81_FR_71834 81 FR 71633 - Metaldehyde; Pesticide Tolerances

81 FR 71633 - Metaldehyde; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 201 (October 18, 2016)

Page Range71633-71638
FR Document2016-25166

This regulation establishes tolerances with regional registration for residues of metaldehyde in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 81 Issue 201 (Tuesday, October 18, 2016)
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Rules and Regulations]
[Pages 71633-71638]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25166]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0558; FRL-9951-78]


Metaldehyde; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances with regional 
registration for residues of metaldehyde in or on multiple commodities 
which are identified and discussed later in this document. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 18, 2016. Objections and 
requests for hearings must be received on or before December 19, 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-2015-0558, 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: [email protected].

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.

[[Page 71634]]

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-2015-0558 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 19, 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-2015-0558, 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 Wednesday, September 9, 2015 (80 FR 
54257) (FRL-9933-26), 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 5E8377) by Interregional Research Project Number 4 (IR-4), 
IR-4 Headquarters, 500 College Road East, Suite 201 W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.523 be amended by 
establishing tolerances for residues of the molluscicide metaldehyde, 
2,4,6,8-tetramethyl-1,3,5,7-tetroxocane, in or on beet, garden, roots 
at 0.05 parts per million (ppm); beet, garden, tops at 0.08 ppm; hop, 
dried cones at 0.05 ppm; rutabaga, roots at 0.05 ppm; turnip, greens 
(tops) at 0.08 ppm; turnip, roots at 0.05 ppm; wheat, forage at 0.05 
ppm; wheat, grain at 0.05 ppm; wheat, hay at 0.05 ppm and wheat, straw 
at 0.05 ppm. That document referenced a summary of the petition 
prepared by Lonza, Inc., the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has made 
certain modifications to the petitioned-for crop tolerances. The reason 
for these changes are explained in Unit IV.C.

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

A. Toxicological Profile

    EPA has evaluated the available toxicity database 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 toxicity profile of metaldehyde shows that the principal toxic 
effects are clinical signs of neurotoxicity. The dog is the most 
sensitive species for the neurotoxic effects. The nervous system 
effects observed in subchronic and chronic oral toxicity studies 
include: (1) Neurotoxic signs, i.e., ataxia; tremor; twitching; 
salivation; emesis; and rapid respiration in dogs and maternal rats; 
and (2) neuropathology, i.e., limb paralysis, spinal cord necrosis, and 
hemorrhage in maternal rats.
    The liver is a target organ following subchronic and chronic oral 
exposure to metaldehyde as evidenced by increased liver weight, 
increased incidence of liver lesions, i.e., hepatocellular necrosis, 
hepatocellular hypertrophy, inflammation, and an increased incidence of 
hepatocellular adenomas/carcinomas in female rats and hepatocellular 
adenomas in both sexes of mice. The testes and prostate are also target 
organs following subchronic and chronic exposure as evidenced by 
atrophy of both organs in dogs.
    Developmental toxicity was not observed in the rat or rabbit 
developmental toxicity studies. Maternal toxicity was not observed in 
the rabbit, although maternal toxicity was observed in the rat, as 
evidenced by clinical signs including ataxia, tremors, and twitching at 
the highest dose tested (HDT). In the rat reproductive toxicity study, 
mortality and clinical signs, i.e., limb paralysis, spinal cord 
necrosis and hemorrhage were observed in the maternal animals, and the 
effects on the offspring consisted of decreased pup body weight and 
body weight gains. Reproductive toxicity was not observed.
    In chronic feeding studies in mice and rats, benign liver tumors 
were seen in both sexes of mice and in female rats. The Agency has 
determined that quantification of risk using a non-linear Reference 
Dose (RfD) approach for metaldehyde will adequately account for all 
chronic toxicity, including carcinogenicity, that could result from 
exposure to metaldehyde. That conclusion is based on the following 
considerations: (1) The tumors found are commonly seen in the mouse; 
(2) the liver tumors (adenomas) in both species were benign; (3) 
metaldehyde is not mutagenic; (4) no carcinogenic response was seen in 
the male rat; (5) incidence of adenomas at the high-dose in the

[[Page 71635]]

female rat was within the historical control range of the testing lab; 
and (6) both the no-observed-adverse-effect-level (NOAEL) and the 
lowest-observed-adverse-effect-level (LOAEL) from the chronic rat study 
on which the chronic RfD/population-adjusted dose (PAD) was based are 
well below the dose at which adenomas were seen.
    Specific information on the studies received and the nature of the 
adverse effects caused by metaldehyde as well as the NOAEL and the 
LOAEL from the toxicity studies can be found at http://www.regulations.gov in document ``Metaldehyde; Human Health Risk 
Assessment for Proposed New Uses on Garden Beets, Hops, Rutabaga, 
Turnips and Wheat with Regional Registration in the Pacific 
Northwest,'' in docket ID number EPA- HQ-OPP-2015-0558.

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 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 PAD or a 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for metaldehyde used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of November 27, 2013 (78 FR 70864) 
(FRL-9388-8).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to metaldehyde, EPA considered exposure under the petitioned-
for tolerances as well as all existing metaldehyde tolerances in 40 CFR 
180.523. EPA assessed dietary exposures from metaldehyde 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 metaldehyde. In estimating acute 
dietary exposure, EPA used the Dietary Exposure Evaluation Model 
software with the Food Commodity Intake Database (DEEM-FCID), Version 
3.16, which incorporates 2003-2008 food consumption data from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA assumed tolerance-level residues for all 
commodities and 100 percent crop treated (PCT). In addition, the Agency 
assumed processing factors to be 1.0 for all commodities except for 
tomato, dried; tomato, juice; cranberry, juice; and high fructose corn 
syrup; for these commodities, DEEM default processing factors were 
used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID, Version 3.16, which incorporates 
2003-2008 food consumption data from the USDA's, NHANES/WWEIA. As to 
residue levels in food, EPA assumed tolerance-level residues for all 
commodities and 100 PCT. Processing factors were assumed to be 1.0 for 
all commodities except for tomato, dried; tomato, juice; cranberry, 
juice; and high fructose corn syrup; for these commodities, DEEM 
default processing factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA 
concluded that quantification of risk using a non-linear RfD approach 
will adequately account for all chronic toxicity, including 
carcinogenicity. Therefore, a dietary exposure assessment for the 
purpose of assessing cancer risk was not conducted.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
metaldehyde. Tolerance-level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water.
    The Agency used screening level water exposure models in the 
dietary exposure analysis and risk assessment for metaldehyde in 
drinking water. These simulation models take into account data on the 
physical, chemical, and fate/transport characteristics of metaldehyde. 
Further information regarding EPA drinking water models used in 
pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of metaldehyde 
for acute exposures are estimated to be 205 parts per billion (ppb) for 
surface water and 1880 ppb for ground water. Chronic exposures for non-
cancer assessments are estimated to be 136 ppb for surface water and 
915 ppb for ground water.
    For acute dietary risk assessment, the full distribution of ground 
water concentrations from the PRZM-GW model was used to assess the 
contribution from drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 915 ppb was used to assess the contribution from 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).
    Metaldehyde is currently registered for the following uses that 
could result in residential exposures: Residential ornamentals and 
lawn/turf applications. EPA assessed residential exposure using the 
following assumptions and exposure factors: For adult residential 
handlers, EPA conducted a short-term exposure assessment of metaldehyde 
for adults based on the inhalation route, incorporating the maximum 
labeled application rate, and unit exposure values and estimates for 
area treated/amount handled taken from the 2012 Residential Standard 
Operating Procedures (SOPs). The scenario resulting in the highest 
adult exposure in a residential setting was hand dispersal of granules, 
which was used in the short-term aggregate assessment. Additional 
scenarios assessed included; loading and applying distinct metaldehyde 
product types, i.e., liquid ready-to-use products applied manually via 
pressurized hand wands, hose-end sprayers, and sprinkler cans, as well 
as

