Document ID: EPA-HQ-OPP-2007-0725-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-11-20T05:00Z

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<h2>REGISTRATION AGREEMENT</h2>

<p>ACETOCHLOR REGISTRATION PARTNERSHIP<br />
c/o Zeneca Ag Products<br />
Concord Pike and New Murphy Road<br />
Wilmington, DE 19897 </p>

<p><strong>DELIVERED VIA FAX/HAND DELIVERY TO FOLLOW</strong></p>

<p>March 8, 1994 </p>

<p>Mr. Frank Sanders, Chief<br />
Fungicide Herbicide Branch<br />
U.S. Environmental Protection Agency<br />
1921 Jefferson Davis Highway<br />
Arlington, VA  22202</p>

<p>Dear Mr. Sanders:</p>

<p><strong>Acetochlor Registration Partnership (ARP) Application for the Conditional          Registration of Acetochlor and Pesticides Containing Acetochlor</strong></p>

<p>The ARP is herein submitting a comprehensive listing of the terms and conditions  proposed for the conditional registration pursuant to section 3(c)(7)(C) of the Federal  Insecticide, Fungicide, and Rodenticide Act (hereinafter called "registration")  of pesticides containing acetochlor. </p>

<p>It is anticipated that by the end of the fifth season of use (1998), the reductions  outlined below will result in a 33 percent reduction from 1992 levels in aggregate use on  corn of the herbicides alachlor, metolachlor, a trazine, EPTC, butylate and 2,4-D.</p>

<p>The ARP wants to make it clear that these reductions will be a result of forces in the  corn herbicide market. The ARP does not mean to imply by these reductions that the current risk posed by the products that will be displaced is unacceptable.</p>

<ol>

<li><h2>Terms and Conditions of Registration for Pesticides Containing Acetochlor</h2>

	<ul>

	<li><h3>1.1 General Provisions</h3>

		<ul>

		<li><h4>1.1.1 Commercial Targets and Competitor Reductions</h4>

		<p>The registration of acetochlor will be automatically canceled if any of  		the following three reductions are not met:</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; or</p>			</li>

			<li><p>At the end of three years from the date of registration a net  			cumulative reduction from 1992 use 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; or</p>			</li>

			<li><p>At the end of five years from the date of registration a net  			cumulative reduction from 1992 use 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>

		<p>The automatic cancellation of the registration of acetochlor will occur if  		EPA makes a determination that any of the conditions set forth in paragraph  		1.1 have not been met. Such cancellation shall be final. The ARP waives any  		rights it may have to challenge the determination or resulting cancellation  		in any court or administrative forum.</p>

		<p>The use reductions outlined in 1.1, above, will be monitored by an  			independent market research firm (IMRF) selected by the ARP and accepted by  		EPA. The ARP shall, within 90 days of issuance of the registration, submit to  		EPA an acceptable design of the monitoring program. The ARP and EPA agree in  		principle that the design of the market research survey and the market  		assumptions on acreage and product usage used to calculate the annual use  		reductions shall be the same as those used to calculate the 18 month, 3 year  		and 5 year use reduction targets. If the design is not submitted within 90  		days, or is not acceptable to EPA, the provisions of Section 7A shall apply.  		The IMRF will report the results of its use reduction monitoring to EPA and  		the ARP annually. The baseline value to which the reductions will be compared  		will be established by consultation with the IMRF before the monitoring 		program begins, and the source of derivation of the annual use reduction  		numbers will remain constant throughout the program.  Current EPA data  		suggest the baseline would be approximately 165 million pounds. The product  		specific baseline values and the source of derivation of the annual use  		reduction numbers are "reserved issues" subject to the provisions  		of Section 7A.</p>

		<p>The ARP will provide directly to the IMRF county level use estimates or  		sales information for acetochlor annually beginning nine months after the  		issuance of the registration. This information will be marked and treated as  		Confidential Business Information.</p>

		<p>The ARP will pay for the monitoring and reporting, and shall have the  		right of review and comment to EPA concerning the conduct of the monitoring  		and the content of the reports. All ARP communications to the IMRF pertaining  		to the design, reporting, or results of the survey shall be conducted through  		EPA. </p>

		</li>
		<li><h4>1.1.2 Sunset Provision</h4>

		<p>The conditional registration shall be automatically canceled on March 7,  		2004, unless:</p>

			<ol>

			<li><p>The ARP submits a complete application for registration by March  			7, 2001; and </p></li> 

			<li><p>The ARP submits by March 7, 2001, all data required by 40 CFR  			Part 158 and guidance issued thereunder as of March 7, 1998, provided  			that additional time shall be allowed for studies that require more  			than 3 years for completion; and </p></li>
 
			<li><p>The data submitted is acceptable and sufficient for EPA to make  			a registration determination pursuant to section 3(c)(5) of FIFRA.</p>			</li>

			</ol>

		<p>If the ARP makes timely and adequate submissions as required above, the  		conditional registration shall continue in effect until EPA determines  		whether the application and submitted data support registration pursuant to  		section 3(c)(5) of FIFRA. If EPA determines that the application and  			submitted data meet the standards set forth in section 3(c)(5) of FIFRA, a  		new registration shall be issued with such terms and conditions as the  		Administrator shall deem appropriate. If EPA determines that the application  		and/or submitted data do not meet the standards set forth in section 3(c)(5)  		of FIFRA, then the application shall be denied and the conditional  			registration shall be automatically canceled immediately (unless stayed  		pending resolution of the denial). The cancellation of the conditional  		registration shall be subject to the provisions of Section 7.</p>

		</li>
		<li><h4>1.1.3 Existing Data</h4>

		<p>The ARP will submit all information in its possession or which it can  		obtain by exercise of due diligence which pertains to the potential adverse  		effects of acetochlor and its degradates of toxicological concern. At  			present, the ARP is not aware of any degradates of toxicological concern. If,  		in the future, the EPA determines that there are degradates of toxicological  		concern, the ARP will submit all information as specified above. Included 		among such information is any information derived from monitoring in any  		country pertaining to the movement of this chemical or its degradates of  		toxicological concern in soil or soil water or into ground or surface waters.		</p></li>

