Environmental Protection Agency (EPA).
This regulation establishes tolerances for residues of aminopyralid, including its metabolites and degradates, in or on corn, field, forage; corn, field, grain; and corn, field, stover. Dow AgroSciences requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective April 7, 2010. Objections and requests for hearings must be received on or before June 7, 2010, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0141. All documents in the docket are listed in the docket index available at 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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5218; e-mail address: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:
- Crop production (NAICS code 111).
- Animal production (NAICS code 112).
- Food manufacturing (NAICS code 311).
- Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/oppts and select “Test Methods & Guidelines” on the left-side navigation menu.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of 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. 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-2009-0141 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 as required by 40 CFR part 178 on or before June 7, 2010.
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 this copy, identified by docket ID number EPA-HQ-OPP-2009-0141, by one of the following methods:
- Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
- Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
- Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of May 6, 2009 (74 FR 20947) (FRL-8412-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8F7455) by Dow AgroSciences, 9330 Zionsville Rd., Indianapolis, IN 46268. The petition requested that 40 CFR 180.610 be amended by establishing tolerances for combined residues of the herbicide aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, and its glucose conjugate, expressed as total parent, in or on corn, forage at 0.30 parts per million (ppm); corn, grain at 0.20 ppm; and corn, stover at 0.20 ppm. That notice referenced a summary of the petition prepared by Dow AgroSciences, the registrant, which is available to the public in the docket, http://www.regulations.gov. Comments were Start Printed Page 17580received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has revised the corn commodity terminology and tolerance expression for aminopyralid. The reasons for these changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.”
Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, 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 for the petitioned-for tolerances for residues of aminopyralid, including its metabolites and degradates, on corn, field, forage at 0.30 ppm; corn, field, grain at 0.20 ppm; and corn, field, stover at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The toxicology database for aminopyralid includes toxicity studies conducted with the acid (XDE-750) and the triisopropanolammonium (TIPA) salt (GF-871). The acute toxicity data indicate that both the acid and salt have low toxicity via oral, dermal, and inhalation routes of exposure; and that neither is a skin irritant or skin sensitizer. The TIPA salt is not irritating to the eye; however, aminopyralid acid is severely irritating to the eye.
Longer term studies indicate that the stomach, ileum, and cecum are targets for aminopyralid. In a subchronic feeding study in rats (XDE-750), hyperplasia of the mucosal epithelium of the ileum and cecum was observed at the highest dose tested (HDT) of 1,000 milligrams/kilograms/day (mg/kg/day). Chronic exposure in rats (XDE-750) also resulted in hyperplasia of the mucosal epithelium, along with cecal enlargement and decreased body weights at a lower dose of 500 mg/kg/day. Hypertrophy and hyperplasia of the mucosal epithelium were seen after subchronic exposure in dogs (XDE-750) at the HDT of 929 mg/kg/day. Thickening of the stomach mucosa (females), hyperplasia and hypertrophy of the mucosal epithelium, slight lymphoid hyperplasia of the gastric mucosa, and very slight/slight chronic mucosal inflammation were observed in dogs after chronic exposure at the HDT of 967 mg/kg/day. No adverse effects were observed in subchronic or chronic feeding studies in mice.
Stomach effects were also observed in a developmental toxicity study in rabbits conducted with the acid (XDE-750). Ulcers and erosions were seen in the glandular mucosa of the stomach at 500 mg/kg/day in maternal animals. Other effects noted were decreased body weights and incoordinated gait. No developmental effects were seen in fetuses at 500 mg/kg/day. The high dose group was removed from the study because of the severity of the clinical signs that were observed (incoordinated gait, significant body weight losses, and decreased food intake). In another developmental rabbit study conducted with the TIPA salt (GF-871), severe inanition (exhaustion from lack of food), body weight loss, decreased fecal output, and incoordinated gait were observed at 260 mg/kg/day. At 520 mg/kg/day, decreased fetal body weights were observed. No effects were noted in developmental toxicity studies in rats with XDE-750 or GF-871 or a reproduction study in rats with XDE-750. There was no qualitative or quantitative evidence of increased susceptibility of fetuses or offspring in any of the developmental and reproduction toxicity studies conducted with aminopyralid.
No systemic toxic effects were observed in a 28-day dermal toxicity study in rats with XDE-750; however, dermal toxicity was indicated by slight epidermal hyperplasia in males at 1,000 mg/kg/day.
In an acute neurotoxicity study in rats (XDE-750), fecal soiling in males and urine soiling in females were observed at 2,000 mg/kg/day. No adverse effects were observed in a chronic neurotoxicity study in rats up to 1,000 mg/kg/day.