[[Page 71636]]

applying granular products via push-type rotary spreaders, belly 
grinders, spoons, cups, hands, and shaker cans.
    For children, the highest estimated metaldehyde exposure resulted 
from post-application incidental oral exposures of short-term duration 
from hand-to-mouth and object-to-mouth contact with treated turf, and 
short- and intermediate-term exposures from treated soil. Further 
information regarding EPA standard assumptions and generic inputs for 
residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 metaldehyde to share a common mechanism of 
toxicity with any other substances, and metaldehyde does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
metaldehyde 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 FQPA Safety 
Factor (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. Developmental toxicity was 
not observed in the rat or rabbit developmental toxicity studies and no 
maternal toxicity observed in the rabbit. Maternal toxicity was 
observed in the rat, as evidenced by clinical signs, i.e., ataxia, 
tremors, and twitching, however these effects were observed only at the 
highest dose tested. In the rat reproductive toxicity study, mortality 
and clinical signs, i.e., limb paralysis, spinal cord necrosis and 
hemorrhage were observed in the maternal animals, and the effects on 
the offspring consisted of decreased pup body weight and body weight 
gains. Reproductive toxicity was not observed.
    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 metaldehyde is complete;
    ii. Although there are indications of neurotoxicity from exposure 
to metaldehyde, there are clear NOAELs/LOAELS for these effects, and 
Points of Departure selected for risk assessment are protective for 
these effects. EPA has determined that the acute and developmental 
neurotoxicity studies are not needed, nor are additional uncertainty 
factors (UFs) necessary to account for neurotoxicity. There were no 
indications of neurotoxic effects in developing rats or rabbits in 
either the developmental or reproductive studies. Although there were 
some effects in adult rats, those effects occurred at doses much higher 
than in the dog study. The dog is the more sensitive species for 
neurotoxic effects and points of departure (30 mg/kg/day and 10 mg/kg/
day) are based on the chronic dog oral toxicity study, which EPA 
considers to be protective of any neurotoxicity at higher dose levels.
    iii. There is no evidence that metaldehyde results in increased 
susceptibility following in utero exposure to metaldehyde in either the 
rat or rabbit developmental toxicity study, and there is no evidence of 
increased susceptibility following in utero and/or pre-/post-natal 
exposure in the 2-generation reproduction study in rats.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on established and proposed tolerance-level residues, 100 PCT, default 
processing factors, and EDWCs from chronic ground water (worst case) 
models to assess exposure to metaldehyde in drinking water. EPA used 
similarly conservative assumptions to assess exposure to adult 
handlers, and post application exposure of children (including 
incidental oral exposure of toddlers). These assessments will not 
underestimate the exposure and risks posed by metaldehyde based on the 
current and proposed use patterns.

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 metaldehyde will occupy 18% of the aPAD for the general population, 
and 55% of the aPAD for all infants less than 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 
metaldehyde from food and water will utilize 22% of the cPAD for the 
general population, and 52% of the cPAD for all infants less than 1 
year old, the population group receiving the greatest exposure. Based 
on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of metaldehyde is 
not expected.
    3. Short-term risk: Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Metaldehyde is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to metaldehyde. Using the 
exposure assumptions described in this unit for short-term exposures, 
EPA has concluded the combined short-term food, water, and residential 
exposures result in aggregate MOEs of 1400 for adults and 580 for 
children. Because EPA's level of concern for metaldehyde

[[Page 71637]]

is an MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Metaldehyde is currently registered for uses that could result 
in intermediate-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with intermediate-term residential exposures to 
metaldehyde. Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in an 
aggregate MOE of 270 (for children only). Because EPA's level of 
concern for metaldehyde is a MOE of 100 or below, this MOE is not of 
concern.
    5. Aggregate cancer risk for U.S. population. Based on the data 
summarized in Unit III, EPA believes that quantification of metaldehyde 
risk using a non-linear RfD approach will adequately account for all 
related chronic toxicity, including carcinogenicity. Based on the 
chronic risk assessment, EPA concludes that aggregate exposure to 
metaldehyde will not pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to metaldehyde residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with mass 
spectrometry (GC/MS) method (EN-CAS\TM\ Method No. ENC-3/99, Revision 
1) is available to enforce the tolerance expression. The limit of 
quantitation (LOQ) for this method is 0.05 ppm for all plant 
commodities except hops, for which it is 0.10 ppm.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

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 not established a MRL for metaldehyde.

C. Revisions to Petitioned-for Tolerances

    For hop, dried cones, the analytical method was not successfully 
validated at the proposed tolerance level of 0.05 ppm. Therefore, EPA 
is establishing the tolerance level for this commodity at the lowest 
validated LOQ for hops of 0.10 ppm. In addition, the commodity 
definition proposed as ``beet, garden, tops'' is corrected to read: 
``beet, garden, leaves''.

V. Conclusion

    Therefore, tolerances are established for residues of metaldehyde, 
2,4,6,8-tetramethyl-1,3,5,7-tetroxocane, in or on beet, garden, leaves 
at 0.08 ppm; beet, garden, roots at 0.05 ppm; hop, dried cones at 0.10 
ppm; rutabaga, roots at 0.05 ppm; turnip, greens at 0.08 ppm; turnip, 
roots at 0.05 ppm; wheat, forage at 0.05 ppm; wheat, grain at 0.05 ppm; 
wheat, hay at 0.05 ppm and wheat, straw at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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).

[[Page 71638]]

List of Subjects in 40 CFR Part 180

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

    Dated: September 30, 2016.
Michael L. Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.523, add alphabetically the commodities ``beet, garden, 
leaves''; ``beet, garden, roots''; ``hop, dried cones''; ``rutabaga, 
roots''; ``turnip greens''; ``turnip, roots''; ``wheat, forage''; 
``wheat, grain''; ``wheat, hay''; and ``wheat, straw'' to the table in 
paragraph (c) to read as follows:


Sec.  180.523  Metaldehyde; tolerances for residues.

