Source: https://www.federalregister.gov/documents/2009/10/07/E9-24188/quinclorac-pesticide-tolerance-for-emergency-exemption
Timestamp: 2018-04-23 02:20:18
Document Index: 678695572

Matched Legal Cases: ['art 180', 'art 178', 'art 178', 'art 178', 'art 2', 'art 158']

Federal Register :: Quinclorac; Pesticide Tolerance for Emergency Exemption
74 FR 51485
51485-51490 (6 pages)
EPA-HQ-OPP-2009-0518
FRL-8434-3
E9-24188
III. Emergency Exemption for Quinclorac on Cranberries and FFDCA Tolerances
https://www.federalregister.gov/d/E9-24188 https://www.federalregister.gov/d/E9-24188
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0518. All documents in the docket are listed in the docket index available in http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
In addition to accessing electronically available documents at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 Start Printed Page 51486through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/​ecfr.
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0518 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before December 7, 2009.
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2009-0518, by one of the following methods:
EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a time-limited tolerance for residues of the herbicide quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, in or on cranberries at 15.0 parts per million (ppm). This time-limited tolerance expires and is revoked on December 31, 2012. EPA will publish a document in the Federal Register to remove the revoked tolerances from the CFR.
The Massachusetts Department of Agriculture Resources (MDAR) requested the use of quinclorac through an emergency exemption to control dodder on cranberries. According to MDAR, dodder is a serious and devastating pest in commercial cranberry production. The MDAR stated that currently available herbicides are inadequate for dodder control and growers have experienced at least a 50% yield loss due to dodder infestation. After having reviewed the submission, EPA determined that emergency conditions exist for this State, and that the criteria for an emergency exemption are met. EPA has authorized under FIFRA section 18 the use of quinclorac on cranberries for control of dodder in Massachusetts.
As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of quinclorac in or on cranberries. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these time-limited tolerances expire and are revoked on December 31, 2012, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on cranberries after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether quinclorac meets FIFRA's registration requirements for use on cranberries or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of quinclorac by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for persons in any State other than Start Printed Page 51487Massachusetts to use this pesticide on these crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for quinclorac, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.
Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerance for residues of quinclorac on cranberries at 15.0 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.
A summary of the toxicological endpoints for quinclorac used for human risk assessment can be found at http://www.regulations.gov in the document Quinclorac. Human Health Risk Assessment for the Proposed Food/Feed Use of the Herbicide (Associated with Section 18 Registation) on Cranberries in Massachusetts, pages 14-41 in docket ID number EPA-HQ-OPP-2009-0518.
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to quinclorac, EPA considered exposure under the time-limited tolerances established by this action as well as all existing quinclorac tolerances in (40 CFR 180.463). EPA assessed dietary exposures from quinclorac in food as follows:
i. Acute exposure. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed 100 percent crop-treated (% CT) and tolerance-level residues for all agricultural commodities. Default processing factors from Dietary Exposure Evaluation Model (DEEM) 7.81 were used (for dried beef and cranberry juice) in the analyses.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed 100% CT, along with tolerance-level residues for all agricultural commodities. Default processing factors from DEEM 7.81 were used (for dried beef and cranberry juice) in the analyses.
iii. Cancer. Based on an evaluation under the 1986 Agency Cancer Assessment Guidelines and the results of carcinogenicity studies in rats and mice, EPA has classified quinclorac as “not classifiable as to carcinogenicity to humans.” The results indicate that there was equivocal evidence of an increase in the incidence of pancreatic acinar cell adenomas in the male rat only, and no increase in female rats nor in mice. A quantification of cancer risk is not warranted because the chronic reference dose is approximately 1,200-fold lower than the dose that induced the benign pancreatic tumors. Therefore, EPA considers the chronic assessment to be protective of potential cancer impacts.
iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for quinclorac. Tolerance level residues and/or 100% CT were assumed for all food commodities.
Based on the modified Tier I Provisional Cranberry Model (PRZM and EXAMS models are not based on typical properties of cranberry bogs, which involves flooding) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of quinclorac for acute exposures and chronic exposures for non-cancer assessments are estimated to be 0.077 parts per billion (ppb) and 0.070 ppb, respectively, for surface water and 0.019 ppb for both acute and chronic (non-cancer) ground water.Start Printed Page 51488
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both acute and chronic dietary risk assessment, the water concentration value of 0.077 ppb was used to assess the contribution to drinking water. Conservative assumptions used in these model estimates help ensure that the outputs are protective of most environments associated with agricultural uses; thus, the estimates are expected to exceed peak values found in the environment in most cases.
