SECTION: IN THE NEWS

LENGTH: 4069 words

HEADLINE: PREPARED TESTIMONY OF
RALPH ENGEL
PRESIDENT
CHEMICAL SPECIALTIES MANUFACTURERS ASSOCIATION
BEFORE THE HOUSE COMMITTEE ON AGRICULTURE
SUBCOMMITTEE ON DEPARTMENT OPERATIONS,
OVERSIGHT, NUTRITION, AND FORESTRY

BODY:


Thank you Mr. Chairman and members of the subcommittee and good afternoon. My name is Ralph Engel. I am President of the Chemical Specialties Manufacturers Association - (CSMA).
CSMA has a membership of some 400 companies who manufacture, formulate, distribute and sell many types of consumer, industrial and institutional products including non-agricultural pesticides.
A significant number of our members' products have pesticidal claims and are, therefore, subject to EPA jurisdiction pursuant to the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act -- FIFRA.
In 1996, Congress passed the Food Quality Protection Act (FQPA), which amended FIFRA. Among FQPA provisions were reforms to the antimicrobial registration process, including the establishment Of performance goals for registration of antimicrobial pesticides which established registration timelines. It also established a statutory definition for these products.
Mr. Chairman, I am pleased to state that the agency has made significant improvements in the overall registration of these products.Unfortunately, other sections of FQPA create uncertainty in the system of registering pesticides for non-agricultural pesticides. Our industry is concerned that EPA appears to be bent on implementation of the FQPA based on an arbitrary deadline that may lead to decisions based on faulty risk assumptions rather than on sound data. Additionally, industry is concerned with the lack of sound science, in that risk management decisions are being made while many of the FQPA science policies are not finalized and remain in draft form and/or have not been issued for public review and comment. This may result in the loss of products that are important to consumers and institutions and lead to potentially significant public health consequences. If the provisions of FQPA are not properly implemented, many products that benefit and protect consumers will be lost. To avoid this, we must have regulations based on sound science and reliable data based on real life assumptions and risks.
I appreciate the opportunity to testify before the subcommittee today. My testimony focuses on four areas:
First an overview of the benefits of non-agricultural pesticides and of public acceptance of these products;
Second, the implementation of the Food Quality Protection Act and the potential loss of some of these valuable residential pesticide products that it may cause;Third, I will report on the industry's progress in generating real wold data and the need for sound science and reliable information; and
Finally, I will discuss the implementation of the antimicrobial reform provisions of FQPA.
BENEFITS OF NON-AGRICULTURAL/CONSUMER PROTECTION HEALTH BENEFIT PRODUCTS
CSMA defines the general-use, residential or non-agricultural pesticide products we represent as Consumer Protection and Health Benefit Products. This definition includes, among other things, any disinfectant, sanitizer, germicide, insecticide, repellent, rodenticide and any pesticide labeled for use on pets as well as any pesticide labeled for use in areas "in or around household premises."
Unfortunately, the term "pesticide" has a visceral negative connotation for the public. Moreover, the term "pesticide" focuses only on the function of the products, completely ignoring the many benefits derived from the use of these products.t
Life today, would be quite different without the use of pesticides-- disease would run rampant, food would be scarce and certain areas of this country would be uninhabitable due to pests such as mosquitoes, ticks and rodents.
There are significant threats to consumer health that can be achieved by the use of Consumer Protection and Health Benefit Products. For example:
- Disinfectant products are used by millions of people every day to keep kitchens and bathrooms clean and help prevent the spread of germs. These products are vitally important to protect health in nursing homes, hospitals, hospices and other health care facilities. (See Attachment A)
- Proper use of disinfectants and sanitizers in dairy farms and food preparation areas can help aid food safety and sanitation efforts by protecting against Salmonella, E. coli, and other bacterial contamination.
- Disinfectant products can be used to eliminate mold that can also cause severe health problems for children, adults, the elderly and those with compromised immune systems. Mold has also been found to be a major contributor to poor indoor air quality and associated physical illness.