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Beet, garden, leaves.......................................         0.08
Beet, garden, roots........................................         0.05
 
                                * * * * *
Hop, dried cones...........................................         0.10
Rutabaga, roots............................................         0.05
 
                                * * * * *
Turnip greens..............................................         0.08
Turnip, roots..............................................         0.05
Wheat, forage..............................................         0.05
Wheat, grain...............................................         0.05
Wheat, hay.................................................         0.05
Wheat, straw...............................................         0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-25166 Filed 10-17-16; 8:45 am]
BILLING CODE 6560-50-P



                                                              Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations                                                       71633

                                           circuit by December 19, 2016. Filing a                    reference, Intergovernmental relations,                     ■ 2. In § 52.1870 the table in paragraph
                                           petition for reconsideration by the                       Nitrogen oxides, Ozone, Volatile organic                    (c) is amended under ‘‘Chapter 3745–21
                                           Administrator of this final rule does not                 compounds.                                                  Carbon Monoxide, Ozone, Hydrocarbon
                                           affect the finality of this action for the                  Dated: October 5, 2016.                                   Air Quality Standards, and Related
                                           purposes of judicial review nor does it                   Robert A. Kaplan,                                           Emission Requirements’’ by revising the
                                           extend the time within which a petition                                                                               entry for 3745–21–09 ‘‘Control of
                                                                                                     Acting Regional Administrator, Region 5.
                                           for judicial review may be filed, and                                                                                 Emissions of Volatile Organic
                                           shall not postpone the effectiveness of                         40 CFR part 52 is amended as follows:
                                                                                                                                                                 Compounds from Stationary Sources
                                           such rule or action. This action may not                                                                              and Perchloroethylene from Dry
                                           be challenged later in proceedings to                     PART 52—APPROVAL AND
                                                                                                     PROMULGATION OF                                             Cleaning Facilities’’ to read as follows:
                                           enforce its requirements. (See section
                                           307(b)(2).)                                               IMPLEMENTATION PLANS
                                                                                                                                                                 § 52.1870    Identification of plan.
                                           List of Subjects in 40 CFR Part 52                        ■ 1. The authority citation for part 52                     *       *    *        *    *
                                             Environmental protection, Air                           continues to read as follows:                                   (c) * * *
                                           pollution control, Incorporation by                           Authority: 42 U.S.C. 7401 et seq.

                                                                                                         EPA-APPROVED OHIO REGULATIONS
                                                                                                                                        Ohio effective
                                             Ohio citation                               Title/subject                                                       EPA approval date                   Notes
                                                                                                                                            date


                                                      *                        *                         *                          *                       *                      *                    *

                                                      Chapter 3745–21         Carbon Monoxide, Ozone, Hydrocarbon Air Quality Standards, and Related Emission Requirements


                                                   *                        *                     *                *                                        *                     *                    *
                                           3745–21–09 ...       Control of Emissions of Volatile Organic Compounds   1/17/2014                           10/18/2016, [Insert Fed-      except (U)(1)(h).
                                                                 from Stationary Sources and Perchloroethylene                                             eral Register citation].
                                                                 from Dry Cleaning Facilities.

                                                      *                        *                         *                          *                       *                      *                    *



                                           *      *       *       *      *                           ADDRESSES:    The docket for this action,                   I. General Information
                                           [FR Doc. 2016–24912 Filed 10–17–16; 8:45 am]              identified by docket identification (ID)
                                                                                                                                                                 A. Does this action apply to me?
                                           BILLING CODE 6560–50–P                                    number EPA–HQ–OPP–2015–0558, is
                                                                                                     available at http://www.regulations.gov                        You may be potentially affected by
                                                                                                     or at the Office of Pesticide Programs                      this action if you are an agricultural
                                           ENVIRONMENTAL PROTECTION                                  Regulatory Public Docket (OPP Docket)
                                           AGENCY                                                                                                                producer, food manufacturer, or
                                                                                                     in the Environmental Protection Agency                      pesticide manufacturer. The following
                                           40 CFR Part 180                                           Docket Center (EPA/DC), West William                        list of North American Industrial
                                                                                                     Jefferson Clinton Bldg., Rm. 3334, 1301                     Classification System (NAICS) codes is
                                           [EPA–HQ–OPP–2015–0558; FRL–9951–78]                       Constitution Ave. NW., Washington, DC                       not intended to be exhaustive, but rather
                                                                                                     20460–0001. The Public Reading Room                         provides a guide to help readers
                                           Metaldehyde; Pesticide Tolerances                         is open from 8:30 a.m. to 4:30 p.m.,                        determine whether this document
                                                                                                     Monday through Friday, excluding legal                      applies to them. Potentially affected
                                           AGENCY:  Environmental Protection
                                                                                                     holidays. The telephone number for the                      entities may include:
                                           Agency (EPA).
                                                                                                     Public Reading Room is (202) 566–1744,
                                           ACTION: Final rule.                                                                                                      • Crop production (NAICS code 111).
                                                                                                     and the telephone number for the OPP
                                                                                                     Docket is (703) 305–5805. Please review                        • Animal production (NAICS code
                                           SUMMARY:   This regulation establishes                                                                                112).
                                           tolerances with regional registration for                 the visitor instructions and additional
                                           residues of metaldehyde in or on                          information about the docket available                         • Food manufacturing (NAICS code
                                           multiple commodities which are                            at http://www.epa.gov/dockets.                              311).
                                           identified and discussed later in this                    FOR FURTHER INFORMATION CONTACT:                               • Pesticide manufacturing (NAICS
                                           document. Interregional Research                          Michael Goodis, Acting Director,                            code 32532).
                                           Project Number 4 (IR–4) requested these                   Registration Division (7505P), Office of
                                           tolerances under the Federal Food,                                                                                    B. How can I get electronic access to
                                                                                                     Pesticide Programs, Environmental                           other related information?
                                           Drug, and Cosmetic Act (FFDCA).
                                                                                                     Protection Agency, 1200 Pennsylvania
                                           DATES: This regulation is effective                       Ave. NW., Washington, DC 20460–0001;                           You may access a frequently updated
                                           October 18, 2016. Objections and                          main telephone number: (703) 305–                           electronic version of EPA’s tolerance
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                                           requests for hearings must be received                    7090; email address: RDFRNotices@                           regulations at 40 CFR part 180 through
                                           on or before December 19, 2016, and                                                                                   the Government Printing Office’s e-CFR
                                                                                                     epa.gov.
                                           must be filed in accordance with the
                                                                                                                                                                 site at http://www.ecfr.gov/cgi-bin/text-
                                           instructions provided in 40 CFR part                      SUPPLEMENTARY INFORMATION:                                  idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                           178 (see also Unit I.C. of the
                                                                                                                                                                 40tab_02.tpl.
                                           SUPPLEMENTARY INFORMATION).



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                                           71634            Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations

