Document ID: EPA-HQ-OPP-2007-0725-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-11-20T05:00Z

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<h2>Conditional Registration Of Acetochlor</h2>

<p>United States Environmental Protection Agency<br />
Prevention, Pesticides And Toxic Substances (7506C)<br />
March 11, 1994</p>

<hr />

<p>On March 11, 1994, EPA conditionally registered the pesticide acetochlor. 
The conditions of registration include stringent control of the use of this
pesticide, oversight efforts to ensure that its use does not cause unreasonable
risks to public health or the environment, and provisions to suspend or cancel
its use if the terms of the agreement are not met.  This document explains more
about this pesticide and how EPA reached its decision to register acetochlor.</p>

<ol id="list">

<li><p><a href="#WHATIS">What is acetochlor, who manufactures it, and what will it be used for?</a></p></li>

<li><p><a href="#WHY">Why has EPA decided to conditionally register acetochlor?</a></p></li>

<li><p><a href="#CANCEL"> Under what conditions will EPA cancel the registration for acetochlor?</a></p></li>

<li><p><a href="#HOW"> How will EPA ensure that the registrants of acetochlor fulfill these commitments?</a></p></li>

<li><p><a href="#HEALTH">What are the possible health effects of acetochlor, based on laboratory studies?</a></p></li>

<li><p><a href="#RISKS">Given the use restrictions, what are the potential risks to agricultural workers and to consumers?  Are there dietary risks to children?</a></p></li>

<li><p><a href="#WHYNOW">EPA first received an application to register acetochlor in 1983.  Why is the Agency making a registration decision now?</a></p></li>

<li><p><a href="#REDUCE">Is this registration decision consistent with the Administration's initiative to reduce the use and risk of pesticides?</a></p></li>

<li><p><a href="#ENVIRISK">What are the potential environmental risks of acetochlor?</a></p></li>

<li><p><a href="#PROTECT">How are these potential environmental risks being addressed?  Is the registration decision consistent with the Administration's efforts to protect ground water?</a></p></li>

<li><p><a href="#COMPARE">How does acetochlor compare in terms of relative risk to other corn herbicides?</a></p></li>

<li><p><a href="#OTHER">Will EPA impose similar use restrictions on other corn herbicides?</a></p></li>

<li><p><a href="#BENES">What potential benefits does acetochlor offer?</a></p></li>

</ol>

<hr />

<ol>

<li><h2 id="WHATIS">What is acetochlor, who manufactures it, and what will it be used for?</h2>

<p>EPA has approved the application of acetochlor by the Acetochlor Registration Partnership, consisting of Monsanto Co. and Zeneca which later sold their shares to Dow  AgroSciences.  Acetochlor is a selective herbicide for control of  annual grasses and  broadleaf weeds. It is marketed under the trade names of Harness (Monsanto) and Surpass,  TopNotch, and Trophy (Dow AgroSciences). </p>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.</p>

<hr />
</li>

<li><h2 id="WHY">Why has EPA decided to conditionally register acetochlor?</h2>

<p>The registration of acetochlor is expected to significantly reduce the total use of corn herbicides in the United States.   Acetochlor will substitute for many corn  herbicides of concern, including alachlor, metolachlor, atrazine, and 2,4-D.  Under this  decision, the Agency is implementing stringent standards for the registration of  pesticides and expects industry to demonstrate its willingness to implement measures to  meet these environmental standards. </p>

<p>EPA has imposed several restrictions and conditions on the use of acetochlor in order  to limit potential risks to human health and the environment.  These restrictions include  limiting its use to certified applicators, preventing aerial application, restricting the  types of soils on which acetochlor can be used, and prohibiting application to water.   Compliance with these limitations will ensure that public health and the environment is  adequately protected.</p>

<p>The registration also includes several early-warning measures to ensure that ground  water and surface water resources remain protected.  EPA is requiring the Partnership to  conduct several prospective ground water studies aimed at limiting the use of acetochlor  in areas where migration to ground water is likely. Furthermore, the Agency has included  a 10-year "sunset" provision in the registration decision. To ensure that  acetochlor continues to meet evolving health and environmental standards, the Partnership  has agreed to submit any additional data needed to support the continued registration of  acetochlor.  Failure to comply with this requirement will result in automatic  cancellation of the registration on March 7, 2004. </p>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.</p>