		</ul>

	</li>
	<li><h3>1.2 Ground Water Studies</h3>

		<ul>

		<li><h4>1.2.1 Prospective Ground Water Study Program</h4>

		<p>Upon registration of acetochlor, the ARP commits to conduct 8 Prospective  		Ground Water Studies (PGW), in accordance with current PGW protocols and time  		lines approved for other herbicides. The test sites will be located in areas  		which are representative of use in accordance with label directions, or in  		accordance with widespread and commonly recognized practice, including  		vulnerable and typical use situations. The eight sites chosen for the PGW 		studies shall represent the full range of vulnerable and general use soil  		textures consistent with labeled use. The timing, design and conduct of the  		PGW shall be a "reserved issue" governed by the provisions of  		Section 7A.</p></li>

		<li><h4>1.2.2 Retrospective Ground Water Study Program</h4>

		<p>The ARP agrees in principle that useful information may be developed by  		the conduct of retrospective ground water studies (RGW). Upon registration of  		acetochlor, the ARP agrees to provide information to EPA concerning the use  		of acetochlor in other countries and at U.S. Experimental Use Permit sites,  		including information on label and use directions, soil types, and climatic  		conditions.  On the basis of this information the ARP and EPA will evaluate 		whether RGW studies would, in fact, provide useful information and, if so,  		whether such studies should be conducted and the scope and nature of such  		studies. The results of RGW studies conducted in other countries shall not be  		subject to Sections 5.1.3.3, Detection Criteria, 5.1.3.4, Additional 			Mitigation Measures, 5.1.3.5, Automatic Suspension, or 5.1.3.6, Cancellation;  		however, if the results of such studies indicate widespread movement of  		acetochlor to ground water as a result of use in a variety of geographic,  		soil and climatic conditions and comparable to use in accordance with U.S.  		label directions or comparable to use in accordance with widespread and  		commonly recognized U.S. agricultural practice, those results will be used to  		evaluate the need for appropriate mitigation and/or cancellation in the  		United States.</p></li>

		</ul>

	</li>
	<li><h3>1.3 Ecological Effects Branch Studies</h3>

	<p>The ARP agrees to repeat an aquatic plant growth study with Skeletonema 	costatum. </p>

	<p>The requirement regarding conduct of a new mallard reproduction study as a  	condition of registration is a "reserved issue" subject to the provisions  	of Section 7A. </p>

	</li>
	<li><h3>1.4. Protection of Endangered Species</h3>

		<ul>

		<li><h4>1.4.1. Endangered Plant Investigation</h4>

		<p>Following the registration of acetochlor, the ARP will conduct an  			investigation to identify the locations of endangered plant species in the  		corn use area as identified in the EEB review of acetochlor dated January 25,  		1994. This investigation will contain the following elements:</p>

		<p>A literature and telephone survey will be conducted to obtain the most  		specific available descriptive information regarding the location of both  		corn use and endangered plant sites (e.g., corn field located "X"  		miles from "XX" road and endangered wetland plant located 1/2 mile  		north of highway "XXX"). Experts knowledgeable about specific  		locations of endangered plant species by county will be included in the  		survey. </p>

		<p>Locations of the endangered plant species will be mapped, and a comparison  		will be made to the usage of acetochlor in the immediate area.</p>

		<p>The ARP agrees to develop similar mitigation terms to those agreed to for  		the flumetsulam registration, but appropriate for acetochlor. </p>

		<p>The ARP will report quarterly to EPA on the progress of the investigation.  		</p>

		<p>The design and issues relating to conduct and timing of the Endangered  		Plant Investigation, and content of the quarterly reports, are "reserved  		issues" subject to the provisions of Section 7A. </p>

		</li>
		<li><h4>1.4.2. Endangered Fish Species and Endangered Aquatic Invertebrates		</h4>

		<p>The ARP agrees to conduct a telephone survey and literature search similar  		in design to the Endangered Plant Investigation outlined in Section 1.4.1 to  		refine the location of the endangered fish and endangered aquatic 			invertebrate species within the counties specified in the Biological Opinion  		as identified in the Ecological Effects Branch acetochlor review dated  		January 25, 1994. The ARP agrees to compare the use pattern for acetochlor  		with the location of the endangered species and appropriately mitigate the  		use of acetochlor in that location as required by the Agency. The design and  		issues relating to conduct and timing of the Endangered Fish and Endangered  		Aquatic Invertebrates Survey, and appropriate mitigation efforts, are  			"reserved issues" subject to the provisions of Section 7A.</p>
		</li>

		</ul>

	</li>

	</ul>

</li>
<li><h2>Clarification of Outstanding Toxicological Studies</h2>

	<ul>

	<li><h3>2.1 Toxicology Studies to be Conducted</h3>

	<p>The ARP has agreed to perform the following clarifying toxicology studies as a  	condition of registration: </p>

		<ul>
		<li><p>Cytogenetics assay for aberration using cultured human lymphocytes for  		Compound 57 </p></li>
		<li><p>Unscheduled DNA synthesis assay in rat hepatocytes for Compound 57</p>		</li>
		</ul>

	</li>
	<li><h3>2.2 Additional Toxicology Work</h3>

	<p>The ARP volunteers to perform a heritable translocation study or alternative to  	this assay on acetochlor as agreed with the Toxicology Branch. The design and  	issues relating to conduct and timing of the heritable translocation study or  	alternative to this assay are "reserved issues" subject to the provisions  	of Section 7A.</p>

	</li>

	</ul>

</li>
<li><h2>Restricted Use Classification Statement</h2>

<p>The ARP agrees that the following statement should appear on the product label.</p>

<p>"RESTRICTED USE PESTICIDE</p>

<p>due to oncogenicity. For retail sale to and use only by Certified Applicators or  persons under their direct supervision and only for those uses covered by the Certified  Applicator's certification."</p>

</li>
<li><h2>Additional Label Mitigation Measures/Language</h2>

	<ul>

	<li><h3>4.1 Ground Water Protection Statements</h3>

		<ul>

		<li><h4>4.1.1. Ground Water Advisory </h4>

		<p>The following statement will appear on the label: </p>

		<p>This chemical demonstrates the properties and characteristics associated  		with chemicals detected in ground water. The use of this chemical in areas  		where soils are permeable, particularly where the ground water is shallow,  		may result in ground water contamination.</p>

		</li>
		<li><h4>4.1.2 Additional Protective Label Statements</h4>

		<p>The following statements also appear as use restrictions on the label:</p>

		<p>Do not apply to coarse soils classified as sands with less than 3% organic  		matter (as determined by soil tests, if not known) where depth to ground  		water is 30 feet or less. </p>