                                           C. How can I file an objection or hearing               08540. The petition requested that 40                 validity, completeness, and reliability as
                                           request?                                                CFR 180.523 be amended by                             well as the relationship of the results of
                                             Under FFDCA section 408(g), 21                        establishing tolerances for residues of               the studies to human risk. EPA has also
                                           U.S.C. 346a, any person may file an                     the molluscicide metaldehyde, 2,4,6,8-                considered available information
                                           objection to any aspect of this regulation              tetramethyl-1,3,5,7-tetroxocane, in or on             concerning the variability of the
                                           and may also request a hearing on those                 beet, garden, roots at 0.05 parts per                 sensitivities of major identifiable
                                                                                                   million (ppm); beet, garden, tops at 0.08             subgroups of consumers, including
                                           objections. You must file your objection
                                                                                                   ppm; hop, dried cones at 0.05 ppm;                    infants and children.
                                           or request a hearing on this regulation
                                                                                                   rutabaga, roots at 0.05 ppm; turnip,                     The toxicity profile of metaldehyde
                                           in accordance with the instructions                                                                           shows that the principal toxic effects are
                                                                                                   greens (tops) at 0.08 ppm; turnip, roots
                                           provided in 40 CFR part 178. To ensure                                                                        clinical signs of neurotoxicity. The dog
                                                                                                   at 0.05 ppm; wheat, forage at 0.05 ppm;
                                           proper receipt by EPA, you must                                                                               is the most sensitive species for the
                                                                                                   wheat, grain at 0.05 ppm; wheat, hay at
                                           identify docket ID number EPA–HQ–                                                                             neurotoxic effects. The nervous system
                                                                                                   0.05 ppm and wheat, straw at 0.05 ppm.
                                           OPP–2015–0558 in the subject line on                                                                          effects observed in subchronic and
                                                                                                   That document referenced a summary of
                                           the first page of your submission. All                                                                        chronic oral toxicity studies include: (1)
                                                                                                   the petition prepared by Lonza, Inc., the
                                           objections and requests for a hearing                                                                         Neurotoxic signs, i.e., ataxia; tremor;
                                                                                                   registrant, which is available in the
                                           must be in writing, and must be                                                                               twitching; salivation; emesis; and rapid
                                                                                                   docket, http://www.regulations.gov.
                                           received by the Hearing Clerk on or                     There were no comments received in                    respiration in dogs and maternal rats;
                                           before December 19, 2016. Addresses for                 response to the notice of filing.                     and (2) neuropathology, i.e., limb
                                           mail and hand delivery of objections                       Based upon review of the data                      paralysis, spinal cord necrosis, and
                                           and hearing requests are provided in 40                 supporting the petition, EPA has made                 hemorrhage in maternal rats.
                                           CFR 178.25(b).                                          certain modifications to the petitioned-                 The liver is a target organ following
                                             In addition to filing an objection or                 for crop tolerances. The reason for these             subchronic and chronic oral exposure to
                                           hearing request with the Hearing Clerk                  changes are explained in Unit IV.C.                   metaldehyde as evidenced by increased
                                           as described in 40 CFR part 178, please                                                                       liver weight, increased incidence of
                                           submit a copy of the filing (excluding                  III. Aggregate Risk Assessment and                    liver lesions, i.e., hepatocellular
                                           any Confidential Business Information                   Determination of Safety                               necrosis, hepatocellular hypertrophy,
                                           (CBI)) for inclusion in the public docket.                 Section 408(b)(2)(A)(i) of FFDCA                   inflammation, and an increased
                                           Information not marked confidential                     allows EPA to establish a tolerance (the              incidence of hepatocellular adenomas/
                                           pursuant to 40 CFR part 2 may be                        legal limit for a pesticide chemical                  carcinomas in female rats and
                                           disclosed publicly by EPA without prior                 residue in or on a food) only if EPA                  hepatocellular adenomas in both sexes
                                           notice. Submit the non-CBI copy of your                 determines that the tolerance is ‘‘safe.’’            of mice. The testes and prostate are also
                                           objection or hearing request, identified                Section 408(b)(2)(A)(ii) of FFDCA                     target organs following subchronic and
                                           by docket ID number EPA–HQ–OPP–                         defines ‘‘safe’’ to mean that ‘‘there is a            chronic exposure as evidenced by
                                           2015–0558, by one of the following                      reasonable certainty that no harm will                atrophy of both organs in dogs.
                                           methods:                                                result from aggregate exposure to the                    Developmental toxicity was not
                                             • Federal eRulemaking Portal: http://                 pesticide chemical residue, including                 observed in the rat or rabbit
                                           www.regulations.gov. Follow the online                  all anticipated dietary exposures and all             developmental toxicity studies.
                                           instructions for submitting comments.                   other exposures for which there is                    Maternal toxicity was not observed in
                                           Do not submit electronically any                        reliable information.’’ This includes                 the rabbit, although maternal toxicity
                                           information you consider to be CBI or                   exposure through drinking water and in                was observed in the rat, as evidenced by
                                           other information whose disclosure is                   residential settings, but does not include            clinical signs including ataxia, tremors,
                                           restricted by statute.                                  occupational exposure. Section                        and twitching at the highest dose tested
                                             • Mail: OPP Docket, Environmental                     408(b)(2)(C) of FFDCA requires EPA to                 (HDT). In the rat reproductive toxicity
                                           Protection Agency Docket Center (EPA/                   give special consideration to exposure                study, mortality and clinical signs, i.e.,
                                           DC), (28221T), 1200 Pennsylvania Ave.                   of infants and children to the pesticide              limb paralysis, spinal cord necrosis and
                                           NW., Washington, DC 20460–0001.                         chemical residue in establishing a                    hemorrhage were observed in the
                                             • Hand Delivery: To make special                      tolerance and to ‘‘ensure that there is a             maternal animals, and the effects on the
                                           arrangements for hand delivery or                       reasonable certainty that no harm will                offspring consisted of decreased pup
                                           delivery of boxed information, please                   result to infants and children from                   body weight and body weight gains.
                                           follow the instructions at http://                      aggregate exposure to the pesticide                   Reproductive toxicity was not observed.
                                           www.epa.gov/dockets/contacts.html.                      chemical residue. . . .’’                                In chronic feeding studies in mice and
                                             Additional instructions on                               Consistent with FFDCA section                      rats, benign liver tumors were seen in
                                           commenting or visiting the docket,                      408(b)(2)(D), and the factors specified in            both sexes of mice and in female rats.
                                           along with more information about                       FFDCA section 408(b)(2)(D), EPA has                   The Agency has determined that
                                           dockets generally, is available at http://              reviewed the available scientific data                quantification of risk using a non-linear
                                           www.epa.gov/dockets.                                    and other relevant information in                     Reference Dose (RfD) approach for
                                                                                                   support of this action. EPA has                       metaldehyde will adequately account
                                           II. Summary of Petitioned-For                                                                                 for all chronic toxicity, including
                                           Tolerance                                               sufficient data to assess the hazards of
                                                                                                   and to make a determination on                        carcinogenicity, that could result from
                                              In the Federal Register of Wednesday,                aggregate exposure for metaldehyde                    exposure to metaldehyde. That
                                           September 9, 2015 (80 FR 54257) (FRL–                   including exposure resulting from the                 conclusion is based on the following
                                           9933–26), EPA issued a document                         tolerances established by this action.                considerations: (1) The tumors found
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                                           pursuant to FFDCA section 408(d)(3), 21                 EPA’s assessment of exposures and risks               are commonly seen in the mouse; (2) the
                                           U.S.C. 346a(d)(3), announcing the filing                associated with metaldehyde follows.                  liver tumors (adenomas) in both species
                                           of a pesticide petition (PP 5E8377) by                                                                        were benign; (3) metaldehyde is not
                                           Interregional Research Project Number 4                 A. Toxicological Profile                              mutagenic; (4) no carcinogenic response
                                           (IR–4), IR–4 Headquarters, 500 College                    EPA has evaluated the available                     was seen in the male rat; (5) incidence
                                           Road East, Suite 201 W., Princeton, NJ                  toxicity database and considered its                  of adenomas at the high-dose in the


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                                                            Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations                                       71635

