Organization of American States - Trade Unit
Chapter Seven: Agriculture and Sanitary and Phytosanitary Measures
Section B - Sanitary and Phytosanitary Measures
Article 709: Scope and Coverage
In order to establish a framework of rules and disciplines to guide the development,
adoption and
enforcement of sanitary and phytosanitary measures, this Section applies to any such
measure of a
Party that may, directly or indirectly, affect trade between the Parties.
Article 710: Relation to Other Chapters
Articles 301 (National Treatment) and 309 (Import and Export Restrictions), and the
provisions of
Article XX(b) of the GATT as incorporated into Article 2101(1) (General Exceptions), do
not apply
to any sanitary or phytosanitary measure.
Article 711: Reliance on Non-Governmental Entities
Each Party shall ensure that any non-governmental entity on which it relies in applying a
sanitary or
phytosanitary measure acts in a manner consistent with this Section.
Article 712: Basic Rights and Obligations
Right to Take Sanitary and Phytosanitary Measures
1. Each Party may, in accordance with this Section, adopt, maintain or apply any sanitary
or
phytosanitary measure necessary for the protection of human, animal or plant life or
health in its
territory, including a measure more stringent than an international standard, guideline or
recommendation.
Right to Establish Level of Protection
2. Notwithstanding any other provision of this Section, each Party may, in protecting
human, animal
or plant life or health, establish its appropriate levels of protection in accordance with
Article 715.
Scientific Principles
3. Each Party shall ensure that any sanitary or phytosanitary measure that it adopts,
maintains or
applies is:
a) based on scientific principles, taking into account relevant factors including, where
appropriate, different geographic conditions;
b) not maintained where there is no longer a scientific basis for it; and
c) based on a risk assessment, as appropriate to the circumstances.
Non-Discriminatory Treatment
4. Each Party shall ensure that a sanitary or phytosanitary measure that it adopts,
maintains or applies
does not arbitrarily or unjustifiably discriminate between its goods and like goods of
another Party, or
between goods of another Party and like goods of any other country, where identical or
similar
conditions prevail.
Unnecessary Obstacles
5. Each Party shall ensure that any sanitary or phytosanitary measure that it adopts,
maintains or
applies is applied only to the extent necessary to achieve its appropriate level of
protection, taking
into account technical and economic feasibility.
Disguised Restrictions
6. No Party may adopt, maintain or apply any sanitary or phytosanitary measure with a view
to, or
with the effect of, creating a disguised restriction on trade between the Parties.
Article 713: International Standards and Standardizing Organizations
1. Without reducing the level of protection of human, animal or plant life or health, each
Partyshall
use, as a basis for its sanitary and phytosanitary measures, relevant international
standards, guidelines
or recommendations with the objective, among others, of making its sanitary and
phytosanitary
measures equivalent or, where appropriate, identical to those of the other Parties.
2. A Party's sanitary or phytosanitary measure that conforms to a relevant international
standard,
guideline or recommendation shall be presumed to be consistent with Article 712. A measure
that
results in a level of sanitary or phytosanitary protection different from that which would
be achieved
by a measure based on a relevant international standard, guideline or recommendation shall
not for
that reason alone be presumed to be inconsistent with this Section.
3. Nothing in Paragraph 1 shall be construed to prevent a Party from adopting, maintaining
or
applying, in accordance with the other provisions of this Section, a sanitary or
phytosanitary measure
that is more stringent than the relevant international standard, guideline or
recommendation.
4. Where a Party has reason to believe that a sanitary or phytosanitary measure of another
Party is
adversely affecting or may adversely affect its exports and the measure is not based on a
relevant
international standard, guideline or recommendation, it may request, and the other Party
shall provide
in writing, the reasons for the measure.
5. Each Party shall, to the greatest extent practicable, participate in relevant
international and North
American standardizing organizations, including the Codex Alimentarius Commission, the
International Office of Epizootics, the International Plant Protection Convention, and the
North American Plant Protection Organization, with a view to promoting the development and
periodic review of international standards, guidelines and recommendations.