		<p>This product may not be mixed or loaded within 50 feet of any wells  		(including abandoned wells and drainage wells), sink holes, perennial or  		intermittent streams and rivers, and natural or impounded lakes and  			reservoirs. This setback does not apply to properly capped or plugged  			abandoned wells and does not apply to impervious pad or properly diked  		mixing/loading areas. </p>

		<p>Operations that involve mixing, loading, rinsing, or washing of this  		product into or from pesticide handling or application equipment or  			containers within 50 feet of any well are prohibited unless conducted on an  		impervious pad constructed to withstand the weight of the heaviest load that  		may be positioned on or moved across the pad. Such a pad shall be designed  		and maintained to contain any product spills or equipment leaks, container or  		equipment rinse or washwater, and rainwater that may fall on the pad. Surface 		water shall not be allowed to either flow over or from the pad, which means  		the pad must be self contained. The pad shall be sloped to facilitate  			material removal. An unroofed pad shall be of sufficient capacity to contain  		at a minimum 110% of the capacity of the largest pesticide container or  		application equipment on the pad. A pad that is covered by a roof of  			sufficient size to completely exclude precipitation from contact with the pad  		shall have a minimum containment capacity of 100% of the capacity of the  		largest pesticide container or application equipment on the pad. Containment  		capacities as described above shall be maintained at all times. The above  		specified minimum containment capacities do not apply to vehicles when  		delivering pesticide shipments to the mixing/loading site. States may have in  		effect additional requirements regarding wellhead setbacks and operational  		containment. </p>

		<p>Do not apply this product through any type of irrigation system.</p>

		<p>Do not use flood irrigation to apply or incorporate this product.</p>

		<p>Product must be used in a manner which will prevent back siphoning in  		wells, spills or improper disposal of excess pesticide, spray mixtures or  		rinsates.</p>

		</li>
		</ul>

	</li>
	<li><h3>4.2 Off-Target and Surface Water Protection Statements</h3>

		<ul>

		<li><h4>4.2.1 Surface Water Advisory</h4>

		<p>The following statements will appear on the label: </p>

		<p>Acetochlor has properties that may result in surface water contamination 		via dissolved runoff and runoff erosion. Practices should be followed to  		minimize the potential for dissolved runoff and/or runoff erosion.</p>

		</li>
		<li><h4>4.2.2 Additional Protective Label Statements</h4>

		<p>The following statements will also appear as use restrictions on the  		label: </p>

		<p>This product is toxic to fish. Do not apply directly to water, or to areas  		where surface water is present or to inter-tidal areas below the mean high  		water mark. Do not contaminate water when disposing of equipment washwaters.		</p>

		<p>Do not apply under conditions which favor runoff or wind erosion of soil  		containing this product to non-target areas.  To prevent off-site movement  		due to runoff or wind erosion:</p>

			<ul>

			<li><p>Avoid treating powdery dry or light sandy soils when conditions 			are favorable for wind erosion. Under these conditions, the soil  			surface should first be settled by rainfall or irrigation.</p></li>

			<li><p>Do not apply to impervious substrates such as paved or highly 
                  compacted surfaces, or frozen, or snow covered soils.</p></li> 

			<li><p>Do not use tail water from the first flood or furrow irrigation 
                  of treated fields to treat non- target crops unless at least 1/2 inch  			of rainfall has occurred between application and the first irrigation.			</p></li>

			</ul>

		<p>Do not apply this product using aerial application equipment.</p> 

		<p>Do not apply when wind conditions favor drift to non-target sites. To  		minimize spray drift to non-target areas:</p>

			<ul>

			<li><p>Use low pressure application equipment capable of producing a  			large droplet spray.</p></li>

			<li><p>Do not use nozzles that produce a fine droplet spray.</p></li>

			<li><p>Minimize drift by using sufficient spray volume to ensure 				adequate coverage with large droplet size sprays.</p></li>

			<li><p>Keep ground driven spray boom as low as possible above the 
                  target surface.</p></li>

			<li><p>Make application when the wind velocity favors on-target 
                  product deposition (approximately 3 - 10 mph). Do not apply when wind  			velocity exceeds 15 mph. Avoid application when gusts approach 15 mph.			</p></li>

			<li><p>Low humidity and high temperatures increase the likelihood of  			spray drift to sensitive areas. Avoid spraying during conditions of low  			humidity and/or high temperatures. Do not apply during inversion  			conditions.</p></li>

			</ul>

		</li>
		</ul>
	</li>
	</ul>
</li>
<li><h2>Ground Water Protection Measures</h2>

	<ul>

	<li><h3>5.1. Ground Water Monitoring</h3>

		<ul>

		<li><h4>5.1.1. Prospective Ground Water Studies</h4>

		<p>See Section 1.2 above on terms and conditions of registration. </p>

		</li> 
		<li><h4>5.1.2. Additional Ground Water Monitoring</h4>

		<p>The ARP will submit for EPA approval validated analytical methods for the  		determination of acetochlor and degradates of toxicological concern in ground  		water samples. At present, the ARP is not aware of any degradates of  			toxicological concern. If, in the future, EPA determines that there are  		degradates of toxicological concern, they shall be included as appropriate in  		the state monitoring programs described below. These analytical methods will  		be made available to any State Pesticide Lead Agency for inclusion in 			monitoring programs. The timing for submission of these methods, their  		content, and EPA's approval will be a "reserved issue" governed by  		the provisions of Section 7A. </p>

		<p>The ARP will fund reasonable monitoring programs in conjunction with the  		Departments of Agriculture in the seven major use states of Wisconsin,  		Illinois, Iowa, Minnesota, Indiana, Nebraska, and Kansas, which collectively  		represent greater than 80% of the expected acetochlor use, and are  			representative of a variety of geographic, soil and climatic conditions. The  		ARP commits to providing a multi-residue method for acetochlor, and will also  		make ELISA methods available to the States to ensure that cost effective  		monitoring can be accomplished. The ARP will develop methods to detect any  		degradates of toxicological concern and will also make all reasonable efforts 		to develop multi-residue methods to include them. It is understood that it  		may not be technically possible to develop multi-residue methods for  			metabolites. </p>