                                           female rat was within the historical                    considered exposure under the                            The Agency used screening level
                                           control range of the testing lab; and (6)               petitioned-for tolerances as well as all              water exposure models in the dietary
                                           both the no-observed-adverse-effect-                    existing metaldehyde tolerances in 40                 exposure analysis and risk assessment
                                           level (NOAEL) and the lowest-observed-                  CFR 180.523. EPA assessed dietary                     for metaldehyde in drinking water.
                                           adverse-effect-level (LOAEL) from the                   exposures from metaldehyde in food as                 These simulation models take into
                                           chronic rat study on which the chronic                  follows:                                              account data on the physical, chemical,
                                           RfD/population-adjusted dose (PAD)                         i. Acute exposure. Quantitative acute              and fate/transport characteristics of
                                           was based are well below the dose at                    dietary exposure and risk assessments                 metaldehyde. Further information
                                           which adenomas were seen.                               are performed for a food-use pesticide,               regarding EPA drinking water models
                                              Specific information on the studies                  if a toxicological study has indicated the            used in pesticide exposure assessment
                                           received and the nature of the adverse                  possibility of an effect of concern                   can be found at http://www2.epa.gov/
                                           effects caused by metaldehyde as well                   occurring as a result of a 1-day or single            pesticide-science-and-assessing-
                                           as the NOAEL and the LOAEL from the                     exposure.                                             pesticide-risks/about-water-exposure-
                                           toxicity studies can be found at http://                   Such effects were identified for                   models-used-pesticide.
                                           www.regulations.gov in document                         metaldehyde. In estimating acute                         Based on the Pesticide Root Zone
                                           ‘‘Metaldehyde; Human Health Risk                        dietary exposure, EPA used the Dietary                Model/Exposure Analysis Modeling
                                           Assessment for Proposed New Uses on                     Exposure Evaluation Model software                    System (PRZM/EXAMS) and Pesticide
                                           Garden Beets, Hops, Rutabaga, Turnips                   with the Food Commodity Intake                        Root Zone Model Ground Water (PRZM
                                           and Wheat with Regional Registration in                 Database (DEEM–FCID), Version 3.16,                   GW), the estimated drinking water
                                           the Pacific Northwest,’’ in docket ID                   which incorporates 2003–2008 food                     concentrations (EDWCs) of metaldehyde
                                           number EPA– HQ–OPP–2015–0558.                           consumption data from the U.S.                        for acute exposures are estimated to be
                                                                                                   Department of Agriculture’s (USDA’s)                  205 parts per billion (ppb) for surface
                                           B. Toxicological Points of Departure/
                                                                                                   National Health and Nutrition                         water and 1880 ppb for ground water.
                                           Levels of Concern
                                                                                                   Examination Survey, What We Eat in                    Chronic exposures for non-cancer
                                              Once a pesticide’s toxicological                                                                           assessments are estimated to be 136 ppb
                                           profile is determined, EPA identifies                   America, (NHANES/WWEIA). As to
                                                                                                   residue levels in food, EPA assumed                   for surface water and 915 ppb for
                                           toxicological points of departure (POD)                                                                       ground water.
                                           and levels of concern to use in                         tolerance-level residues for all
                                                                                                                                                            For acute dietary risk assessment, the
                                           evaluating the risk posed by human                      commodities and 100 percent crop
                                                                                                                                                         full distribution of ground water
                                           exposure to the pesticide. For hazards                  treated (PCT). In addition, the Agency
                                                                                                                                                         concentrations from the PRZM–GW
                                           that have a threshold below which there                 assumed processing factors to be 1.0 for
                                                                                                                                                         model was used to assess the
                                           is no appreciable risk, the toxicological               all commodities except for tomato,
                                                                                                                                                         contribution from drinking water.
                                           POD is used as the basis for derivation                 dried; tomato, juice; cranberry, juice;                  For chronic dietary risk assessment,
                                           of reference values for risk assessment.                and high fructose corn syrup; for these               the water concentration of value 915
                                           PODs are developed based on a careful                   commodities, DEEM default processing                  ppb was used to assess the contribution
                                           analysis of the doses in each                           factors were used.                                    from drinking water.
                                           toxicological study to determine the                       ii. Chronic exposure. In conducting                   3. From non-dietary exposure. The
                                           dose at which the NOAEL and the                         the chronic dietary exposure assessment               term ‘‘residential exposure’’ is used in
                                           lowest dose at which adverse effects of                 EPA used the DEEM–FCID, Version                       this document to refer to non-
                                           concern are identified (the LOAEL).                     3.16, which incorporates 2003–2008                    occupational, non-dietary exposure
                                           Uncertainty/safety factors are used in                  food consumption data from the                        (e.g., for lawn and garden pest control,
                                           conjunction with the POD to calculate a                 USDA’s, NHANES/WWEIA. As to                           indoor pest control, termiticides, and
                                           safe exposure level—generally referred                  residue levels in food, EPA assumed                   flea and tick control on pets).
                                           to as a PAD or a RfD—and a safe margin                  tolerance-level residues for all                         Metaldehyde is currently registered
                                           of exposure (MOE). For non-threshold                    commodities and 100 PCT. Processing                   for the following uses that could result
                                           risks, the Agency assumes that any                      factors were assumed to be 1.0 for all                in residential exposures: Residential
                                           amount of exposure will lead to some                    commodities except for tomato, dried;                 ornamentals and lawn/turf applications.
                                           degree of risk. Thus, the Agency                        tomato, juice; cranberry, juice; and high             EPA assessed residential exposure using
                                           estimates risk in terms of the probability              fructose corn syrup; for these                        the following assumptions and exposure
                                           of an occurrence of the adverse effect                  commodities, DEEM default processing                  factors: For adult residential handlers,
                                           expected in a lifetime. For more                        factors were used.                                    EPA conducted a short-term exposure
                                           information on the general principles                      iii. Cancer. Based on the data                     assessment of metaldehyde for adults
                                           EPA uses in risk characterization and a                 summarized in Unit III.A., EPA                        based on the inhalation route,
                                           complete description of the risk                        concluded that quantification of risk                 incorporating the maximum labeled
                                           assessment process, see http://                         using a non-linear RfD approach will                  application rate, and unit exposure
                                           www2.epa.gov/pesticide-science-and-                     adequately account for all chronic                    values and estimates for area treated/
                                           assessing-pesticide-risks/assessing-                    toxicity, including carcinogenicity.                  amount handled taken from the 2012
                                           human-health-risk-pesticides.                           Therefore, a dietary exposure                         Residential Standard Operating
                                              A summary of the toxicological                       assessment for the purpose of assessing               Procedures (SOPs). The scenario
                                           endpoints for metaldehyde used for                      cancer risk was not conducted.                        resulting in the highest adult exposure
                                           human risk assessment is discussed in                      iv. Anticipated residue and PCT                    in a residential setting was hand
                                           Unit III.B. of the final rule published in              information. EPA did not use                          dispersal of granules, which was used in
                                           the Federal Register of November 27,                    anticipated residue or PCT information                the short-term aggregate assessment.
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                                           2013 (78 FR 70864) (FRL–9388–8).                        in the dietary assessment for                         Additional scenarios assessed included;
                                                                                                   metaldehyde. Tolerance-level residues                 loading and applying distinct
                                           C. Exposure Assessment                                  and 100 PCT were assumed for all food                 metaldehyde product types, i.e., liquid
                                             1. Dietary exposure from food and                     commodities.                                          ready-to-use products applied manually
                                           feed uses. In evaluating dietary                           2. Dietary exposure from drinking                  via pressurized hand wands, hose-end
                                           exposure to metaldehyde, EPA                            water.                                                sprayers, and sprinkler cans, as well as


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                                           71636            Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations

                                           applying granular products via push-                      2. Prenatal and postnatal sensitivity.              used similarly conservative assumptions
                                           type rotary spreaders, belly grinders,                  Developmental toxicity was not                        to assess exposure to adult handlers,
                                           spoons, cups, hands, and shaker cans.                   observed in the rat or rabbit                         and post application exposure of
                                              For children, the highest estimated                  developmental toxicity studies and no                 children (including incidental oral
                                           metaldehyde exposure resulted from                      maternal toxicity observed in the rabbit.             exposure of toddlers). These
                                           post-application incidental oral                        Maternal toxicity was observed in the                 assessments will not underestimate the
                                           exposures of short-term duration from                   rat, as evidenced by clinical signs, i.e.,            exposure and risks posed by
                                           hand-to-mouth and object-to-mouth                       ataxia, tremors, and twitching, however               metaldehyde based on the current and
                                           contact with treated turf, and short- and               these effects were observed only at the               proposed use patterns.
                                           intermediate-term exposures from                        highest dose tested. In the rat
                                                                                                   reproductive toxicity study, mortality                E. Aggregate Risks and Determination of
                                           treated soil. Further information                                                                             Safety
                                           regarding EPA standard assumptions                      and clinical signs, i.e., limb paralysis,
                                           and generic inputs for residential                      spinal cord necrosis and hemorrhage                      EPA determines whether acute and
                                           exposures may be found at http://                       were observed in the maternal animals,                chronic dietary pesticide exposures are
                                           www2.epa.gov/pesticide-science-and-                     and the effects on the offspring                      safe by comparing aggregate exposure
                                           assessing-pesticide-risks/standard-                     consisted of decreased pup body weight                estimates to the acute PAD (aPAD) and
                                           operating-procedures-residential-                       and body weight gains. Reproductive                   chronic PAD (cPAD). For linear cancer
                                           pesticide.                                              toxicity was not observed.                            risks, EPA calculates the lifetime
                                              4. Cumulative effects from substances                  3. Conclusion. EPA has determined                   probability of acquiring cancer given the
                                           with a common mechanism of toxicity.                    that reliable data show the safety of                 estimated aggregate exposure. Short-,
                                           Section 408(b)(2)(D)(v) of FFDCA                        infants and children would be                         intermediate-, and chronic-term risks
                                           requires that, when considering whether                 adequately protected if the FQPA SF                   are evaluated by comparing the
                                                                                                   were reduced to 1x. That decision is                  estimated aggregate food, water, and
                                           to establish, modify, or revoke a
                                                                                                   based on the following findings:                      residential exposure to the appropriate
                                           tolerance, the Agency consider
                                                                                                     i. The toxicity database for                        PODs to ensure that an adequate MOE
                                           ‘‘available information’’ concerning the                metaldehyde is complete;
                                           cumulative effects of a particular                                                                            exists.
                                                                                                     ii. Although there are indications of
                                           pesticide’s residues and ‘‘other                                                                                 1. Acute risk. Using the exposure
                                                                                                   neurotoxicity from exposure to
                                           substances that have a common                                                                                 assumptions discussed in this unit for
                                                                                                   metaldehyde, there are clear NOAELs/
                                           mechanism of toxicity.’’                                                                                      acute exposure, the acute dietary
                                                                                                   LOAELS for these effects, and Points of
                                              EPA has not found metaldehyde to                                                                           exposure from food and water to
                                                                                                   Departure selected for risk assessment
                                           share a common mechanism of toxicity                                                                          metaldehyde will occupy 18% of the
                                                                                                   are protective for these effects. EPA has
                                           with any other substances, and                                                                                aPAD for the general population, and
                                                                                                   determined that the acute and
                                           metaldehyde does not appear to                          developmental neurotoxicity studies are               55% of the aPAD for all infants less than
                                           produce a toxic metabolite produced by                  not needed, nor are additional                        1 year old, the population group
                                           other substances. For the purposes of                   uncertainty factors (UFs) necessary to                receiving the greatest exposure.
                                           this tolerance action, therefore, EPA has               account for neurotoxicity. There were                    2. Chronic risk. Using the exposure
                                           assumed that metaldehyde does not                       no indications of neurotoxic effects in               assumptions described in this unit for
                                           have a common mechanism of toxicity                     developing rats or rabbits in either the              chronic exposure, EPA has concluded
                                           with other substances. For information                  developmental or reproductive studies.                that chronic exposure to metaldehyde
                                           regarding EPA’s efforts to determine                    Although there were some effects in                   from food and water will utilize 22% of
                                           which chemicals have a common                           adult rats, those effects occurred at                 the cPAD for the general population,
                                           mechanism of toxicity and to evaluate                   doses much higher than in the dog                     and 52% of the cPAD for all infants less
                                           the cumulative effects of such                          study. The dog is the more sensitive                  than 1 year old, the population group
                                           chemicals, see EPA’s Web site at http://                species for neurotoxic effects and points             receiving the greatest exposure. Based
                                           www2.epa.gov/pesticide-science-and-                     of departure (30 mg/kg/day and 10 mg/                 on the explanation in Unit III.C.3.,
                                           assessing-pesticide-risks/cumulative-                   kg/day) are based on the chronic dog                  regarding residential use patterns,
                                           assessment-risk-pesticides.                             oral toxicity study, which EPA                        chronic residential exposure to residues
                                                                                                   considers to be protective of any                     of metaldehyde is not expected.
                                           D. Safety Factor for Infants and                                                                                 3. Short-term risk: Short-term
                                           Children                                                neurotoxicity at higher dose levels.
                                                                                                     iii. There is no evidence that                      aggregate exposure takes into account
                                             1. In general. Section 408(b)(2)(C) of                metaldehyde results in increased                      short-term residential exposure plus
                                           FFDCA provides that EPA shall apply                     susceptibility following in utero                     chronic exposure to food and water
                                           an additional tenfold (10X) margin of                   exposure to metaldehyde in either the                 (considered to be a background
                                           safety for infants and children in the                  rat or rabbit developmental toxicity                  exposure level).
                                           case of threshold effects to account for                study, and there is no evidence of                       Metaldehyde is currently registered
                                           prenatal and postnatal toxicity and the                 increased susceptibility following in                 for uses that could result in short-term
                                           completeness of the database on toxicity                utero and/or pre-/post-natal exposure in              residential exposure, and the Agency
                                           and exposure unless EPA determines                      the 2-generation reproduction study in                has determined that it is appropriate to
                                           based on reliable data that a different                 rats.                                                 aggregate chronic exposure through food
                                           margin of safety will be safe for infants                 iv. There are no residual uncertainties             and water with short-term residential
                                           and children. This additional margin of                 identified in the exposure databases.                 exposures to metaldehyde. Using the
                                           safety is commonly referred to as the                   The dietary food exposure assessments                 exposure assumptions described in this
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                                           FQPA Safety Factor (SF). In applying                    were performed based on established                   unit for short-term exposures, EPA has
                                           this provision, EPA either retains the                  and proposed tolerance-level residues,                concluded the combined short-term
                                           default value of 10X, or uses a different               100 PCT, default processing factors, and              food, water, and residential exposures
                                           additional safety factor when reliable                  EDWCs from chronic ground water                       result in aggregate MOEs of 1400 for
                                           data available to EPA support the choice                (worst case) models to assess exposure                adults and 580 for children. Because
                                           of a different factor.                                  to metaldehyde in drinking water. EPA                 EPA’s level of concern for metaldehyde


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                                                            Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations                                        71637

