Propamocarb; Pesticide Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes a tolerance for residues of propamocarb in or on potato. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective February 7, 2017. Objections and requests for hearings must be received on or before April 10, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0083, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY 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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

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 site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 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-2016-0083 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 10, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

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 (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0083, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

In the Federal Register of October 27, 2016 (81 FR 74753) (FRL-9954-27), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F8430) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.499 be amended by increasing the tolerance for residues of the fungicide propamocarb hydrochloride, in or on potato from 0.06 to 0.30 parts per million (ppm). That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received concerning this action for propamocarb in response to the notice of filing.

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 FFDCA section 408(b)(2)(D), and 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 for propamocarb-HCl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with propamocarb-HCl 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.

Propamocarb-HCl is a List C carbamate fungicide with specific activity against numerous Oomycete species, which cause foliar diseases and seedling, seed, root, foot, and stem rot in various edible and ornamental crops.

Consistent with other carbamates, propamocarb-HCl's database showed evidence of neurotoxicity in rats, though it does not inhibit cholinesterase. Neurotoxic effects include decreased motor activity following acute exposure and vacuolization of the choroid plexus (ventricles of the brain which produce cerebral spinal fluid) following subchronic and chronic durations. Other effects observed are indicative of toxicity to the digestive and GI tracts in dogs (chronic erosive gastritis, vacuolization of the salivary gland and stomach), and the eye in dogs and rats (hyporeflectability of the fundus, retinal degeneration, and vacuolization of the retinal gland). In all species, decreases in body weights, body-weight gains, and food consumption were observed following subchronic and chronic exposure. Available immunotoxicity data does not indicate an immunotoxic effect from exposure to propamocarb.

Effects in the route-specific dermal and inhalation studies were primarily portal-of-entry effects. Dermal exposure caused dermal irritation in rats and rabbits at relatively high doses (>500 milligram/kilogram/day (mg/kg/day)). Inhalation exposure caused labored breathing and the appearance of red material around the nose. Systemic effects were observed following inhalation exposure at similar doses that caused portal-of-entry effects and included kidney cysts and changes in hematological parameters.

Effects were observed in fetuses and offspring in the database at the same doses that elicited less severe effects in parental animals. In the developmental rat study, fetal effects included increased death, increased incidences of minor skeletal anomalies, increased incidences of small fetus, inter-atrial septal defects, and hemorrhage in the ears, upper GI tract, and nasopharynx/sinuses. Maternal effects consisted of decreased absolute body-weights, decreased food consumption, post-implantation loss, and mortality. In the rat two-generation reproduction study, offspring effects consisted of deaths, decreased weights, and decreased viability and lactation indices and litter size. Parental effects were consistent with those previously described for adults in the hazard database. Reproductive effects consisted of increased vacuolization and decreased weight of the epididymides, decreased sperm counts and motility, and abnormal sperm morphology.

Propamocarb-HCl was categorized as having low acute toxicity via the oral, dermal, and inhalation routes (Toxicity Categories III-IV). It is not a dermal irritant or a dermal sensitizer. It is considered a slight eye irritant.

EPA classified propamocarb-HCl as “not likely to be carcinogenic to humans” by all routes of exposure based upon lack of evidence of carcinogenicity in rats and mice.

Specific information on the studies received and the nature of the adverse effects caused by propamocarb-HCl 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 document, “Propamocarb Hydrochloride (propamocarb-HCl): Human Health Assessment for Registration Review and a Petition for Increasing the Permanent Tolerance for Residues in/on Potato” at pp. 16-18 in docket ID number EPA-HQ-OPP-2016-0083.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). 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 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 toxicological endpoints for propamocarb-HCl used for human-health risk assessment is shown in Table 1 of this unit.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to propamocarb, EPA considered exposure under the petitioned-for tolerances as well as all existing propamocarb tolerances in 40 CFR 180.499. EPA assessed dietary exposures from propamocarb 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. Such effects were identified for propamocarb. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA used tolerance-level residues and assumed 100% crop treated (PCT) for all commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA used tolerance-level residues and assumed 100 PCT for all commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that propamocarb does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for propamocarb. Tolerance level residues and/or 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 propamocarb in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of propamocarb. 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.

The revised estimated drinking water concentrations (EDWCs) are those modeled for surface waters based on current labels and newly submitted fate and transport data for the registration review of propamocarb-HCl. All currently labeled uses were assessed including the potato tolerance increase described in this action.