		<p>In the State Monitoring Program (SMP), the ARP will monitor 25 wells in  		each of the above seven states. Those wells may be existing monitoring wells,  		or other monitoring wells not installed by the ARP. If, prior to initiation  		of SMP monitoring, the ARP has reason to believe that a well is damaged or  		otherwise inappropriate for monitoring, it will raise this issue with the  		State Lead Pesticide Agency to ensure that such well is not selected for the  		SMP. The wells shall be located in areas of high acetochlor use that range 		from vulnerable to general use conditions including a variety of geographic,  		soil, and climatic conditions, and shall be a reasonable distance down  		gradient from acetochlor treated areas, as agreed with the States. The wells  		shall be sampled for analysis once per month. The ARP will fund the  			installation of two (2) new monitoring wells in each of these states, if  		necessary to meet the monitoring requirements of that state. </p>

		<p>Detections will be confirmed by GC-MS at ARP's expense. The need for  		continued monitoring will be reassessed by the ARP and EPA every 5 years. The  		ARP shall agree on the timing, design and issues relating to the analytical  		methods and the conduct of the monitoring programs (not to exceed monthly  		sampling of 25 wells per state) with the State Lead Pesticide Agency in the  		seven major use states as provided in this section. The ARP shall provide EPA  		with quarterly status reports on its negotiations with such states. If the  		ARP is unable to agree on the timing, design, and issues relating to the  		analytical methods and the conduct of the monitoring programs with such  		states by January 15, 1995, the matters on which there is disagreement will  		be governed by the provisions of Section 7B. The initial determination of the  		identity of degradates of toxicological concern will be a "reserved 		issue" governed by the provisions of Section 7A. The ARP shall make  		annual reports to the EPA on the status of the state monitoring programs, 		beginning in February 1995. </p>

		<p>The ARP will provide technical assistance to community water system  		operators in monitoring for acetochlor residues at community water supply  		wells by adding acetochlor and degradates of toxicological concern to EPA  		method 505, if technically feasible. </p>

		</li>
		<li><h4>5.1.3. Response to Ground Water Detections</h4>

			<ul>

			<li><h5>5.1.3.1 Investigation of Cause of Detections</h5>

			<p>Any information pertaining to detection of acetochlor and any  			degradates of toxicological concern which become known to the ARP,  			Monsanto, Zeneca or their agents will be reported to EPA within 15 days  			of the date such information becomes known to the ARP, Monsanto,  			Zeneca, or their agents. The ARP may respond to any detections of  			acetochlor or its degradates of toxicological concern reported by  			investigators, using confirmed analytical methods, by sending a  				qualified third party representative to investigate the incident. The  			investigation shall be completed within 60 days of receipt of the  			report and the results reported to EPA within 30 days of completion of  			the investigation, unless the ARP and EPA agree to extend those  				deadlines. The investigation may include any additional sampling useful  			in determining if the detection is due to a point source or intentional  			contamination. The EPA shall consider the results of any such  				investigation in determining whether a reported and investigated  			detection will be considered a "detection" for the purpose of  			establishing a pattern of movement, or the need for additional  				mitigation, or for triggering suspension or cancellation under this  			Section 5.1.3. </p>

			</li>
			<li><h5>5.1.3.2 Exposure Reduction</h5>

			<p>For detections verified by the ARP's GC/MS method (at ARP's 				expense), occurring at a level at or above 1.0 ppb in rural drinking  			water wells, the ARP will offer without conditions a Well Assistance  			Program to compensate rural well owners by paying for the cost of  			drilling the new well, or installing and maintaining filters, or  			connecting to public water supplies, and other appropriate measures.  			The ARP will unconditionally pay for all costs associated with this  			remediation up to $5,000 per well (in 1994 dollars). All private rural  			drinking water wells and community drinking water supply wells in rural  			areas are eligible for the ARP well assistance program. </p>

			<p>Public wells in rural areas which have verified detections (using  			the ARP's GC-MS method) at ARP's expense of acetochlor at a level at or  			above 1.0 ppb, that are not associated with product mishandling will  			be, at ARP's expense, remediated to provide drinking water below a  			detection limit of 0.10 ppb. </p>

			</li>
			<li><h5>5.1.3.3. Detection Criteria </h5> 

			<p>The data from either the PGW or other sampling/monitoring programs  			may indicate a pattern of movement of acetochlor or degradates of  			toxicological concern toward ground water, as a result of use according  			to label directions or in accordance with widespread and commonly  			recognized practice. At present, the ARP is not aware of any degradates  			of toxicological concern.  If, in the future, EPA determines there are  			degradates of toxicological concern, the detection concentrations noted 			below will be reviewed and will be revised, if appropriate, based upon  			the toxicologic effect of the degradate. A pattern of movement is  			defined as being: </p>

				<ul>

				<li><p>detections of acetochlor or degradates of toxicological 				concern confirmed by the approved and validated GC-MS method, and				</p></li>

				<li><p>IN THE PGW STUDIES. Detections of acetochlor or degradates 				of toxicological concern that are greater than or equal to 0.10  				ppb in ground water which are consistent with recharge as  					measured with tracers and/or suction lysimeters; OR</p> 

				<p>Detections of acetochlor or degradates of toxicologic concern  				at a concentration greater than or equal to 1.0 ppb in soil water  				collected by suction lysimeters at a depth of 9 feet below the  				land surface. Such soil water detections must be consistent with  				the movement of soil water as determined by conservative tracers,  				and consistent with detections in the three and six foot  					lysimeters in that cluster. Lysimeter samples from the same depth  				will be composited to ensure adequate sample size (for the 					purpose of analysis) when necessary; or </p></li>

				<li><p>IN THE STATE MONITORING PROGRAMS. For reports of  					detections of acetochlor or degradates of toxicological concern  				in the state monitoring programs described in section 5.1.2, a  				detection greater than or equal to a concentration of 0.10 ppb in  				ground water subsequently detected at greater than or equal to  				0.10 ppb in two follow-up samples collected monthly over a period  				of six months; or</p></li> 

				<li><p>OTHER MONITORING STUDIES (outside of the PGW study or 				State Monitoring Programs (defined in section 5.1.2)). For 					reports of any other detections of acetochlor, a detection 					greater than or equal to a concentration of 0.20 ppb in ground  				water, subsequently detected at greater than or equal to 0.20 ppb  				in two or more follow-up samples collected monthly over a period  				of six months. </p></li>

				</ul>

			<p>If the ARP does not take appropriate steps to secure follow-up 			sampling, the initial report of the detection shall be treated as  			sufficient to define a pattern of movement. The determination of what  			constitutes appropriate steps to be taken is a "reserved 				issue" subject to the provisions of Section 7A. </p>

