BIO: APHIS strategy needs regulatory clarity to boost innovation

barley field with sunrise

In comments to the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), the biotech sector suggests the agency needs to implement a plan to encourage innovation and “expedite regulatory paths for breakthrough technology solutions.”

The primary focus of APHIS is to regulate biotechnology in agriculture. The agency sought insights from stakeholders about a strategic plan that will direct its activities and work over the next five years.

The Biotechnology Innovation Organization (BIO) issued a seven-page letter that praises the efforts of APHIS and their strategy, while also recommending certain improvements.

BIO argues that solutions such as carbon capture and nitrogen-fixing cannot be commercialized due to the fundamental regulatory challenges they face. Therefore clear regulatory frameworks are essential.

BIO also seeks clarity regarding the non-plant genetically engineered organisms that might fall under the APHIS’s Part 340.

APHIS must harmonize its innovation policy with the EPA and the FDA, BIO adds.

In terms of animal biotechnology, a new regulatory system that will involve the FDA and other agencies is highly needed. BIO commits to being part of this system’s development.

When it comes to international regulation, BIO cited Mexico’s policies toward genetically engineered products and called on the USDA to work with their partners in order to create a harmonized regulatory framework around the world aimed at improving the time to market.

Diversity is critical to APHIS strategy

When it comes to diversity, BIO suggests APHIS enter partnerships with land-grant universities, community colleges, and HBCUs, in order to bolster a talented and diverse workforce.

Bolstering diversity also means “partnering with USDA extension services to expand technical assistance to underserved producers, potentially providing opportunities for rural development,” BIO says.

APHIS has extended that timeframe for receiving comments on improving their strategic plan and the new date is July 31.

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