BioBricks Kit Problem

This year, our team faced problems due to the delay in the delivering of the BioBricks Kit. The arrival of the kit on the right time is essential for the wet lab activities to happen as planned, so the iGEM project can present the desired results. This kind of delay can be prejudicial for the iGEM teams' performance along with the bureaucratic difficulties already intrinsic to the importation of biological material, especially on Latin American countries. In 2014, the iGEM Tec-Monterrey team faced a similar hold-up that led to the creation of a law project to facilitate importation process.

In Brazil, the National Agency of Sanitary Vigilance (Anvisa – Agência Nacional de Vigilância Sanitária) is the responsible for the regularization of products, equipments, food, drugs and cosmetics, among other national and international products. Created in 1999 (Law n° 9.782, January), Anvisa carries out sanitary supervision as well as the economical supervision of the Brazilian market. One of the functions performed by the agency is the sanitary inspection of products, seeking to know their origins, use and destiny of the imported goods. It's a highly bureaucratic process that demands a long time from the receivers, once it's necessary to fill forms, elaborate texts and even pay a sending tax (GRU – "Guia de Recolhimento da União"). In several cases, the bureaucracy coordinated by Anvisa keeps the products from arriving to its destination and sends the imported product back to its original country.

Our team's BioBricks kit, as well as other Brazilian teams' (Brasil-USP and UFMG-Brazil), were kept by Anvisa's sanitary inspection on May, what resulted in a three-week delay on the delivering time. We've highlighted that the shipping was tax-free, since we've been helped by the University's administrative sector. The team also sought information on the necessary papers for the liberation, as well as all the available information about the BioBricks. That being said, our team proposes to iGEM organization a way to facilitate the kit's inspection by providing some useful information and forms with the future kits. We've listed below the main information and forms to ease the bureaucratic procedures in Brazil:

Uses and applications' declaration: specifying the origins, the importation’s motive, the contents and what the BioBricks will be used for. It's also necessary to inform the workplace where the products will be used, the University's name, laboratory and responsible chiefs/technicians.

Responsibility term on the importation vinculum to scientific research: it's the most thorough file, which asks for information on scientific records and fabrication code, that wasn't available to the team.

Non-Consent Term: lists the possible application and uses of the imported product.

Payment confirmation of the BioBricks kit: this document is already given automatically along with the iGEM's joining payment.

On the links below, we present samples of the files that can come with the kit on the next years. The problems with biological material importation in our country are frequent, and there are law projects being created to make this process easier. In Political, we discuss more thoroughly how the Brazilian Congress intends to ease the importation of biological material, which spoils scientific researches all over the country.

Document - Biobricks

References

1. iGEM Tec de Monterrey 2014 Policy & Practices (2014). Retrieved August 24, 2015, from: https://2014.igem.org/Team:Tec-Monterrey/ITESM14_policy_practice.html#tab_law-proposal.

2. http://s.anvisa.gov.br/wps/s/r/zH5