New Antibiotic Regulation

BIRMINGHAM, Ala. (DTN) -- California's legislature is being given kudos for passing a tough bill aimed at halting the development of antibiotic resistant bacteria. Senate Bill 27 (SB 27) adds a level of regulation to the FDA's implementation of GFI No. 209, commonly referred to within the livestock industry as the Veterinary Feed Directive (VFD).

The state and national regulations go into effect exactly one year apart -- the VFD in January 2017 and SB 27 in January 2018. While there are similarities between the two, some of the distinctions could make SB 27 a much more onerous law for both industry and veterinarians in the state of California.

Valerie Fenstermaker, executive director of the California Veterinary Medical Association, said the association strongly believes medically important antimicrobial drugs should be ordered by a licensed veterinarian, through a prescription or a veterinary feed directive within an established veterinary-client-patient relationship. The group supported SB 27.

"A veterinarian's oversight of antimicrobial drugs to treat, prevent and control disease or infection in livestock will minimize pain, suffering and mortality while addressing antimicrobial resistance," she said. She added veterinarians in the state "welcome the opportunity to develop new relationships with food producers and provide excellent care for their animals."

MEDICALLY IMPORTANT ANTIBIOTICS

From the perspective of livestock producers, Justin Oldfield said SB 27 has one major difference when compared to the federal regulations. While federal changes pertain specifically to antibiotics delivered through feed or water, SB 27 applies to all medically important antibiotics that are currently available over the counter, including injectables. Oldfield is vice president of government affairs with the California Cattlemen's Association (CCA).

"There are a whole host of drugs used now that are antibiotics and that already require a veterinary prescription. This extends that to some products producers are currently able to buy over the counter," explained Oldfield. His biggest concern is that smaller producers will have to find a veterinarian to consult with to purchase products previously purchased over the counter, such as treatments to routine ailments like pinkeye in cattle. In some rural areas this will present a challenge.

For veterinarians in the state, both the federal regulations and California's new law bring into being a whole new level of responsibility in terms of veterinary oversight.

"If veterinarians are controlling the use of these products, they would need to determine what is appropriate antibiotic use and what isn't," said Christine Hoang, assistant director for the American Veterinary Medical Association. She added that the AVMA's Judicious Use Guidelines are consistent with SB 27's definition of stewardship.

Like the federal guidelines, SB 27 applies to "medically important antimicrobial drugs." This means an antimicrobial drug listed in Appendix A of the federal Food and Drug Administration's Guidance for Industry No. 152. (That list begins on page 28 at http://1.usa.gov/…). A veterinarian can issue a prescription for a drug on the list for up to six months under SB 27, the same as under the VFD.

USE GUIDELINES MADE CLEAR

CCA's Oldfield said there have been inaccurate reports as to when these antibiotics can and cannot be used under SB 27. He stressed the law does not prohibit the use of antibiotics in the prevention of disease.

"This does not prevent a veterinarian from saying 'I think this pen of steers has a good chance of getting shipping fever, so I'll treat them to prevent the contraction of pneumonia'. This does not prohibit that."

Specifically SB 27 says use of a medically important antibiotic is allowed when a veterinarian deems it "necessary" in these situations: (1) To treat a disease or infection; (2) To control the spread of disease or infection; (3) For surgery or a medical procedure; (4) To address an elevated risk of contraction of a particular disease or infection.

As in the case of the federal guidelines, SB 27 is clear that medically important antibiotics cannot be used to promote weight gain or feed efficiency.

REPORTING AND CONFIDENTIALITY

Another concern with SB 27 has been that some sort of mandatory reporting requirement in the law would compile data on who buys antibiotics and in what quantity, and then report that on a website. Oldfield said first, this tracking component of the bill is voluntary, and second, it is confidential.

"There are very strict confidentiality provisions in the law to prohibit the release of that information. It cannot be released under a Freedom of Information Act request, or a public records request. There is a provision that allows the CDFA [California Department of Food and Agriculture] to go to the veterinary medical board if they feel there is some sort of malpractice going on. But they cannot release names to the public."

AVMA's Hoang points out that SB 27 does make it clear the CDFA is charged with gathering information on medically important antimicrobial usage, as well as on antimicrobial resistant bacteria and livestock management practices.

However, the legislation says the CDFA is to work with "willing participants" and that it will seek funds from federal, state and other sources to implement those efforts. In January 2019, the CDFA will report back to the legislature whether there has been enough participation in the program to provide statistically relevant data.

The California livestock industry must comply with both the federal regulations and SB 27. Producers in other states who sell products in California will not have to meet the state's additional standards.

Victoria Myers can be reached at vicki.myers@dtn.com

(CZ/GH/KM )

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