                                           is an MOE of 100 or below, these MOEs                   safety standards and agricultural                     contain any information collections
                                           are not of concern.                                     practices. EPA considers the                          subject to OMB approval under the
                                              4. Intermediate-term risk.                           international maximum residue limits                  Paperwork Reduction Act (PRA) (44
                                           Intermediate-term aggregate exposure                    (MRLs) established by the Codex                       U.S.C. 3501 et seq.), nor does it require
                                           takes into account intermediate-term                    Alimentarius Commission (Codex), as                   any special considerations under
                                           residential exposure plus chronic                       required by FFDCA section 408(b)(4).                  Executive Order 12898, entitled
                                           exposure to food and water (considered                  The Codex Alimentarius is a joint                     ‘‘Federal Actions to Address
                                           to be a background exposure level).                     United Nations Food and Agriculture                   Environmental Justice in Minority
                                           Metaldehyde is currently registered for                 Organization/World Health                             Populations and Low-Income
                                           uses that could result in intermediate-                 Organization food standards program,                  Populations’’ (59 FR 7629, February 16,
                                           term residential exposure, and the                      and it is recognized as an international              1994).
                                           Agency has determined that it is                        food safety standards-setting                            Since tolerances and exemptions that
                                           appropriate to aggregate chronic                        organization in trade agreements to                   are established on the basis of a petition
                                           exposure through food and water with                    which the United States is a party. EPA               under FFDCA section 408(d), such as
                                           intermediate-term residential exposures                 may establish a tolerance that is                     the tolerance in this final rule, do not
                                           to metaldehyde. Using the exposure                      different from a Codex MRL; however,                  require the issuance of a proposed rule,
                                           assumptions described in this unit for                  FFDCA section 408(b)(4) requires that                 the requirements of the Regulatory
                                           intermediate-term exposures, EPA has                    EPA explain the reasons for departing                 Flexibility Act (RFA) (5 U.S.C. 601 et
                                           concluded that the combined                             from the Codex level.                                 seq.), do not apply.
                                           intermediate-term food, water, and                         The Codex has not established a MRL                   This action directly regulates growers,
                                           residential exposures result in an                      for metaldehyde.                                      food processors, food handlers, and food
                                           aggregate MOE of 270 (for children                      C. Revisions to Petitioned-for Tolerances             retailers, not States or tribes, nor does
                                           only). Because EPA’s level of concern                                                                         this action alter the relationships or
                                           for metaldehyde is a MOE of 100 or                         For hop, dried cones, the analytical
                                                                                                   method was not successfully validated                 distribution of power and
                                           below, this MOE is not of concern.                                                                            responsibilities established by Congress
                                              5. Aggregate cancer risk for U.S.                    at the proposed tolerance level of 0.05
                                                                                                   ppm. Therefore, EPA is establishing the               in the preemption provisions of FFDCA
                                           population. Based on the data                                                                                 section 408(n)(4). As such, the Agency
                                           summarized in Unit III, EPA believes                    tolerance level for this commodity at the
                                                                                                   lowest validated LOQ for hops of 0.10                 has determined that this action will not
                                           that quantification of metaldehyde risk                                                                       have a substantial direct effect on States
                                           using a non-linear RfD approach will                    ppm. In addition, the commodity
                                                                                                   definition proposed as ‘‘beet, garden,                or tribal governments, on the
                                           adequately account for all related                                                                            relationship between the national
                                           chronic toxicity, including                             tops’’ is corrected to read: ‘‘beet, garden,
                                                                                                   leaves’’.                                             government and the States or tribal
                                           carcinogenicity. Based on the chronic                                                                         governments, or on the distribution of
                                           risk assessment, EPA concludes that                     V. Conclusion                                         power and responsibilities among the
                                           aggregate exposure to metaldehyde will                     Therefore, tolerances are established              various levels of government or between
                                           not pose a cancer risk.                                 for residues of metaldehyde, 2,4,6,8-                 the Federal Government and Indian
                                              6. Determination of safety. Based on                                                                       tribes. Thus, the Agency has determined
                                                                                                   tetramethyl-1,3,5,7-tetroxocane, in or on
                                           these risk assessments, EPA concludes                                                                         that Executive Order 13132, entitled
                                                                                                   beet, garden, leaves at 0.08 ppm; beet,
                                           that there is a reasonable certainty that                                                                     ‘‘Federalism’’ (64 FR 43255, August 10,
                                                                                                   garden, roots at 0.05 ppm; hop, dried
                                           no harm will result to the general                                                                            1999) and Executive Order 13175,
                                                                                                   cones at 0.10 ppm; rutabaga, roots at
                                           population, or to infants and children                                                                        entitled ‘‘Consultation and Coordination
                                                                                                   0.05 ppm; turnip, greens at 0.08 ppm;
                                           from aggregate exposure to metaldehyde                                                                        with Indian Tribal Governments’’ (65 FR
                                                                                                   turnip, roots at 0.05 ppm; wheat, forage
                                           residues.                                                                                                     67249, November 9, 2000) do not apply
                                                                                                   at 0.05 ppm; wheat, grain at 0.05 ppm;
                                           IV. Other Considerations                                wheat, hay at 0.05 ppm and wheat,                     to this action. In addition, this action
                                                                                                   straw at 0.05 ppm.                                    does not impose any enforceable duty or
                                           A. Analytical Enforcement Methodology                                                                         contain any unfunded mandate as
                                              Adequate enforcement methodology                     VI. Statutory and Executive Order                     described under Title II of the Unfunded
                                           (gas chromatography with mass                           Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                           spectrometry (GC/MS) method (EN–                          This action establishes tolerances                  1501 et seq.).
                                           CASTM Method No. ENC–3/99, Revision                     under FFDCA section 408(d) in                            This action does not involve any
                                           1) is available to enforce the tolerance                response to a petition submitted to the               technical standards that would require
                                           expression. The limit of quantitation                   Agency. The Office of Management and                  Agency consideration of voluntary
                                           (LOQ) for this method is 0.05 ppm for                   Budget (OMB) has exempted these types                 consensus standards pursuant to section
                                           all plant commodities except hops, for                  of actions from review under Executive                12(d) of the National Technology
                                           which it is 0.10 ppm.                                   Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
                                              The method may be requested from:                    Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                           Chief, Analytical Chemistry Branch,                     October 4, 1993). Because this action
                                                                                                                                                         VII. Congressional Review Act
                                           Environmental Science Center, 701                       has been exempted from review under
                                           Mapes Rd., Ft. Meade, MD 20755–5350;                    Executive Order 12866, this action is                   Pursuant to the Congressional Review
                                           telephone number: (410) 305–2905;                       not subject to Executive Order 13211,                 Act (5 U.S.C. 801 et seq.), EPA will
                                           email address: residuemethods@                          entitled ‘‘Actions Concerning                         submit a report containing this rule and
                                           epa.gov.                                                Regulations That Significantly Affect                 other required information to the U.S.
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                                                                                                   Energy Supply, Distribution, or Use’’ (66             Senate, the U.S. House of
                                           B. International Residue Limits                         FR 28355, May 22, 2001) or Executive                  Representatives, and the Comptroller
                                             In making its tolerance decisions, EPA                Order 13045, entitled ‘‘Protection of                 General of the United States prior to
                                           seeks to harmonize U.S. tolerances with                 Children from Environmental Health                    publication of the rule in the Federal
                                           international standards whenever                        Risks and Safety Risks’’ (62 FR 19885,                Register. This action is not a ‘‘major
                                           possible, consistent with U.S. food                     April 23, 1997). This action does not                 rule’’ as defined by 5 U.S.C. 804(2).


