G/SPS/W/317  
 
9 July 2019  
(19-4542) Page: 1/5 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
ENABLING ACCESS TO T OOLS AND TECHNOLOGIE S: 
TOWARDS SAFER AND MO RE SUSTAINABLE AGRIC ULTURE THROUGH REGUL ATORY 
COLLABORATION  
SUBMISSION FROM  BRAZIL, KENYA, PARAG UAY AND THE UNITED STATES OF AMERICA  
The following communication, received on 5 July 2019, is being circulated at the request of the 
Delegation of Brazil , Kenya , Paraguay  and the United States of America . 
 
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1  INTRODUCTION  
1.1.  In G/SPS/W/305, the cosponsors noted that col laboration at the regional and international level 
to streamline and improve regulatory approaches to pre -market approvals and inspection systems 
with respect to products to manage fall armyworm (FAW) could support national and regional efforts 
to increase  access to those products. In particular, the cosponsors noted that approaches that reduce 
unnecessary burdens and increase the efficiency and predictability of science -based outcomes could 
help put urgently needed tools in the hands of farmers while prote cting public health and the 
environment.  
1.2.  At the Committee 's thematic session on fall armyworm held  on 19 March 2019, presenters 
echoed the themes noted in G/SPS/W/305. Presenters emphasized the importance of integrated 
pest management (IPM) strategies, as well as national and regional strategies to coordinate in 
monitoring and surveillance activities, research and development, and in the evaluation and 
registration of control options. We appreciate the range of experiences presented at the thematic 
session on collaboration at the national, regional and international levels on systems and strategies 
to combat FAW.  
1.3.  The objective of this follow -on submission is to provide an initial compilation of concepts that 
support collaboration at the regional and internat ional level and that can be employed, on a voluntary 
basis, to improve and streamline regulatory processes, while safeguarding human, plant and animal 
health.  Such a compilation could serve as a resource, in particular, for authorities with capacity 
constr aints to help identify regulatory efficiencies that can lead to greater and faster access to safe 
tools and technologies to manage FAW and other SPS challenges.  
1.4.  Brazil, Kenya, Paraguay and the United States propose that the concepts identified below could 
productively be a subject of further Committee discussion in connection with FAW and could be 
assembled into a Committee document, connected to the Fifth Review, on approaches to streamline 
regulatory processes with respect to FAW. We recognize these conce pts can be helpful in addressing 
other SPS challenges as well, particularly for authorities facing capacity constraints. Such a 
document could assist Members in strengthening implementation of Article 9 of the SPS Agreement.  
1.1  Data portability  
1.5.  Data produced in one locality can be relevant and useful to support the assessment of the same 
product in another locality.  
1.6.  Background:  Across many sectors, data portability is a well -established and proven 
mechanism for reducing regulatory burdens and increasing both t he speed and efficiency of G/SPS/W/317  
 
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  regulatory assessments and decision making. In its most basic form, data portability refers to the 
characteristics of the data that allow them to be used by others in decision -making processes.  
1.1.1   Laboratory data  
1.7.  Laboratory data, by  nature of being generated under very tightly controlled conditions, should 
always be geographically portable provided there is acceptance of the methodologies used in 
generating those data.  In the context of FAW, laboratory data requirements may include t oxicity 
studies of pesticides, biopesticides, or resistant plant varieties, or for purposes of food safety 
assessments, environmental chemistry, or impact on non -target organisms (where required).  
1.1.2   Field trial data  
1.8.  For field studies, recent efforts to categ orize agro -climate zones may allow field trial data to 
be portable across similar agro -climatic zones with similar field conditions where a product might be 
expected to perform similarly. In the context of FAW, field trial data may be required to support 
various regulatory actions, such as seed variety registration, biosafety review, and crop protection 
authorization. For certain regulatory actions, regulatory entities may require national field trials at 
multiple sites, and over multiple planting years. Th ese trials come at a cost to the product developer 
or registrant and increase the workload of regulators, so there is interest in streamlining the process 
to lower budgetary and regulatory hurdles. Eliminating redundant field trials by acceptance of field 
trial data generated in comparable agro -climatic zones could reduce the time, effort and expense 
required to bring a useful and efficacious product to market.  
1.9.  Relevant publications:  Nakai, Hoshikawa, Shimono, & Ohsawa, 2015; Garcia -Alonso et al., 
2014; Dr aft Guidance Document on Crop Field Trials, OECD Environment, Health and Safety 
Publications, March 2016; Canada Food Inspection Agency Guidance for Plants with Novel Traits; 
Codex guidelines for foods derived from modern biotechnology; etc.  
1.2  Common applica tion dossiers  
1.10.   A common application dossier sets out a uniform format and standardized concepts for 
submission of data as part of an approval procedure.  
1.11.   Background:  Most countries make use of substantially similar information for performance 
and risk analys is, based on international agreements, guidance from standard setting bodies and 
international norms.  However, design of dossier specifications at the individual country level, absent 
coordination across countries, has developed a patchwork of application processes that requires 
companies to devote considerable resources to each individual country application, often repeating 
similar data but in a different format. These unique country -level dossier formats present a 
challenge, particularly when emergency r esponses are required in dozens of countries 
simultaneously, as in the case of FAW. Harmonizing application dossier formats across countries, 
feasible when there are compatible data requirements, reduces product registration costs for the 
company and facil itates information sharing between regulators across jurisdictions, reducing the 
time needed for product review.  In cases where international standards exist, they can be used as 
the bases for a common dossier.  
1.12.   Examples:  Common Technical Document  (CTD) of the International Conference on 
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; OECD 
dossier for pesticide maximum residue levels (MRLs); etc.  
1.3  Joint risk assessments  
1.13.   Joint risk assessments are conducted collaboratively by two or more regulatory authorities 
(or delegated to an agreed -upon third entity) and are used as the basis for risk management 
decisions by each national authority.  
1.14.   Background: Joint risk assessments allow jurisdictions to share resource s and capacities. 
Regulators work together to collect, review, and analyze data for a particular product.  Joint 
assessments may be especially beneficial in cases, such as with FAW, where regional pest problems G/SPS/W/317  
 
