“Yeah, right,” you say. But really, according to a series of releases from USDA’s Animal and Plant Health Inspection Service, new technologies for improving farm and ranch productivity soon could become available more quickly,. The agency announced plans to streamline the approval process for veterinary biologics such as vaccines and bacterins, and for deregulating genetically engineered organisms.
According to APHIS figures, the new system will cut about 100 days, or 20 percent, from the current 500 days needed to process a license application for a veterinary biologic product.
A common complaint among those in the animal-health business is the lengthy, and costly, process for gaining approval and bringing a new product to market. Ed Avalos, USDA undersecretary for marketing and regulatory programs, says companies have estimated that a one-year delay costs them $5 to $10 million.
“What’s important to us is that the changes we are undertaking will not only have a direct benefit for the biologics businesses, but also the livestock industry,” Avalos says. “Our new process will create valuable savings and help drive growth.”
Naturally it is in the best interest of producers, consumers and animal-health companies that vaccines and other products are safe and effective, which is the intent of the licensing process. APHIS indicates it can maintain its standards while achieving time savings through several improvements in efficiency, including:
- Allowing industry to provide a project development plan to identify the steps that must be completed to gain licensure.
- Establishing agreements that document mutually agreed upon standards.
- Simplifying the product reference qualification/requalification process for older legacy products and extending the use of these references to 15 years.
- Standardizing the statistical data submissions by industry in support of licensing and other services.
- Simplifying the conduct and review of studies that support the efficacy of veterinary biologics while maintaining the high quality of data review.
- Streamlining the process that occurs once all of the materials necessary to recommend product licensure are submitted by industry.
APHIS also announced plans to streamline the decision process on petitions for nonregulated status for genetically engineered (GE) plants. APHIS grants such petitions when it determines that a GE product does not pose a plant pest risk and should not be subject to APHIS regulation. “With the improvements announced today, APHIS will significantly reduce the average length of the petition process while maintaining strong oversight,” Avalos says.
Somehow a government agency pledging to become faster and more efficient sounds like my dentist saying “This won’t hurt a bit.” The overall trend tends to favor more bureaucracy, red tape and delays, but I’ll take APHIS at their word and applaud them for at least acknowledging a need to improve. Improving these approval processes will benefit producers who use the technologies and the companies that develop them, helping create jobs and contributing to the economy as a whole.