (Form DFW 1044A (New 412017)),
which is incorporated by reference herein.
Subsection (i) of Section 42 describes the annual reporting,requirements under the
regulation.
Subsection 0) of Section 42 describes the terms of shipping live native rattlesnakes
under the authority of this regulation and clarifies that this regulation does not
supersede any federal, state, local, or shipping entity's rules regarding shipment of live
rattlesnakes,
Subsection (c) of Section 43 restricts the pale, possession, transportation, importation,
exportation, and propagation of native reptiles for commercial purposes except as
provided in subsection 40(f) and the species identified within Section 43. To ensure
consistency with the new regulation, this amendment adds an exception for entities
permitted through Section 42.
Subsection (a) of Section 651 limits the sale of native reptiles and amphibians to
scientific or educational institutions to biological supply houses that operate under a
permit issued by the Department. This proposed amendment states that persons who
hold a valid commercial native rattlesnake permit issued by the department and
commercial developers of biomedical or therapeutic agents shall be considered
scientific and educational institutions for the purposes of this section.
Subsection (a)(2)-of.Section 703 specifies the forms and fees associated with the
Commercial Native Rattlesnake Permit.
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FORMS INCORPORATED BY REFERENCE
2018 Commercial Native Rattlesnake Permit Application
Form DFW 1044 (New 4.2017)
Commercial Native Rattlesnake Permit Record
Form DFW 1044A (New 412017)
BENEFITS OF THE REGULATIONS
Allowing for limited collection and possession of native rattlesnakes as described in
Section 42 is expected to result in more effective and cheaper antivenom and vaccines
as well as other therapeutic agents.
CONSISTENCY WITH STATE AND FEDERAL REGULATIONS
Article IV, Section 20 of the State.Constitution specifies that the Legislature may
delegate to the Fish and Game Commission such powers relating to the protection and
propagation of fish and game as the Legislature sees fit. The Legislature has delegated
to the Commission the power to regulate commercial take of native reptiles (Fish &
Game Code, §5061). The Commission has reviewed its own regulations and finds that
the proposed regulations are neither inconsistent nor incompatible with existing state
regulations. The Commission has searched the California Code of Regulations and
finds no other state agency regulations pertaining to native rattlesnakes. Further, the
Commission has determined that the proposed regulations are neither incompatible nor
inconsistent with existing federal regulations.
NOTICE IS ALSO GIVEN that any person interested may present statements, orally or
in writing, relevant to this action at a hearing to be held at the SpringHill Suites by
Marriott, 900 EI Camino Real, Atascadero, California, on Wednesday, October 11,
2017, at 8:00 a.m., or as soon thereafter as the matter may be heard. It is requested,
but not required, that written comments be submitted on or before 5:00 p.m. on
September 28, 2017 at the address given below, or by email to FGC f c_ca. ov.
Written comments mailed, or emailed to the Commission office, must be received
before 12:00 noon on October 6, 2017. All comments must be received no later than
October 11, 2017, at the hearing. If you would like copies of any modifications to this
Availability of Documents
The Initial Statement of Reasons, text of the regulations, as well as all related
documents upon which the proposal is based (rulemaking file), are on file and available
for public review from the agency representative, Valerie Termini, Executive Director,
Fish and Game Commission, 1416 Ninth Street, Box 944209, Sacramento, California
94244-2090, phone (916) 653-4899. Please direct requests for the above mentioned
documents and inquiries concerning the regulatory process to Valerie Termini or Sheri
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Tiemann at the preceding address or phone number. Laura Patterson, Department of
Fish and Wildlife, has been designated to respond to questions on the substance
of the proposed regulations. Ms. Patterson can be reached at(916) 341-6981 or
Laura.Patterson&-wildlife.ca.gov. Copies of the Notice of Proposed Action, the Initial
Statement of Reasons, and the text of the regulation in underline and strikeout can be
accessed through our website at http://www.fgc.ca.gov.
Availability of Modified Text
If the regulations adopted by the Commission differ from but are sufficiently related to
the action proposed, they will be available to the public for at least 15 days prior to the
date of adoption. Any person interested may obtain a copy of said regulations prior to
the date of adoption by contacting the agency representative named herein.
If the regulatory proposal is adopted, the final statement of reasons may be obtained
from the address above when it has been received from the agency program staff.
Impact of Regulatory Action/Results of the Economic Impact Assessment
The potential for significant statewide adverse economic impacts that might result from
the proposed regulatory action has been assessed, and the following initial
determinations relative to the required statutory categories have been made:
(a) Significant Statewide Adverse Economic Impact Directly Affecting Businesses,
Including the Ability of California Businesses to Compete with Businesses in
Other States:
The proposed action will not have a significant statewide adverse economic
impact directly affecting business, including the ability of California businesses to
compete with businesses in other states. It establishes the ability for California
companies to compete with out-of-state companies in the development and sale
of pharmaceutical products derived from native rattlesnakes.
(b) Impact on the Creation or Elimination of Jobs Within the State, the Creation of
New Businesses or the Elimination of Existing Businesses, or the Expansion of
Businesses in California; Benefits of the Regulation to the Health and Welfare of
California Residents, Worker Safety, and the State's Environment:
The Commission does not anticipate significant impacts on the creation or
elimination of jobs, the creation of new business, the elimination of existing
businesses or the expansion of businesses in California due to the limited
number of anticipated permit applications.
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The Commission anticipates benefits to the health and welfare of California
residents through the development of improved therapeutic agents to treat
rattlesnake bites in pets and domestic livestock. The Commission does not
anticipate any non-monetary benefits to worker safety.
(c) Cost Impacts on a Representative Private Person or Business:
The Commission estimates that a representative private person or business
would necessarily incur $815 in permitting and inspection costs in the first year
and $113. in annual costs in reasonable compliance with the proposed action.
(d) Costs or Savings to State Agencies or Costs/Savings.in Federal Funding to the
State:
The Commission anticipates revenue to recover the.Department's administrative
costs from initial inspections and permit fees for the first year from each business
and annual renewal fees thereafter. The proposed action will not affect any other
State Agency.
(e) Nondiscretionary Costs/Savings to Local Agencies: .
None.
(f) Programs Mandated on Local Agencies or School Districts:
None.
(g) Costs Imposed on Any local Agency or School District that is Required to be
Reimbursed Under Part 7 (commencing with Section 17500) of Division. 4,
Government Code:
None.
(h) Effect on Housing Costs:
None.
Effect on Small Business
It has been determined that the adoption of these regulations may affect small business.
The Commission has drafted the regulations in Plain English pursuant to Government
Code-Sections 11342.580 and 11346,2(a)(1).
Consideration of Alternatives
The Commission must determine that no reasonable alternative considered by the
Commission, or that has otherwise been identified and brought to the attention of the
Commission, would be more effective in carrying out the purpose for which the action is
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proposed, would be as effective and less burdensome to affected private persons than
the proposed action, or would be more cost effective to affected private persons and
equally effective in implementing the statutory policy or other provision of law.
FISH AND GAME COMMISSION
Valerie Termini
Dated: July 18, 2017 Executive Director
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