3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Quinclorac is currently registered for the following use that could result in residential exposures: turf and lawns. EPA assessed residential exposure using the following assumptions for toddlers:
i. Five percent of the application rate has been used to calculate the day-zero turf transferable residue (TTR) levels used for assessing risks from hand-to-mouth exposures, since quinclorac-specific turf transferable residue study data are not available;
ii. Twenty percent of the application rate has been used to calculate the day-zero turf transferable residue (TTR) residue levels used for assessing risks from object-to-mouth exposures (a higher percent transfer has been used for object-to-mouth behaviors, because it involves a teething action believed to be more analogous to DFR/leaf wash sample collection, where 20% is also used);
iii. Three year-old toddlers are expected to weigh 15 kilograms (representing an average weight from years 1 to 6);
iv. Hand-to-mouth exposures are based on a frequency of 20 events/hour, and a surface area per event of 20 square centimeters, representing the palm-side surfaces of three fingers;
v. Saliva extraction efficiency is 50%, meaning that every time the hand goes in the mouth, approximately half of the residues on the hand are removed;
vi. Object-to-mouth exposures are based on a 25 square centimeter surface area;
vii. Exposure durations for turfgrass scenarios are estimated to be 2 hours, based on information in HED's Exposure Factors Handbook; and
viii. Soil residues are contained in the top centimeter, and soil density is 0.67 milliliters per gram.
EPA has not found quinclorac to share a common mechanism of toxicity with any other substances, and quinclorac does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that quinclorac does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/​pesticides/​cumulative.
2. Prenatal and postnatal sensitivity. There is no qualitative evidence of increased prenatal and/or postnatal susceptibility and, due to the marginal nature of the effects observed on pup viability in the multigeneration reproductive toxicity study, no residual uncertainties with regard to prenatal toxicity following in utero exposures of rats or rabbits to quinclorac (developmental toxicity studies), and prenatal and/or postnatal exposure of rats to quinclorac (reproductive toxicity study) at the estimated aggregate exposure levels. Furthermore, the exposure levels selected for use in risk assessment are measurably lower than the NOAEL from the multigeneration study, and therefore protective against the marginal effects seen in pups.
i. The toxicity database for quinclorac is sufficiently complete to inform the determination for the FQPA safety factor. Although recent changes to 40 CFR part 158 make acute and subchronic neurotoxicity testing (OPPTS Harmonized Guideline 870.6200), and immunotoxicity testing (OPPTS Harmonized Guideline 870.7800) required for pesticide registration, the available data for quinclorac do not show the potential for immunotoxic nor neurotoxic effects. However, future registration actions may require additional toxicity studies.
ii. There is no indication that quinclorac is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity for purposes of this time-limited tolerance.
iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to quinclorac in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by quinclorac.
EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the Start Printed Page 51489product of all applicable UFs is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to quinclorac will occupy less than 1% of the aPAD for females age 13 to 49, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to quinclorac from food and water will utilize 3% of the cPAD for children 1 to 2 years of age, the population group receiving the greatest exposure, while the general U.S. population utilizes 2% of the cPAD. Quinclorac is not expected to pose a chronic dietary risk for the general population (including infants and children). The chronic risk estimates for all populations, resulting from aggregate exposure to quinclorac in food and drinking water, is below EPA's chronic LOC, and therefore not of concern.
3. Short-term and intermediate-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Intermediate-term aggregate exposure takes into account intermediate-term non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). Because short- and intermediate-term exposure may occur as a result of quinclorac use in residential settings, both assessments were based on toddler exposure from an oral route: hand-to-mouth, object-to-mouth, and incidental soil ingestion. The oral MOEs for residential post-application exposure of toddlers range from 6,300 to 1,800,000. The combined MOE of 5,000 is greater than the LOC. These values are greater than the LOC (100) for the short-term and intermediate-term risk assessment and therefore not of concern. The post-application exposure scenarios from the use on turf represent worst-case estimates of exposure and risk. To evaluate short- and intermediate-term aggregate risk, EPA has included the post-application combined MOE (5,000) with the MOE derived from chronic dietary exposure estimates (to reflect background dietary exposure). The behaviors associated with post-application exposures are applicable to toddlers, so only those age groups (infants, children 1-2 years of age, and children 3-5 years of age) have been assessed for short- and intermediate-term aggregate risk. Aggregate MOEs are all greater than 100 (MOEs range from 2,900 to 2,700), and are therefore below EPA's short-term and intermediate-term LOC.
4. Aggregate cancer risk for U.S. population. Quinclorac has been classified as “not classifiable as to carcinogenicity to humans.” Therefore, aggregate cancer risk from quinclorac is not of concern.
5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to quinclorac residues.
Adequate analytical methods, utilizing gas chromatography with electron capture detection (GC/ECD), are available to enforce the tolerance expression on plant (BASF Method A8902; MRID# 41063537) and animal (BASF Method 268/1; MRID# 41063536) commodities. Both methods have undergone successful Agency method validation trials, and have been submitted to FDA for publication in PAM II as the tolerance enforcement methods. The limit of quantitation (LOQ) for both methods is 0.05 ppm in all matrices. Furthermore, FDA has reported that quinclorac can be detected by Multiresidue Protocol B. No additional data are needed.
There are currently no established Codex, Canadian, or Mexican maximum residue limits for residues of quinclorac in/on cranberry.
Therefore, a time-limited tolerance is established for residues of quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, in or on cranberry at 15.0 ppm. This tolerance expires and is revoked on December 31, 2012.
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller Start Printed Page 51490General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the “Federal Register.” This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).
2. Section 180.463 is amended by revising paragraph (b) to read as follows:
(b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. The tolerances expire and are revoked on the date specified in the table.
Cranberry 15.0 12/31/12
[FR Doc. E9-24188 Filed 10-06-09; 8:45 am]