|
Normatividad
RELEASE
DATE: JULY 11TH, 1996, FEDERAL OFFICIAL DIARY
Mexican
Official Standard: NOM-056-FITO-1995
HEREBY
SETS FORTH ALL PHYTOSANITARY REQUIREMENTS FOR NATIONAL MOBILIZATION,
IMPORTS AND FIELD TESTS SETTLING PERTAINING TO ORGANISMS MANIPULATED
THROUGH GENETIC ENGINEERING APPLICATION.
On the edge, a seal of the National Coat- of- Arms reading:
Mexican United States.- Agriculture, Livestock and Rural Development
Ministry
MEXICAN OFFICIAL STANDARD NOM-056-FITO-1995, THROUGH WHICH
ALL PHYTOSANITARY REQUIREMENTS FOR NATIONAL MOBILIZATION,
IMPORTS AND FIELD TESTS SETTLING PERTAINING TO ORGANISMS MANIPULATED
THROUGH GENETIC ENGINEERING APPLICATION ARE SET FORTH.
Roberto Zavala Echevarría, Legal General Director
of the Agriculture, Livestock and Rural Development Ministry,
based on Articles 1st, 2nd, 6th, 23 Fraction 1, 29 and 43
detaching from the Plant Health Federal Statute; 38 Fraction
II, 40, 41, 43 and 47 Fraction IV detaching from Metrology
and Normalization Federal Statute; 35 Fraction IV detaching
from the Federal Public Administration Institution Statute;
12 Fraction XXIX and XXX detaching from the Internal Regulation
of this Entity, and
WHEREAS
Over the last ten years genetic engineering application in
plants became highly popular worldwide with different purposes
such as increase production in agricultural activities, extend
shelf- life for perishable products as well as their resistance
against pests and diseases.
Trials carried out using vegetal origin individuals manipulated
through genetic engineering must be performed under strict
control practices to ensure no unexpected effect will occur
within the agricultural environment, for such reason, mobilization
of this kind of materials as well as field tests must be carried
out according to the criteria set forth under this standard.
Our country owns a wide plants and animals variety and is
also considered worldwide as a species natural reserve. Introduction
of organisms manipulated using genetic engineering for agricultural
applications poses a high risk and thereupon, their import,
mobilization and use within national territory shall be carried
out with strict adherence to biosafety measures set forth
for such organisms.
No comments with regard to the Standard Project were received,
nevertheless it should be necessary to clarify that rights
collection was duly stated under Article 86t–C Fraction
III detaching from the Rights Federal Statute, published in
the Federal Official Diary on December 15th, 1995, through
environment release phytosanitary certificate of organisms
manipulated through genetic engineering, which shall be attached
to the Official Standard herein for the due compliance with
such legal rule.
To achieve the objectives described in paragraph hereinabove,
on December 20th, 1995; the Mexican Official Standard Project
NOM-056-FITO-1995 referred to as “Phytosanitary requirements
hereby set forth for mobilization, import and field tests
settlement, within national territory, pertaining to organisms
manipulated through genetic engineering application,”
was published in the Federal Official Diary by initiating
all formalities as described under Articles 45, 46, and 47
detaching from the Metrology and Normalization Federal Statute.
By virtue of the results arising out of the aforementioned
legal procedure hereof the MEXICAN OFFICIAL STANDARD NOM-056-FITO-1995,
WHERETHROUGH THE PHYTOSANITARY REQUIREMENTS HEREBY SET FORTH
FOR MOBILIZATION, IMPORT AND FIELD TESTS SETTLEMENT, WITHIN
NATIONAL TERRITORY, PERTAINING TO ORGANISMS MANIPULATED THROUGH
GENETIC ENGINEERING APPLICATION are both set forth and issued.
1. OBJECT AND APPLICATION SCOPE
The object of this Mexican Official Standard is to establish
control with regard to mobilization within national territory,
imports, release and assessment to the environment or experimental
tests performed to organisms manipulated through Genetic Engineering
for agricultural purposes.
Compliance with this Standard is mandatory for all official
or private institutions and individuals who may somehow intervene
in the mobilization and release to the environment processes
as well as in transgenic products evaluation.
2. DEFINITIONS
2.1 Approval: Action through which the Ministry acknowledges
either individuals or legal entities as capable to operate
as national normalization organizations, certification organizations,
verification units or tests laboratories.
2.2 Agriculture Biosafety National Committee: The Genetic
Engineering Plants Health General Direction’s ancillary
advisory organization integrated by a body of experts in related
matters.
2.3 Biological Diversity: Is understood as live organisms’
variability from any source, including, among others, terrestrial
and marine ecosystems, as well as other related aquatic ecosystems
and ecological complexes; also comprising species diversity,
diversity among the species and ecosystems as well.
