Guatemala: An evaluation of Biosafety Regulations

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Dec 5, 2012 (4 years and 11 months ago)

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Guatemala: An
evaluation of

Biosafety Regulations

Drew L. Kershen

Earl Sneed Centennial Professor

Univ. of Oklahoma, College of Law

Copyright 2007, all rights reserved

Guatemala:

Objectives


Comply with International Obligations


World Trade Organization (WTO) Agreements


Cartagena Protocol on Biosafety (CPB)


Seek compatibility between both obligations


Focus on Agricultural Biotechnology


Encourage innovation, science and investment


Develop the agricultural sector


Insure food and feed safety


Protect environmental values and resources


Promote health and general welfare


Promote Science Based Regulatory Policy


Unless Guatemala uses science, cannot fulfill the two
prior objectives


i.e. comply and focus

Way Forward:

General Ideas


Rely upon 20+ years research and 10+
years commercial use of agricultural
biotechnology


Do not repeat what has already been done
properly and correctly


Improve what has already functioned well


Use existing Guatemalan laws and regulations


e.g. Acuerdo Ministerial No. 386
-
2006 (AM 386)


Use Models that support, rather than
undermine, the objectives of Guatemala


e.g. Libro de referencia de normativas sobre
seguridad de la biotechnolog
í
a,
http://www.arentfox.com/modelbiosafetyact.html

Transgenic Crops:

Food and Feed and Processed


Cartagena Protocol


Art. 11: excludes from
Advance Informed
Agreement (AIA)


Art. 18: Documents


Art. 13: simplified
procedures of notification
or exemption


Notification from Art. 18


Art. 14: agreements and
arrangements


Additional impositions raise
significant questions of
WTO violations


Not science based


Discriminate against like
products


Excessive and disguised
barriers


Guatemala


Learn that these have
approvals and safety in
country of export


Direct notification


Biosafety Clearing House


Nothing else required to
comply with CPB and WTO


Risk assessment already
done in country of export


Decisions on science
already done in country of
export


If any additional
questions, use the existing
laws of Guatemala on food
and feed safety


clearly
identify the safety issue,
such as a legitimate
concern of toxic mixture


Transgenic Crops:

Introduction into the Environment


Cartagena Protocol


(CBD) Convention on
Biological Diversity:
“conservation and
sustainable use of
biological diversity”


Arts. 7
-
10, Arts. 15
-
16,
AIA procedures, risk
assessment, and risk
management


Core articles and core
concern


Compatible with WTO if:


Based in science


Nondiscriminatory


Not excessive or disguised
barriers to trade


Guatemala


AM 386


AM Arts. 4
-
14


equivalent
AIA, risk assessment and risk
management


AM Arts. 15
-
16


technical
scientific advice
--

coordinate


Make nondiscriminatory, i.e.
for all introductions not just
for export production


AM Arts. 18
-
20


CPB Arts 13
& 14: simplified procedures


Approvals in other nations


Rely on already done risk
assessments and risk
management plans


Only reconsider if a specific,
legitimate additional concern
about biodiversity


Approvals should be final


transparent, clear, and
certain

Transgenic Organisms:

Contained Use, Pharmaceuticals, and Transit


Cartagena Protocol


Arts. 5 & 6


AIA does
not apply


Recognizes and defers
to other laws and
agreements


Compatible with WTO


Outside the scope of
CPB, no conflict possible


Focus shifts:
compatibility of other
laws with WTO


Concept especially of
nondiscrimination
between like products



Guatemala


AM 386


amend to
delete references to
contained use


Field trials


Laboratory
experiments


Rely upon existing laws
and regulations


No need for special
laws or regulations for
transgenic organisms


Rely upon good
laboratory practices,
good plant breeding
protocols, good
scientific practices


100 years of scientific
plant breeding

Cartagena Concepts:

Unrelated and Unneeded


Socio
-
economic
considerations


CPB Art. 26: “… may take
into account, consistent
with their international
obligations …”


Permissive, not
mandatory


WTO obligations are
based in science, not
socio
-
economic
considerations


Guatemala need not and
should not include socio
-
economic considerations in
its biosafety laws.


Liability and redress


CPB Art. 27 “…
appropriate elaboration of
international rules and
procedures …”


The appropriate
elaboration is no
international rules and
procedures


Guatemala need not
address liability and
redress in its biosafety
laws


Use existing laws for
comparable harms and
damages, if any


Environmental laws about
damage should be
nondiscriminatory


i.e.
should be general laws
that do not single out
transgenic crops


General Concepts:

Unrelated and Unneeded


Consumer labeling


Not addressed in CPB


Guatemala


Use existing laws and
regulations about
consumer labeling


Label for safety and
nutrition


need to
know information


Voluntary labels for
niche markets at the
cost of the retailer and
consumer seeking niche
product


Genetic resources and
benefit
-
sharing


Not addressed in CPB


CBD and International
Treaty on Plant Genetic
Resources for Food and
Agriculture (PGRFA)


Guatemala


Transgenic agriculture
is only distantly related
to these concerns.


Address in laws that are
separate and distinct
from biosafety laws.


Guatemala:

A Law Focused on


Agricultural Biotechnology


Can be compatible with CPB and WTO
obligations.


Can be transparent, clear, and certain.


Can provide a science
-
based regulatory
policy while avoiding unrelated and
unneeded concepts.


Can promote the benefits of modern plant
breeding for the good of Guatemalan
society without compromising health and
environmental safety.


Libro de referencia de normativas sobre
seguridad de la biotecnolog
í
a


a Model

Thank you.

I welcome questions and further
discussions on these very important
issues for the benefit of Guatemala and
other developing nations.