Article 714: Equivalence
1. Without reducing the level of protection of human, animal or plant life or health, the
Parties shall, to
the greatest extent practicable and in accordance with this Section, pursue equivalence of
their
respective sanitary and phytosanitary measures.
2. Each importing Party:
a) shall treat a sanitary or phytosanitary measure adopted or maintained by an exporting
Party
as equivalent to its own where the exporting Party, in cooperation with the importing
Party,
provides to the importing Party scientific evidence or other information, in accordance
with
risk assessment methodologies agreed on by those Parties, to demonstrate objectively,
subject
to subparagraph (b), that the exporting Party's measure achieves the importing Party's
appropriate level of protection;
b) may, where it has a scientific basis, determine that the exporting Party's measure does
not
achieve the importing Party's appropriate level of protection; and
c) shall provide to the exporting Party, on request, its reasons in writing for a
determination
under subparagraph (b).
3. For purposes of establishing equivalence, each exporting Party shall, on the request of
an
importing Party, take such reasonable measures as may be available to it to facilitate
access in its
territory for inspection, testing and other relevant procedures.
4. Each Party should, in the development of a sanitary or phytosanitary measure, consider
relevant
actual or proposed sanitary or phytosanitary measures of the other Parties.
Article 715: Risk Assessment and Appropriate Level of Protection
1. In conducting a risk assessment, each Party shall take into account:
a) relevant risk assessment techniques and methodologies developed by international or
North
American standardizing organizations;
b) relevant scientific evidence;
c) relevant processes and production methods;
d) relevant inspection, sampling and testing methods;
e) the prevalence of relevant diseases or pests, including the existence of pest-free or
disease-free areas or areas of low pest or disease prevalence;
f) relevant ecological and other environmental conditions; and
g) relevant treatments, such as quarantines.
2. Further to paragraph 1, each Party shall, in establishing its appropriate level of
protection
regarding the risk associated with the introduction, establishment or spread of an animal
or plant pest
or disease, and in assessing the risk, also take into account the following economic
factors, where
relevant:
a) loss of production or sales that may result from the pest or disease;
b) costs of control or eradication of the pest or disease in its territory; and
c) the relative cost-effectiveness of alternative approaches to limiting risks.
3. Each Party, in establishing its appropriate level of protection:
a) should take into account the objective of minimizing negative trade effects; and
b) shall, with the objective of achieving consistency in such levels, avoid arbitrary or
unjustifiable distinctions in such levels in different circumstances, where such
distinctions result
in arbitrary or unjustifiable discrimination against a good of another Party or constitute
a
disguised restriction on trade between the Parties.
4. Notwithstanding paragraphs (1) through (3) and Article 712(3)(c), where a Party
conducting a
risk assessment determines that available relevant scientific evidence or other
information is
insufficient to complete the assessment, it may adopt a provisional sanitary or
phytosanitary measure
on the basis of available relevant information, including from international or North
American
standardizing organizations and from sanitary or phytosanitary measures of other Parties.
The Party
shall, within a reasonable period after information sufficient to complete the assessment
is presented
to it, complete its assessment, review and, where appropriate, revise the provisional
measure in the
light of the assessment.
5. Where a Party is able to achieve its appropriate level of protection through the phased
application
of a sanitary or phytosanitary measure, it may, on the request of another Party and in
accordance
with this Section, allow for such a phased application, or grant specified exceptions for
limited
periods from the measure, taking into account the requesting Party's export interests.
Article 716: Adaptation to Regional Conditions
1. Each Party shall adapt any of its sanitary or phytosanitary measures relating to the
introduction,
establishment or spread of an animal or plant pest or disease, to the sanitary or
phytosanitary
characteristics of the area where a good subject to such a measure is produced and the
area in its
territory to which the good is destined, taking into account any relevant conditions,
including those
relating to transportation and handling, between those areas. In assessing such
characteristics of an
area, including whether an area is, and is likely to remain, a pest-free or disease-free
area or an area
of low pest or disease prevalence, each Party shall take into account, among other
factors:
a) the prevalence of relevant pests or diseases in that area;
b) the existence of eradication or control programs in that area; and
c) any relevant international standard, guideline or recommendation.
