[Federal Register Volume 74, Number 149 (Wednesday, August 5, 2009)]
[Rules and Regulations]
[Pages 38956-38962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18348]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0042; FRL-8424-4]


Methyl Poly(Oxyethylene)C<INF>8-</INF>C<INF>18</INF> 
Alkylammonium Chlorides; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of methyl poly(oxyethylene)C<INF>8</INF>-
C<INF>18</INF> alkylammonium chlorides where the poly(oxyethylene) 
content is n=2-15 and where C<INF>8</INF>-C<INF>18</INF> alkyl is 
linear and may be saturated or unsaturated, herein referred to in this 
document as methyl poly(oxyethylene)C<INF>8</INF>-C<INF>18</INF> 
alkylammonium chlorides (MPOACs), when used as an inert ingredient in 
pesticide formulations for pre-harvest uses under 40 CFR 180.920 at a 
maximum of 10% by weight in herbicide formulations and 5% by weight in 
all other formulations. The Joint Inerts Task Force (JITF), Cluster 
Support Team (CST No. 7), submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of MPOACs.

DATES: This regulation is effective August 5, 2009. Objections and 
requests for hearings must be received on or before October 5, 2009, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0042. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8811; e-mail address: <a href="/cdn-cgi/l/email-protection#3559505c5350471b5e5047474c755045541b525a43"><span class="__cf_email__" data-cfemail="9bf7fef2fdfee9b5f0fee9e9e2dbfeebfab5fcf4ed">[email protected]</span></a>.

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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Hamonized 
Guidlines referenced in this document, go directly to the guidelines at 
http://www.epa.gpo/opptsfrs/home/suidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0042 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before October 5, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0042, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background

    In the Federal Register of March 4, 2009 (74 FR 9397) (FRL-8401-8), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 9E7518) 
by The JITF, CST No. 7, c/o CropLife America, 1156 15<SUP>th</SUP> St., 
NW., Suite 400, Washington, DC 20005. The petition requested that 40 
CFR 180.920 be

[[Page 38957]]

amended by establishing exemptions from the requirement of a tolerance 
for residues of the inert ingredient methyl 
poly(oxyethylene)C<INF>8</INF>-C<INF>18</INF> alkylammonium chlorides 
where the poly(oxyethylene) content is n=2-15 and where C<INF>8</INF>-
C<INF>18</INF> alkyl is linear and may be saturated or unsaturated 
(MPOACs) for pre-harvest uses at a maximum of 10% by weight in 
herbicide formulations and 5% by weight in all other formulations. That 
notice referenced a summary of the petition prepared by The JITF, CST 
No. 7, the petitioner, which is available to the public in the docket, 
http://www.regulations.gov.
    The Agency received two comments in response to the notice of 
filing. Both comments was received from private citizens who opposed 
the authorization to sell any pesticide that leaves a residue on food. 
The Agency understands the commenters' concerns and recognizes that 
some individuals believe that no residue of pesticides should be 
allowed. However, under the existing legal framework provided by 
section 408 of FFDCA, EPA is authorized to establish pesticide 
tolerances or exemptions where persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute.
    This petition was submitted in response to a final rule of August 
9, 2006, (71 FR 45415) (FRL-8084-1) in which the Agency revoked, under 
section 408(e)(1) of the FFDCA, the existing exemptions from the 
requirement of a tolerance for residues of certain inert ingredients 
because of insufficient data to make the determination of safety 
required by section 408(b)(2) of FFDCA. The expiration date for the 
tolerance exemptions subject to revocation was August 9, 2008, which 
was later extended August 9, 2009 by a final rule published in the 
Federal Register of August 4, 2008. (73 FR 45312) (FRL-8372-7) to allow 
for data to be submitted to support the establishment of tolerance 
exemptions for these inert ingredients prior to the effective date of 
the tolerance exemption revocation.

 III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of 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. . . .
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
exemption from the requirement of a tolerance for residues of MPOACs 
when used as inert ingredients in pesticide formulations for pre-
harvest uses at a maximum of 10% by weight in herbicide formulations 
and 5% by weight in all other formulations. EPA's assessment of 
exposures and risks associated with establishing tolerances follows.

