97-8387. Propamocarb Hydrochloride; Pesticide Tolerance for Emergency Exemptions  

  • [Federal Register Volume 62, Number 63 (Wednesday, April 2, 1997)]
    [Rules and Regulations]
    [Pages 15615-15620]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-8387]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 180
    
    [OPP-300464; FRL-5597-2]
    RIN 2070-AC78
    
    
    Propamocarb Hydrochloride; Pesticide Tolerance for Emergency 
    Exemptions
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This regulation establishes time-limited tolerances for 
    residues of the fungicide propamocarb hydrochloride in or on the raw 
    agricultural commodities potatoes, milk; and meat, meat by-products, 
    and fat of cattle, goat, horse, sheep, and hogs in connection with 
    EPA's granting of emergency exemptions under section 18 of the Federal 
    Insecticide, Fungicide, and Rodenticide Act authorizing use of 
    propamocarb hydrochloride on potatoes in the states of California, and 
    Texas. This regulation establishes maximum permissible levels for 
    residues of propamocarb hydrochloride in these foods pursuant to 
    section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as 
    amended by the Food Quality Protection Act of 1996. The tolerances will 
    expire and be revoked by EPA on March 15, 1999.
    
    DATES: This regulation becomes effective April 2, 1997. Objections and 
    requests for hearings must be received by EPA on or before June 2, 
    1997.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number, [OPP-300464], must be submitted to: Hearing 
    Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
    SW., Washington, DC 20460. Fees accompanying objections and hearing 
    requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
    EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
    P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
    hearing requests filed with the Hearing Clerk identified by the 
    document control number, [OPP-300464], must also be submitted to: 
    Public Response and Program Resources Branch, Field Operations Division 
    (7506C), Office of Pesticide Programs, Environmental Protection Agency, 
    401 M St., SW., Washington, DC 20460.
        In person, bring a copy of objections and hearing requests to Rm. 
    1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA. A copy of 
    objections and hearing requests filed with the Hearing Clerk may also 
    be submitted electronically by sending electronic mail (e-mail) to: 
    opp-docket@epamail.epa.gov. Copies of objections and hearing requests 
    must be submitted as an ASCII file avoiding the use of special 
    characters and any form of encryption. Copies of objections and hearing 
    requests will also be accepted on disks in WordPerfect 5.1 file format 
    or ASCII file format. All copies of objections and hearing requests in 
    electronic form must be identified by the docket control number [OPP-
    300464]. No Confidential Business Information (CBI) should be submitted 
    through e-mail. Electronic copies of objections and hearing requests on 
    this rule may be filed online at many Federal Depository Libraries.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration 
    Division (7505W), Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460. Office location, telephone number, and e-mail: 
    Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway, 
    Arlington, VA 22202. (703) 308-8326, e-mail: 
    pemberton.libby@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
    section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
    (FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for 
    residues of propamocarb hydrochloride on potatoes at 0.5 parts per 
    million (ppm) and in milk; and meat, meat by-products, and fat of 
    cattle, goat, horse, sheep, and hogs at 0.1
    
    [[Page 15616]]
    
    ppm. These tolerances will expire on March 15, 1999.
    
    I. Background and Statutory Authority
    
        The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
    was signed into law August 3, 1996. FQPA amends both the Federal Food, 
    Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
    Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
    seq. The FQPA amendments went into effect immediately. Among other 
    things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
    activities under a new section 408 with a new safety standard and new 
    procedures. These activities are described below and discussed in 
    greater detail in the final rule establishing the time-limited 
    tolerance associated with the emergency exemption for use of 
    propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
        New section 408(b)(2)(A)(i) 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) 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, but does not include 
    occupational exposure. Section 408(b)(2)(C) 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. . . .''
        Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
    agency from any provision of FIFRA, if EPA determines that ``emergency 
    conditions exist which require such exemption.'' This provision was not 
    amended by FQPA. EPA has established regulations governing such 
    emergency exemptions in 40 CFR part 166. Section 408(l)(6) of the FFDCA 
    requires EPA to establish a time-limited tolerance or exemption from 
    the requirement for a tolerance for pesticide chemical residues in food 
    that will result from the use of a pesticide under an emergency 
    exemption granted by EPA under section 18 of FIFRA. Section 408(l)(6) 
    also requires EPA to promulgate regulations by August 3, 1997, 
    governing the establishment of tolerances and exemptions under section 
    408(l)(6) and requires that the regulations be consistent with section 
    408(b)(2) and (c)(2) and FIFRA section 18.
        Section 408(l)(6) allows EPA to establish tolerances or exemptions 
    from the requirement for a tolerance, in connection with EPA's granting 
    of FIFRA section 18 emergency exemptions, without providing notice or a 
    period for public comment. Thus, consistent with the need to act 
    expeditiously on requests for emergency exemptions under FIFRA, EPA can 
    establish such tolerances or exemptions under the authority of section 
    408(e) and (l)(6) without notice and comment rulemaking.
        In establishing section 18-related tolerances and exemptions during 
    this interim period before EPA issues the section 408(l)(6) procedural 
    regulation and before EPA makes its broad policy decisions concerning 
    the interpretation and implementation of the new section 408, EPA does 
    not intend to set precedents for the application of section 408 and the 
    new safety standard to other tolerances and exemptions. Rather, these 
    early section 18 tolerance and exemption decisions will be made on a 
    case-by-case basis and will not bind EPA as it proceeds with further 
    rulemaking and policy development. EPA intends to act on section 18-
    related tolerances and exemptions that clearly qualify under the new 
    law.
    
