(Beyond Pesticides, May 10, 2013) The U.S. Environmental Protection Agency (EPA) published on May 8 a final rule to revise and update use patterns and data requirements for antimicrobial pesticides. Though the new rule is the first revision to EPA data requirements for antimicrobial pesticide registrations since 1984, remaining inconsistencies among data submissions and data gaps, these new rules are a step in the right direction when it comes to regulating antimicrobial pesticides, considering the proliferation of consumer products that contain these chemicals. However, even with these new rules in place, certain antimicrobial pesticides that are already in consumer products, such as triclosan, will still present serious hazards for human and environmental health.
More than 5,000 antimicrobial products are currently registered with EPA. Initially designed for hospitals and clinics, many antimicrobial pesticides are found in products ranging from household cleaners to mattresses and bedding, cosmetics, toys, toothpaste and even chopsticks. Antibacterial products are being marketed to the health conscious without firm evidence of real benefits and amid growing concern about unintended externalities. One prime example of this is triclosan, which is formulated into hundreds of personal care products, toys and textiles. Studies show that triclosan is an endocrine disruptor, accumulates in human fatty tissue and can influence the onset of bacterial resistance.
Recently, the Associated Press reported that the U.S. Food and Drug Administration (FDA) will rule on the safety of the antibacterial chemical triclosan this year, after 40 years of delay. FDA published several draft guidelines over the years but never finalized the results, which has allowed companies to keep the chemical in their products. Though the FDA review of triclosan is not connected to these new rules finalized by the EPA, it does show that federal agencies are slowly, but finally, moving towards determining the safety of the antimicrobial chemicals. EPA will also review the safety of triclosan this year.
Under these new rules, eleven new data requirements for antimicrobial pesticides are being codified. This codification of the rules is important because, according to comments released by Beyond Pesticides in 2009, “Often the agency [EPA] would conduct case by case determinations to instruct registrants on what data was needed for antimicrobial pesticides.” This process leads to inconsistent data being submitted by registrants. These new rules set up unique data requirements specifically for antimicrobials and create a uniform process.
Some of the new data requirements establish evaluations for: developmental neurotoxicity; immunotoxicity; photodegradation in soil; soil residue dissipation; ready biodegradability study; porous pot study; activated sludge sorption isotherm study; and modified activated sludge, respiration inhibition test. Additionally, EPA will require a down-the-drain analysis for every product with an applicable use or exposure scenario.
According to Beyond Pesticides’ 2009 comments, “This [down-the-drain] model proposed by the agency to estimate concentrations of chemicals in surface waters, as a result of disposal of consumer products into wastewaters, is a useful tool to assist wastewater treatment agencies with the wastewater treatment process, and to monitor the fate and effects of these chemicals once in the waterways.”
However, Beyond Pesticides’ 2009 comments also point out some of these new rules’ short comings. First, under these new rules, EPA will delineate between high and low indirect food use exposures to antimicrobial pesticides. Continual low dose exposure over time can result in high exposure as antimicrobial chemicals, like triclosan, can build in fat tissue. Continual low dose exposure has been shown in the scientific literature to pose significant long term risk, especially for developing infants.
Second, the EPA should take a closer look at chemical mixtures currently found in the nation’s waterways and their possible synergistic effects. Several studies detail the presence of varied concentrations of pharmaceuticals in surfaces waters, including several antimicrobials. However, the evaluation does not evaluate how these chemicals interact with each other in the environment, or their combined effects on human and environmental health.
The news rules will go into effect on July 8, 2013.
For more information on antimicrobials or antibacterials please visit Beyond Pesticides’ Antimicrobials and Antibacterials page.
All unattributed positions and opinions in this piece are those of Beyond Pesticides.