HomeMy WebLinkAboutF&G - Transgenic Definition (2) Commissioners STATE OF CALIFORNlA Sonke Mastrup,Executive Director
Jack Baylis,President Edmund O.Brown Jr.,Governor 1416 Ninth Street,Room 1320
Los Angeles Sacramento,CA 95814
Jim Kellogg,Vice President (916)653-4899
Discovery Bay Fish and, Game Commission
Jacque Hostler-Carmesin,Member www,fgc.ca.gov
McKinleyville
Eric Sklar,Member
Saint Helena Via
Anthony C.Williams,Member
Huntington Beach
Wildlife Heritage and Conservation
Since 1870
tit) (jr.
August 20, 2015 00011
TO ALL INTERESTED AND AFFECTED PARTIES:
This is to provide you with a copy of the notice of proposed regulatory action relative to
Sections 1.92 and 70,3, Title 14, California Code of Regulations, relating to Transgenic
Definition; Application and Fee Regulations, which will be published in the California
Regulatory Notice Register on August 21, 2015.
Please note the date of the public hearing related to this matter and associated
deadlines for receipt of written cornments.
Mr. Roger Bloom, Department of is and Wildlife, one 916-445-3777, has been
designated to respond to questions on the substance of the proposed
regulations.
Sincerely,
on Sne m
AssociateGovern ental Program Analyst
Attachment
/U
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 Sections 200, 202, 205, 210, 220, 395, 396, 398,
713, 1002, 1050, 1053, 1745, 2116, 2116.5, 2117, 2118, 2120, 2122, 2125, 2150,
2150.2, 2150.4, 2151, 2157, 2190, 2193, 2271, 3005.5, 3007, 3503, 3503.5, 3511,
3513, 3950, 10500, 12000 and 12002, Fish and Game Code and to implement, interpret
or make specific Sections 1050 and 2271, of said Code; and Title 50, Code of Federal
Regulations, Parts 21.29 and 21.30, proposes to amend Sections 1.92 and 703,
Title 14, California Code of Regulations, relating to Transgenic Definition; Application
and Fee Regulations.
Informative Digest/Policy Statement Overview
Current law provides for a definition of"transgenic" as:
"Genetically altered by introducing DNA (1) from another species or (2) through
engineered endogenous constructs by means such as but not limited to recombinant
DNA and RNA techniques to produce, gene addition, deletion, and doubling, or
changing the position of the gene. This definition excludes DNA vaccines, individuals
produced by the techniques of whole genome ploidy manipulation, and hybridization
between closely related species, as in traditional hybridization." - Section 1.92, Title
14, CCR
The Department's review of the current definition of transgenic in Section 1.92 has
revealed several vulnerabilities that could prevent the Commission and the Department
from adequately protecting native fish, wildlife, and plants from the threat of predation
by, competition with, or hybridization with potentially threatening transgenic animals.
First, the definition is structured around a finite list of prohibited methods of genetic
manipulation coupled with a finite list of exceptions to that prohibition.
A producer of transgenic animals could evade the protections set forth in Title 14,
sections 671 and 671.1 (relating to restricted species permits), which incorporate the
transgenic definition in Section 1.92, by withholding the first generation of animals
subject to direct genetic manipulation and by importing, distributing, and selling only the
progeny of that first generation.
Also, as currently written, the definition excludes "hybridization between closely related
species" but does not expressly indicate that to qualify for the exemption such
hybridization cannot involve transgenic animals. If this interpretation were to prevail it
would undermine the entire regulatory program by allowing any producer of transgenic
animals to evade regulatory protections merely by importing, distributing, and selling
only those transgenic animals that had been hybridized with other lines of transgenic
animals.
Current law also provides for regulatory protections of the state from detrimental
animals as set forth in Title 14, Section 671:
671(a): "It shall be unlawful to import, transport, or possess live animals restricted in
subsection (c) below except under permit issued by the department."
671(b): `:..Those species listed because they pose a threat to native wildlife, the
agriculture interests of the state or to public health or safety are termed "detrimental
animals"and are designated by the letter"D"..."
671(c)(11): "Transgenic Aquatic Animals.
Includes freshwater and marine fishes, invertebrates, amphibians, and reptiles (D).
Note: Unpermitted transgenic aquatic animals are determined to be detrimental to
native wildlife, therefore the exemption provided for in Fish and Game Code Section
2150(e) is not applicable."
Fish and Game Code, §2150(e) "Any university, college, governmental research
agency, or other bona fide scientific institution, as defined in regulations adopted by the
commission, engaging in scientific or public health research is exempt from any permit
requirement pursuant to this chapter except for animals whose importation,
transportation, or possession is determined by the department, in cooperation with the
Department of Food and Agriculture, to be detrimental or cause damage to agriculture,
native wildlife, or the public health or safety."
The Department's proposed revision to the definition of transgenic addresses each of
these vulnerabilities and, in doing so, seeks to enhance the ability of the Commission
and the Department to protect native fish, wildlife, and plants.
It also includes an exemption process for a determination to be made by the
Department to render a decision to label a particular transgenic aquatic animal
(aquarium fish) as "not detrimental" and therefore not subject to Section 671 and
subsection 671.1(a)(8), Title 14, CCR.
The Department is proposing the following regulatory changes:
• Delete the present definition of transgenic in Section 1.92.