    II. Emergency Exemptions for Propamocarb Hydrochloride on Potatoes 
    and FFDCA Tolerances
    
        EPA has authorized use under FIFRA section 18 of propamocarb 
    hydrochloride on potatoes for control of late blight. Recent failures 
    to control late blight in potatoes as well as tomatoes with the 
    registered fungicides, have been caused almost exclusively by immigrant 
    strains of late blight (Phytophthora infestans), which are resistant to 
    the control of choice, metalaxyl. Before the immigrant strains of late 
    blight arrived, all of the strains in the U.S. were previously 
    controlled by treatment with metalaxyl. Presently, there are no 
    fungicides registered in the U.S. that will provide adequate control of 
    the immigrant strains of late blight. After having reviewed their 
    submission, EPA concurs that an emergency condition exists.
        As part of its assessment of these specific exemptions, EPA 
    assessed the potential risks presented by residues of propamocarb 
    hydrochloride on potatoes and milk; and meat, meat by-products, and fat 
    of cattle, goat, horse, sheep, and hogs. In doing so, EPA considered 
    the new safety standard in FFDCA section 408(b)(2), and EPA decided 
    that the necessary tolerances under FFDCA section 408(l)(6) would 
    clearly be consistent with the new safety standard and with FIFRA 
    section 18. These tolerances for residues of propamocarb hydrochloride 
    will permit the marketing of potatoes treated in accordance with the 
    provisions of the section 18 emergency exemptions and the marketing of 
    milk; and meat, meat by-products, and fat of cattle, goat, horse, 
    sheep, and hogs with secondary residues resulting from the feeding of 
    the feedstuffs of treated potatoes. Consistent with the need to move 
    quickly on these emergency exemptions in order to address an urgent 
    non-routine situation and to ensure that the resulting food is safe and 
    lawful, EPA is issuing these tolerances without notice and opportunity 
    for public comment under section 408(e) as provided in section 
    408(l)(6). Although these tolerances will expire and be revoked by EPA 
    on March 15, 1999, under FFDCA section 408(l)(5), residues of 
    propamocarb hydrochloride not in excess of the amount specified in 
    these tolerances remaining in or on potatoes and milk; and meat, meat 
    by-products, and fat of cattle, goat, horse, sheep, and hogs after that 
    date will not be unlawful, provided the pesticide is applied during the 
    term of, and in accordance with all the conditions of, the emergency 
    exemptions. EPA will take action to revoke these tolerances earlier if 
    any experience with, scientific data on, or other relevant information 
    on this pesticide indicates that the residues are not safe.
        EPA has not made any decisions about whether propamocarb 
    hydrochloride meets the requirements for registration under FIFRA 
    section 3 for use on potatoes or whether a permanent tolerance for 
    propamocarb hydrochloride for potatoes and milk; and meat, meat by-
    products, and fat of cattle, goat, horse, sheep, and hogs would be 
    appropriate. This action by EPA does not serve as a basis for 
    registration of propamocarb hydrochloride by a State for special local 
    needs under FIFRA section 24(c). Nor does this action serve as the 
    basis for any States other than California, Texas and States which are 
    subsequently granted specific exemptions for this use to use this 
    product on this crop under section 18 of FIFRA without following all 
    provisions of section 18 as identified in 40 CFR part 166. For 
    additional information regarding the emergency exemptions for 
    propamocarb hydrochloride, contact the
    
    [[Page 15617]]
    
    Agency's Registration Division at the address provided above.
    