Aminopyralid is classified as “not likely to be carcinogenic to humans.” No increase in any tumors was found in carcinogenicity studies in rats and mice. Aminopyralid was negative in all mutagenicity studies, except for an in vitro chromosome aberration assay in Sprague Dawley rats. In this assay, XDE-750 induced chromosome aberrations, but only at cytotoxic concentrations. The clastogenic response was induced secondarily to toxicity.
Specific information on the studies received and the nature of the adverse effects caused by aminopyralid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document “Aminopyralid. Human Health Risk Assessment for the Proposed Use on Field Corn (PP#8F7455)” at page 40 in docket ID number EPA-HQ-OPP-2009-0141.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a benchmark dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The Start Printed Page 17581aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the level of concern (LOC).
For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for aminopyralid used for human risk assessment can be found at http://www.regulations.gov in the document “Aminopyralid: Human Health Risk Assessment for the Proposed Use on Field Corn (PP#8F7455)” at page 20 in docket ID number EPA-HQ-OPP-2009-0141.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to aminopyralid, EPA considered exposure under the petitioned-for tolerances as well as all existing aminopyralid tolerances in 40 CFR 180.610. EPA assessed dietary exposures from aminopyralid in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for aminopyralid; therefore, a quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that residues are present in all commodities at the tolerance level and that 100% of commodities are treated with aminopyralid. The Dietary Exposure Evaluation Model (DEEM)(tm) 7.81 default concentration factors were used to estimate residues of aminopyralid in processed commodities.
iii. Cancer. Based on the results of carcinogenicity studies in rats and mice, EPA classified aminopyralid as “not likely to be carcinogenic to humans.” Therefore, an exposure assessment to evaluate cancer risk is unnecessary for this chemical.
iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for aminopyralid. Tolerance level residues and 100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for aminopyralid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of aminopyralid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of aminopyralid for chronic exposures for non-cancer assessments (the only dietary exposure scenario of concern for aminopyralid) are estimated to be 1.937 parts per billion (ppb) for surface water and 0.63 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 1.937 ppb was used to assess the contribution to drinking water.
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).
Aminopyralid is currently registered for the following uses that could result in residential exposures: Natural recreation areas, such as wildlife management areas, campgrounds, trailheads and trails. EPA assessed residential exposure using the following assumptions:
Aminopyralid is not applied by homeowners to residential or recreational settings; therefore, only post-application residential exposures were considered. A dermal endpoint of concern has not been identified for aminopyralid and postapplication inhalation exposure following treatment of recreation areas is expected to be negligible for adults and children. There is, however, the potential for short-term postapplication oral exposure of children playing in areas treated with aminopyralid. EPA assessed the following incidental oral exposure scenarios: Hand-to-mouth transfer of residues; object-to-mouth transfer of residues; and ingestion of soil containing aminopyralid residues.
4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
EPA has not found aminopyralid to share a common mechanism of toxicity with any other substances, and aminopyralid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that aminopyralid 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 EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factors (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for aminopyralid includes harmonized guideline rat and rabbit developmental toxicity studies for both the acid and TIPA salt of aminopyralid and a two-generation reproduction toxicity study in rats conducted using aminopyralid acid. As discussed in Unit III.A (Toxicological Profile), there is no Start Printed Page 17582quantitative or qualitative evidence of increased susceptibility of fetuses or offspring in any of these studies.
3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:
i. The toxicity database for aminopyralid is adequate to assess pre- and postnatal toxicity. In accordance with 40 CFR part 158 Toxicology Data requirements, an immunotoxicity study (guideline 870.7800) is required for aminopyralid. In the absence of specific immunotoxicity studies, EPA has evaluated the available aminopyralid data to determine whether an additional uncertainty factor is needed to account for potential immunotoxicity. The toxicology database for aminopyralid does not show any evidence of treatment-related effects on the immune system. The overall weight-of-evidence suggests that this chemical does not directly target the immune system, and the Agency does not believe that conducting a functional immunotoxicity study will result in a lower POD than that currently used for overall risk assessment. Therefore, a database uncertainty factor (UFDB) is not needed to account for the lack of this study.
ii. No evidence of neurotoxicity was observed in acute or chronic neurotoxicity studies. Incoordinated gait, along with a lack of ambulatory movement, was observed in developmental toxicity studies (XDE-750 and GF-871) in rabbits at 500 mg/kg/day. However, the incoordination was transient (complete resolution within 2 hours postdosing) and considered to be a result of frank toxicity, rather than a neurotoxic event. Additionally, no signs of neurotoxicity were observed in other toxicity studies, and no evidence of quantitative or qualitative susceptibility was observed in developmental toxicity studies in rats or rabbits or a reproduction study in rats. Based on these findings, EPA has concluded that there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that aminopyralid results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or offspring in the 2-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to aminopyralid in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by aminopyralid.