			</li>
			<li><h5>5.1.3.4. Additional Mitigation Measures </h5> 

			<p>If EPA determines that a pattern of movement, as defined in 5.1.3.3.  			has occurred from use in accordance with label directions or in  				accordance with widespread and commonly recognized practice, then the  			ARP, in conjunction with EPA, will determine whether the movement is  			limited to a geographical area or soil type. In that case, the ARP will  			revise the acetochlor label to include geographic or additional soil  			type label restrictions. </p>

			</li>
			<li><h5>5.1.3.5. Automatic Suspension </h5> 

			<p>If EPA determines that a pattern of movement toward ground water as  			defined in 5.1.3.3., above has occurred arising from use in accordance  			with label directions or in accordance with widespread and commonly  			recognized practice, and if within 30 days EPA and the ARP cannot agree  			on an immediate mitigation option, the registration shall be  				automatically suspended on a geographic basis. This suspension will  			terminate if EPA determines that the ARP has taken adequate steps to  			implement appropriate mitigation measures. The determination of  				appropriate mitigation options shall be governed by the provisions of 			Section 7. </p>

			</li>
			<li><h5>5.1.3.6. Cancellation </h5> 

				<ul>

				<li><p><strong>GW Scenario 1 </strong></p>

				<p>For the PGW studies, if EPA determines that out of the 8  				sites, 4 sites in a variety of geographic, and climatic 					conditions under both vulnerable and general use conditions, (as  				determined by EPA) in corn growing areas indicate a pattern of  				movement of acetochlor toward ground water, as defined in  					5.1.3.3. from use in accordance with label directions or in  				accordance with widespread and commonly recognized practice,  				registration shall be automatically canceled. The sites at which  				a pattern of movement occurs shall represent a range of  					vulnerable and general use soil textures consistent with labeled  				use. </p>

				</li>
				<li><p><strong>GW Scenario 2 </strong></p>

				<p>For monitoring programs outside the PGW studies, the 					registration of acetochlor will be automatically canceled if EPA  				determines that either of the criteria specified below have been  				met. All detections shall be verified by the ARP's GC-MS method  				at the ARP's expense. </p>

					<ul>

					<li><p>Criterion 1:</p>

					<p>Detections occur in 20 or more wells included in the  					State Monitoring Program at or above 0.10 ppb followed by  					two subsequent detections of at least 0.10 ppb in monthly  					sampling of each of those wells, conducted over a period of  					six months. </p>

					</li>
					<li><p>Criterion 2:</p> 

					<p>Detections occur in 150 or more individual wells at or  					above 0.20 ppb, followed by two subsequent detections of at  					least 0.20 ppb in monthly sampling of each of those wells,  					conducted over a period of six months across a wide variety  					of geographic, soil, and climatic conditions in corn  					growing area. </p>

					</li>

					</ul>

				</li>
				<li><p><strong>GW Scenario 3 </strong></p>

				<p>For monitoring programs outside the PGW studies, the 					registration of acetochlor will be automatically canceled if EPA  				determines that detections occur in twenty (20) or more wells  				across a wide variety of geographic, soil, and climatic  					conditions in corn growing areas at a concentration of at least  				1.0 ppb, followed by two subsequent detections of at least 1.0  				ppb in monthly sampling of each of those wells, conducted over a  				period of six months. All detections shall be verified by the  				ARP's GC-MS method at the ARP's expense. </p>

				</li>

				</ul>

			<p>An initial detection shall be treated as sufficient to meet these  			cancellation criteria if the ARP has failed to take timely and  				appropriate steps to secure follow-up samples. </p>

			<p>If EPA determines at any time that mitigation measures have been or  			will be undertaken which are likely to be effective, the Agency may  			treat, for a period of up to 18 months, some or all detections within  			the area subject to such mitigation measures (mitigation area) as  			insufficient to meet the cancellation criteria in section 5.1.3.6. No  			later than 18 months after such mitigation measures have been  				initiated, EPA shall make a final determination whether the mitigation  			measures have been or are likely to be effective. During this time, the 			ARP may investigate whether such mitigation measures have been, or are  			likely to be, effective. The EPA shall notify the ARP 60 days prior to  			making its determination, and shall consider the results of any such  			investigation, if timely received, in making that determination. If  			EPA's final determination is that the mitigation measures have not been  			or are not likely to be successful, all detections within the  				mitigation area shall be subject to the provisions of sections  				5.1.3.3., 5.1.3.5., and 5.1.3.6. If EPA's final determination is that  			the mitigation measures have been or are likely to be successful, some  			or all detections within the mitigation area may be designated by EPA  			as insufficient to meet the cancellation provisions of Section 5.1.3.6.  			Such final determination will be consistent, to the extent feasible,  			with relevant existing policies and procedures. </p>

			<p>Point source contamination detections shall be treated as sufficient  			to meet these cancellation criteria unless EPA determines that such  			contamination:</p>

				<ol style="list-style-type:lower-roman;">

				<li><p>does not result from use in accordance with label  					directions or widespread and commonly recognized practice, or</p>				</li>

				<li><p>results from use in accordance with label directions or in  				accordance with widespread and commonly recognized practice, but  				that the general cause of the contamination can be mitigated with  				product stewardship, label language or repair/replacement of  				damaged or inadequately installed wells. </p></li>

				</ol>

			</li>
			</ul>

		</li>
		</ul>

	</li>
	<li><h3>5.2. State Management Plans</h3>
	
	<p>If at any time after the registration EPA decides to nominate acetochlor for  	inclusion in State Management Plans, the ARP will not file any objection to such  	inclusion, nor will it challenge such action in any court or administrative forum.  	</p>

	</li>
	<li><h3>5.3. Continued Stewardship</h3>

	<p>Regardless of whether the data indicate any pattern of movement toward  	groundwater, the ARP will continue its product stewardship commitment and cooperate  	with the Agency to develop and implement additional product stewardship measures  	considered appropriate.</p>

	</li>
	</ul>

</li>
<li><h2>Surface Water Protection Measures</h2>

	<ul>

	<li><h3>6.1. Surface Water Monitoring </h3> 

	<p>The ARP will submit for EPA approval a validated multi-residue analytical method  	for the determination of acetochlor and other acetanilides and acetamides in  	surface water samples. The EPA-approved analytical method will be made available to  	any drinking water suppliers as necessary for inclusion in monitoring programs. At  	present, the ARP is not aware of any acetochlor degradates of toxicological  	concern. If, in the future, EPA determines there are acetochlor degradates of  	toxicological concern, the ARP will develop methods to detect such degradates and 	will also make all reasonable efforts to develop multi-residue methods to include  	them. It is understood that it may not be technically possible to develop 
	multi-residue methods for degradates of toxicological concern.  The timing for  	submission of the analytical method for acetochlor and the adequacy of the method  	shall be "reserved issues" governed by the provisions of Section 7A. </p>