2. Further to paragraph 1, each Party shall, in determining whether an area is a pest-free
or
disease-free area or an area of low pest or disease prevalence, base its determination on
factors such
as geography, ecosystems, epidemiological surveillance and the effectiveness of sanitary
or
phytosanitary controls in that area.
3. Each importing Party shall recognize that an area in the territory of the exporting
Party is, and is
likely to remain, a pest-free or disease-free area or an area of low pest or disease
prevalence, where
the exporting Party provides to the importing Party scientific evidence or other
information sufficient
to so demonstrate to the satisfaction of the importing Party. For this purpose, each
exporting Party
shall provide reasonable access in its territory to the importing Party for inspection,
testing and other
relevant procedures.
4. Each Party may, in accordance with this Section:
a) adopt, maintain or apply a different risk assessment procedure for a pest-free or
disease-free area than for an area of low pest or disease prevalence, or
b) make a different final determination for the disposition of a good produced in a
pest-free or
disease-free area than for a good produced in an area of low pest or disease prevalence,
taking into account any relevant conditions, including those relating to transportation
and
handling.
5. Each Party shall, in adopting, maintaining or applying a sanitary or phytosanitary
measure relating
to the introduction, establishment or spread of an animal or plant pest or disease, accord
a good
produced in a pest-free or disease-free area in the territory of another Party no less
favorable
treatment than it accords a good produced in a pest-free or disease-free area, in another
country,
that poses the same level of risk. The Party shall use equivalent risk assessment
techniques to
evaluate relevant conditions and controls in the pest-free or disease-free area and in the
area
surrounding that area and take into account any relevant conditions, including those
relating to
transportation and handling.
6. Each importing Party shall pursue an agreement with an exporting Party, on request, on
specific
requirements the fulfillment of which allows a good produced in an area of low pest or
disease
prevalence in the territory of an exporting Party to be imported into the territory of the
importing
Party and achieves the importing Party's appropriate level of protection.
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North American Free Trade Agreement
Chapter Seven: Agriculture and Sanitary and Phytosanitary Measures
Article 717: Control, Inspection and Approval Procedures
1. Each Party, with respect to any control or inspection procedure that it conducts:
(a) shall initiate and complete the procedure as expeditiously as possible and in no less
favorable manner for a good of another Party than for a like good of the Party or of any
other
country;
(b) shall publish the normal processing period for the procedure or communicate the
anticipated processing period to the applicant on request;
(c) shall ensure that the competent body
(i) on receipt of an application, promptly examines the completeness of the
documentation and informs the applicant in a precise and complete manner of any
deficiency,
(ii) transmits to the applicant as soon as possible the results of the procedure in a form
that is precise and complete so that the applicant may take any necessary corrective
action,
(iii) where the application is deficient, proceeds as far as practicable with the
procedure
if the applicant so requests, and
(iv) informs the applicant, on request, of the status of the application and the reasons
for
any delay;
(d) shall limit the information the applicant is required to supply to that necessary for
conducting the procedure;
(e) shall accord confidential or proprietary information arising from, or supplied in
connection
with, the procedure conducted for a good of another Party
(i) treatment no less favorable than for a good of the Party, and
(ii) in any event, treatment that protects the applicant's legitimate commercial
interests,
to the extent provided under the Party's law;
(f) shall limit any requirement regarding individual specimens or samples of a good to
that
which is reasonable and necessary;
(g) should not impose a fee for conducting the procedure that is higher for a good of
another
Party than is equitable in relation to any such fee it imposes for its like goods or for
like goods
of any other country, taking into account communication, transportation and other related
costs;
(h) should use criteria for selecting the location of facilities at which the procedure is
conducted
that do not cause unnecessary inconvenience to an applicant or its agent;
(i) shall provide a mechanism to review complaints concerning the operation of the
procedure
and to take corrective action when a complaint is justified;
(j) should use criteria for selecting samples of goods that do not cause unnecessary
inconvenience to an applicant or its agent; and
(k) shall limit the procedure, for a good modified subsequent to a determination that the
good
fulfills the requirements of the applicable sanitary or phytosanitary measure, to that
necessary
to determine that the good continues to fulfill the requirements of that measure.
