[Rodenticide Update] What's Next

It has the makings of a great Hollywood movie. Children’s health. Children’s safety. Lawyers. Government regulation. And mice. And rats. And lots of them.

In January, the Environmental Protection Agency (EPA) issued a Federal Register notice announcing proposed measures to reduce exposures and risks associated with nine rodenticides. The risk mitigation measures include:

1) All second-generation anticoagulant rodenticides would be classified as Restricted Use Pesticides (RUPs).

2) All rodenticide bait products available for sale to consumers would be marketed only in tamper-resistant bait stations with solid bait blocks.

3) Additional restrictions and labeling improvements would be required.

HISTORY. In 1998, EPA was reviewing the "rodenticide cluster" (five rodenticides) as part of its RED (Reregistration Eligibility Decision) process, which looks at the safety of older pesticides. "During the course of putting together that document, it became clear that EPA needed to do more work looking at the environmental effects of (rodenticides on) non-target species," said Kelly Sherman, team leader, Special Review and Reregistration Division in the Office of Pesticide Programs, EPA.

As a result, further analysis of rodenticides was performed and EPA compared nine rodenticides to rank them against one another. EPA wanted to ensure that if it imposed risk mitigation on one rodenticide (and not others) users wouldn’t switch to another product with which EPA had the same issues — and then EPA would be back at square one. "It was a long complex assessment. It went to EPA’s science advisory panel several times, it was peer reviewed and released for public comment twice," Sherman said. The data was made public in January 2003 and September 2004.

EPA also was examining rodenticides’ exposures to children. As part of EPA’s RED, the agency decided to require manufacturers to include bittering agents and indicator dyes in their products. The theory was that bittering agents would make products unpalatable to children and indicator dyes would show parents if a child had eaten a product, and thus was in need of medical attention.

It was decided that EPA would convene an external work group to further look into children’s exposure. The Rodenticide Stakeholder Work group (RSW), which met five times in 1999 and 2000, found that there wasn’t any indicator dye that would work as was discussed. Second, data came forward that sometimes rodents were less likely to eat the rodenticide if it had a bittering agent in it. As a result, it was decided in 2001 that companies could voluntarily put a bittering agent in their products if so desired.

The RSW concluded, and EPA agreed, that rodenticide manufacturers should not be required to include a bittering agent and indicator dye in rodenticide products to reduce the exposures to children.

In November 2004, a lawsuit was brought challenging EPA’s decision to not impose the dye and bittering agent regulations. The result? "The court said it agreed with the indicator dye decision but told us to go back and reconsider the bittering agent decision," Sherman said. "Once that happened, it sort of gave new focus to children’s risk issues."

EPA set out to determine how it could address the expsoure to wildlife and decrease the number of children’s exposures but at the same time allow people to still have access to a variety of effective and affordable products to control rodents. "An important part of rodenticides is that they also have strong benefits in terms of public health," Sherman said.

CONSUMER MARKET. According to EPA, the recent risk mitigation proposals are aimed at changing consumers’ use of rodenticides. "That’s where most of the risk is coming from, both in terms of children’s exposure and environmental impact," Sherman said.

"The second-generation anticoagulants are much more toxic and more persistent than the other anticoagulants. A homeowner doesn’t need that much strength," Sherman said. "They’re using a machine gun when they need a hand gun. It’s unreasonably risky for somebody with a few mice in their home to use second-generation anticoagulants, because they are much more toxic and much more persistent and end up causing exposure to wildlife."

The first risk mitigation measure, which would reclassify all second-generation anticoagulant rodenticides as RUPs, is designed to take those products off the consumer market. Consumers won’t be able to buy those active ingredients under this proposal (professional applicators who are certified applicators will still be able to do so).

Manufacturers that sell to the retail, professional and animal health markets will most certainly be impacted by this decision. "It becomes an even larger issue for the over-the-counter rodenticide products available to consumers; anything from rodenticides in a grocery store or Home Depot to an agricultural setting like a local farm store," said Al Smith, director of marketing and business development, Liphatech. "Basically, anything with brodifacoum, bromadiolone or difethialone formulated into pellets, meals or 1-pound bar baits are going to be taken away from these customers. This will leave them with less effective multi-feed anticoagulants and only in mini-block form."

Liphatech, for example, sells a substantial quantity of rodenticides to farm stores. Also, these mitigation measures have the potential to heavily impact retail sales through Liphatech’s private label customers. "We are highly concerned about our retail business should these proposed mitigation measures be implemented as written," Smith said.

The second proposal, which would require all rodenticide bait products available for sale to consumers to be marketed only in tamper-resistant bait stations with solid bait blocks, is designed to get at consumers who don’t know they should be putting these products in bait stations, according to EPA. EPA said it believes most professionals are already following this standard. "Our sense is the most professional applicators that would apply rodenticides in a home setting, where there are children and pets, are already using a bait station," Sherman said.

According to EPA, the RUP classification is in response to ecological risk, not children’s exposure. And the tamper-resistant bait station recommendations are only designed to mitigate children’s exposure, not ecological risk.

EPA reports that 12,000 to 15,000 children a year are exposed to rodenticides. The agency also points out that rodenticides aren’t the only way to kill rodents. "Snap traps are much less expensive and a lot of experts think they’re more effective — they’re reusable — as are glue traps," Sherman says. "These products aren’t the only way to control rodents," she said, also noting that structural modifications and other IPM techniques are effective as well.