2.4 Gene: Basic hereditary unit located at cell chromosomes
level and duplicated during each cellular division; this mechanism
allows hereditary characteristics transference from the progenitor
to the offspring.
2.5 Germoplasm: Set formed by the entire hereditary material
– or genetic bank – containing all possible variations
shown, among others, by one or several species, populations
and groups.
2.6 Genetic Engineering: Set of recombining deoxyribonucleic
acid and ribonucleic acid manipulation techniques, either
in vitro or under special laboratory conditions.
2.7 Phytosanitary Raw Materials: Refers to any substance
or mixture used for pest control in vegetables such as pesticides,
biological control agents, transgenic material, attracting
pheromones and pest resistant cultivated plant varieties.
2.8 The Ministry: Means Agriculture, Livestock and Rural
Development Ministry;
2.9 Release into the Environment: Refers to the use of a
manipulated product out of a closed area’s normal physical
confinement boundaries such as laboratories, greenhouses,
fermenting devices or any other closed structure, under biosafety
conditions as established by the Ministry.
2.10 Environment: Refers to the soil, air or water as well
as each and every live organisms in connection with or living
in such elements.
2.11 Genetic Material: Is understood as all vegetal, animal
and microbial material or otherwise having inheritance functional
units.
2.12 Transgenic Material: Artificially modified genotypes
which, due to their multiplication and permanence into the
environment characteristics, are capable to transfer recombining
genes to other organism.
2.13 Mobilization: Stands for transporting, carrying or shifting
from one place to another.
2.14 Organism: Any form of life from vegetal or animal kingdoms.
2.15 Receiving Organism: Refers to an organism receiving
genetic material form a donor.
2.16 Pest: Vegetal, animal or pathogenic agent form of life
either harmful or potentially harmful to vegetables.
2.17 Plant: Any member of the vegetal kingdom or any part
of it.
2.18 Manipulated or Transgenic Product: Vegetal or microbial
material subject to in vitro recombination or under special
laboratory conditions through genetic engineering application.
2.19 Vector or Vector Agent: Organism, material or object
used for transferring genetic material from donor’s
organism to receiver’s organism.
3. SPECIFICATIONS
3.1 For releasing into the environment and/or importing transgenic
products a phytosanitary certificate is required. For interstate
mobilization the requesting party will be required to notify
the Plant Health General Direction (DGSV per its Spanish acronym)
according to the format attached hereto as Exhibit 1.
3.2 Pertaining to transgenic products’ release into
the environment certificate.
3.2.1 To obtain the Release into the Environment Certificate,
the requesting party shall submit such request in the corresponding
format according to Exhibit 1 attached hereto, before the
Plant Health General Direction (DGSV ), both original and
two hardcopies. Response to such petition shall be issued
by this entity within a term no longer than 120 natural days,
provided information submitted in the application format is
complete. Otherwise, the requesting party will be requested
to provide the missing information and thereupon, the 120-day
term shall commence as of submittal of complete information.
3.2.2 The DGSV will submit such request before the Agricultural
Biosafety National Committee for review and once a favorable
report from the Committee is obtained, the DSGV will be responsible
for granting the Release into the Environment Certificate
for products manipulated through genetic engineering in compliance
with Exhibit 3 thereof.
Copy of the Committee’s report as well as the release
certificate shall be handed over to the State Government(s)
and State Delegation(s) where such releasing is to be carried
out. In turn, State Agencies shall notify the DSGV about releasing
activities and shall be liable to send their comments with
regard to in a term which shall not exceed 30 natural days.
3.2.3 Applicant is to provide all necessary information with
regard to the activity to be performed as described under
Exhibit 1 and shall note the following:
a) Name, private address, phone number, professional certificate
number as well as a resume of the person conducting the subject
matter field test. Such person shall be acquainted on and/or
experienced in genetic engineering, molecular biology and
biotechnology matters, among others.
b) Name, address and phone numbers of other people involved
in field tests having decision authority.
c) Scientific and common names as well as all designations
used to identify the receiving organism or organisms and vector
agents used in the construction of each manipulated product.
d) Name, address and phone number of the people developing
or supplying the product.
e) Description of the container or wrapping that will be
used for product mobilization.
f) Quantitative description of the product to be mobilized
as well as mobilization and/or import proposed schedule.
g) Biological material description (for instance, culture
means) accompanying manipulated product during its mobilization
as well as a detailed description about the method which will
be used for its destruction.
h) Manipulated product mobilization route, including a description
of the place of origin, proposed destination, intermediate
destinations and final destinations.
i) Procedure and biosafety measures description that shall
be applied to prevent manipulated product release and spreading.