<hr />
</li>

<li><h2 id="CANCEL">Under what conditions will EPA cancel the registration for acetochlor?</h2>

<p>EPA has established several criteria that may trigger the automatic cancellation of 
acetochlor. The Partnership has agreed  that if the Agency decides to cancel the  registration of acetochlor based on these factors, this decision will be final. </p>

	<ul>
	<li><h3>Cancellation for Failure to Achieve Use Reduction Targets</h3>

	<p>If any of the following three use reduction goals are not met, the registration  	will be automatically canceled:</p>

		<ol>

		<li><p>At the end of 18 months from the date of registration, a net  			cumulative reduction from 1992 levels, adjusted for planted acreage  			differences, of 4 million pounds of the herbicides alachlor, metolachlor,  		atrazine, EPTC, butylate, and 2,4-D used on corn.</p></li>

		<li><p>At the end of 3 years from the date of registration, a net cumulative    		reduction from 1992 levels, adjusted for planted acreage differences, of 22.6  		million pounds of the herbicides alachlor, metolachlor, atrazine, EPTC,  		butylate, and 2,4-D used on corn. </p></li>

		<li><p>At the end of 5 years from the date of registration, a net cumulative   		reduction from 1992 levels, adjusted for planted acreage differences, of 66.3
		million pounds of the herbicides alachlor, metolachlor, atrazine, EPTC, 		butylate, and 2,4-D used on corn.</p></li>

		</ol>

	</li>
	<li><h3>Cancellation for Failure to Protect Ground Water</h3>

	<p>Three scenarios have been established for automatically canceling the  	registration for acetochlor based on ground water concerns.  The registration for  	acetochlor will be automatically canceled if any one of the following conditions is  	met:</p>

		<ol>

		<li><p>If EPA determines that prospective ground water studies from 4 sites  		out of a total of 8 sites indicate a pattern of movement of acetochlor toward  		ground water from use in accordance with label directions or in accordance  		with widespread and commonly recognized practice. </p></li>

		<li><p>If detections occur in ≥ 20 wells included in a State Monitoring  		Program at a concentration of ≥ 0.10 parts per billion (ppb) followed by 2    		subsequent detections at ≥ 0.10 ppb in monthly sampling of each of these   		wells, conducted over a 6-month period or if detections of acetochlor occur 		in ≥ 150 individual wells at a concentration of ≥ 0.20 ppb followed by 		two subsequent detections of ≥ 0.20 ppb in monthly sampling of those 		wells, conducted over a period of 6 months. </p></li>

		<li><p>If detections of acetochlor occur in ≥ 20 wells at a concentration  		of ≥ 1.0 ppb, followed by two subsequent detections at ≥ 1.0 ppb in 		monthly sampling of those wells, conducted over a period of 6 months.</p>		</li>

		</ol>

	</li>
	<li><h3>Cancellation for Failure to Protect Surface Water</h3>

	<p>Two scenarios have been established for automatically canceling the registration 	for acetochlor based on surface water concerns:</p>

		<ol>

		<li><p>If a community water supply system that derives its water primarily  		from surface water detects an annual concentration of acetochlor of ≥ 2.0  		ppb, EPA may prohibit use of acetochlor in the related watershed.  As an  		alternative to cancellation, the Partnership could be required to upgrade the  		system. </p> </li>

		<li><p>If EPA determines that two large community water supply systems  		(systems serving over 100,000 people) or 10 community water supply systems of  		any size have an annual concentration of acetochlor of ≥ 2.0 ppb.</p></li>

		</ol>

	<p>In addition, if any community water system detects a single peak concentration 	of ≥ 8.0 ppb of acetochlor, the Partnership will make biweekly sampling of 	that water system throughout the following 12 months to determine whether the 2.0  	ppb annual concentration has been exceeded.</p>

	</li>
	</ul>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.</p>

<hr />

</li>
<li><h2 id="HOW">How will EPA ensure that the registrants of acetochlor fulfill these commitments?</h2>

<p>EPA's registration of acetochlor includes several reporting mechanisms to ensure compliance with the conditions of use.  These provisions include:</p>