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  are most effectively addressed by regional ado ption of mitigation strategies. Involvement of regional 
economic communities, if applicable, can leverage national efforts.  
1.15.   Examples:  Food Standards Australia and New Zealand (FSANZ) on food safety evaluations; 
Australia -Canada work; COMESA regional biotec hnology framework; Joint FAO/WHO meeting on 
Pesticide Residues; Joint FAO/WHO Meeting on Pesticide Specifications; The Joint FAO/WHO Expert 
Committee on Food Additives; etc.  
1.4  Adaptation to regional conditions  
1.16.   The use of integrated pest management (IPM) stra tegies, as well as the access to safe 
technologies should take into account the sanitary or phytosanitary characteristics of the area, 
including the level of prevalence of specific diseases or pests and the existence of eradication or 
control programmes.  
1.17.   Background:  Taking into consideration that FAW is native to tropical and subtropical regions 
of the Americas and has been spreading rapidly through tropical and subtropical regions of Eastern, 
Western and Southern Africa, Members should consider th e natural  characteristics of agriculture in 
the tropics, particularly the pressures related to prevalence of pests in tropical climates. In that 
sense, best practices applied in other Member countries could be adapted to the regional conditions 
of affected countrie s, in order to promote sustainable agriculture practices in tropical areas.  
1.18.   Example:  The FAW Study Tour, organized by national cooperation agencies of Brazil and the 
United State s, in coordination with multilateral organizations, promoted knowledge of emer gency 
strategies to combat and control the pest, based on the experiences of Brazil.  
1.5  Unilateral recognition  
1.19.   Unilateral recognition occurs when one national authority recognizes data collected in another 
jurisdiction as being applicable to its own, or when it accepts the regulatory decisions of another 
body. An authority can do the former without the latter.  
1.20.   Background:  Generally, unilateral recognition requires the country employing it to 
understand the data and regulatory process of the other country, and to have confidence that the 
other country 's risk assessment will adequately meet its needs.  When recognition is possible, it 
creates tremendous efficiencies in regulatory decision making, and could greatly improve the speed 
with which technologies can be d eployed to combat pests such as FAW.  Unilateral recognition does 
not require negotiation or permission from the country generating the assessment or issuing the 
decision, and implies but does not necessarily require formal harmonization. However, where a 
national authority wants to recognize data collected in another jurisdiction, the data must be portable 
and the assessment be publicly available for any country that wishes to use it.  
1.21.   Examples:  Examples are plentiful and include recognition of residue limit s for chemicals or 
pesticides in food or the FAO "GM Foods Platform " for food safety assessments of genetically 
engineered crops.  
1.6  Mutual recognition  
1.22.   Mutual recognition is an arrangement between two or more national authorities to recognize 
one another 's data or regulatory decisions.  Such arrangements may, for example, provide for mutual 
recognition of one another 's standards, data, conformity assessment results, or product approvals, 
and set out conditions or processes that each side must follow to allow fo r such mutual recognition. 
Mutual recognition agreements can allow decisions or data produced by one authority within the 
agreed terms to be automatically accepted by the other(s) and vice versa . 
1.23.   Background:  Different from unilateral recognition, mutual re cognition reflects an agreement 
between two or more national authorities to accept one another 's data or regulatory decisions.  
Parties to a mutual recognition agreement generally have substantially similar regulatory aims, 
requirements, and capabilities wh ich enables regulatory authorities to have confidence that any 
decision made by one party will sufficiently meet the requirements of the other(s).  Although mutual 
recognition of both data and decisions is the best -case scenario, mutual recognition of data might G/SPS/W/317  
 