    III. Risk Assessment and Statutory Findings
    
        EPA performs a number of analyses to determine the risks from 
    aggregate exposure to pesticide residues. First, EPA determines the 
    toxicity of pesticides based primarily on toxicological studies using 
    laboratory animals. These studies address many adverse health effects, 
    including (but not limited to) reproductive effects, developmental 
    toxicity, toxicity to the nervous system, and carcinogenicity. For many 
    of these studies, a dose response relationship can be determined, which 
    provides a dose that causes adverse effects (threshold effects) and 
    doses causing no observed effects (the ``no-observed effect level'' or 
    ``NOEL'').
        Once a study has been evaluated and the observed effects have been 
    determined to be threshold effects, EPA generally divides the NOEL from 
    the study with the lowest NOEL by an uncertainty factor (usually 100 or 
    more) to determine the Reference Dose (RfD). The RfD is a level at or 
    below which daily aggregate exposure over a lifetime will not pose 
    appreciable risks to human health. An uncertainty factor (sometimes 
    called a ``safety factor'') of 100 is commonly used since it is assumed 
    that people may be up to 10 times more sensitive to pesticides than the 
    test animals, and that one person or subgroup of the population (such 
    as infants and children) could be up to 10 times more sensitive to a 
    pesticide than another. In addition, EPA assesses the potential risks 
    to infants and children based on the weight of the evidence of the 
    toxicology studies and determines whether an additional uncertainty 
    factor is warranted. Thus, an aggregate daily exposure to a pesticide 
    residue at or below the RfD (expressed as 100% or less of the RfD) is 
    generally considered acceptable by EPA.
        Lifetime feeding studies in two species of laboratory animals are 
    conducted to screen pesticides for cancer effects. When evidence of 
    increased cancer is noted in these studies, the Agency conducts a 
    weight of the evidence review of all relevant toxicological data 
    including short-term and mutagenicity studies and structure activity 
    relationship. Once a pesticide has been classified as a potential human 
    carcinogen, different types of risk assessments (e.g., linear low dose 
    extrapolations or margin of exposure calculation based on the 
    appropriate NOEL) will be carried out based on the nature of the 
    carcinogenic response and the Agency's knowledge of its mode of action.
        In examining aggregate exposure, FFDCA section 408 requires that 
    EPA take into account available and reliable information concerning 
    exposure from the pesticide residue in the food in question, residues 
    in other foods for which there are tolerances, and other non-
    occupational exposures, such as where residues leach into groundwater 
    or surface water that is consumed as drinking water. Dietary exposure 
    to residues of a pesticide in a food commodity are estimated by 
    multiplying the average daily consumption of the food forms of that 
    commodity by the tolerance level or the anticipated pesticide residue 
    level. The Theoretical Maximum Residue Contribution (TMRC) is an 
    estimate of the level of residues consumed daily if each food item 
    contained pesticide residues equal to the tolerance. The TMRC is a 
    ``worst case'' estimate since it is based on the assumptions that food 
    contains pesticide residues at the tolerance level and that 100% of the 
    crop is treated by pesticides that have established tolerances. If the 
    TMRC exceeds the RfD or poses a lifetime cancer risk that is greater 
    than approximately one in a million, EPA attempts to derive a more 
    accurate exposure estimate for the pesticide by evaluating additional 
    types of information (anticipated residue data and/or percent of crop 
    treated data) which show, generally, that pesticide residues in most 
    foods when they are eaten are well below established tolerances.
    
    IV. Aggregate Risk Assessment and Determination of Safety
    
        Consistent with section 408(b)(2)(D), EPA has reviewed the 
    available scientific data and other relevant information in support of 
    these actions. Propamocarb hydrochloride is registered by EPA for turf 
    and ornamental use. EPA believes it has sufficient data to assess the 
    hazards of propamocarb hydrochloride and to make a determination on 
    aggregate exposure, consistent with section 408(b)(2), for the time-
    limited tolerances for residues of propamocarb hydrochloride on 
    potatoes at 0.5 parts per million (ppm) and in milk; and meat, meat by-
    products, and fat of cattle, goat, horse, sheep, and hogs at 0.1 ppm. 
    EPA's assessment of the dietary exposures and risks associated with 
    establishing these tolerances follows.
    