	<ol>

	<li><p>annual reporting from an independent market research firm on the status of  	the reductions in use of selected corn herbicides;</p> </li>

	<li><p>quarterly status reports on the Partnership's negotiations with the states  	on developing ground water monitoring programs, followed by annual reporting  	beginning in February of 1995; and </p></li>

	<li><p>notice to EPA within 15 days of a detection of acetochlor in ground water or  	surface water.  </p></li>

	</ol>

<p>In addition, standard record keeping and inspection requirements are included in the registration notice. </p>

<p>Critical to the effectiveness of monitoring programs are effective methods for detecting residues of acetochlor.  The Partnership has agreed to submit to EPA a  validated method for detecting acetochlor and degradates (breakdown products) of concern  in water samples.  The methods will include analyte-specific methods, multi-residue  methods, and low-cost enzyme immunoassay methods.  The approved methods will be made  available to drinking water suppliers.</p>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.</p>

<hr />

</li>
<li><h2 id="HEALTH">What are the possible health effects of acetochlor based on  
laboratory studies?</h2>

<p>Based on laboratory studies submitted by the registrants and reviewed by EPA, the  Agency believes that acetochlor will not pose unreasonable risks to public health.  Although acetochlor has the potential to cause adverse effects, EPA  believes that actual  exposure will be low and that the resulting risks will not be of concern, as described in  Question 6.  Below is a summary of the findings of the acetochlor laboratory studies  submitted to the Agency:</p>

	<ul>
	<li><h3>Carcinogenicity</h3>

	<p>EPA has classified acetochlor as a probable human carcinogen (Group B2).  This 	classification is based on evidence of carcinogenicity from several sources.  	Laboratory animal tests found an increased incidence of cancer or tumors (benign or  	malignant) of the liver, thyroid, lung, uterus, ovaries, kidney, and nose.  (Not  	all of these effects were observed in each type or sex of laboratory animal 	tested.)  Certain tests also indicated that acetochlor is a mutagen, causing 	changes to cellular DNA.  Finally, positive carcinogenicity data have been found 	for chemically similar pesticides (alachlor and metolachlor).</p></li>

	<li><h3>Reproductive and Developmental Effects</h3>

	<p>Studies have indicated that acetochlor, in sufficiently high doses, can cause 	adverse reproductive and developmental effects in laboratory animals.  The main 	effects observed were decreased weight of parent and offspring.  Birth defects were  	not detected.</p></li>

	<li><h3>Other Effects Of Long-Term Exposure</h3>

	<p>Long-term studies of exposure (three months to one year) indicated that 	acetochlor could cause adverse effects to laboratory animals at sufficiently high  	doses.  The findings included decreased body weight, adverse effects to testes, and 	blood chemistry effects.</p></li>

	<li><h3>Short-term Risks Of Exposure (other than reproductive/developmental  	effects)</h3>

	<p>EPA has also reviewed a number of other studies on laboratory animals of the 	short-term or acute effects of acetochlor.  Generally, these studies have indicated  	that acetochlor, as well as the formulated products, Harness and Surpass, are of  	low to moderate toxicity if ingested, inhaled, or absorbed through the skin.  	Harness has been found to be a strong eye irritant, although Surpass has not.</p>	</li>

	</ul>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.</p>

<hr />

</li>
<li><h2 id="RISKS">Given the use restrictions, what are the potential risks to  agricultural workers and to consumers?  Are there dietary risks to children?</h2>

<p>As is the case with many chemicals, EPA recognizes that overexposure to acetochlor has  the potential to pose significant risks to human health.  Prior to making a registration  decision, EPA made an extensive assessment of acetochlor's potential health risks,  including risks to sensitive subgroups, such as children. Based on scientific studies,  EPA has concluded that acetochlor will not pose unreasonable risks to health if it is  used in accordance with the label requirements. </p>

<p>In estimating dietary risks of cancer, EPA has taken a conservative approach in a  number of its assumptions to be protective of public health.  For example, EPA has  assumed that 100% of the corn crop will be treated with acetochlor and that residues will  be present at the tolerance levels, neither of which are likely to occur.  The resulting  estimate of the upper-bound or "worst-case" risk of cancer is approximately two  in one million.  This figure is slightly higher than the risk level generally regarded as  negligible, but EPA believes the risk is not unreasonable given the conservative risk  assumptions used.</p>