2. Each Party shall apply, with such modifications as may be necessary, paragraphs 1(a)
through (i)
to its approval procedures.
3. Where an importing Party's sanitary or phytosanitary measure requires the conduct of a
control or
inspection procedure at the level of production, an exporting Party shall, on the request
of the
importing Party, take such reasonable measures as may be available to it to facilitate
access in its
territory and to provide assistance necessary to facilitate the conduct of the importing
Party's control
or inspection procedure.
4. A Party maintaining an approval procedure may require its approval for the use of an
additive, or
its establishment of a tolerance for a contaminant, in a food, beverage or feedstuff,
under that
procedure prior to granting access to its domestic market for a food, beverage or
feedstuff containing
that additive or contaminant. Where such Party so requires, it shall consider using a
relevant
international standard, guideline or recommendation as the basis for granting access until
it completes
the procedure.
Article 718: Notification, Publication and Provision of Information
1. Further to Articles 1802 (Publication) and 1803 (Notification and Provision of
Information), each
Party proposing to adopt or modify a sanitary or phytosanitary measure of general
application at the
federal level shall:
(a) at least 60 days prior to the adoption or modification of the measure, other than a
law,
publish a notice and notify in writing the other Parties of the proposed measure and
provide to
the other Parties and publish the full text of the proposed measure, in such a manner as
to
enable interested persons to become acquainted with the proposed measure;
(b) identify in the notice and notification the good to which the measure would apply, and
provide a brief description of the objective and reasons for the measure;
(c) provide a copy of the proposed measure to any Party or interested person that so
requests
and, wherever possible, identify any provision that deviates in substance from relevant
international standards, guidelines or recommendations; and
(d) without discrimination, allow other Parties and interested persons to make comments in
writing and shall, on request, discuss the comments and take the comments and the results
of
the discussions into account.
2. Each Party shall seek, through appropriate measures, to ensure, with respect to a
sanitary or
phytosanitary measure of a state or provincial government:
(a) that, at an early appropriate stage, a notice and notification of the type referred to
in
paragraphs 1(a) and (b) are made prior to their adoption; and
(b) observance of paragraphs 1(c) and (d).
3. Where a Party considers it necessary to address an urgent problem relating to sanitary
or
phytosanitary protection, it may omit any step set out in paragraph 1 or 2, provided that,
on adoption
of a sanitary or phytosanitary measure, it shall:
(a) immediately provide to the other Parties a notification of the type referred to in
paragraph
1(b), including a brief description of the urgent problem;
(b) provide a copy of the measure to any Party or interested person that so requests; and
(c) without discrimination, allow other Parties and interested persons to make comments in
writing and shall, on request, discuss the comments and take the comments and the results
of
the discussions into account.
4. Each Party shall, except where necessary to address an urgent problem referred to in
paragraph 3,
allow a reasonable period between the publication of a sanitary or phytosanitary measure
of general
application and the date that it becomes effective to allow time for interested persons to
adapt to the
measure.
5. Each Party shall designate a government authority responsible for the implementation at
the federal
level of the notification provisions of this Article, and shall notify the other Parties
thereof. Where a
Party designates two or more government authorities for this purpose, it shall provide to
the other
Parties complete and unambiguous information on the scope of responsibility of each such
authority.
6. Where an importing Party denies entry into its territory of a good of another Party
because it does
not comply with a sanitary or phytosanitary measure, the importing Party shall provide a
written
explanation to the exporting Party, on request, that identifies the applicable measure and
the reasons
that the good is not in compliance.