	<p>The ARP will fund reasonable monitoring programs in conjunction with the  	appropriate Lead Agencies in the seven major use states of Wisconsin, Illinois,  	Iowa, Minnesota, Indiana, Nebraska, and Kansas.  The ARP will fund a monitoring  	program of 175 biweekly sampling stations in representative hydrologic units of  	varying size of drainage areas across the seven major use states. The timing,  	design, and the analytical methods and the conduct of the monitoring program  	identified in this paragraph shall be governed by the provisions of Section 7A. The  	determination of what constitutes representative hydrologic units is a 	"reserved issue" governed by the provisions of Section 7A. The ARP  	commits to providing a multi-residue method for acetochlor and other acetanilides 	and acetamides. ELISA methods will be provided to the States to ensure cost  	effective monitoring can be accomplished. The need for continued monitoring will be  	reassessed every 5 years. The ARP shall make annual reports to EPA on the status of  	the state monitoring programs. </p>

	</li>
	<li><h3>6.2 Response to Surface Water Detections </h3> 

	<p>The ARP agrees in principle to provisions relating to surface water, which  	include a sampling program, investigation of the source of surface water 	detections, and mitigation measures. The elements of the response to surface water  	detections will parallel those described in Section 5 for ground water protection. 	</p>

		<ul>

		<li><h4>6.2.1 Investigation of Cause of Detections </h4> 

		<p>The ARP may respond to any detections of acetochlor or degradates of  		toxicological concern, using confirmed analytical methods, by sending a  		qualified third party representative to investigate the incident. The  			investigation shall be completed within 60 days of the incident becoming  		known to the ARP and the results reported to EPA within 30 days of completion  		of the investigation, unless the ARP and EPA agree to extend those deadlines.  		The investigation may include any additional sampling useful in determining  		if the detection is due to a point source or intentional contamination.  The  		EPA shall consider the results of any such investigation in determining  		whether a reported and investigated detection will be considered a  			"detection" for the purpose of establishing the need for mitigation  		or for triggering cancellation under Section 6.2.2. </p>

		</li>
		<li><h4>6.2.2 Mitigation and Cancellation </h4> 

		<p>At present, the ARP is not aware of any degradates of toxicological 			concern. If, in the future, EPA determines there are degradates of  			toxicological concern, the detection concentrations noted below will be  		reviewed and will be revised, if appropriate, based upon the toxicologic  		effect of the degradate. </p>

			<ul>

			<li><p><strong>SW Scenario I:</strong></p>

			<p>If one (1) community water supply system, that derives its water  			primarily from surface water, detects an annual time-weighted mean  			concentration of 2.0 ppb, acetochlor, then either; </p>

				<ul>

				<li><p>The use of acetochlor in the related watershed will be 				prohibited. Such prohibition will be implemented by means of  				amendment of the acetochlor registration to prohibit sale,  				distribution, and use in the specified watershed.  The timing,  				content, and implementation of such restriction shall be governed  				by the provisions of Section 7; or</p> 

				</li>
				<li><p>The ARP will absorb 100% of costs required to restore the  				community water supply system to compliance. If EPA determines  				that the ARP has failed to meet this obligation, it may cancel  				the registration without opportunity for hearing. </p>

				</li>

				</ul>

			</li>
			<li><p><strong>SW Scenario II:</strong></p> 

			<p>If EPA determines that two (2) large (serving 100,000 people) 				community water supply systems, or ten (10) community water supply  			systems of any size across a wide variety of corn growing, soil, and  			climatic have an annual time-weighted mean concentration of 2.0 ppb or  			are otherwise determined to be out of compliance based on Office of  			Water criteria, the registration will be automatically canceled. </p>

			<p>If any community water supply system that derives its water 				primarily from surface water detects a single peak concentration of 8.0  			ppb of acetochlor, the ARP will make biweekly sampling of that water  			system throughout the following 12 months to determine whether the 2.0  			ppb annual time-weighted mean concentration has been exceeded. </p>

			</li>

			</ul>

		</li>
		</ul>

	</li>
	</ul>

</li>
<li><h2>General Provision for Reserved Issues and Compliance Determinations</h2>

<p>The ARP recognizes that this registration could not have been granted in a timely  manner without deferring a number of decisions for later resolution. The ARP understands  that timely resolution of these deferred decisions is essential to the validity of this                 registration. </p>

	<ol style="list-style-type:upper-alpha;">

	<li><h3>Reserved Issues </h3>

	<p>Any matter identified in this application as a "Reserved Issue" will  	be resolved by agreement between the ARP and EPA by November 15, 1994. 	"Reserved Issues" identified within this application for which no  	agreement has been reached by November 15, 1994, shall be resolved by the sole  	determination of EPA. Such determination will become final unless submitted within  	10 working days to:</p>

		<ol>

		<li><p>The Assistant Administrator for those reserved issues affecting 			suspension or cancellation; or</p></li>

		<li><p>The Director of OPP for all other Reserved Issues.</p></li>

		</ol>

	<p>During such review, the ARP will have the opportunity to present its position in  	a meeting before the Assistant Administrator or Director of OPP, as applicable. The  	ARP agrees to be bound by the final determination of the Assistant Administrator or  	Director of OPP, as applicable. </p>

	<p>Upon final determination of those matters identified in this application as  	"Reserved Issues", the substance of all of the terms and conditions  	contained in this application will have been decided. These final determinations  	shall be deemed to be amendments to the registration. If the Agency determines that  	any additional term or condition should be imposed, it shall do so by means of the  	procedures set forth in FIFRA Sections 3 and/or 6. </p>

	</li>
	<li><h3>Interpretation and Compliance Determinations </h3>

		<ol>

		<li><p>The ARP recognizes that in implementing or complying with the terms  		and conditions of this registration, issues may arise regarding the  			interpretation, application, or implementation of those terms and conditions.  		At any time during the term of this registration and upon notice from EPA to  		the ARP, such issues shall be resolved as a "Reserved Issue", even  		though not identified as such in this application provided that a 30 day  		period for agreement between the ARP and EPA shall begin upon receipt of such  		notice by the ARP, and provided further that such 30 day period may be  		extended by agreement by the EPA and the ARP.</p>