<p>For dietary risks other than cancer, EPA believes that acetochlor residues in food  will be significantly less than levels that would be of health concern.  EPA has taken  into account the diets of infants and children, which differ significantly from adults,  in making this determination.</p>

<p>Agricultural workers could be exposed to acetochlor primarily via the dermal route.  Assuming that the maximum application rate is used, and that workers wear long pants,  long sleeve shirts, and chemical resistant gloves (as required by the label), EPA's  estimate of the worst-case additional cancer risk ranges from about two to 40 in one  million (1.6 x 10<sup>-6</sup> to 4.2 x 10<sup>-5</sup>).  This risk is comparable to the  risks to workers posed by other pesticides and EPA believes that it is not unreasonable. </p>

<p>EPA believes that the measures described previously to prevent acetochlor from reaching ground and surface water supplies, including the automatic cancellation provisions, will ensure that there will not be a significant health risk from acetochlor  residues in drinking water.</p>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.</p>

<hr />

</li>
<li><h2 id="WHYNOW">EPA first received an application to register acetochlor in 1983.   Why is the Agency making a registration decision now?</h2>

<p>Before EPA can register a pesticide, the Agency must determine that the use of the  pesticide will not cause any unreasonable adverse effect on human health or the  environment.  Although Monsanto submitted its original application for registration in  September 1983 (and Zeneca in July 1991), not until November 1992 did the Agency receive  all the information needed to complete its review of the potential health and  environmental risks posed by acetochlor.</p>

<p>Based on this information and the subsequent negotiations conducted between EPA and  the Partnership, EPA has now determined, based on the agreed upon conditions of the  registration, that the controlled use of acetochlor will not cause any unreasonable  adverse effect on the environment and that use of acetochlor is in the public interest.</p>

<p>These restrictions are comparably stringent to those in the Food Quality Protection  Act (FQPA).  Although acetochlor has been classified as a probable human carcinogen, the  level of exposure determines the magnitude of the risk. EPA believes that the potential  for exposure in food and to applicators is low. Therefore, under the conditions of the  registration, acetochlor meets the Agency's proposed "reasonable certainty of no harm" standard for human health. </p>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.</p>

<hr />

</li>
<li><h2 id="REDUCE">Is this registration decision consistent with the Administration's  initiative to reduce the use and risk of pesticides?</h2>

<p>Acetochlor will be a new tool for managing a variety of difficult-to-control weed  species and weeds resistant to currently-registered herbicides. Use of this new corn  herbicide will decrease the total pounds needed to control a variety of weeds and will  help reduce our reliance on pesticides in the United States. The registration also  includes unprecedented early detection measures to prevent ground water emergencies,  including the most protective early-warning system ever included in a pesticide  registration. </p>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.</p>

<hr />

</li>    
<li><h2 id="ENVIRISK">What are the potential environmental risks of acetochlor?</h2>

<p>Before EPA registers a pesticide, the Agency requires the applicants to submit studies  of the pesticide's potential fate in the environment and the effects it may cause, just  as health effects studies are required.  This answer summarizes the findings of those  studies for acetochlor.  The measures EPA is taking to prevent the potential adverse  effects from occurring are described in the answer to Question 10.</p>

	<ul>

	<li><h3>Environmental Fate</h3>

	<p>Studies indicate that acetochlor and its degradates are moderately persistent 	and moderately to very mobile in soil, depending on the characteristics of the soil  	where it is applied.  As a result, there is a relatively high potential for  	acetochlor residues to reach ground and surface water.  Acetochlor does not appear  	to pose a significant risk of concentrating through the food chain.</p></li>

	<li><h3>Ecological Effects</h3>

	<p>Studies, that EPA has reviewed, indicate that acetochlor is slightly toxic to 	mammals and birds.  Because acetochlor will be applied only once per season and  	because of its relatively low persistence on food items, minimal chronic effects to  	birds and mammals are anticipated.  Available data indicate that acetochlor is  	practically nontoxic to insects, moderately toxic to aquatic invertebrates, and  	highly toxic to fish.  Acetochlor is also highly toxic to certain aquatic and  	terrestrial plants.</p>

