Dichlormid; Pesticide Tolerances

Federal Register, Volume 81 Issue 194 (Thursday, October 6, 2016)

Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)

Rules and Regulations

Pages 69401-69407

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2016-24214

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2016-0121; FRL-9951-90

Dichlormid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of dichlormid in or on all commodities for which there is a tolerance for metolachlor and S-metolachlor. Drexel Chemical Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 6, 2016. Objections and requests for hearings must be received on or before December 5, 2016, 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-2016-0121, 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: Michael Goodis, Acting Director, 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:

  1. General Information

    1. 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).

    2. How can I get electronic access to other related information?

      You may access a frequently updated electronic version of EPA's tolerance

      Page 69402

      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.

    3. 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-2016-0121 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 December 5, 2016. 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-2016-0121, 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.

  2. Summary of Petitioned-for Tolerance

    In the Federal Register of April 25, 2016 (81 FR 24044) (FRL-9944-

    86), 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 IN-10858) by Drexel Chemical Company, P.O. Box 13327, Memphis, TN 38113-03227. Although the notice announced the petition requested that 40 CFR 180.469 be amended by establishing tolerances for residues of the inert ingredient (safener) dichlormid, in or on all commodities for which there is a tolerance for metolachlor and S-metolachlor at 0.05 parts per million (ppm), the notice of filing submitted simply listed numerous commodities that were intended to correspond to the commodities for which metolachlor and s-metolachlor tolerances were established. That document referenced a summary of the petition prepared by Drexel Chemical Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    To ensure consistency between the notice of filing and the petition filed and to avoid any confusion, EPA requested that Drexel revise and resubmit their notice of filing to clarify that the request is to establish tolerances for residues of the inert ingredient (safener) dichlormid, in or on all commodities for which there is a tolerance for metolachlor and S-metolachlor at 0.05 ppm. Upon receiving that revised petition, EPA issued a notice of filing of that petition pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3) in the Federal Register of July 20, 2016 (81 FR 47150) (FRL-9948-45). The petition requested that 40 CFR 180.469 be amended by establishing tolerances for residues of the inert ingredient (safener) dichlormid, in or on all commodities for which there is a tolerance for metolachlor and S-metolachlor at 0.05 ppm. That revised petition prepared by Drexel Chemical Company, the registrant, is available in the docket, http://www.regulations.gov. There was one comment received in response to this notice of filing; however, the comment was not related to this chemical or petition and is therefore, not relevant to this action.

  3. 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 dichlormid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with dichlormid follows.

    1. 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 database for dichlormid has been previously reviewed by the Agency, most recently March 23, 2011 when the permanent tolerance for dichlormid was issued (76 FR 16308) (FRL-8866-2). No new data was reviewed as part of this petition for tolerance.

      Specific information on the studies received and the nature of the adverse effects caused by dichlormid as well as the no-observed-

      adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-

      level (LOAEL) from the toxicity studies are discussed in this unit.

      In acute toxicity studies, dichlormid exhibits low to moderate toxicity, depending on the route of exposure. The oral lethal dose (LD)50 for dichlormid in rats is 2,816 milligram/kilogram (mg/kg) in males and 2,146 mg/kg for females (Category III). The dermal LD50 of dichlormid in rats is greater than 2,000 mg/kg (Category III). The acute inhalation lethal concentration (LC)50 in rats is greater than 5.5 mg/(L) (Category IV). Dichlormid is mildly irritating to the skin of rabbits (Category IV) and severely irritating to the eyes of rabbits

      Page 69403

      (Category II). Dichlormid is a mild dermal sensitizer.

      The liver is the target organ in subchronic and chronic toxicity studies in rats and dogs. There are two 90-day rat toxicity studies are available. One older study (1972), was determined to be an unacceptable study. In the other study, toxicity was manifested as minor decreased in body weight gains and food efficiency in females and on increased liver weight and a slightly increased (not statistically significant) incidence of liver lipidosis in males. Similarly two 90-day toxicity studies in dogs are available. In the newer study, via capsules, decreased body weight gains, hematological and clinical chemistry alternations, liver toxicity and voluntary muscle pathological changes were observed. In a 1-year toxicity study in the dogs, voluntary muscle fiber degeneration and slight to moderate vacuolation of the adrenal cortex was observed at 20 mg/kg/day. There was also increased in alkaline phosphatase activity in both sexes and decreased in aspartate aminotransferase activity in females. Liver weights (absolute and relative to body) were increased in both sexes.

      In a developmental toxicity study in rats, decreased mean absolute body weights, body weight gains, and food consumption was observed in maternal animals. Developmental toxicity in rats was manifested as marginal increased in skeletal anomalies in the presence of maternal toxicity. In the developmental toxicity study in rabbits, increased incidence of alopecia and decreased mean maternal body weight gains and food consumption was observed in maternal animals. The fetal effects in rabbits, exhibited in the presence of maternal toxicity, were manifested as increases in post-implantation loss accompanied by an increase number of resorptions/doe (both early and late resorptions), decreased number of live/fetuses/litter, and slightly decreased mean fetal body weights. In a 2-generation reproduction study in rats, no treatment related effects on reproductive parameters were observed. Minimal increased liver weight, minimal decreased weight gain and minimal decreased in food consumption was observed in parental animals. Increased liver weights were observed in the offspring.

      No increased incidences of treatment related tumors were observed in mice and rats. In the carcinogenicity study in mice, kidney changes and changes in reproductive organs were observed, while rats exhibited decreased body weights and liver toxicity. Mutagenic potential for dichlormid was evaluated in an adequate battery of in vivo and in vitro assays. A negative response was observed in these assays except in one in vitro assay (mouse lymphoma assay). However, the in vivo mouse micronucleus assay was negative.

      In an acute neurotoxicity study in rats, decreased body weight gains with lower food consumption was observed in both sexes. Functional observational battery (FOB) measurements at the time of peak effect (4 hrs post dose) showed decreased activity, hunching, increased touch response, lachrimation, piloerection, reduced splay reflex, and signs of salivation. These effects were deemed slight with a greater incidence in females. No treatment-related changes in bodyweight, food consumption, FOB, motor activity, brain weight, or neuropathology were identified in the 90-day neurotoxicity study in rats; however, the high dose of 750 ppm (equal to 55.4 mg/kg/day) was not considered as adequate for testing. No evidence of immunotoxicity was observed in a dietary immunotoxicity study in rats. There were no treatment related effects on spleen and thymus weights at any of the doses of dichlormid tested.

      Approximately 90% of the orally administered dose was absorbed in rats. Urinary excretion was the major route of elimination of orally administered dichlormid, consistently accounting for 60-78% of the administered dose over 48-168 hours following a single oral dose. Fecal excretion accounted for ~8-20% of a single oral dose. Approximately 70-

      77% of urinary excretion (representing 52-54% of the administered dose) occurred within 24 hours. No gender-related difference in rate or amount of urinary excretion was observed. No significant accumulation in the body was observed. Dichlormid was metabolized via two pathways:

      1. Initial dechlorination followed by formation of various chlorinated, water-soluble metabolites, and;

      2. Formation of various chlorinated metabolites.

      In a subchronic inhalation toxicity study in rats via whole body exposure for 6 hours a day, 5 days/week for 14 weeks, decreased body weights and increased liver weights were observed at the highest dose tested. The increased liver weights was considered as an adaptive response. Chromorhinorrhea, a respiratory system clinical observation based on the discharge of colored secretion from the nostrils, was exhibited consistently in the two top dose exposure groups. Microscopic pathology identified in the two top dose exposure groups, dose-

      dependent respiratory tract tissue alterations involving the olfactory epithelium for both genders.

    2. 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 no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). 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 the toxicological endpoints for dichlormid used for human health risk assessment are shown in Table 1 of this unit.

      Page 69404

      Table 1--Summary of Toxicological Dose and Endpoints for Dichlormid Use in Human Risk Assessment \1\

      ----------------------------------------------------------------------------------------------------------------

      FQPA SF and

      Exposure scenario Dose and factors endpoint for risk Study and toxicological effects

      assessment

      ----------------------------------------------------------------------------------------------------------------

      Acute Dietary, all populations NOAEL = 10 mg/kg.... FQPA SF = 1........ Developmental Toxicity Study--Rat

      including infants and children. UF = 100............ aPAD = acute RfD/ Maternal LOAEL = 40 mg/kg/day

      Acute RfD = 0.10 mg/ FQPA SF = 0.10 mg/ based on decreased body weight

      kg/day. kg/day. gain and food consumption (most

      significant on days 7-10 of

      dosing).

      Chronic Dietary, all populations. NOAEL = 5 mg/kg/day. FQPA SF = 1........ 1-year Study--Dog

      UF = 100............ cPAD = chr RfD/FQPA LOAEL = 20 mg/kg/day (male,

      Chronic RfD = 0.05 SF = 0.05 mg/kg/ female), based on increased liver

      mg/kg/day.. day.. weights, increased in alkaline

      phosphatase activity, minimal

      muscle fiber degeneration in,

      slight to moderate vacuolation of

      the inner cortex of the adrenal

      gland, and increased kidney

      weights (females).

      ----------------------------------------------------------------------------------------------------------------

      Dermal Absorption................ 100% default; neither a dermal absorption study nor a dermal toxicity study

      (for extrapolation) is available in the database.

      ----------------------------------------------------------------------------------------------------------------

      Short-term Dermal................ Oral NOAEL = 10.0 mg/ MOE = 100.......... Developmental toxicity Study--Rats

      kg/day. Maternal LOAEL = 40 mg/kg/day

      based on decreased body weight

      gain and food consumption (most

      significant on days 7-10 of

      dosing). This dose/endpoint/study

      was used for deriving the aRfD.