Article 719: Inquiry Points
1. Each Party shall ensure that there is one inquiry point that is able to answer all
reasonable inquiries
from other Parties and interested persons, and to provide relevant documents, regarding:
(a) any sanitary or phytosanitary measure of general application, including any control or
inspection procedure or approval procedure, proposed, adopted or maintained in its
territory
at the federal, state or provincial government level;
(b) the Party's risk assessment procedures and factors it considers in conducting the
assessment and in establishing its appropriate levels of protection;
(c) the membership and participation of the Party, or its relevant federal, state or
provincial
government authorities in international and regional sanitary and phytosanitary
organizations
and systems, and in bilateral and multilateral arrangements within the scope of this
Section, and
the provisions of those systems and arrangements; and
(d) the location of notices published pursuant to this Section or where such information
can be
obtained.
2. Each Party shall ensure that where copies of documents are requested by another Party
or by
interested persons in accordance with this Section, they are supplied at the same price,
apart from
the actual cost of delivery, as the price for domestic purchase.
Article 720: Technical Cooperation
1. Each Party shall, on the request of another Party, facilitate the provision of
technical advice,
information and assistance, on mutually agreed terms and conditions, to enhance that
Party's sanitary
and phytosanitary measures and related activities, including research, processing
technologies,
infrastructure and the establishment of national regulatory bodies. Such assistance may
include
credits, donations and grants for the acquisition of technical expertise, training and
equipment that will
facilitate the Party's adjustment to and compliance with a Party's sanitary or
phytosanitary measure.
2. Each Party shall, on the request of another Party:
(a) provide to that Party information on its technical cooperation programs regarding
sanitary
or phytosanitary measures relating to specific areas of interest; and
(b) consult with the other Party during the development of, or prior to the adoption or
change
in the application of, any sanitary or phytosanitary measure.
Article 721: Limitations on the Provision of Information
Nothing in this Section shall be construed to require a Party to:
(a) communicate, publish texts or provide particulars or copies of documents other than in
an
official language of the Party; or
(b) furnish any information the disclosure of which would impede law enforcement or
otherwise be contrary to the public interest or would prejudice the legitimate commercial
interests of particular enterprises.
Article 722: Committee on Sanitary and Phytosanitary Measures
1. The Parties hereby establish a Committee on Sanitary and Phytosanitary Measures,
comprising
representatives of each Party who have responsibility for sanitary and phytosanitary
matters.
2. The Committee should facilitate:
(a) the enhancement of food safety and improvement of sanitary and phytosanitary
conditions
in the territories of the Parties;
(b) activities of the Parties pursuant to Articles 713 and 714;
(c) technical cooperation between the Parties, including cooperation in the development,
application and enforcement of sanitary or phytosanitary measures; and
(d) consultations on specific matters relating to sanitary or phytosanitary measures.
3. The Committee:
(a) shall, to the extent possible, in carrying out its functions, seek the assistance of
relevant
international and North American standardizing organizations to obtain available
scientific and
technical advice and minimize duplication of effort;
(b) may draw on such experts and expert bodies as it considers appropriate;
(c) shall report annually to the Commission on the implementation of this Section;
(d) shall meet on the request of any Party and, unless the Parties otherwise agree, at
least once
each year; and
(e) may, as it considers appropriate, establish and determine the scope and mandate of
working groups.
Article 723: Technical Consultations
1. A Party may request consultations with another Party on any matter covered by this
Section.
2. Each Party should use the good offices of relevant international and North American
standardizing
organizations, including those referred to in Article 713(5), for advice and assistance on
sanitary and
phytosanitary matters within their respective mandates.
3. Where a Party requests consultations regarding the application of this Section to a
Party's sanitary
or phytosanitary measure, and so notifies the Committee, the Committee may facilitate the
consultations, if it does not consider the matter itself, by referring the matter for
non-binding technical
advice or recommendations to a working group, including an ad hoc working group, or to
another
forum.