j) Objective and purpose for introducing, mobilizing and/or
releasing into the environment the transgenic product.
k) Description of material’s reproductive or multiplicative
biology prior genetic modification including, as for vegetal
organisms: life cycle with an special emphasis on self crossbreeding,
pollination, habitat, wild species and their distribution,
mechanisms and self crossbreeding frequency among the species
members; and as for microbial organisms: life cycle, pathogenic
characteristics, hosts, development stages description (inoculation,
inoculation type, penetration… etc.), spreading, hibernation
and interaction with other organisms.
l) Description of donor and receiver organisms and vector
as well as country and location where manipulated product
was collected, developed or produced.
m) Description of current or anticipated modification produced
by genetic material, integrated to manipulated product and
how such modification differs from a non-modified organism.
Genetic construction maps will be attached.
n) Detailed description of donor-receiver-vector system molecular
biology sustaining manipulated product procurement.
o) Statement regarding to the potential impact to agricultural
environment which may be derived from product releasing.
p) The proposed experimental design for releasing the substance
into the environment as well as the production system shall
be described in detail.
q) Description of the genetically manipulated product amount
to be released as well as the amount to be used in each trial
provided more than one is established. Schedule specifying
agronomic practices and/or proposed trials.
r) A map of the proposed trial site will be attached and
shall indicate geographical location as well as the exact
location where transgenic product trials will be established
by taking into account the following:
— When several genetic constructions may be carried
out in different sites, the number of tested constructions
will be indicated per site.
— When several trials are applied on the same site,
specific location for each trial will be indicated.
— Description of the adjoining premises activities,
either current or former, as well as the exact location where
trials shall be established. With regard to vegetal transgenic
products, a listing and description for wild and cultivated
species, phylogenetically related to transgenic plant which
may be transgenic pollen receivers will be attached.
— Specify both dimensions and area to be occupied by
the trials (do not include non- genetically modified material
boundaries or rows), and provide a description of manipulated
organism allocation sites such as greenhouses, laboratories,
growing chambers, etc.
s) Provide a detailed description about biosafety measures
and procedures to be used for preventing manipulated product
uncontrolled contamination, release and spreading.
t) Provide a detailed description about transgenic material
final disposal proposed method at experiment’s completion
as well as final disposal or cleaning practices with regard
to other materials which have been in contact with the transgenic
material during the trial, for example, non- transgenic culture
treated with a transgenic bio- insecticide and agro- machinery,
among others.
u) Rights payment receipt evidencing the rate in force as
stated by the Rights Federal Statute.
In the specific case no interstate mobilization or imports
are carried out, paragraph items e), f), g), h), and i) herein
will be omitted.
3.2.4 In the case product mobilization and/or import may
be carried out prior release into the environment request,
a copy of the corresponding import and/or mobilization certificate
will be attached.
3.2.5 The applicant shall write a commitment letter stating
his/her responsibility with regard to product handling or
destruction in such a way as to prevent release into the environment
after trials completion and, in the same way, will prepare
a statement letter at the time such activities are carried
out.
3.2.6 Released, mobilized and/or imported transgenic product
shall be maintained within areas and rooms as specified in
the application.
3.2.7 Transgenic product to be released, mobilized and/or
imported shall be identified through a label containing all
the required information as described under paragraph 3.5
hereinbefore.
3.2.8 The person authorized by the Ministry to perform both
inspections and follow- up to released transgenic product
shall regularly notify this entity about product behavior
based upon requirements compliance as specified in the corresponding
certificate.
3.2.9 Either the individual or corporation granted with phytosanitary
release certificate shall provide the DGSV with periodical
reports and a final report about transgenic product characteristics
and behavior according to certificate’s specifications.
3.2.10 The DGSV shall be notified in the following cases:
a) Accidental release of a transgenic product, which shall
be notified within 24 hours as of unexpected event occurrence.
b) If the associated host organism or manipulated product
shows substantially different characteristics to those listed
in the application or if disease signs are present or otherwise
if mortality occurs or any other unforeseen effect caused
to organisms not directly involved, shall be notified in written
within the following five business days to event.
3.2.11 Authorized personnel by the Ministry may inspect the
location where manipulated products are to be released into
the environment as well as closed areas, before and after
mobilization, and product record logs as many times as necessary.
Expenses arising out of verification tasks performed by one
or more Agricultural Biosafety National Committee members
shall be the applicant company sole liability.
3.3 Imports Phytosanitary Certificate for Transgenic Products
and Mobilization Notification.