		</li> 
		<li><p>The EPA may, from time to time, make determinations and notify the ARP  		that the ARP has failed to comply with terms or conditions of this  			registration, or that conditions for mitigation, suspension, or cancellation  		have been triggered. The ARP shall have 15 working days from receipt of such  		notice to request arbitration of such determination by:</p>

			<ol style="list-style-type:lower-alpha;"> 

			<li><p>The Assistant Administrator if that determination would result  			in suspension or cancellation; or </p></li>

			<li><p>The Director of OPP for all other such determinations.</p></li>

			</ol>

		</li>
		</ol>

	<p>During any arbitration, both the EPA and the ARP will present their  		positions to the Assistant Administrator or Director of OPP, as applicable.  		The ARP agrees to be bound by the arbitration decision of the Assistant  		Administrator or Director of OPP, as applicable. The decision of the  			Assistant Administrator will be consistent, to the extent feasible, with  		relevant existing policies and precedents. </p>

	</li>
	<li><h3>Waiver </h3>

	<p>The ARP waives any rights it may have to challenge final determinations under  	this Section 7, or any terms or conditions, label amendment, suspension, or  	cancellation imposed by these terms and conditions, in any court or administrative  	forum. The ARP further agrees not to provide aid or encouragement to any other  	party seeking to challenge such final determination, term, condition or action.</p>

	</li>
	</ol>

</li>
</ol>

<p>Sincerely,</p>

<p>Robert E. Ridsdale, Ph.D.<br />
Managing Agent<br />
Acetochlor Registration Partnership</p>

<hr />
<p>This concludes the Registration Agreement. </p>
<hr />

<h2>Attachment to March 8, 1994 letter setting forth the conditions of registration of Acetochlor </h2>

<p>Acetochlor Registration Partnership<br />
c/o ZENECA Ag Products<br />
1800 Concord Pike<br />
Wilmington, DE 19850<br />
302-886-1218</p>

<p>March 30, 1995</p>

<p>Mr. Donald Stubbs, Chief<br />
Fungicide & Herbicide Branch(7505C)<br />
U.S. Environmental Protection Agency<br />
Crystal Mall 2, Room 243<br />
1921 Jefferson Davis Highway<br />
Arlington, VA 22202</p>

<p>Dear Mr. Stubbs:</p>

<p>This letter is offered by the Acetochlor Registration Partnership ("ARP") in  accordance with your request during a meeting on January 13, 1995, as an Attachment to  the March 8, 1994 letter from the ARP to the EPA setting forth the conditions of  registration of acetochlor and pesticides containing acetochlor. </p>

<p>By letter of November 18, 1994, the EPA agreed to amend Section 7A of the referenced  March 8 letter to extend the date for resolution of "reserved issues" to  January 15, 1995. Attached to its November 11, 1994 letter requesting that amendment, the  ARP provided a "Reserved Issues" Status Report. The ARP has continued in good faith to satisfy the conditions of the acetochlor registration in reliance on the agreements set forth in that attachment and on agreements reached in subsequent  discussions with the Agency, in the absence of formal documentation of these agreements  by the Agency. </p>

<p>The ARP and the Agency have continued to work diligently to reach agreement on the  reserved issues pursuant to the March 8 letter and Section 7 of that letter. The parties  met on January 13, 1995 to review the status of agreement on the remaining reserved issues, and to establish deadlines for the submission of various deliverables. This  letter sets forth those agreements and the new deadlines. </p>

<p>In that regard, the ARP requests that the March 8, 1994 agreement be amended with the  following Section 7A agreements reached between the ARP and the EPA:</p>
 
<h3>Section 1.1.1 Commercial Targets and Competitor Reductions:</h3>

	<ol style="list-style-type:lower-alpha;">

	<li><p>EPA has accepted Doane Marketing Research as the independent market research  	firm.</p></li>

	<li><p>EPA has accepted the use reduction monitoring study design submitted by the  	ARP on October 18, 1994.</p></li>

	<li><p>Zeneca will submit its first year county level use information to Doane  	Marketing Research by January 31, 1995.</p></li>

	<li><p>The ARP will enter into a contract with Doane Marketing Research for the  	conduct of the use reduction monitoring study in accordance with its design on or  	before March 31, 1995.</p></li>

	<li><p>Monsanto will submit its first year county level use information to Doane  	Marketing Research on or before March 31, 1995.</p></li>

	</ol>

<h3>Section 1.2.1 Prospective Ground Water Study Program:</h3>

	<ol style="list-style-type:lower-alpha;">

	<li><p>The EPA agreed to the following phasing of acetochlor applications in PGW  	studies and targeted soil textures and geographies:</p>

	<table class="table zebra">

	<tr><th scope="row">Wisconsin </th><td> Loamy sand </td><td> 1995 </td></tr>
	<tr><th scope="row">Ohio </th><td> Silt loam </td><td> 1995 </td></tr>
	<tr><th scope="row">Minnesota </th><td> Clay loam </td><td> 1996 </td></tr>
	<tr><th scope="row">Iowa </th><td> Loam </td><td> 1996 </td></tr>
	<tr><th scope="row">Illinois/Indiana </th><td> Sandy loam </td><td>1996</td></tr>
	<tr><th scope="row">NC/SC/GA </th><td> Loamy sand </td><td> 1996 </td></tr>
	<tr><th scope="row">Pennsylvania </th><td> Silt loam </td><td> 1997 </td></tr>
	<tr><th scope="row">Kansas/Nebraska </th><td> Clay loam </td><td> 1997 </td></tr>
	</table>

	</li>
	<li><p>EPA agreed to the following schedule for additional required actions</p>

		<ol>

		<li><p>March 2, 1995 - The ARP and EPA will participate in a PGW site update  		meeting to discuss:</p>

			<ol>
			<li><p>current information on WI and OH sites; and </p></li>
			<li><p>background information on MN and IA sites.</p></li>
			</ol>

		</li>
		<li><p>Spring 1995 - The ARP and EPA will hold monthly meetings to reach  		agreement on the WI and OH sites.</p></li>

		<li><p>Not later than September 30, 1995 - The ARP and EPA will have selected  		1996 sites for detailed characterization.</p></li>

		<li><p>Not later than December 31, 1995 - ARP will present all soil 			characterization data on 1996 candidate sites.</p></li>