- Pet products are vital to keeping both families and pets healthy and comfortable by protecting them from disease-carrying fleas and ticks. (See Attachment B)
Insect repellents are critical to protecting the public against tick- borne diseases that have become a rapidly emerging public health threat. For example, the annual reported number of Lyme Disease cases increased 25-fold between 1982 and 1997, with a cumulative total of more than 103,000 cases reported in that period, l Recent reports suggest that the threat of Lyme disease this summer may be greater than ever. Moreover, several new tick-borne diseases that can potentially cause death have recently been identified. (See Attachment C)
- Additionally, insect repellents are essential to public protection from mosquitoes. Mosquitoes can transmit serious, potentially fatal diseases such as encephalitis, dengue fever and malaria, all of which occur in the US. Various parasitic diseases once considered exotic in the U.S. including mosquito-borne diseases, are emerging or re- emerging as public health threats.
Insect and rodent control products protect against the transmission of disease by these pests. For example, cockroaches have been found to carry hundreds of different types of bacteria, and rodents can transmit many diseases, including the potentially fatal Hantavirus.2
The health threat posed by rodents and insects should not be minimized. Our own capital city has a serious rodent problem, which could, if not controlled, put the citizens of the District of Columbia at risk. According to the US EPA, in the United States each year, rats bite approximately 14,000 people.3
According to the American Association of Poison Control Centers, approximately 6,000 people each year are treated for insect stings in health care facilities. In fact up to five percent of the US population can have a severe, allergic, life-threatening reaction known as anaphylaxis in response to insect stings.

4
Recent research has found that.cockroach allergens are a leading trigger for asthma among inner-city children. According to the American Lung Association, there are 15 million people with asthma in the United states. Nearly one-third of them are children under 18 years of age. Asthma is the most prevalent chronic illness of children and the greatest incidence of this condition occurs among inner city children. A May 1997 study published in the New England Journal of Medicines found that children allergic to cockroach allergens and heavily exposed to the insects at home were three times more likely to be-hospitalized than other asthmatic youth.
Recently, the President's Task Force on Environmental Health Risks to Children cited these studies and noted that:
"...the role of indoor allergens on exacerbation of asthma, different allergens, such as those associated with cockroaches, dust mites, and mold, have been implicated in different cities... Reducing exposures of children with asthma to airborne allergens and pollutants will reduce the health burden of asthma and significantly improve their quality of life." 6
CSMA COMMISSIONED SURVEY OF CALIFORNIA RESIDENTS
In November 1998, CSMA contracted with a respected public opinion research firm, Market Strategies Inc., to conduct a telephone survey of 1,300 California residents about their concerns relating to health threats posed by insects, rodents and microbial contamination. The survey was conduced in accordance with the demographic profile of the state of California. We have attached a copy of the survey results into the hearing record. (See Attachment E)
We undertook this survey because we believe that the public has significant concerns regarding the health threats posed by pests. We found that 78 percent of respondents believe that society should do more to protect children from insect and rodent pests. Forty seven percent of survey respondents believe that California children are becoming sick due to contact with insects and rodents. And 64 percent of all respondents affirmed that household pesticide products are crucial for keeping their homes free from insects and rodents.
These public health benefits should be fully considered and weighed heavily during the regulatory and decision making implementation of FQPA.
PUBLIC HEALTH PESTS
In addition, Congress saw the need to protect against public health pests and, therefore, Section 28 of FIFRA was amended to direct the EPA Administrator in coordination with the Secretary of Agriculture and the Secretary of Health and Human Services to identify pests of significant public health importance and to implement special programs to facilitate the use of chemical, biological and other methods to control such pests:
"(d) PUBLIC HEALTH PESTS. --The Administrator, in coordination with the Secretary of Agriculture and the Secretary of Health and Human Services, shall identify pests of significant public health importance and, in coordination with the Public Health Service, develop and implement programs to improve and facilitate the safe and necessary use of chemical, biological, and other methods to combat and control such pests of public health importance." ?