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  occur without t he mutual recognition of regulatory decisions. A mutual recognition agreement is 
generally the result of a significant history of cooperation to develop the confidence needed to be 
able to accept data or decisions produced by parties t o the agreement and takes time to negotiate.  
However, once in place, mutual recognition can provide regulatory efficiency and facilitate 
coordinated responses between countries to local and regional challenges like FAW.  Importantly, 
commitment of Members t o follow the principles laid out in the SPS Agreement represents a good 
starting point for discussions around mutual recognition.  
1.24.   Examples:  Ongoing efforts in the East Africa Community (EAC) aim at the mutual recognition 
of pesticide registrations, which w ill reduce required field trials from sixteen down to three or four; 
OECD arrangement for mutual recognition of Good Laboratory Practice (GLP) data; regional seed 
trade harmonization initiatives in SADC  and COMESA  allow approved seed varieties to be traded 
among member States with similar agro -ecological zones once the variety is approved at the regional 
level.  
1.7  Familiarity  
1.25.   Knowledge and experience with a specific product or similar product can be used to support 
regulatory assessment and decision making.  
1.26.   Background:  Familiarity can refer to the product 's or similar product 's record of assessments 
and authorizations. It can refer to assessment and authorization experiences with products with the 
same mode of action, or for an existing product already labelled  for use on other pests.  Criteria can 
be established to determine wh en facilitated assessment and authorization based on familiarity 
would be applicable.  
1.27.   Examples:  The US Department of Agriculture Animal and Plant Health Inspection Agency 
(USDA APHIS) Extension process for GE plants; US Food and Drug Administration (US FDA ) 
biosimilar drug process; US Environmental Protection Agency (US EPA) Office of Pesticide Programs 
"me-too" pesticide product registration of pesticide products that are similar in formulation to 
pesticide products already registered by the US EPA.  
1.8  Histor y of safe use  
1.28.   In some circumstances, safety can be presumed from an absence of evidence of harm when 
a product has a sufficient history of use.  
1.29.   Background:  Jurisdictions have used the term "history of safe use " to deem many products 
to be generally safe. A lthough determining a history of safe use requires familiarity with the product, 
some products with which a country is familiar might not have a history of safe use and therefore 
the terms are not equivalent.  
1.30.   Examples:  Health Canada employs a category of f oods for which there is "significant human 
consumption … (over several generations and in a large, genetically diverse population) and for 
which there exist adequate toxicological and allergenicity data to provide reasonable certainty that 
no harm will res ult from consumption of the food ''; the US FDA has a category of foods that are 
"generally recognized as safe ". 
1.9  Equivalence  
1.31.   An equivalence process involves determining whether another jurisdiction 's regulatory 
requirements or specific scheme in a particula r area achieve the appropriate level of protection 
applied in one 's own jurisdiction , where the exporting Member objectively demonstrates that its 
measure or  measures meets the importing Members appropriate level of protection.  
1.32.   Background:  Jurisdictions ma y have compatible protection goals, while differing in the 
regulatory process and measures used to achieve that goal. International standards and harmonized 
technical  guidelines can facilitate equivalence. Countries can verify equivalency based on establis hed 
criteria, or by bilateral agreements.  G/SPS/W/317  
 
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  1.10  Harmonization  
1.33.   Members may establish, recognize, and apply, common standards, guidelines, 
recommendations, or regulatory approaches.  
1.34.   Background:  Harmonization can be implemented at various levels. For example, the 
requirements for application dossiers, technical guidelines and guidance documents, data 
requirements, methodologies, terminologies or recommendations can be made consistent across 
jurisdictions to facilitate applications for authorization.  Harmonized stand ards in data collection 
would support data portability across jurisdictions, reduce regulatory redundancy, promote access 
to scientific information across multiple jurisdictions, and could serve as the foundation for regulatory 
cooperation, unilateral reco gnition (section 1.5), mutual recognition (section 1.6) and equivalence 
(section 1.9). 
1.11  Emergency Use Authorization  
1.35.   Emergency exemptions or authorizations (EUA) allow for unregistered use of products to 
address an urgent, non -routine situation that requires  intervention. Often use is granted on a 
temporary basis and occurs while formal product registration is being pursued.  
1.36.   Background:  In most countries, pesticides must be registered for specific crop -pest 
applications. As an invasive pest, FAW would be unli kely to have any existing product registrations 
even though effective pesticides may already be registered in an affected country for different crop -
pest applications. In these cases, a EUA can draw on existing safety data from related pests for the 
pestic ide in question, allowing it to be used for FAW. In rare cases, an entirely new product might 
be approved that does not have a label for any pest. A EUA is limited for the time of crisis and allows 
authorities to respond quickly and decisively to mitigate or contain the crisis.  Criteria can be 
established to determine the trigger for a EUA, and EUAs can be time limited and/or geographically 
limited.  
1.37.   Example:  South African and Kenyan Fall Armyworm Task Forces; US FDA Emergency Use 
Authorization authority to approve new drugs or new indications for previously approved drugs 
during a declared emergency; US EPA Emergency Exemptions to permit the unregistered use of 
pesticide in emergency pest conditions.  
 
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