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October 7, 2002

Public Information and Records Integrity Branch
Information Resources and Services Division (7502C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA

RE: Docket ID number OPP-2002-0196 -- Diazinon; Receipt of Requests for Amendments, and Cancellations

These comments are submitted on behalf of the Children’s Environmental Health Network (the Network), Consumers Union of United States, Inc. (CU), and the Institute for Children's Environmental Health (ICEH). These organizations welcome the opportunity to comment on the requests received by the Agency to delete certain uses and to cancel certain registrations for the organophosphorus pesticide diazinon.
The Network is a non-partisan and multi-disciplinary national project whose mission is to protect the fetus and the child from environmental hazards and to promote a healthy environment. The Network’s three areas of concentration are education, research and policy.

Consumers Union is a nonprofit membership organization chartered in 1936 to provide consumers with information, education and counsel about goods, services, health, and personal finances and to initiate and cooperate with individual and group efforts to maintain and enhance the quality of life for consumers. Consumers Union’s income is solely derived from the sale of Consumer Reports, its other publications and from noncommercial contributions, grants and fees.

The Institute for Children's Environmental Health (ICEH), founded in 1999, is a non-profit, non-partisan educational organization working to ensure a healthy, just and sustainable future for children and the planet. ICEH's primary mission is to foster collaborative initiatives to reduce and ultimately eliminate environmental exposures that can undermine the health of current and future generations.

Our organizations applaud the proposed elimination of all permitted indoor uses of this pesticide. The Network submitted comments in July 2000 on the Health Effects Division’s (HED) April 12, 2000 memorandum on “DIAZINON. Revised HED
Preliminary Human Health Risk Assessment for the Reregistration Eligibility Decision (RED) D262343. PC Code: 057801. List A Case No. 0238” (HRA) and March 23, 2000 memorandum on “Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document for Diazinon” (ORE).

We have serious concerns regarding children’s exposure to this pesticide, especially related to indoor uses. The EPA exposure assessments referenced above provide ample evidence that the extent of children’s exposure to diazinon from home, lawn and garden uses is excessive and makes a case that this pesticide cannot be used safely in these settings.

The EPA examined a number of “likely use scenarios” for this pesticide; in these scenarios, children’s potential exposures to diazinon resulting from indoor treatments were unacceptable. For example: “Children’s postapplication short-term dermal exposures . . . result in MOEs (or “margin of exposure”) less than 100. For children, the inhalation exposure, based on chemical-specific data, results in a MOE of 1.2.” (In this scenario, an “acceptable” MOE would be 100 or above; the larger the number the better.) Other concerns that were identified include:

þ “Toddlers are the most highly exposed subgroup following lawn and carpet treatments through direct dermal exposures (crawling) and oral exposures (hand-to-mouth).”

þ Air monitoring data showed the presence of diazinon at significant levels in residential air in homes in both northern and southern areas.

þ Diazinon was found in a variety of media. “Diazinon has been detected in influent and effluent from Publicly Owned Treatment Works (POTWs) indicating that diazinon is entering sewer systems in urban areas as a result of residential uses. Diazinon has also been detected in air, rain, and fog in California.” “In general, diazinon was the most frequently detected insecticide in surface water in the NAWQA program. It is detected more frequently and at higher concentrations in samples from urban sites than at agricultural sites.”

þ “About 15% of households (in EPA’s one-time survey of homeowner pesticide usage) reported using diazinon. Of those, approximately 23% of all applications were made indoors, most commonly to the kitchen.”

Although incidence of ingestion and poisoning reports provide only limited evidence about exposure, the overall incident experience of diazinon offered a telling perspective about widespread consumer use and its widespread presence in residential settings:

þ “Diazinon ranked 5th as a cause of systemic poisoning in California from 1990 through 1994.” “A report of all hospitalized cases in California for 1982 through 1994 ranked diazinon first as the leading cause of hospitalization. . . Among the accidental hospitalized cases most occurred among homeowners who misused the product or left it within the reach of very young children.”

þ The data presented on the frequency and pattern of diazinon poisonings indicated widespread use and presence in the home. For example: “HED concludes that the majority of the reported incidents of acute reactions to diazinon, reported as "poisoning incidents", occur in the home.”

Our organizations are also concerned about exposure to diazinon’s degradates. The Agency’s Environmental Fate and Effects Division Environmental Risk Assessment (science chapter) for diazinon found that “in addition to adverse effects resulting from exposure to parent diazinon, terrestrial vertebrates may be exposed to the environmental degradates, diazoxon and oxypyrimidine. . . The toxicity of these degradates to terrestrial vertebrates is unknown, although submitted human health effect data implies that diazoxon may be more toxic than parent diazinon.”

These facts and others raised major and extremely significant concerns about the impact on human health of the more than 6 million pounds of diazinon used annually in the United States

We believe that the proposed registration cancellations and use deletions will be an important step toward lowering children’s exposures to this pesticide.

Other Steps

Children in Farm Communities: We are concerned that these actions will not begin to address the disproportionate exposures to diazinon by children who live in farm communities where diazinon is used. EPA has yet to adopt policies that will assure that this large subgroup of children are considered in reassessments of this and other pesticides. All children -- not just urban children -- deserve adequate protection from potentially harmful pesticide exposures. Until these children are considered in risk assessments, we believe that the EPA is not following through with the requirement to assess aggregate risks of pesticides to children.