INDUSTRY POSITIONS. The National Pest Management Association has been actively involved in the RED process for many years. NPMA is not necessarily on the same page as the rodenticide manufacturers when it comes to the agency’s proposed reclassification of brodifacoum, bromadiolone and difethialone as Restricted Use Products. "We clearly have a different perspective than the manufacturers, and it’s actually the only time in 10 years working together that that’s happened," NPMA Senior Vice President Bob Rosenberg said.

Rosenberg concedes that many PCOs don’t like the prospects of using Restricted Use Products, but "it also means that home-owners won’t have access to those products. So it should address the non-target wildlife issue, without depriving PCOs of these important tools," he said. Rosenberg also notes that the likely alternative to RUP status for second-generation anticoagulant rodenticides was to prohibit their use outside of structures, which would have been unmanageable for PCOs. "Some PCOs may not like using RUPs, but the alternative would have been far worse," he said.

Still, manufacturers contacted by PCT expressed concerns. "It could be positive for PMPs from the standpoint that they may pick up business provided building owners maintain the rodent control programs the tenants were previously doing," said Liphatech’s Smith. "Or, it may leave lower-income people with a severe public health problem."

This latter scenario is what concerns the Rodenticide Registrants Task Force (RRTF), an organization of rodenticide manufacturers that have joined together to address such issues. "The RRTF is preparing detailed comments on EPA’s proposed mitigation measures, and in them will explain exactly how EPA’s proposed risk mitigation measures are excessive, unlawful, lacking factual merit and, in a word, dangerous because if implemented, these measures could very well increase public health risks," said RRTF attorney Lynn L. Bergeson, Bergeson & Campbell PC, Washington, D.C.

The RRTF says it believes that if implemented, EPA’s proposed measures would diminish rodenticides’ availability to exactly the people who need them most, namely low-income communities. Further, the RRTF said it believes that the proposed measures greatly overstate the potential harm rodenticides could cause and greatly underestimate the public health benefits provided by these products.

"Rodenticides are extremely cost-effective and efficiently control rodents. They blunt the spread of disease, and limit the ability of rodents to compromise food safety and destroy property," Bergeson said.

Another manufacturer concern is that PCOs could incur higher costs. "Costs are going to go up," said Steve Levy, president of Bell Laboratories. "For example, administrative costs will go up — for recording rodenticide usage."

Manufacturers also expressed disappointment in EPA’s decision-making process. Specifically, manufacturers say they do not believe the products in question should have been reclassified as RUP based on their toxicological profiles.

"We believe the re-classification is not warranted, especially considering EPA’s own advisory panel did not recommend the reclassification," said John Hott, technical consultant for human safety, Syngenta Professional Products. "There is simply a lack of data showing that those rodenticides are a significant risk to wildlife."

Bell Labs’ Levy expressed similar concerns, adding that he would have preferred EPA to use a more science-based approach in assessing brodifacoum, bromadiolone and difethialone. "What I’d like to see is a scientific advisory panel to review the science and review the data and see if it warrants RUP status," he said. "I think that if a scientific advisory panel would review the data it would not support making all second-generation anticoagulant restricted use."

Additionally, manufacturers that are a part of the RRTF say they completed stringent full ecological risk assessment that went well above the actions required by EPA.

Manufacturers also expressed concerns about the big-picture implication of such a decision. "The question then becomes at what point does (EPA restricting product use) spill into other products — other rodenticides," said Bell’s Levy. "This was a broad assessment that all second-generation products have these risks when in fact the product data does not show that. The concern is that process continues with other actives outside of the three."

WHAT’S NEXT? Currently, the issue is in its comment period, which has been extended to April 19. The comment period is a time for any stakeholder to submit comments to EPA regarding the issue. After the comment period, EPA takes into consideration the comments they receive and the agency will analyze and respond to each comment. This likely will take four to six months. After the review period is over, a final Federal Register notice will appear in late summer or early fall, which will announce EPA’s decision. At a minimum, it will be 12 months before changes are seen by pest management professionals and consumers, and it could take up to two years. That schedule will likely hold true to form unless the registrants litigate, which could occur.

Manufacturers are moving forward with their comments. "The RRTF will submit its comments to EPA, seek to meet with senior EPA representatives, and engage in extensive outreach to RRTF member stakeholders including distributors, consumers and others, and urge them to express their strong opposition to the proposed measures and urge EPA to reconsider its proposal," Bergeson said.

Among other product stewardship initiatives, the Rodenticide Registrants Task Force has created an RRTF-supported Web site that allows consumers to obtain rodent control resources, information on IPM strategies, product use and related information. "The RRTF believes that some of the measures EPA has identified have merit, and Task Force members have expressed their willingness to enhance efforts to educate consumers on the proper management and use of their rodenticide products," Bergeson said. "EPA concluded a few years ago, for example, that rodenticide product labels could be clearer in terms of communicating hazard and risk information. That is exactly why the RRTF proposed label improvements a few years ago, and more recently urged EPA to accelerate its review and approval of these changes. Unfortunately, EPA has yet to do so despite the Task Force’s repeated urgings.

"The RRTF believes, however, that most of EPA’s proposed measures are unwise, unnecessary, and could well undermine public health, and certainly the public’s ability to combat effectively rodent infestations," Bergeson said.

The authors are editor and Internet editor, respectively, for PCT magazine and www.pctonline.com.