	<p>These fate and toxicity characteristics indicate that acetochlor poses potential 	risks to aquatic plants and animals and to terrestrial plants in wet areas, 	including endangered species that inhabit those areas.</p></li>

	</ul>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.  </p>

<hr />

</li>
<li><h2 id="PROTECT">How are these potential environmental risks being addressed?  Is the  registration decision consistent with the Administration's efforts to protect ground water?</h2>

<p>EPA is requiring the Partnership to meet a number of conditions in order to address  any potential environmental risks. To ensure the protection of ground water resources,  the Partnership has agreed to conduct prospective ground water studies in 8 locations  representing the full range of soil textures consistent with the acetochlor label. The  results from these studies will be used to further limit, if necessary, the areas where  acetochlor may be used. If leaching from agricultural use occurs in half of the studies,  the use of acetochlor will be canceled. In addition, the Partnership will monitor 25  wells in each of seven states (Wisconsin, Illinois, Iowa, Minnesota, Indiana, Nebraska,  and Kansas) and at 175 surface water monitoring locations in the same area, representing  over 80 percent of the expected use of acetochlor.  These innovative approaches to ground  and surface water protection will provide several early-warning mechanisms to assure the  protection of these vital resources. </p>

<p>The Partnership has also agreed to investigate the locations of endangered plants,  fish, and aquatic invertebrates in certain corn-growing areas and to take mitigation  actions in areas where endangered species are identified.  EPA believes that these  measures will ensure that acetochlor does not pose unreasonable risks to the environment,  including endangered species.</p>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.</p>

<hr />

</li>
<li><h2 id="COMPARE">How does acetochlor compare in terms of relative risk to other corn  herbicides?</h2>

<p>Compared with a major alternative, alachlor,  acetochlor is equally or less toxic to  both humans and the environment. Monsanto Agricultural Company, a member of the Partnership, also holds the registration for alachlor. EPA believes that Monsanto will  use its marketing abilities to shift a large portion of the alachlor market to acetochlor. </p>

<p>A second major alternative, atrazine, is a possible human carcinogen.  Through the use  limitations imposed in this registration, acetochlor will also be relatively less toxic  for this use pattern.  Under the mandated use restrictions, acetochlor is also relatively  less toxic than other herbicides of toxicological concern, including metolachlor and 
2,4-D.</p>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question.</p>

<hr />

</li>
<li><h2 id="OTHER">Will EPA impose similar use restrictions on other corn herbicides?</h2>

<p>EPA is making available to growers a new tool for weed control management.  This agreement establishes a model for registering corn herbicides that have health and  environmental characteristics similar to acetochlor.  Restrictions on other corn  herbicides will be dependent on the results of all health and ecological effects testing,  the potential to leach to ground water, the possibility of harming surface water, and any  threats to endangered species.</p>

<p>As the Agency evaluates corn herbicides in its reregistration process, EPA will consider the restrictions placed on acetochlor in determining the eligibility for  reregistration of toxicologically similar active ingredients.  Corn herbicides with  properties similar to acetochlor may be subject to identical use limitations, ground and  surface water monitoring programs, and endangered species protection requirements in  order to meet the standard for reregistration.</p>

<p>You may continue reading the Questions and Answers in order or return to the
<a href="#LIST">list</a> to select another question. </p>

<hr />

</li>
<li><h2 id="BENES">What potential benefits does acetochlor offer?</h2>

<p>EPA has identified several benefits to the public from the use of acetochlor:</p>

	<ul>

	<li><p>Acetochlor will be a direct competitor with established pre-plant grassy  	weed control chemicals.</p> </li> 

	<li><p>It has a broader spectrum of activity and is applied at lower rates of  	application than the available alternatives.</p></li>  

	<li><p>Acetochlor is likely to reduce the total pounds of herbicides applied to  	corn by substituting primarily for alachlor and metolachlor.  Some reduction in the  	use of atrazine is also likely.</p></li>

	</ul>

</li>
</ol>

<p>
This concludes the Questions and Answers section.  You may return to the
<a href="#LIST">list</a> to select another question.  </p>

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