Existing Stocks: Our organizations object to the continued manufacture of these products for export. First, this lowers protection for US children since such pesticides can be illegally reimported for use in the US. For example, just two years ago, illegal household formulations of aldicarb were found in the US. These had been smuggled from other countries. Second, this assures the continued exposure of children in other countries to this compound merely because of the accident of their birth. If this nation has come to agreement that these products’ uses are no longer deserving of support in the United States, how can we defend selling them to others? It is highly unlikely that these pesticides can be used more safely in developing countries than in the US. Our organizations strongly urge the Agency to use any means possible to stop the manufacture of these products in the US.

Tolerance Revocation: The Agency’s notice of these actions includes a list of requests to amend the registrations of their pesticide end-use products containing diazinon to delete certain uses from certain products. The crops affected include bananas, celery, cucumbers, citrus, potatoes and many more. However, the notice did not indicate that the related tolerances for these uses would also be revoked. Given that these products apparently are being permitted to be made for export (see above), withdrawing these uses without also revoking their tolerances on these crops will not protect U.S. children from imported produce treated with these products. Our organizations urge that EPA revoke these tolerances as soon as possible, taking into consideration flow through of food that contains these residues due to legal use prior to these actions being taken.

Garden and Lawn Uses: As outlined above, the myriad concerns about children’s exposure to diazinon are not limited to exposure resulting from indoor uses. Exposures due to lawn and other outdoor uses are a potent source of exposure.

þ “Diazinon has a wide variety of homeowner uses including lawn treatments, spot treatments, and indoor carpet treatments. Diazinon is applied by many methods including spray equipment, and granular spreaders.” “EPA’s one-time survey of homeowner pesticide usage found that diazinon was most frequently applied outdoors by the general public. About 15% of households reported using diazinon. Of those, approximately 23% of all applications were made indoors….”

Since an estimated 77% of household uses are for lawns and gardens, concerns about children’s exposure to this pesticide around the home will continue until these uses are discontinued as well. Infants and young children have much greater potential exposure to pesticides in lawn and garden use and these are around the environment of children, and can accidentally be ingested. Thus, our organizations not only strongly support the cancellation of all indoor uses, we also strongly urge the Agency to also immediately eliminate all lawn and garden uses.

On-going Cumulative Risk Assessment Re-evaluation: We have previously urged the Agency to assure that its approaches to conducting cumulative and aggregate risk assessments reflect the new science and data that will clearly emerge as the Agency meets the challenge of regulating based on cumulative exposures. Our organizations are specifically concerned with the example the Agency is providing in its process of moving forward with organophosphorus pesticides (OPs). On one hand, the Agency has issued a cumulative risk assessment (CRA) for the OPs, yet it is issuing use and tolerance decisions on individual OPs without clearly indicating how these individual decisions relate to the CRA or when an updated CRA, reflecting these changes, will be issued,.

The impact of the cancellation of certain OP uses must be examined. For example, in the OP CRA, the Agency makes the implicit assumption that farmers losing the chance to use a canceled OP will not switch to another OP. Clearly, some shift in acreage from canceled OPs to still registered ones is occurring and will continue to occur. Similarly, the impact of canceling indoor uses of diazinon while allowing indoor uses of other OPs raises the question of whether these cancellations will result in a net decrease of OP exposures, or just a switch from the OP diazinon to a different organophosphorus pesticide.

At the same time, new science and data are emerging which will bring new understanding about the toxicology and exposure levels of these pesticides. For example, we anticipate that new information related to down regulation of muscarinic receptors and decreased brain DNA synthesis in addition to information about inhibition of brain acetylcholinesterase will demand a reassessment of the CRA in the next few years.

Results of future OP-CRAs will be critical in assessing the degree of progress, or slippage, made in the attainment of cumulative OP risk reduction goals. OP-CRA results should serve as an aggregate benchmark of the adequacy of risk mitigation measures imposed to date. If the desired and hoped for degree of risk reduction does not materialize, EPA should then impose another round of risk mitigation measures targeted at known-risk drivers.

OP-CRA results should be updated annually, incorporating new residue, usage and exposure data and any updated toxicological information. As a part of this process, the Agency should continue to solicit public comment.

We have urged the Agency to move forward to mitigate the risks that have been identified in the OP CRA; in particular, the Agency should move promptly to reduce exposures to children from OP and carbamate pesticides. In so doing, it should make it clear, perhaps by granting only time limited tolerances for remaining uses, that this is a work in progress. Our organizations reiterate this call. We continue to ask for a schedule under which EPA will incorporate more complete data on developmental neurotoxicity and aggregate exposures to children in its cumulative assessment. In the interim, we would urge prompt and decisive action to lower exposures to OP and carbamate pesticides to children.
Conclusion

Our organizations appreciate the opportunity to comment on these important issues. We commend the Agency for its prompt action on these matters and we urge action on the steps listed above.

Sincerely,

Daniel Swartz Adam J. Goldberg Elise G. Miller
Executive Director, Children's Environmental Health Network Policy Analyst, Consumers Union Executive Director, Institute for Children's Environmental Health

Cc: The Honorable Christine Todd Whitman, Administrator, EPA
Mr. John Howard, Council on Environmental Quality
Mr. Steven Johnson, Office of Prevention, Pesticides & Toxics
Ms. Joanne Rodman, Acting Office Director, Office of Child Health Protection


 
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