      Dermal toxicity study is not

      available. 100% dermal absorption

      factor should be used for this

      risk assessment.

      Intermediate- and Long-Term Oral NOAEL = 5 mg/kg/ MOE = 100.......... 1-year study--Dog

      (Dermal). day. LOAEL = 20 mg/kg/day (male,

      female), based on increased liver

      weights, increased in alkaline

      phosphatase activity, minimal

      muscle fiber degeneration in,

      slight to moderate vacuolation of

      the inner cortex of the adrenal

      gland, and increased kidney

      weights (females).

      Inhalation (All Durations)....... 2 mug/L........... MOE = 100.......... 14-week inhalation study

      LOAEL = 20 mug/L based on

      clinical signs, increased liver

      and kidney weights, gross

      pathology and non-neoplastic

      histopathology. The route of

      exposure in this study is

      appropriate for this risk

      assessment.

      Cancer........................... .................... ................... No evidence of carcinogenicity in

      rats and mice.

      ----------------------------------------------------------------------------------------------------------------

      \1\ UF = uncertainty factor; FQPA SF = FQPA Safety Factor; NOAEL = no observed adverse effect level; LOAEL =

      lowest observed adverse effect level; PAD = population adjusted dose (a = acute, c = chronic); RfD = reference

      dose; LOC = level of concern; MOE = margin of exposure.

    3. Exposure Assessment

      1. Dietary exposure from food and feed uses. In evaluating dietary exposure to dichlormid, EPA considered exposure under the petitioned-

        for tolerances as well as all existing dichlormid tolerances in 40 CFR 180.469. The assessment was conducted using the proposed tolerance of 0.05 ppm for those commodities for which there is a current tolerance for metolachlor and S-metolachlor as well as for all commodities to account for the potential dietary exposure that could result from dichlormid should additional tolerances be established for metolachlor and S-metolachlor. EPA assessed dietary exposures from dichlormid 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 dichlormid. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used tolerance level residues (i.e., 0.05 ppm) and 100% crop treated.

        ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 CSFII. As to residue levels in food, EPA used tolerance level residues (i.e., 0.05 ppm) and 100% crop treated.

        iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that dichlormid 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 dichlormid. Tolerance level residues (i.e., 0.05 ppm) and 100% CT were assumed for all food commodities.

      2. Dietary exposure from drinking water. For the current screening level dietary risk assessment, to support the request for expanded tolerances for dichlormid, a conservative drinking water concentration value of 100 parts per billions (ppb), based on screening level modeling, was used to account for the contribution of the additional commodities to drinking water for the chronic dietary risk assessments for the parent compound. These values were directly entered into the dietary exposure model.

      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). Dichlormid is not contained in any pesticide formulation registered for any specific use patterns that would result in residential exposure.

      4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether

        Page 69405

        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 dichlormid to share a common mechanism of toxicity with any other substances, and dichlormid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that dichlormid 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.

    4. 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 susceptibility of infants and children from in utero exposure to dichlormid based on developmental toxicity study in rats. In this study the developmental toxicity was manifested as marginal increased in skeletal anomalies (developmental toxicity NOAEL 40 mg/kg/day) at a one dose higher than the NOAEL for maternal toxicity (NOAEL 10 mg/kg/

        day). There is qualitative evidence of increased susceptibility demonstrated following in utero exposure in the prenatal developmental toxicity study in rabbits, since fetal effects observed (resorptions, decreased live fetuses per litter, and decreased fetal body weight) are considered to be more severe than those observed in maternal animals (increased alopecia, decreased body weight gain and food consumption). In this study the NOAEL for maternal and developmental toxicity is 30 mg/kg/day. There is no evidence increased susceptibility of infants and children from pre-and post-natal exposure to dichlormid in the two generation reproduction study. In this study, increased liver, weights, decreased body weight gain and decreased food consumption was observed in parental animals and increased liver weights in the offspring.

        There is no/low concern for increased qualitative susceptibility seen in the developmental toxicity study in rabbits because there is well characterized NOAEL for the developmental 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 dichlormid is complete. All part 158 data requirements are fulfilled. The dichlormid toxicity database included subchronic studies in rats and dogs, mutagenicity battery, carcinogenicity studies in mice and rats, developmental toxicity study in rats and rabbits, 2-generation reproduction study, acute and subchronic neurotoxicity study, immunotoxicity study, metabolism and repeat dose inhalation toxicity study.

        ii. There is no indication that dichlormid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity based on acute and subchronic neurotoxicity study.

        iii. There is no evidence that dichlormid results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. There was some evidence of increased qualitative susceptibility seen in the developmental toxicity study in rabbits, however, there is no residual uncertainty or concern because there is well characterized NOAEL for the developmental toxicity and regulatory end points are below the NOAEL for the developmental effects thus providing additional margin of safety.

        iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to dichlromid in drinking water. These assessments will not underestimate the exposure and risks posed by dichlromid.

    5. 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 dichlormid will occupy 26.2% of the aPAD for all infants (

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