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                                           71638                Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Rules and Regulations

                                           List of Subjects in 40 CFR Part 180                            Supplement (NFS) to provide needed                    PART 1823—ENVIRONMENT, ENERGY
                                             Environmental protection,                                    editorial changes.                                    AND WATER EFFICIENCY,
                                           Administrative practice and procedure,                         DATES: Effective: October 18, 2016.                   RENEWABLE ENERGY
                                           Agricultural commodities, Pesticides                           FOR FURTHER INFORMATION CONTACT:                      TECHNOLOGIES, OCCUPATIONAL
                                           and pests, Reporting and recordkeeping                         Manuel Quinones, NASA, Office of                      SAFETY, AND DRUG-FREE
                                           requirements.                                                  Procurement, Contract and Grant Policy                WORKPLACE
                                              Dated: September 30, 2016.                                  Division, via email at
                                                                                                                                                                1823.7001    [Amended]
                                           Michael L. Goodis,                                             manuel.quinones@nasa.gov, or
                                           Acting Director, Registration Division, Office
                                                                                                          telephone (202) 358–2143.                             ■ 3. Amend section 1823.7001(c) by
                                           of Pesticide Programs.                                         SUPPLEMENTARY INFORMATION:                            removing the word ‘‘clause’’ and adding
                                             Therefore, 40 CFR chapter I is                               I. Background                                         word ‘‘provision’’ wherever it occurs.
                                           amended as follows:
                                                                                                             As part of NASA’s retrospective                    PART 1832—CONTRACT FINANCING
                                           PART 180—[AMENDED]                                             review of existing regulations NASA is
                                                                                                          conducting periodic reviews of the                    ■ 4. Amend section 1832.908 by adding
                                           ■ 1. The authority citation for part 180                       NASA FAR Supplement (NFS) to ensure                   paragraph (c)(2) to read as follows:
                                           continues to read as follows:                                  the accuracy of information
                                               Authority: 21 U.S.C. 321(q), 346a and 371.                 disseminated to the acquisition                       1832.908    Contract clauses.
                                                                                                          community. This rule makes
                                           ■  2. In § 180.523, add alphabetically the                                                                              (c)(2) When the clause at FAR 52.232–
                                                                                                          administrative changes to the NFS to
                                           commodities ‘‘beet, garden, leaves’’;                                                                                25, Prompt Payment, is used in such
                                                                                                          correct typographical errors as well as
                                           ‘‘beet, garden, roots’’; ‘‘hop, dried                                                                                contracts with the Canadian
                                                                                                          inadvertent omissions from prior
                                           cones’’; ‘‘rutabaga, roots’’; ‘‘turnip                                                                               Commercial Corporation (CCC), insert
                                                                                                          rulemaking actions. A summary of
                                           greens’’; ‘‘turnip, roots’’; ‘‘wheat,                                                                                ‘‘17th’’ in lieu of ‘‘30th’’ in paragraphs
                                                                                                          changes follows:
                                           forage’’; ‘‘wheat, grain’’; ‘‘wheat, hay’’;                                                                          (a)(1)(i)(A) and (B) and (a)(1)(ii).
                                                                                                             • Section 1816.406–70(c) is revised to
                                           and ‘‘wheat, straw’’ to the table in
                                                                                                          correct a typographical error.
                                           paragraph (c) to read as follows:                                                                                    PART 1845—GOVERNMENT
                                                                                                             • Section 1823.7001(c) is revised by
                                                                                                          replacing the word ‘‘clause’’ with the                PROPERTY
                                           § 180.523 Metaldehyde; tolerances for
                                           residues.                                                      word ‘‘provision.’’
                                                                                                             • Section 1832.908 is revised to add               ■  5. The authority citation for part 1845
                                           *       *    *           *        *
                                               (c) * * *                                                  a clause prescription inadvertently                   is revised to read as follows:
                                                                                                          omitted.                                                Authority: 51 U.S.C. 20113(a) and 48 CFR
                                                                                           Parts             • Section 1845.107–70(e) is revised to             chapter 1.
                                                        Commodity                           per           replace the word ‘‘property’’ with
                                                                                           million        ‘‘equipment’’ and paragraph (m) is                    1845.107–70       [Amended]
                                           Beet, garden, leaves ................                   0.08   revised to replace the term ‘‘NASA
                                                                                                          owned property’’ with ‘‘NASA real                     ■ 6. Amend section 1845.107–70—
                                           Beet, garden, roots ...................                 0.05
                                                                                                          property.’’                                           ■ a. In paragraph (e) introductory text,
                                              *         *           *               *              *         • Section 1852.217–72 is revised to                by removing ‘‘Government Property’’
                                           Hop, dried cones ......................                 0.10   correct the clause date.                              and adding ‘‘Government Equipment’’
                                           Rutabaga, roots ........................                0.05      • Section 1852.223–73 is revised to                in its place; and
                                                                                                          replace the word ‘‘clause’’ with the                  ■ b. In paragraph (m), by removing
                                              *         *              *               *           *      word ‘‘provision.’’
                                           Turnip greens ...........................               0.08                                                         ‘‘NASA owned property’’ and adding
                                                                                                             • Section 1852.231–71 is revised to                ‘‘NASA real property’’ in its place.
                                           Turnip, roots .............................             0.05
                                           Wheat, forage ...........................               0.05   correct the clause date.
                                           Wheat, grain .............................              0.05   List of Subject in 48 CFR Parts 1816,                 PART 1852—SOLICITATION
                                           Wheat, hay ...............................              0.05   1823, 1832, 1845, and 1852                            PROVISIONS AND CONTRACT
                                           Wheat, straw .............................              0.05                                                         CLAUSES
                                                                                                               Government procurement.
                                           *       *       *        *        *                            Manuel Quinones,                                      1852.217–72       [Amended]
                                           [FR Doc. 2016–25166 Filed 10–17–16; 8:45 am]
                                                                                                          NASA FAR Supplement Manager.                          ■ 7. Amend section 1852.217–72 by
                                           BILLING CODE 6560–50–P
                                                                                                            Accordingly, 48 CFR parts 1816, 1823,               removing ‘‘MAY 2000’’ and adding
                                                                                                          1832, 1845, and 1852 are amended as                   ‘‘NOV 2011’’ in its place.
                                           NATIONAL AERONAUTICS AND                                       follows:
                                                                                                                                                                1852.223–73       [Amended]
                                           SPACE ADMINISTRATION                                           ■ 1. The authority citation for parts
                                                                                                          1816, 1823, 1832, and 1852 continues to               ■ 8. Amend section 1852.223–73 by
                                           48 CFR Parts 1816, 1823, 1832, 1845,                           read as follows:                                      removing the word ‘‘clause’’ and adding
                                           and 1852                                                                                                             in its place the word ‘‘provision’’
                                                                                                            Authority: 51 U.S.C. 20113(a) and 48 CFR
                                                                                                          chapter 1.                                            wherever it occurs.
                                           NASA Federal Acquisition Regulation
                                           Supplement                                                     PART 1816—TYPES OF CONTRACTS                          1852.231–71       [Amended]
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                                           AGENCY:  National Aeronautics and                              1816.406–70       [Amended]                           ■ 9. Amend section 1852.231–71 by
                                           Space Administration.                                                                                                removing ‘‘MAR 1994’’ and adding
                                           ACTION: Technical amendments.                                  ■ 2. Amend section 1816.406–70(e) by
                                                                                                          removing the words ‘‘in cost an award                 ‘‘APR 2015’’ in its place.
                                                  NASA is making technical
                                           SUMMARY:                                                       fee’’ and adding ‘‘in award fee’’ in its              [FR Doc. 2016–25014 Filed 10–17–16; 8:45 am]
                                           amendments to the NASA FAR                                     place.                                                BILLING CODE 7510–13–P




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Document Created: 2016-10-17 23:52:09
Document Modified: 2016-10-17 23:52:09
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective October 18, 2016. Objections and requests for hearings must be received on or before December 19, 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).
ContactMichael 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
FR Citation81 FR 71633 

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