Evidence map›Paper›PMID 32047744›Full record

ArticleFrontiers in bioengineering and biotechnology2019

Familiarity in the Context of Risk Assessment of Transgenic Crops: Focus on Some Countries in the Americas.

Deise M F Capalbo, Phil Macdonald, Patricia Machado Bueno Fernandes, Clara Rubinstein, Carmen Vicién

Abstract read
In one paragraph

Article in Frontiers in bioengineering and biotechnology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. What´s in a name: the issue with regulatory definitions.Frontiers in bioengineering and biotechnology · 2026
    Article
  2. Review
  3. Review
  4. Article
  5. Article
  6. Update of Argentina's Regulatory Policies on the Environmental Risk Assessment.Frontiers in bioengineering and biotechnology · 2021
    Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Deise M F CapalboEmbrapa Environment and International Life Sciences Institute, São Paulo, Brazil.
Phil MacdonaldCanadian Food Inspection Agency, Ottawa, ON, Canada.
Patricia Machado Bueno FernandesFederal University of Espírito Santo, Vitoria, Brazil.
Clara RubinsteinBayer Crop Science and International Life Sciences Institute, Buenos Aires, Argentina.
Carmen ViciénUniversity of Buenos Aires and International Life Sciences Institute, Buenos Aires, Argentina.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Problem formulation is the formal opening stage of a risk assessment that determines its purpose and scope and hence guides the gathering of information data. The concepts of familiarity and history of safe use are an integral part of problem formulation. These concepts do not replace the case-by-case approach and are not taken as safety standards but are valuable components of the process that shape the generation of plausible, testable risk hypotheses. The International Life Sciences Institutes in Brazil and Argentina have facilitated numerous discussions on the scientific principles for risk assessment of transgenic crops in the Latin American region in the past 5-6 years. The session held at ISBR 15th elaborated on the familiarity concept and derived tools and their role in the evolution of risk evaluation criteria. Examples of how different countries in the Americas interpret and apply these conceptual tools show that familiarity is a valuable concept, although terms are very often confused and vaguely defined. Formalizing these terms with clear definitions and scope of application in guidelines and regulatory documents would reduce ambiguity, enhance predictability, and add transparency to the evaluation processes.

Indexed as

familiarityharmonizationhistory of safe useproblem formulationregulatory frameworkrisk assessment

Identifiers

PMID32047744
PMCPMC6997124

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.