		<li><p>Not later than June 1, 1996 - ARP will present all soil  				characterization data on 1997 candidate sites.</p></li>

		</ol>

	</li>
	<li><p>Although EPA had identified the acetochlor "sulfonic acid" as the  	preferred marker metabolite for determination in PGW studies, with a detection  	limit of 1.0 ppb, the Agency will consider the "oxanilic acid" as an  	alternative based on a report by the ARP which establishes the impossibility, based  	on current technology, of separating the sulfonic acid metabolites of three 
	widely-used acetanilides.</p>

	</li>
	</ol>

<h3>Section 1.3 Ecological Effects Branch Studies</h3>

<p>On August 2, 1994, the ARP submitted three previously unsubmitted reports of  investigations of the effects of acetochlor on reproduction in the avian species,  bobwhite quail, and mallard duck. Submission of the reports satisfied the condition  specified in Section 1.3. </p>

<h3>Section 1.4 Protection of Endangered Species:</h3>

<p>In a letter dated January 12, 1995, the EPA agreed to ARP participation in an industry  sponsored task force on endangered species protection, and to the timing of that task  force's plan including a delay in submission of the protocol until July 30, 1995, in  satisfaction of the condition specified in Section 1.4. </p>

<h3>Section 2 Clarification of Outstanding Toxicological Studies:</h3>

	<ol style="list-style-type:lower-alpha;">

	<li><p>The EPA has reviewed and accepted the ARP's submission of July 18, 1994,  	detailing the discussion of the ARP/EPA meeting of July 7, 1994, under Section 2.1  	regarding heritable translocation study requirements.  The need for a heritable  	translocation study will be reassessed by EPA following the review of the results  	of the ARP's dominant lethal studies and research program to investigate fertility 
      effects.</p></li>

	<li><p>The ARP submitted protocols for dominant lethal studies in the rat and mouse  	on Jan 30, 1995, EPA has agreed that final reports for the rat and mouse are due 12  	and 18 months, respectively, after EPA notifies the ARP, in writing, that the  	protocols are approved.</p></li>

	</ol>

<h3>Section 5 Groundwater Protection Measures - Analytical Methods:</h3>

	<ol style="list-style-type:lower-alpha;">

	<li><p>EPA will provide information essential to an ARP analysis of the suitability  	of including acetochlor in EPA Method 505 for health-based surface water monitoring  	programs.</p></li>

	<li><p>Not later than February 28, 1995 - The ARP will provide a status report on  	its determination of inclusion of acetochlor in Method 505 to achieve an LOQ of at  	least 0.60 ppb, which EPA agreed would be satisfactory for health-based surface  	water monitoring.</p></li>

	<li><p>Not later than March 1, 1995 - The ARP will submit the analytical methods to  	be used in the ground and surface water monitoring programs.</p></li>

	<li><p>Not later than March 15, 1995 - The ARP will submit a report evaluating the  	capability of the two available ELISA methods in detecting acetanilides.</p></li>

	<li><p>Not later than April 15, 1995 - The ARP will validate and submit an  	acetochlor specific, PGW analytical method, based on external standards, capable of  	quantifying at least 0.10 ppb.</p></li>

	</ol>

<h3>Section 5.1.2 Additional Groundwater Monitoring:</h3>
 
	<ol style="list-style-type:lower-alpha;">

	<li><p>Not later than May 15, 1995 - The ARP will submit a "confidential  	business information" map and report listing all individual site locations  	included in the ground water monitoring (GWM) program.</p></li>

	<li><p>Not later than July 31, 1995 - The ARP will submit a draft table of contents  	and a list of parameters to be reported in GWM annual reports.</p></li>

	<li><p>Not later than November 1, 1995 - The ARP will submit a "confidential  	business information" report providing site characterization data and maps for  	all sites being monitored in the GWM program.</p></li>

	<li><p>Not later than February 28, 1996 - The ARP will submit the first annual GWM  	report of acetochlor analytical data generated in 1995.</p></li>

	</ol>

<h3>Section 6.1 Surface Water Monitoring:</h3>

	<ol style="list-style-type:lower-alpha;">

	<li><p>EPA agreed that the surface water monitoring (SWM) program sampling schedule  	(based on 1/13/95 Memo of Conference), basic design elements and states in which  	the program will be conducted (including OH, MO, PA, MD, and DE), as proposed by  	the ARP, are acceptable to EPA.</p></li>

	<li><p>Not later than March 1, 1995 - The ARP will submit a list of individual site  	locations and a map displaying the geographical distribution of community water  	systems (CWS) selected for the SWM program.</p></li>

	<li><p>Not later than March 15, 1995 - The ARP will begin sampling finished water  	in CWS.</p></li>

	<li><p>Not later than July 31, 1995 - The ARP will submit a report detailing  	specific SWM site information, including watershed mapping.</p></li>

	<li><p>Not later than July 31, 1995 - The ARP will submit a draft table of contents  	and list of parameters to be reported in SWM annual reports.</p></li>

	<li><p>Not later than January 31, 1996 - The ARP will submit the first annual SWM  	analytical report to the Agency, with subsequent annual reports on January 31, each  	year.</p></li>

	</ol>

<h3>Other Issues: </h3> 

	<ol style="list-style-type:lower-alpha;">

	<li><p>Not later than March 31, 1995 - The ARP will submit the final Quarterly  	Report for the water monitoring programs.</p></li>

	<li><p>ELISA Reports - The EPA agrees that reported ELISA test results will not  	constitute the basis for follow-up, report, or response by the ARP, or the basis  	for any regulatory action by the EPA for the purposes of the letter of March 8,  	1994, unless confirmed using specific gas-chromatographic methods with 
	mass-selective detection.  The ARP has no obligation to perform such confirming  	analyses of ELISA test results.</p></li>

	</ol>

<p>The ARP believes the foregoing accurately sets forth the current status of "reserved issues" and the agreements reached between the ARP and the EPA. If  you agree, please sign the additional two copies of this letter, and return them to me at  your earliest convenience. </p>

<p>Thank you for your assistance in bringing this to closure. </p>

<p>Sincerely,</p>

<p>Robert E. Ridsdale, Managing Agent [signed] <br />
Acetochlor Registration Partnership</p>

<p>Donald Stubbs [signed]<br />
Chief, Fungicide & Herbicide Branch </p>

<p>This concludes the attachment to the March 8, 1994 letter.</p>

<hr />

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