    A. Toxicological Profile
    
        1. Chronic toxicity. Based on the available chronic toxicity data, 
    EPA's Office of Pesticide Programs (OPP) has established the RfD for 
    propamocarb hydrochloride at 0.11 milligrams (mg)/kilograms (kg)/day. 
    The RfD was established based on a threshold LOEL (lowest observable 
    effect level) of 33.31 mg/kg/day in males and 33.27 mg/kg in females in 
    a 11-year dog feeding study. The LOEL was based on body weight gain 
    depression, decreased food efficiency and gastritis. An uncertainty 
    factor (UF) of 100 was used to account for both inter-species 
    extrapolation and intra-species variability. An additional UF of 3 was 
    used to account for the lack of a NOEL.
        2. Acute toxicity. Agency toxicologists have recommended that the 
    developmental NOEL of 150 mg/kg/day from the rabbit developmental 
    toxicity study be used for acute dietary risk calculations. The 
    developmental LOEL of 300 mg/kg/day is based on increased post-
    implantation loss (developmental) and decreased body weight gain 
    (maternal). The population of concern for this risk assessment is 
    females 13+ years old.
        3. Short-term non-dietary inhalation and dermal toxicity. OPP 
    recommends use of the developmental toxicity study in rabbits for 
    short- and intermediate term MOE calculations. The maternal NOEL was 
    150 mg/kg/day and the LOEL of 300 mg/kg/day was based on decreased body 
    weight gain during gestation days 6-18. The developmental NOEL was 150 
    mg/kg/day. The developmental LOEL of 300 mg/kg/day was based on 
    increased post-implantation loss.
        4. Carcinogenicity. Propamocarb hydrochloride is classified as a 
    ``Group D,'' not classifiable as to human carcinogenicity due to 
    inadequacy of the data. Dietary rodent studies conducted in 1983 in 
    Germany showed no evidence of carcinogenicity. The registrant is 
    currently conducting studies in accordance with U.S. protocols.
    
    B. Aggregate Exposure
    
        There are no established U.S. tolerances for propamocarb 
    hydrochloride, and there are no registered uses for propamocarb 
    hydrochloride on food or feed crops in the United States.
        For the purpose of assessing chronic dietary exposure from 
    propamocarb hydrochloride, EPA assumed tolerance level residues and 
    100% of crop treated for the proposed use of propamocarb hydrochloride. 
    These conservative assumptions result in overestimation of human 
    dietary exposures.
        In examining aggregate exposure, FQPA directs EPA to consider 
    available
    
    [[Page 15618]]
    