E. Aggregate Risks and Determination of Safety
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 product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, aminopyralid is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to aminopyralid from food and water will utilize <1% of the cPAD for the general U.S. population and all population subgroups, including children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of aminopyralid is not expected.
3. Short-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). Aminopyralid is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to aminopyralid.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures aggregated result in aggregate MOEs of between 25,000 and 33,000 for children's population subgroups. The aggregate MOEs include dietary exposures from food and drinking water as well as postapplication incidental oral exposure of children and toddlers playing in recreational areas treated with aminopyralid. Although short-term residential postapplication exposure of adults could result from the use of aminopyralid, inhalation exposures are expected to be negligible and a dermal endpoint of concern has not been identified for aminopyralid. Therefore, the short-term aggregate risk for adults is the sum of the risk from exposure to aminopyralid through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.
4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Aminopyralid is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to aminopyralid through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.
5. Aggregate cancer risk for U.S. population. Based on a lack of evidence for carcinogenicity in mice and rats following long-term dietary administration, aminopyralid is not expected to pose a cancer risk.
6. 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 aminopyralid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS), Method GRM 07.07, is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: email@example.com.Start Printed Page 17583
B. International Residue Limits
No Codex, Canadian or Mexican MRLs have been established for corn commodities.
C. Response to Comments
EPA received comments from an anonymous submitter objecting to pesticides and other “toxic” chemicals generally and recommending against any tolerances greater than zero for this product. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned completely. However, the existing legal framework provided by section 408 of the FFDCA contemplates that tolerances greater than zero may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This submitter's comments appear to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.
D. Revisions to Petitioned-For Tolerances
EPA has revised the commodity terms “corn, forage,” “corn, grain,” and “corn, stover,” to read “corn, field, forage,” “corn, field, grain,” and “corn, field, stover” to agree with the Agency's Food and Feed Commodity Vocabulary.
EPA is also revising the tolerance expression for existing tolerances and the new tolerances on corn commodities to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be measured. Plant tolerances are currently expressed in terms of “free and conjugated residues of the herbicide aminopyralid, 2-pyridine carboxylic acid, 4-amino-3,6-dichloro-, calculated as aminopyralid.” Livestock tolerances are currently expressed in terms of “residues of the herbicide aminopyralid.” The tolerance expression for plants is being revised to make clear that the tolerances cover residues of aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, including its metabolites and degradates. Compliance with the tolerances is to be determined by measuring only free and conjugated aminopyralid. Similarly, the tolerance expression for livestock commodities is being revised to clarify that the tolerances cover residues of aminopyralid, including its metabolites and degradates, but that compliance with the tolerance levels will be determined by measuring only aminopyralid.
EPA has determined that it is reasonable to make these changes final without prior proposal and opportunity for comment, because public comment is not necessary, in that the changes have no substantive effect on the tolerances, but rather are merely intended to clarify the existing tolerance expressions.
Therefore, tolerances are established for residues of aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, including its metabolites and degradates, in or on corn, field, forage at 0.30 ppm; corn, field, grain at 0.20 ppm; and corn, field, stover at 0.20 ppm. Compliance with these tolerance levels is to be determined by measuring only free and conjugated aminopyralid.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
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 General 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).Start List of Subjects
List of Subjects in 40 CFR Part 180
- Environmental protection
- Administrative practice and procedure
- Agricultural commodities
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: March 26, 2010.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:End Amendment Part Start Part Start Printed Page 17584
PART 180—[AMENDED]End Part Start Amendment Part
1. The authority citation for part 180 continues to read as follows:End Amendment Part Start Amendment Part
2. Section 180.610 is amended by revising the introductory text in paragraphs (a)(1) and (a)(2) and alphabetically adding commodities to the table in paragraph (a)(1) to read as follows:End Amendment Part
(a) * * * (1) Tolerances are established for residues of the herbicide aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only free and conjugated aminopyralid.
|Commodity||Parts per million|
|Corn, field, forage||0.30|
|Corn, field, grain||0.20|
|Corn, field, stover||0.20|
|* * * * *|
(2) Tolerances are established for residues of the herbicide aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only aminopyralid.End Supplemental Information
[FR Doc. 2010-7749 Filed 4-6-10; 8:45 am]
BILLING CODE 6560-50-S