We support and encourage the EPA in its efforts to establish programs aimed at combating pests of public health importance.
IMPLEMENTATION OF FQPA AND POTENTIAL LOSS OF VALUABLE RESIDENTIAL OR NON-AGRICULTURAL PESTICIDE PRODUCTS
Science-based implementation of FQPA requires both time and a process that will accommodate the data and assessment methods that industry is working to develop in cooperation with EPA.
As a result of a memo issued by Vice President Gore to EPA and USDA regarding the implementation of the FQPA, the Tolerance Reassessment Advisory Committee TRAC-- was formed. TRAC was composed of representatives from the environmental/consumer/farmworker perspective, agriculture/farmer representatives, pesticide companies and trade associations, NACEPT/SAP representatives, and academia. CSMA is on the committee and represents the non-agricultural pesticide industry.
TRAC is not a technical panel, but rather is charged with developing and recommending policy and strategy issues for FQPA implementation. To establish an overall reference framework, TRAC began focusing on organophosphates at the request of EPA.
FQPA directs EPA to consider both aggregate exposure and cumulative effect of pesticides in the registration process. As a result, TRAC has focused on the development of nine science policies including two that are of extreme importance to CSMA: residential exposure and aggregate risk.
RESIDENTIAL EXPOSURE EPA intends to refine its exposure models based on data that the pesticide industry is generating as well as other reliable data. In the meantime, the Agency will use a combination of relevant data and model estimates to assess residential exposure.
CSMA has a number of concerns with EPA's Draft Standard Operating Procedures (SOPs) for Residential Exposure Assessments. These are:
1. EPA SOPs for residential exposure assessment do not currently utilize/incorporate all publicly available scientific literature. This literature would most certainly displace some of the overly conservative "default assumptions." Further, in the absence of a careful and complete review of existing literature, EPA cannot accurately determine data gaps. Where data gaps do exist, due to the incomplete and draft status of the Series 875 (Group B Post- Application Exposure Monitoring Test Guidelines), adequate guidance is not available for development efforts. Many of the test methods in the Series 875 still need to be validated and peer reviewed. In essence then, development Of studies cannot begin until these guidelines are finalized.
2. To overcome the problem of compounding conservative estimates, EPA needs to address the utilization of probabilistic versions of the "models" being proposed for use in addressing potential residential exposures. Probabilistic (e.g., Monte Carlo) techniques are necessary for characterizing the variability associated with many of the key aspects of residential exposures, e.g., time-activity patterns, consumer and professional product use/usage practices, exposure monitoring data, physiological and residential exposure factors, etc.
3. The residential modeling approach being developed needs to be transparent with respect to the assumptions and algorithms used, particularly given the "evolutionary process" that is occurring as new data and information become available and are incorporated into the methods/models. To facilitate this process, a more articulate presentation of the overall modeling process and the various elements that contribute should be developed. The current draft SOPs do not sufficiently explain the source and rationale of the default assumptions.
4. Product label and use information is one of the key elements in the residential exposure assessment process (both aggregate and cumulative). The utility of this information and associated publicly available sources should be more clearly described in the EPA SOPs and/or the 875 Series guidelines.5. The Agency should use the revised SOPs only as a first-tier screen to determine whether more data and/or higher-tier exposure assessments are needed. The SOPs should not be used in aggregate risk assessments or to show that a pesticide use causes a certain actual amount of exposure or poses a certain level of risk that warrants action against a registration, registration application or tolerance.
We have attached a copy of the comments CSMA submitted on March 5, 1999 regarding the SOPs. (See Attachment F)
CSMA does not believe EPA should make final assessments prior to availability of data. Interim assessments may be made with final decisions contingent on the outcome of the data being developed.

If final decisions are made prior to availability of data, valuable non-agricultural pesticide products could be lost.
AGGREGATE EXPOSURE
Aggregate exposure to a pesticide can occur by multiple routes: ingestion, inhalation, and/or dermal absorption and from multiple sources including residential, pet and lawn care uses. EPA has developed models for estimating exposures but these models are based on unrealistic assumptions and appear to overestimate the actual exposure to these products.Thus, when aggregated assumptions for a given product are too conservative, an exaggerated exposure scenario can result. If final decisions are made prior to availability of data, valuable non-agricultural pesticide products may be lost. That is why it is so important to base decisions on good data.
Risk Cup Concerns
In addition, we are also concerned about allocation of the so-called "risk cup" and the need to preserve residential pesticide uses which may be forced out by other uses. Nonagricultural pesticide products may be lost if faulty risk assumptions are allowed to cause the "risk cup" to overflow. The "risk cup" is a mechanism for calculating permissible total exposure to an active ingredient. It is likely that these uses would be focused in the agricultural arena, not the non- agricultural sector. If the cup overflows, active ingredient manufacturers would be forced to choose where they would market the active ingredient in question. In some instances, the dietary exposure will completely fill the risk cup leaving little or no space for non- agricultural uses. Therefore, the agency needs to establish a process to ensure that non-agricultural pesticides are not forced from of the risk cup.There is ample authority under Section 25(a)(1) of FIFRA8 for the Agency to take into account differences in concepts and usage between various classes of pesticides, including public health pesticides, and the differences in environmental risks and appropriate data between agricultural and nonagricultural pesticides:
"(1) REGULATIONS.-The Administrator is authorized in accordance with the procedure described in paragraph (2), to prescribe regulations to carry out the provisions of the Act. Such regulations shall take into account the difference in concept and usage between various classes of pesticides, including public health pesticides, and differences in environmental risk and the appropriate data for evaluating such risk between agricultural, nonagricultural, and public health pesticides."
Therefore, it is appropriate for EPA to address both agricultural and non-agricultural pesticides separately in the implementation of the requirements of FQPA. The agency needs to ensure that these valuable Consumer Protection Health Benefit Products are not lost. DATA GATHERING
In order to respond to FQPA issues related to non-agricultural pesticides, CSMA has established two joint ventures. The first one being the Indoor Residential Exposure Joint Venture (IREJV). This is a group of companies that manufacture and formulate pesticide products for residential and commercial markets. The IREJV is creating a database relating to product use that may be incorporated in modeling tools that are being designed to create exposure and risk assessments for pesticides products. The IREJV has undertaken a program consisting of two comprehensive projects, a label data entry system and an unprecedented major national consumer use survey.
The beta version of the label data entry system is complete and currenly being tested. The database combines currently available information from several sources including EPA-maintained databases, the National Home and Garden Pesticide Use Survey and company-specific product label information. This important tool will allow assimilation of information on product labels such as application rates, method of application and pests treated.
The IREJV is working with a Regulatory Advisory Committee, including participants from the EPA, Cal EPA, and Health Canada, that will ensure that appropriate decisions are made regarding data needs and regulatory requirements.
The second joint venture is the recently formed Antimicrobial Exposure Joint Venture (AEJV) which also operates under CSMA auspices and consists of manufacturers and formulators of antimicrobials. The AEJV is currently collecting information and developing a viable program to address necessary antimicrobial data requirements.
ANTIMICROBIAL REFORM PROVISIONS OF FQPA
As noted earlier, FQPA Subtitle B, Antimicrobial Pesticide Registration Reform, directs EPA to change the manner in which it regulates antimicrobial pesticides. Some of the key provisions include:
- Statutory goals for making decisions on different categories of applications for registration of antimicrobial pesticides and a requirement to report to Congress annually on EPA's success in meeting the goals.
- Statutory deadlines for issuance of regulations to streamline the registration process in order to meet the goal timelines of decisions on antimicrobial registration actions. - A direction to work with states to eliminate duplicative, burdensome regulation.CSMA has been working closely with the Antimicrobial Division of EPA since the passage of FQPA. According to the statute, the Agency was to have proposed a rule in May of 1997 and issued a final rule in May of 1998. Neither of these timelines has been met, however CSMA has had the opportunity to review and comment on two drafts of the pre-proposed rule.