    information concerning exposures from the pesticide residue in food and 
    all other non-occupational exposures. The primary non-food sources of 
    exposure the Agency looks at include drinking water (whether from 
    groundwater or surface water), and exposure through pesticide use in 
    gardens, lawns, or buildings (residential and other indoor uses).
        Because the Agency lacks sufficient water-related exposure data to 
    complete a comprehensive drinking water risk assessment for many 
    pesticides, EPA has commenced and nearly completed a process to 
    identify a reasonable yet conservative bounding figure for the 
    potential contribution of water related exposure to the aggregate risk 
    posed by a pesticide. In developing the bounding figure, EPA estimated 
    residue levels in water for a number of specific pesticides using 
    various data sources. The Agency then applied the estimated residue 
    levels, in conjunction with appropriate toxicological endpoints (RfD's 
    or acute dietary NOEL's) and assumptions about body weight and 
    consumption, to calculate, for each pesticide, the increment of 
    aggregate risk contributed by consumption of contaminated water. While 
    EPA has not yet pinpointed the appropriate bounding figure for 
    consumption of contaminated water, the ranges the Agency is continuing 
    to examine are all below the level that would cause propamocarb 
    hydrochloride to exceed the RfD if the tolerances being considered in 
    this document were granted. The Agency has therefore concluded that the 
    potential exposures associated with propamocarb hydrochloride in water, 
    even at the higher levels the Agency is considering as a conservative 
    upper bound, would not prevent the Agency from determining that there 
    is a reasonable certainty of no harm if the tolerances are granted.
        Based on the available studies used in EPA's assessment of 
    environmental risk, propamocarb hydrochloride is relatively non-
    persistent and mobility varies as a function of soil texture and soil 
    reaction. There is no entry for propamocarb hydrochloride in the 
    ``Pesticides in Groundwater Data Base'' (EPA 734-12-92-001, September 
    1992). There is no established Maximum Concentration Level (MCL) for 
    residues of propamocarb hydrochloride in drinking water. No drinking 
    water health advisory levels have been established for propamocarb 
    hydrochloride.
        Propamocarb hydrochloride is registered for uses, such as lawn and 
    ornamental, that could result in non-occupational exposure and EPA 
    acknowledges that there may be short-, intermediate-, and long-term 
    non-occupational, non-dietary exposure scenarios. At this time, the 
    Agency has insufficient information to assess the potential risks from 
    such exposure. However, available data for propamocarb hydrochloride 
    indicate no evidence of toxicity by the dermal or inhalation routes.
        Section 408(b)(2)(D)(v) 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.'' The Agency believes that ``available 
    information'' in this context might include not only toxicity, 
    chemistry, and exposure data, but also scientific policies and 
    methodologies for understanding common mechanisms of toxicity and 
    conducting cumulative risk assessments. For most pesticides, although 
    the Agency has some information in its files that may turn out to be 
    helpful in eventually determining whether a pesticide shares a common 
    mechanism of toxicity with any other substances, EPA does not at this 
    time have the methodologies to resolve the complex scientific issues 
    concerning common mechanism of toxicity in a meaningful way. EPA has 
    begun a pilot process to study this issue further through the 
    examination of particular classes of pesticides. The Agency hopes that 
    the results of this pilot process will increase the Agency's scientific 
    understanding of this question such that EPA will be able to develop 
    and apply scientific principles for better determining which chemicals 
    have a common mechanism of toxicity and evaluating the cumulative 
    effects of such chemicals. The Agency anticipates, however, that even 
    as its understanding of the science of common mechanisms increases, 
    decisions on specific classes of chemicals will be heavily dependent on 
    chemical specific data, much of which may not be presently available.
        Although at present the Agency does not know how to apply the 
    information in its files concerning common mechanism issues to most 
    risk assessments, there are pesticides as to which the common mechanism 
    issues can be resolved. These pesticides include pesticides that are 
    toxicologically dissimilar to existing chemical substances (in which 
    case the Agency can conclude that it is unlikely that a pesticide 
    shares a common mechanism of activity with other substances) and 
    pesticides that produce a common toxic metabolite (in which case common 
    mechanism of activity will be assumed).
        EPA does not have, at this time, available data to determine 
    whether propamocarb hydrochloride has a common mechanism of toxicity 
    with other substances or how to include this pesticide in a cumulative 
    risk assessment. Unlike other pesticides for which EPA has followed a 
    cumulative risk approach based on a common mechanism of toxicity, 
    propamocarb hydrochloride does not appear to produce a toxic metabolite 
    produced by other substances. For the purposes of this tolerance 
    action, therefore, EPA has not assumed that propamocarb hydrochloride 
    has a common mechanism of toxicity with other subtances.
    
    C. Safety Determinations For U.S. Population
    
        Taking into account the completeness and reliability of the 
    toxicity data, EPA has concluded that dietary exposure to propamocarb 
    hydrochloride in food from published tolerances will utilize 2% of the 
    RfD for the U.S. population. A dietary (food only) MOE of greater than 
    118 would not be of Agency concern. A MOE of 30,000 was calculated.
        EPA does not believe exposure to propamocarb hydrochloride in 
    drinking water or from residential uses would raise the percent of RfD 
    utilized or lower the MOE, to such extent that there was not an 
    adequate margin of exposure. While EPA has not yet pinpointed the 
    appropriate bounding figure for consumption of contaminated water, the 
    ranges the Agency is continuing to examine are all below the level that 
    would cause propamocarb hydrochloride to exceed the RfD if the 
    tolerance being considered in this document were granted. The Agency 
    has therefore concluded that the potential exposures associated with 
    propamocarb hydrochloride in water, even at the higher levels the 
    Agency is considering as a conservative upper bound, would not prevent 
    the Agency from determining that there is a reasonable certainty of no 
    harm if the tolerance is granted. An appropriate bounding figure for 
    residential exposure is expected to be lower than for drinking water. 
    Therefore, EPA concludes that there is a reasonable certainty that no 
    harm will result from aggregate exposure to propamocarb hydrochloride 
    residues.
    
    D. Determination of Safety for Infants and Children.
    
        FFDCA section 408 provides that EPA shall apply an additional ten-
    fold
    
    [[Page 15619]]
    
    margin of exposure (safety) for infants and children in the case of 
    threshold effects to account for pre-and post-natal toxicity and the 
    completeness of the data base unless EPA determines that a different 
    margin of exposure (safety) will be safe for infants and children. 
    Margins of exposure (safety) are often referred to as uncertainty 
    (safety) factors. EPA believes that reliable data support using the 
    standard margin of exposure (usually 100x for combined inter- and 
    intra-species variability)) and not the additional ten-fold margin of 
    exposure when EPA has a complete data base under existing guidelines 
    and when the severity of the effect in infants or children or the 
    potency or unusual toxic properties of a compound do not raise concerns 
    regarding the adequacy of the standard margin of exposure. Based on 
    current toxicological data requirements, the data base for propamocarb 
    hydrochloride relative to pre- and post-natal toxicity is not complete.
        The pre- and post-natal toxicology data base for propamocarb is not 
    complete with respect to current toxicological data requirements. 
    Although two acceptable prenatal developmental toxicity studies (in 
    rats and rabbits) have been submitted to the Agency, the available rat 
    reproductive toxicity study is not adequate. The RfD Committee 
    considered it to be supplementary and not upgradeable based on the lack 
    of systemic toxicity at dose levels, which did not achieve the limit 
    dose, indicating inadequacy of the high dose for reproductive toxicity. 
    Thus conclusions concerning post-natal sensitivity cannot be made.
        In the developmental toxicity study in rabbits, the developmental 
    and maternal NOELs were both 150 mg/kg/day. The developmental and 
    maternal LOELs of 300 mg/kg/day were based on increased post-
    implantation loss (developmental) and decreased body weight gain 
    (maternal). The NOELs and LOELs occurred at the same doses for 
    developmental and maternal findings; there was no indication of pre-
    natal sensitivity for infants and children.
        In the developmental toxicity study in rats, the developmental NOEL 
    was 221 mg/kg/day and was below the maternal NOEL (740 mg/kg/day). The 
    developmental LOEL of 740 mg/kg/day was based on increased fetal death, 
    and an increased incidence of minor skeletal anomalies (incomplete 
    ossification of some vertebrae and sternebrae). The maternal NOEL was 
    740 mg/kg/day, based on increased maternal death, spastic gait and 
    decreased body weight at the LOEL of 2,210 mg/kg/day. These findings 
    indicate the possibility of increased prenatal sensitivity of fetuses 
    to in utero exposure to propamocarb. An additional uncertainty factor 
    of 10x for infants and children would be deemed appropriate for 
    propamocarb, based upon the lack of data to evaluate postnatal exposure 
    (due to the inadequate reproduction study) and based upon the increased 
    sensitivity to prenatal exposure (indicated by the rat developmental 
    study NOELs). However, considering the large dietary MOE calculated for 
    females 13+ years (MOE = 30,000), even if an additional ten-fold 
    uncertainty factor were applied, aggregate acute risk estimates would 
    not exceed the margin of exposure. Therefore, EPA concludes that this 
    tolerance will pose reasonable certainty of no harm to infants and 
    children.
        EPA has concluded that the percent of the RfD that will be utilized 
    by chronic dietary (food) exposure to residues of propamocarb 
    hydrochloride ranges from 2% for nursing infants (<1 year="" old)="" up="" to="" 7%="" for="" non-nursing="" infants=""><1 year="" old).="" however,="" this="" calculation="" assumes="" tolerance="" level="" residues="" for="" all="" commodities="" and="" is="" therefore="" an="" over-estimate="" of="" dietary="" risk.="" refinement="" of="" the="" dietary="" risk="" assessment="" by="" using="" anticipated="" residue="" data="" would="" reduce="" dietary="" exposure.="" the="" addition="" of="" potential="" exposure="" from="" propamocarb="" hydrochloride="" residues="" in="" drinking="" water="" is="" not="" expected="" to="" result="" in="" an="" exposure="" which="" would="" exceed="" the="" rfd.="" v.="" other="" considerations="" the="" metabolism="" of="" propamocarb="" hydrochloride="" in="" potatoes="" is="" adequately="" understood="" for="" the="" purposes="" of="" this="" tolerance.="" there="" are="" no="" codex="" maximum="" residue="" levels="" established="" for="" residues="" of="" propamocarb="" hydrochloride.="" the="" residue="" of="" concern,="" for="" the="" purposes="" of="" this="" tolerance,="" is="" propamocarb="" hydrochloride.="" the="" proposed="" enforcement="" method="" designated="" upsr="" 22/91="" (mrid="" no.="" 439840-04)="" submitted="" with="" petition="" 6f4707="" is="" adequate="" to="" support="" the="" proposed="" time-limited="" tolerances.="" the="" method="" has="" been="" adequately="" radiovalidated="" for="" recovery="" of="" parent="" compound;="" however,="" an="" independent="" laboratory="" validation="" has="" not="" been="" submitted.="" further="" the="" method="" has="" not="" undergone="" agency="" method="" validation.="" the="" method="" is="" available="" to="" anyone="" who="" is="" interested="" in="" pesticide="" residue="" enforcement="" from:="" by="" mail,="" calvin="" furlow,="" public="" response="" and="" program="" resources="" branch,="" field="" operations="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" crystal="" mall="" #2,="" rm.="" 1128,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va="" 22202,="" 703-305-5805.="" vi.="" conclusion="" therefore,="" tolerances="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" are="" established="" for="" residues="" of="" propamocarb="" hydrochloride="" in="" or="" on="" potatoes="" at="" 0.5="" parts="" per="" million="" (ppm)="" and="" in="" milk;="" and="" meat,="" meat="" by-products,="" and="" fat="" of="" cattle,="" goat,="" horse,="" sheep,="" and="" hogs="" at="" 0.1="" ppm.="" these="" tolerances="" will="" expire="" and="" be="" revoked="" by="" epa="" on="" march="" 15,="" 1999.="" vii.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" june="" 2,="" 1997,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" (including="" the="" revocation="" provision)="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" genuine="" and="" substantial="" issue="" of="" fact;="" there="" is="" a="" reasonable="" possibility="" that="" available="" evidence="" identified="" by="" the="" requestor="" would,="" if="" established,="" resolve="" one="" or="" more="" of="" such="" issues="" in="" favor="" of="" the="" requestor,="" taking="" into="" account="" [[page="" 15620]]="" uncontested="" claims="" or="" facts="" to="" the="" contrary;="" and="" resolution="" of="" the="" factual="" issues="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" confidential="" business="" information="" (cbi).="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" viii.="" public="" docket="" a="" record="" has="" been="" established="" for="" this="" rulemaking="" under="" docket="" number="" [opp-300464].="" a="" public="" version="" of="" this="" record,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 1132="" of="" the="" public="" response="" and="" program="" resources="" branch,="" field="" operations="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" the="" official="" record="" for="" this="" rulemaking,="" as="" well="" as="" the="" public="" version,="" as="" described="" above,="" is="" kept="" in="" paper="" form.="" accordingly,="" in="" the="" event="" there="" are="" objections="" and="" hearing="" requests,="" epa="" will="" transfer="" any="" copies="" of="" objections="" and="" hearing="" requests="" received="" electronically="" into="" printed,="" paper="" form="" as="" they="" are="" received="" and="" will="" place="" the="" paper="" copies="" in="" the="" official="" rulemaking="" record.="" the="" official="" rulemaking="" record="" is="" the="" paper="" record="" maintained="" at="" the="" address="" in="" ``addresses''="" at="" the="" beginning="" of="" this="" document.="" ix.="" regulatory="" assessment="" requirements="" under="" executive="" order="" 12866="" (58="" fr="" 51735,="" october="" 4,="" 1993),="" this="" action="" is="" not="" ``a="" significant="" regulatory="" action''="" and,="" since="" this="" action="" does="" not="" impose="" any="" information="" collection="" requirements="" as="" defined="" by="" the="" paperwork="" reduction="" act,="" 44="" u.s.c.="" 3501="" et="" seq.,="" it="" is="" not="" subject="" to="" review="" by="" the="" office="" of="" management="" and="" budget.="" this="" action="" does="" not="" impose="" any="" enforceable="" duty,="" or="" contain="" any="" ``unfunded="" mandates''="" as="" described="" in="" title="" ii="" of="" the="" unfunded="" mandates="" reform="" act="" of="" 1995="" (pub.