Surface water values were obtained from FLnurserySTD_V2 model for the acute value, and NJnurserySTD_V2 model for the chronic values representing foliar application to ornamentals in nurseries. Ground Water acute and chronic values were obtained from FLCITRUS_STD.SCN GW scenario.

The EDWCs of propamocarb for acute exposures are 4,860 parts per billion (ppb) for surface water, and 73 ppb for ground water. The EDWCs of propamocarb for chronic exposure for non-cancer assessments are 385 ppb for surface water, and 70 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 4,860 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 385 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). Propamocarb is registered for use on golf course turf, which may result in dermal post-application exposures. Although potential dermal post-application exposures were previously assessed (K. Lowe, 05/15/2013, D377624), EPA no longer considers the effects found in the dermal study to be adverse and therefore, no longer identifies a dermal hazard. As a result, there is no need to conduct a quantitative residential exposure assessment.

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 propamocarb to share a common mechanism of toxicity with any other substances, and propamocarb does not appear to produce a toxic metabolite produced by other substances. Although a carbamate, propamocarb-HCl is not an N-methyl carbamate and does not cause cholinesterase inhibition. Thus, it was not included in the N-methyl carbamate cumulative risk assessment. For the purposes of this tolerance action, therefore, EPA has assumed that propamocarb 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 Web site 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 Factor (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. There is no evidence of increased quantitative pre- or post-natal susceptibility following exposure to propamocarb-HCl. There is evidence of increased qualitative susceptibility in the database; however, concern for these effects is low because: (1) The effects are well characterized, (2) clear NOAELs were established, (3) the endpoints selected are protective of these effects, and (4) the effects were seen in the presence of maternal/parental toxicity.

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 propamocarb is complete.

ii. Although there was evidence of neurotoxicity (decreased motor activity and vacuolization of the choroid plexus) in several studies following propamocarb-HCl exposure, including the ACN and SCN studies; there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity because the neurotoxicity effects are well-characterized with clear NOAEL/LOAEL values and the selected endpoints are protective of the observed effects.

iii. Although there is evidence of increased qualitative susceptibility from exposure to propamocarb, there is no need to retain the 10X FQPA SF because: (1) The effects are well characterized; (2) clear NOAELs were established; (3) the endpoints selected are protective of these effects; and (4) the effects were seen in the presence of maternal/parental toxicity.

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 propamocarb in drinking water. These assessments will not underestimate the exposure and risks posed by propamocarb.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to propamocarb will occupy 21% of the aPAD for females (13-49 years old) and 42% of the aPAD for infants (<1 year old), 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 propamocarb from food and water will utilize 26% of the cPAD for children (3-5 years old) the population group receiving the greatest exposure. There are no chronic or long-term residential exposures from uses of propamocarb.

3. Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no short-term or intermediate-term adverse effect was identified, propamocarb is not expected to pose a short-term or intermediate-term risk.

IV. Other Considerations

A. Analytical Enforcement Methodology

A gas chromatography/nitrogen-phosphorus detection (GC/NPD) method is available for the enforcement of residues of propamocarb in plant commodities. This method has undergone a successful independent laboratory validation (ILV) and petition method validation (PMV), and is currently listed in the Pesticide Analytical Manual (PAM) Vol. II. An adequate liquid chromatography with tandem mass spectrometry (LC/MS/MS) for the enforcement of residues of propamocarb and its metabolites in livestock commodities has been submitted to the Agency. This method has undergone successful ILVs and a PMV. The results of a Food and Drug Administration (FDA) multiresidue testing study indicate that propamocarb and its metabolites are not recovered by any of the protocols. The recoveries of propamocarb with the QuEChERS multiresidue method are marginally adequate (68-69%; http://www.crl-pesticides.eu/library/docs/fv/CRLFV_Multiresidue_methods.pdf ).

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has established a MRL for propamocarb in or on potato at 0.30 ppm. This MRL is the same as the tolerance established for propamocarb in the United States.

V. Conclusion

Therefore, a tolerance is established for residues of propamocarb in or on potato at 0.30 ppm.

VI. Statutory and Executive Order Reviews

This action establishes a tolerance under FFDCA section 408(d) 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 action has been exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests
• Reporting and recordkeeping requirements

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

2. In § 180.499, revise the entry for “Potato” in the table in paragraph (a) to read as follows: