Highlights:

On July 3, 2016, President Putin signed Federal Law 358-FZ “On amendments to certain legislative acts of the Russian Federation concerning improvement of the state regulation in the sphere of genetic-engineering activities." These amendments prohibit cultivation of genetically engineered plants and breeding of genetically engineered animals on the territory of the Russian Federation, strengthen state control and monitoring of processing and imports of GE organisms and products derived from such organisms and set penalties for violations of this federal law.

General Information:

President Vladimir Putin signed Federal Law No 358 of July 3, 2016 “On amendments to certain legislative acts of the Russian Federation concerning improvement of the state regulation in the sphere of genetic-engineering activities." These amendments prohibit cultivation of genetically engineered plants and breeding of genetically engineered animals on the territory of the Russian Federation, except for cultivation and breeding of plants and animals required for scientific expertise or research. The amendments provide that controlling bodies of the executive power shall monitor: the effects of GE organisms, and products derived from such organisms, not only on the environment but also on the health of human beings; shall conduct state registration of such organisms and products, and in case of violations may ban imports of such products. The penalties for officials, violating this law, will be from 10,000 rubles to 50,000 rubles. The penalties for juridical persons violating this law will be from 100,000 rubles to 500,000 rubles. Federal Law 358 will come into force on the date of its official publication (July 4, 2016), except the article pertaining to penalties in case of violations, which will come into force on July 1, 2017.

Federal Law 358 amends four major legislative acts of the Russian Federation:

  • Federal Law of July 05, 1996, No. 86-FZ “On the State Regulation in the Sphere of Genetic-
  • Engineering Activity." The amendments emphasize the role of state control over the release of genetically-engineered organisms into the environment, state monitoring of the effects of such release on the environment and also on the health of human beings. The amendments add the responsibility of control and monitoring, as well as registration, of genetically engineered organisms and products, including imported goods, to the state. The amendments broaden the meaning of
  • “safety control in the sphere of genetic engineering," and emphasize that, based on the results of monitoring the effect of GE organisms and products on environment and human health, the authorized bodies of the executive power can ban imports of genetically-engineered organisms and/or products derived from GE organisms into Russia;
  • Federal Law of December 17, 1997, No. 149-FZ “On Seed Industry." The amendments to this FL ban imports of GE planting seeds into Russia, with the exception of sowing (planting) such seeds “in the course of expert examination and research activities;"
  • Russian Federation Code of Administrative Offences. The amendments to this Code specify penalties for violations of the legislation of the Russian Federation in the sphere of genetic engineering (from 10,000 rubles to 50,000 rubles for officials, and from 100,000 rubles to 500,000 rubles for individuals from the judiciary), and specifies the bodies of the executive power which can consider violations;
  • Federal Law of January 10, 2002 No, 7-FZ “On Protection of the Environment." The amendments to this FL ban growing and/or breeding of genetically –engineered (modified) plants and animals in the territory of the Russian Federation, except growing and breeding of such plants and animals in the course of expert examination and research activities.

Background information

Until adoption of the Federal Law 358 on July 3, 2016, the ban on cultivation of GE crops and breeding of animals existed de-facto because there were no administrative mechanisms for registration of genetically engineered crops and animals for release into environment. In October 2010, on the eve of WTO accession, Russia adopted a Federal Law that allowed the Government to regulate issues of genetic engineering through legislative documents at the government level. Thus, in September 2013 the Russian Government issued Resolution No. 839 that allowed for the development of a mechanism for the registration of GE crops for release into the environment (i.e. cultivation), and set July 1, 2014 as the date of initiation of this mechanism for the registration of GE crops for release into environment. Industry analysts estimated the registration process for GE crops for cultivation would take approximately five to six years. With this estimate, it was anticipated that the initiation of cultivation of such crops in Russia would not begin before 2023 to 2024. Resolution No. 839 caused a mass media and public campaign that argued of the imminent threat to the health of Russian population and the environment due to GE crops and products. This campaign was supported by some top Russian officials, including the Russian Minister of Agriculture. On June 16, 2014, the Government of the Russian Federation issued Resolution No. 548 that delayed the start of registration of GE crops for cultivation in Russia to July 1, 2017. Never-the-less, the anti-GE campaign continued, and Federal Law No. 358, banning the cultivation of GE crops and breeding of GE animals in Russia, was passed on July 3, 2016.

The “GMO" issue is a “hot topic" in mass media, and they refer to FL 358 as a law that also bans the importation of GE organisms and products. However, the law stipulates that the Government has such authority only when monitoring finds that a certain GE organisms or a product creates a negative impact on the environment and/or human health.

Federal Law 358 does not ban imports of GE organisms for scientific research, although industry analysts have indicated that they believe research will cease because the scientific community will not be interested in conducting expensive research without prospects for commercialization.

Federal Law 358 does not ban imports of GE organisms and products (for food and feed use) if they are already registered for food and feed use in Russia. However, Federal Law 358 provides that the Russian controlling agencies may ban imports of products if they find a threat to the environment, people, or animals, or if they determine that the imported product(s) are not registered in Russia. Russian controlling agencies, such as the Russian Federal Service for Surveillance in the Sphere of Human Wellbeing (Rospotrebnadzor) and the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor – VPSS), already have this responsibility based on regulatory documents that describe their functions.However, Federal Law 358 affixes the responsibilities under the federal law on the state regulation of genetic engineering activities.