• . Add a new subsection (a) to Section 1.92 defining transgenic to include all animals
"whose genome has been deliberately altered, modified, or engineered through
means not possible under natural conditions, by insertion of a foreign gene or genes
using genetic engineering methods." This definition is supplemented by four
subsections further defining the scope of the definition, which include the following:
o Subsection (a)(1) clarifies that an animal is transgenic if it contains any
artificially transferred genetic material, even if that material is not directly
"from another species."
a Subsection (a)(2) includes a non-exclusive list of examples designed to
address some of the most common methods for genetic manipulation.
o Subsection (a)(3) includes an explicit statement that the "progeny of a
transgenic animal or any animal that is the result of breeding involving
transgenic animals is transgenic within the meaning of this section."
o Subsection (a)(4) reiterates and refines provisions in the existing definition
that indicate that animals subject to standard breeding and hybridization
practices commonly used by fish hatcheries (when no transgenic animals are
involved), whole genome ploidy manipulation, and therapeutic treatment with
DNA vaccine are not transgenic.
• Add a new subsection (b) to Section 1.92 which includes a narrowly circumscribed
exemption to cover certain transgenic aquarium animals subject to the following
restrictions:
o The transgenic animals will be maintained in closed systems and not placed
in the waters of the state; and
o the Department has determined the transgenic animals are "not detrimental"
and pose no risk to native fish, wildlife, or plants; and
a to qualify for this exemption, the person or entity seeking to import, possess,
distribute and sell transgenic aquatic animals within California must submit a
letter of application, based on credible science; and
o to qualify for this exemption, the person or entity seeking to import, possess,
distribute, and sell individual transgenic aquatic animals within California must
pay a nonrefundable application fee.
• Amend Section 703 by adding a new subsection 703(a)(3) which describes the
application process, requirements, and nonrefundable fee of$4,790 to cover the
Department's costs incurred in processing the application, and the Department's
findings.
Benefits of the Proposed Regulations
The proposed revisions to the definition of transgenic will improve the protection of the
environment and the state's fish, wildlife,and plant resources by providing a modern
definition that accounts for future changes in genetic methods and eliminates potential
loop holes associated with the progeny of transgenic animals or animals resulting from
hybridization with transgenic animals. The new application and approval process for
certain transgenic aquatic animals will allow the Department to thoroughly review
relevant scientific data to determine there is no reasonably foreseeable risk to native
fish, wildlife, or plants. If supported by credible scientific evidence, the Department may
make a determination that the animal is not detrimental and therefore not subject to
Section 671 and subsection 671.1(a)(8).
Evaluation of Incompatibility with Existing Regulations
The proposed regulations are neither inconsistent nor incompatible with existing State
regulations. The Legislature has delegated authority to the Commission to adopt
regulations for ornamental marine or freshwater plants and animals that are not utilized
for human consumption or bait purposes and are maintained in closed systems for
personal, pet industry, or hobby purposes (Fish and Game Code, Section 2271). The
proposed regulations are consistent with current restricted species regulations in
Section 671, Title 14, CCR. Commission staff has searched the California Code of
Regulations and has found no other State regulations related to the use of transgenic
species.
NOTICE IS GIVEN that any person interested may present statements, orally or in
writing, relevant to this action at a hearing to be held at Embassy Suites— LAX North,
9801 Airport Boulevard, Los Angeles, California, on Thursday, October 8, 2015, 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 October 6, 2015, at the address given
below, or by e-mail to FGC(c fgc.ca.gov. Written comments mailed or e-mailed to the
Commission office, must be received before 5 p.m. on October 5, 2015. All comments
must be received no later than October 8, 2015, at the hearing in Los Angeles,
California. If you would like copies of any modifications to this proposal, please include
your name and mailing address.
The regulations as proposed in strikeout-underline format, as well as an initial statement
of reasons, including environmental considerations and all information upon which the
proposal is based (rulemaking file), are on file and available for public review from the
agency representative, Sonke Mastrup, 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 Sonke Mastrup or Jon Snellstrom at the
preceding address or phone number. Roger Bloom, Department of Fish and Wildlife,
phone 916-445-3777, has been designated to respond to questions on the
substance of the proposed regulations. Copies of the Initial Statement of Reasons,
including the regulatory language, may be obtained from the address above. Notice of
the proposed action shall be posted on the Fish and Game Commission website at
hftp://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. Circumstances beyond the control of the Commission (e.g., timing of
Federal regulation adoption, timing of resource data collection, timelines do not allow,
etc.) or changes made to be responsive to public recommendation and comments
during the regulatory process may preclude full compliance with the 15-day comment
period and the Commission will exercise its powers under Section 202 of the Fish and
Game Code. Regulations adopted pursuant to this section are not subject to the time
periods for adoption, amendment or repeal of regulations prescribed in Sections
11343.4, 11346.4 and 11346.8 of the Government Code. 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 Analysis
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. The proposed regulation is likely to have a positive
effect on hobby and pet aquarium businesses within the State.
(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: The regulation is unlikely to affect jobs or businesses.
Benefits of the Regulation to the Health and Welfare of California Residents,
Worker Safety: The amendment is unlikely to affect resident's health and welfare
or worker safety. Benefits of the Regulation to the State's Environment: The
proposed amendment allows for a scientific determination to be made by the
Department that qualifying transgenic aquatic animals pose no reasonably
foreseeable risk to native fish, wildlife, or plants.
(c) Cost Impacts on a Representative Private Person or Business:
The agency is not aware of any cost impacts that a representative private person
or business would necessarily incur in reasonable compliance with the proposed
action.
(d) Costs or Savings to State Agencies or Costs/Savings in Federal Funding to the
State: None.
(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
5
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
proposed, would be as effective and fess 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
Sonke Mastrup
Dated: Executive Director
6