="" l.="" 104-4),="" or="" require="" prior="" consultation="" as="" specified="" by="" executive="" order="" 12875="" (58="" fr="" 58093,="" october="" 28,="" 1993),="" entitled="" enhancing="" the="" intergovernmental="" partnership,="" or="" special="" consideration="" as="" required="" by="" executive="" order="" 12898="" (59="" fr="" 7629,="" february="" 16,="" 1994).="" because="" ffdca="" section="" 408(l)(6)="" permits="" establishment="" of="" this="" regulation="" without="" a="" notice="" of="" proposed="" rulemaking,="" the="" regulatory="" flexibility="" analysis="" requirements="" of="" the="" regulatory="" flexibility="" act,="" 5="" u.s.c.="" 604(a),="" do="" not="" apply.="" nonetheless,="" the="" agency="" has="" previously="" assessed="" whether="" establishing="" tolerances="" or="" exemptions="" from="" tolerances,="" raising="" tolerance="" levels,="" or="" expanding="" exemptions="" adversely="" impact="" small="" entities="" and="" concluded,="" as="" a="" generic="" matter,="" that="" there="" is="" no="" adverse="" impact="" (46="" fr="" 24950,="" may="" 4,="" 1981).="" under="" 5="" u.s.c.="" 801(a)(1)(a)="" of="" the="" administrative="" procedure="" act="" (apa)="" as="" amended="" by="" the="" small="" business="" regulatory="" enforcement="" fairness="" act="" of="" 1996="" (title="" ii="" of="" pub.="" l.="" 104-121,="" 110="" stat.="" 847),="" epa="" submitted="" 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="" general="" accounting="" office="" prior="" to="" publication="" of="" this="" rule="" in="" today's="" federal="" register.="" this="" rule="" is="" not="" a="" ``major="" rule''="" as="" defined="" by="" 5="" u.s.c.="" 804(2)="" of="" the="" apa="" as="" amended.="" 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="" 17,="" 1997.="" stephen="" l.="" johnson,="" director,="" registration="" division,="" office="" of="" pesticide="" programs.="" 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.="" 346a="" and="" 371.="" 2.="" by="" adding="" sec.="" 180.499="" to="" read="" as="" follows:="" sec.="" 180.499="" propamocarb="" hydrochloride,="" tolerances="" for="" residues.="" time-limited="" tolerances="" are="" established="" for="" residues="" of="" the="" fungicide="" propamocarb="" hydrochloride="" in="" connection="" with="" use="" of="" the="" pesticide="" under="" section="" 18="" emergency="" exemptions="" granted="" by="" epa.="" the="" tolerances="" are="" specified="" in="" the="" following="" table.="" the="" tolerances="" expire="" and="" will="" be="" revoked="" on="" the="" date="" specified="" in="" the="" table="" by="" epa.="" ------------------------------------------------------------------------="" expiration/="" commodity="" parts="" per="" million="" revocation="" date="" ------------------------------------------------------------------------="" potatoes="" 0.5="" march="" 15,="" 1999="" cattle,="" fat="" 0.1="" march="" 15,="" 1999="" cattle,="" meat="" 0.1="" march="" 15,="" 1999="" cattle,="" mbyp="" (except="" kidney="" and="" 0.1="" march="" 15,="" 1999="" liver)="" goats,="" fat="" 0.1="" march="" 15,="" 1999="" goats,="" meat="" 0.1="" march="" 15,="" 1999="" goats,="" mbyp="" (except="" kidney="" and="" 0.1="" march="" 15,="" 1999="" liver)="" hogs,="" fat="" 0.1="" march="" 15,="" 1999="" hogs,="" meat="" 0.1="" march="" 15,="" 1999="" hogs,="" mbyp="" (except="" kidney="" and="" 0.1="" march="" 15,="" 1999="" liver)="" horse,="" fat="" 0.1="" march="" 15,="" 1999="" horse,="" meat="" 0.1="" march="" 15,="" 1999="" horse,="" mbyp="" (except="" kidney="" and="" 0.1="" march="" 15,="" 1999="" liver)="" sheep,="" fat="" 0.1="" march="" 15,="" 1999="" sheep,="" meat="" 0.1="" march="" 15,="" 1999="" sheep,="" mbyp="" (except="" kidney="" and="" 0.1="" march="" 15,="" 1999="" liver)="" milk="" 0.1="" march="" 15,="" 1999="" ------------------------------------------------------------------------="" [fr="" doc.="" 97-8387="" filed="" 4-1-97;="" 8:45="" am]="" billing="" code="" 6560-50-f="">

Document Information

Effective Date:
4/2/1997
Published:
04/02/1997
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-8387
Dates:
This regulation becomes effective April 2, 1997. Objections and requests for hearings must be received by EPA on or before June 2, 1997.
Pages:
15615-15620 (6 pages)
Docket Numbers:
OPP-300464, FRL-5597-2
RINs:
2070-AC78: Guidance on Environmentally Preferable Purchasing for Federal Agencies
RIN Links:
https://www.federalregister.gov/regulations/2070-AC78/guidance-on-environmentally-preferable-purchasing-for-federal-agencies
PDF File:
97-8387.pdf
CFR: (1)
40 CFR 180.499