Although the rule has yet to be proposed, the Agency is currently operating under the goal timelines for processing registration actions that are delineated in the statute. CSMA anxiously awaits publication of the procedural rule, which, we understand, is scheduled to be proposed in the fall.
DATA COORDINATION
Additionally, CSMA has always sought to maximize the coordination between State pesticide regulatory agencies and the US EPA. Fundamentally, the elimination of redundancies and the coordination of scientific reviews minimize both the cost to government and the cost to registrants. Moreover, coordination provides opportunity to streamline and make more efficient the regulatory process. The Congress concurred with this position and as part of the FQPA, (FIFRA Section 3 (c) (2)(B) (viii), Congress empowered the EPA with the authority, to the maximum extent practicable, to "coordinate data requirements, test protocols, timetables and standards of review." In this provision Congress noted the need to "reduce burdens and redundancy caused to the registrant by multiple requirements." In addition, the Administrator is directed to "develop a process to identify and assist in alleviating future disparities between Federal and State data requirements."
The experience of CSMA members is that procedural impediments at US EPA have resulted in a lack of coordination and an absence of data sharing between US EPA and State pesticide agencies. In order to fully implement this provision, we encourage the EPA to implement a clear procedure to facilitate this process, whereby registrants can authorize and direct EPA to share data reviews with State agencies. The lack of coordination to date should make clear the need for such a procedure to be implemented in order for registrants to avail themselves of the relief provided for in this provision of FQPA.
CONCLUSION
In conclusion, the implementation of the Food Quality Protection Act must be based on good data sound science. Non-agricultural pesticides or Consumer Protection and Health Benefit Products provide important benefits to our society, beyond the aesthetic benefits of keeping our surroundings clean, protected and free of pests.Our products play an important role in limiting the spread of germs and are essential for controlling pests such as fleas, ticks, roaches, mosquitoes and rodents that can spread human illnesses. Should the Food Quality Protection Act be enacted on the basis of faulty risk assumptions rather than on real world data, the likelihood is that some products that are vital to the protection of public health may be lost. The result would be detrimental to the, consumer, industrial, and institutional users of these products.
Industry is working with EPA to provide the needed data. We need your help to make sure there is time to do the work. We believe it is more important for the agency to make the fight decisions based on good data and sound science than it is to meet any arbitrary deadlines.
We urge the subcommittee to instruct EPA to allow sufficient time to:
1) gather residential exposure and aggregate risk data,
2) permit data generation under appropriate study guidelines and protocols,
3) and most importantly, to establish a process to ensure that non- agricultural pesticides are not forced from the risk cup arbitrarily.On behalf of CSMA, I appreciate the opportunity to appear today to discuss the many benefits of non-agricultural pesticides and implementation issues related to FQPA.
FOOTNOTES:
1 Source: Center for Disease Control (http://www.cdc.gov/ncidod/dvbid/lymegen.htm)
2 Source: Center for Disease Control (http://www.cdc.gov/ncidod/disease/hanta/hps/intro2.htm)
3 United States Environmental Protection Agency, Prevention, Pesticides and Toxic Substances, Reregistration Eligibility Decision (RED) Zinc Phosphide, EPA 738-R-98-006, July 1998, p.34.
4 Source: American Academy of Asthma Allergy and Immunology (http://www.aaai.org/public/fasffacts/statistics.html)
5 The New England Journal of Medicine, "The Role of Cockroach Allergy and Exposure to Cockroach Allergen in Causing Morbidity among Inner- City Children with Asthma." May 8, 1997.
6 Report of the President's Task Force on Environmental Health Risks and Safety Risks to Children, Asthma and The Environment: A Strategy to Protect Children, 1998. P16.
7 7 USE Section 136w-3(d).
8 7 USC Section 136w(a)(1).
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LOAD-DATE: August 5, 1999