Golden rice meets food safety stan­dards in three global lead­ing reg­u­la­tory agen­cies

Agriculture - - Contents -

LOS BAÑOS, PHILIP­PINES – GR2E Golden Rice, a provi­ta­min-A bio­for­ti­fied rice va­ri­ety, com­pleted its third pos­i­tive food safety eval­u­a­tion, this time with the United States Food and Drug Ad­min­is­tra­tion (US FDA). In an of­fi­cial re­sponse re­ceived by the In­ter­na­tional Rice Re­search In­sti­tute (IRRI) on 24 May (EST), the US FDA con­curred with IRRI’s as­sess­ment re­gard­ing the safety and nu­tri­tion of Golden Rice.

The US FDA state­ment comes on the heels of the safety and nu­tri­tion ap­provals from Food Stan­dards Aus­tralia New Zealand (FSANZ) and Health Canada in Fe­bru­ary and March 2018, re­spec­tively. These three na­tional reg­u­la­tory agen­cies carry out their as­sess­ments based on con­cepts and prin­ci­ples de­vel­oped over more than two decades by in­ter­na­tional or­ga­ni­za­tions such as the World Health Or­ga­ni­za­tion (WHO), the Food and Agri­cul­ture Or­ga­ni­za­tion (FAO) of the United Na­tions, the Or­gan­i­sa­tion for Eco­nomic Co-op­er­a­tion and De­vel­op­ment (OECD) and the Codex Ali­men­ta­r­ius Com­mis­sion.

“Each reg­u­la­tory ap­pli­ca­tion that Golden Rice com­pletes with na­tional reg­u­la­tory agen­cies takes us one step closer to bring­ing Golden Rice to the peo­ple who need it the most,” says IRRI Direc­tor Gen­eral Matthew Morell. “The rig­or­ous safety stan­dards ob­served by the US FDA and other agen­cies pro­vide a model for de­ci­sion-mak­ing in all coun­tries wish­ing to reap the ben­e­fits of Golden Rice.” For those who strug­gle with Vi­ta­min A de­fi­ciency (VAD), in­clud­ing an es­ti­mated 250 mil­lion preschool age chil­dren, this an­nounce­ment rep­re­sents one more step for­ward to mak­ing this rice avail­able to them. Once Golden Rice re­ceives all nec­es­sary na­tional ap­provals, a sus­tain­able de­ploy­ment pro­gram will en­sure that Golden Rice is ac­cept­able and ac­ces­si­ble to its tar­get com­mu­ni­ties.

Vi­ta­min A de­fi­ciency re­mains a per­va­sive public health prob­lem world­wide. WHO es­ti­mates that along­side chil­dren un­der 5 years of age, a sub­stan­tial num­ber of preg­nant and lac­tat­ing women are af­flicted with VAD; South and South­east Asia rank high among the re­gions where VAD is preva­lent.

Golden Rice is in­tended as a com­ple­men­tary, food-based so­lu­tion to ex­ist­ing nu­tri­tional in­ter­ven­tions, such as diet di­ver­si­fi­ca­tion and oral sup­ple­men­ta­tion. It achieves this by pro­vid­ing 30-50% of the es­ti­mated av­er­age re­quire­ment for Vi­ta­min A of women and chil­dren.

GR2E Golden Rice is the first nu­tri­tion­ally en­hanced ge­net­i­cally mod­i­fied rice to re­ceive reg­u­la­tory ap­proval for use in food. IRRI is work­ing with na­tional re­search part­ners in the de­vel­op­ment and de­ploy­ment of health­ier rice va­ri­eties that have more iron, zinc, and beta-carotene con­tent to im­prove the nu­tri­tional sta­tus of vulnerable pop­u­la­tions with lim­ited ac­cess to di­verse di­ets. Be­cause rice is al­ready widely grown and eaten, these bio­for­ti­fied rice va­ri­eties have the po­ten­tial to reach many peo­ple.

In Bangladesh and the Philip­pines, the Bangladesh Rice Re­search In­sti­tute (BRRI) and Philip­pine Rice Re­search In­sti­tute (PhilRice) are de­vel­op­ing high-yield­ing in­bred lo­cal rice va­ri­eties with the beta-carotene pro­duc­ing GR2E Golden Rice trait. Golden Rice ap­pli­ca­tions with the ap­pro­pri­ate na­tional reg­u­la­tory agen­cies have been made by BRRI in Bangladesh, and a joint IRRI/PhilRice ap­pli­ca­tion has been sub­mit­ted in the Philip­pines. Both were lodged in 2017.

Ac­cord­ing to Dr Rus­sell Reinke, Health­ier Rice pro­gram lead at IRRI, reg­u­la­tory ap­pli­ca­tions are a nec­es­sary step in the re­search and de­vel­op­ment process. “Reg­u­la­tory ap­proval en­ables or­ga­ni­za­tions such as IRRI to con­duct fur­ther tri­als and nu­tri­tion as­sess­ments that can as­sure the public that our health­ier rice va­ri­eties meet their needs.”

Along­side the con­tin­u­ing work on the GR2E Golden Rice va­ri­ety, IRRI is also de­vel­op­ing high iron and zinc rice and stacked be­tac­arotene, iron and zinc va­ri­eties to ad­dress other mi­cronu­tri­ent de­fi­cien­cies among im­pov­er­ished com­mu­ni­ties.

“Each com­po­nent of IRRI’s ef­forts to im­prove the nu­tri­tional con­tent of rice re­sponds to crit­i­cal and en­dur­ing global nu­tri­tion se­cu­rity con­cerns,” as­serts Dr. Morell.

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