4. The Committee should consider any matter referred to it under paragraph 3 as
expeditiously as
possible, particularly regarding perishable goods, and promptly forward to the Parties any
technical
advice or recommendations that it develops or receives concerning the matter. The Parties
involved
shall provide a written response to the Committee concerning the technical advice or
recommendations within such time as the Committee may request.
5. Where the involved Parties have had recourse to consultations facilitated by the
Committee under
paragraph 3, the consultations shall, on the agreement of the Parties involved, constitute
consultations
under Article 2006 (Consultations).
6. The Parties confirm that a Party asserting that a sanitary or phytosanitary measure of
another Party
is inconsistent with this Section shall have the burden of establishing the inconsistency.
Article 724: Definitions For purposes of this Section:
animal includes fish and wild fauna;
appropriate level of protection means the level of protection of human, animal or plant
life or
health in the territory of a Party that the Party considers appropriate;
approval procedure means any registration, notification or other mandatory administrative
procedure for:
(a) approving the use of an additive for a stated purpose or under stated conditions; or
(b) establishing a tolerance for a stated purpose or under stated conditions for a
contaminant,
in a food, beverage or feedstuff prior to permitting the use of the additive or the
marketing of a food,
beverage or feedstuff containing the additive or contaminant;
area means a country, part of a country or all or parts of several countries;
area of low pest or disease prevalence means an area in which a specific pest or disease
occurs
at low levels;
contaminant includes pesticide and veterinary drug residues and extraneous matter;
control or inspection procedure means any procedure used, directly or indirectly, to
determine that
a sanitary or phytosanitary measure is fulfilled, including sampling, testing, inspection,
evaluation,
verification, monitoring, auditing, assurance of conformity, accreditation, registration,
certification or
other procedure involving the physical examination of a good, of the packaging of a good,
or of the
equipment or facilities directly related to production, marketing or use of a good, but
does not mean
an approval procedure;
international standard, guideline or recommendation means a standard, guideline or
recommendation:
(a) regarding food safety, adopted by the Codex Alimentarius Commission, including one
regarding decomposition elaborated by the Codex Committee on Fish and Fishery
Products, food additives, contaminants, hygienic practice, and methods of analysis and
sampling;
(b) regarding animal health and zoonoses, developed under the auspices of the
International
Office of Epizootics;
(c) regarding plant health, developed under the auspices of the Secretariat of the
International Plant Protection Convention in cooperation with the North American Plant
Protection Organization; or
(d) established by or developed under any other international organization agreed on by
the
Parties;
pest includes a weed;
pest-free or disease-free area means an area in which a specific pest or disease does not
occur;
plant includes wild flora;
risk assessment means an evaluation of:
(a) the potential for the introduction, establishment or spread of a pest or disease and
associated biological and economic consequences; or
(b) the potential for adverse effects on human or animal life or health arising from the
presence
of an additive, contaminant, toxin or disease-causing organism in a food, beverage or
feedstuff;
sanitary or phytosanitary measure means a measure that a Party adopts, maintains or
applies to:
(a) protect animal or plant life or health in its territory from risks arising from the
introduction,
establishment or spread of a pest or disease,
(b) protect human or animal life or health in its territory from risks arising from the
presence of
an additive, contaminant, toxin or disease-causing organism in a food, beverage or
feedstuff,
(c) protect human life or health in its territory from risks arising from a
disease-causing
organism or pest carried by an animal or plant, or a product thereof, or
(d) prevent or limit other damage in its territory arising from the introduction,
establishment or
spread of a pest,
including end product criteria; a product-related processing or production method; a
testing,
inspection, certification or approval procedure; a relevant statistical method; a sampling
procedure; a
method of risk assessment; a packaging and labelling requirement directly related to food
safety; and
a quarantine treatment, such as a relevant requirement associated with the transportation
of animals
or plants or with material necessary for their survival during transportation; and
scientific basis means a reason based on data or information derived using scientific
methods.
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