3.3.1 The Phyto-zoosanitary Inspection General Direction
in Ports, Airports and Borderlines shall be responsible for
transgenic products Phytosanitary Imports Certificate issuance
and for such purpose, the requesting party shall submit the
following documentation a the country’s inland customs
and shall comply with specifications thereof:
a) Biosafety Measures and Phytosanitary Requirements for
Transgenic Products Imports original document as described
in Exhibit 2 thereof.
b) Country of origin international phytosanitary certificate.
3.3.2 The DGSV shall be liable to issue all biosafety measures
and phytosanitary requirements needed for transgenic products
imports. Applications shall receive the same treatment applicable
to release into the environment as described under Section
3.2.2 hereinbefore.
3.3.3 As for transgenic product interstate mobilization,
the requesting party shall notify the DGSV by attaching request
to the corresponding format in accordance with Exhibit 1 thereof.
The DGSV shall officially reply the requesting party if such
mobilization may be carried out during import and under the
same procedure as stated under Section 3.3.4 hereinbelow.
3.3.4 If intended objective is solely and exclusively aimed
to transgenic material imports and/or mobilization, the application
shall contain all the necessary information as described under
Section 3.2.3 hereinbefore skipping paragraph items p), q),
r), s) and t). Such application shall be delivered to the
DGSV, original and two hardcopies, in the corresponding format.
Within a 75 natural days time period, the DGSV will issue
the corresponding response provided application’s required
information is complete, otherwise, the requesting party shall
be asked to furnish missing information and the 75-day period
shall be counted as of application’s complete information
may be delivered.
3.3.5 Wrapping materials, containers and any other material
accompanying imported or mobilized transgenic product shall
be handled in such a way as to prevent spreading and settlement.
3.3.6 Individuals or corporations granted with the transgenic
product import certificate shall notify the DGSV about product’s
arrival date to its final destination or otherwise if such
event was not performed.
3.3.7 Transgenic products shall comply with the import phytosanitary
requirements as set forth under the Mexican Official Standards
with regard to vegetal or plant quarantine, according to the
agricultural product as the case may be, such as: fruits,
vegetables, seeds, spreading material or sawn flowers or blossoms
pretended to be imported.
3.3.8 Issued certificate is valid only for field release
and/or imports and/or mobilization with research or material
reproduction purposes. This certificate does not include the
commercialization of transgenic products in Mexico. Thereupon,
all transgenic material trials and mobilizations performed
within national territory are subject to the DGSV’s
surveillance and permission.
3.4 Pertaining to Release into the Environment Phytosanitary
Certificate Cancellation.
The DGSV reserves the right to cancel the release into the
environment certificate if one or more conditions related
thereto are not accomplished, notifying the cancellation reasons
within a 10-day time period.
3.5 Pertaining to marking and identification.
3.5.1 Any manipulated product to be mobilized, imported and/or
released shall clearly and correctly specify the following
information adhered either to the container or wrapping:
— Nature, in general terms, and contents amount.
— Country and/or location where such product was collected,
developed, manufactured, cultivated or reproduced.
— Carrier and forwarder’s name and address.
— Consignee’s name, address and phone number.
— Release and/or import phytosanitary certificate number.
— Label shall be clearly visible from the outside.
4. STANDARD ENFORCEMENT
Shall be the Ministry’s liability to enforce and oversee
each and every objective and disposal set forth under this
Standard.
5. PENALTIES
Failure to comply with disposals set forth under this Standard
will be cause of penalties and sanctions according to Plant
Health Federal Statute and Metrology and Normalization Federal
Statute.
6. BIBLIOGRAPHY
Canada’s Agriculture and Agri-food 1994. Field trials
performed to genetically modified plants in Canada, guidelines
and information required for field applications and subduing
under confined conditions. Canada.
Canada’s Agriculture and Agri-food 1994. Estimation
criteria to determine genetically modified plants’ environmental
safety. Canada.
IICA 1991. Guide for genetically modified organisms released
into the environment. Costa Rica.
ISAAA – SEI, 1994. Biosafety fro Sustainable Agriculture:
Sharing Biotechnology Regulatory Experiences of the Western
Hemisphere. USA.
OCAE, 1993. Biotechnology, Agriculture and Nourishment. Spain.
OCAE, 1990. Good Developmental Practices jar Small Scale
Research with genetically modified plants and microorganisms.
Paris, France.
7. CONSISTENCY WITH INTERNATIONAL STANDARDS
This standard has no consistency with any other international
standard or recommendations since no references were available
at the time it was written.
8. TRANSIENT DISPOSALS
This Mexican Official Standard shall be in force as of the
following publication day on the Federal Official Diary.
Sufragio Efectivo. No Reelección.
Mexico City, July 13th, 1996.- The Legal General Director,
Roberto Zavala Echevarría.- Signature
|