 A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
     The toxicity data available on the MPOACs consists of acute 
toxicity studies, mutagenicity studies, and an OPPTS Harmonized 
Guideline 870.3650 combined repeated dose toxicity study with the 
reproduction/developmental toxicity screening test. The majority of the 
MPOAC compounds are reported as ``not acutely toxic'' for lethality by 
the oral and dermal routes of exposure (Toxicity Category III). 
However, CAS Reg. No. 70750-47-9, the representative test compound, is 
more toxic by the oral and dermal routes (Toxicity Category II). All 
MPOACs are severely irritating to the eye (Toxicity Category I), and 
the MPOAC identified by CAS Reg. No.70750-47-9 (quatenary ammonium 
compounds, coco alkylbis(hydroxyethyl)methy1, chlorides) is severely 
irritating to the skin. Inhalation data on two of the MPOACs indicate 
irritation at high doses.
    The OPPTS Harmonized Guideline 870.3650 study on the representative 
surfactant, (CAS Reg. No. 70750-47-9) demonstrated severe toxicity in 
rats, as evidenced by deaths of all test subjects at 100 milligrams/
kilogram/day (mg/kg/day) after 5 days, and deaths of 5 out of 10 
females at 50 mg/kg/day after 6-8 days of exposure. Given the extremely 
corrosive nature of the test material, the Agency believes that the 
high mortality rate is secondary to the forestomach lesions seen in the 
rats. Further, the Agency notes that the severity of the effects may be 
related to the unique anatomy of the rats. Humans do not have a 
forestomach which serves as a storage reservoir in rodents; therefore, 
effects seen in the rat forestomach are likely to be significantly more 
severe than what would be expected from the compound in the glandular 
stomachs in humans and therefore, have less relevance to humans.
    The no observed adverse effect level (NOAEL) for developmental and 
reproductive toxicity is 25 mg/kg/day, the lowest dose tested (LDT). 
Although no reproductive or developmental effects were observed at the 
next higher dose of 50 mg/kg/day, the evaluation at

[[Page 38958]]

this dose level included only 5 surviving female animals. While the 
actual lowest observed adverse effect level (LOAEL) for reproductive 
developmental effects may be higher, or reproductive developmental 
effects may not occur at all as a result of exposure to this chemical, 
in the absence of a sufficient number of animals to assess, the Agency 
has conservatively assumed that if more animals had been available at 
the mid-dose, developmental or reproductive toxicity might have been 
observed. There are no concerns for sensitivity of offspring.
    There was no evidence of neurotoxicity in this study; functional- 
observational battery and motor-activity data were similar in all the 
treatment groups. Liver enzymes were elevated but were not accompanied 
by microscopic lesions or increased organ weight and were not 
considered adverse. No carcinogenicity studies are available for the 
MPOACs. A qualitative structure activity relationship database, DEREK 
Version 11, identified no structural alerts suggestive of 
carcinogenicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by MPOACs as well as the NOAEL and the LOAEL 
from the toxicity studies can be found at http://www.regulations.gov in 
document MPOACs-JITF CST No. 7 Inert Ingredients). Human Health Risk 
Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as Inert Ingredients in Pesticide Formulations 
pages 9-13 and pages 25-26 in docket ID number EPA-HQ-OPP-2009-0042.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose tested (HDT) at 
which the NOAEL in the toxicology study identified as appropriate for 
use in risk assessment. However, if a NOAEL cannot be determined, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) or a benchmark dose (BMD) approach is sometimes used for risk 
assessment. Uncertainty/safety factors (UFs) are used in conjunction 
with the POD to take into account uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. Safety is assessed for acute and chronic dietary 
risks by comparing aggregate food and water exposure to the pesticide 
to the acute population adjusted dose (aPAD) and chronic population 
adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the 
POD by all applicable UFs. Aggregate short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the level of concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for MPOACs used for human 
health risk assessment is shown in Table 1 of this unit.

    Table 1.--Summary of Toxicological Doses and Endpoints for MPOACs for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)                            Acute toxicity was not identified.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 25 mg/kg/day     Chronic RfD = 0.25 mg/   LOAEL = 50 mg/kg/day
                                       UFA = 10x..............   kg/day                   based on stomach
                                       UFH = 10x..............  cPAD = 0.25 mg/kg/day..   inflammation and
                                       Food quality protection                            mortality associated
                                        act (FQPA) SF = 1x.                               with the forestomach
                                                                                          inflammation
----------------------------------------------------------------------------------------------------------------
Incidental oral (short-term and        NOAEL= 25 mg/kg/day      Residential LOC for MOE  LOAEL = 50 mg/kg/day
 intermediate-term)                     UFA = 10x.............   = 100                    based on stomach
                                       UFH = 10x..............                            inflammation and
                                       FQPA SF = 1x...........                            mortality associated
                                                                                          with the forestomach
                                                                                          inflammation.
----------------------------------------------------------------------------------------------------------------
Dermal and inhalation (all durations)  Quantitative assessment not required: Cluster is corrosive irritating and
                                           exposure will be self limiting; expected low-dermal and inhalation
                                          absorptions; product is used in low percentages in household products
                                                                  (i.e., low exposure).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)         Classification: No animal toxicity data available for an assessment.
                                            Based on SAR analysis, MPOACs is not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
 POD = A data point or an estimated point that is derived from observed dose-response data and used to mark the
  beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.
  NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty
  factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity
  among members of the human population (intraspecies). PAD = population adjusted dose (a=acute, c=chronic).
  FQPA SF = FQPA Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A =
  not applicable.

C. Exposure Assessment

     Sufficient data were provided on the chemical identity of the 
MPOACs; however, limited data are available on the metabolism and 
environmental degradation of these compounds. The Agency relied 
collectively on information provided on the representative chemical 
structures, the generic cluster structures, the submitted 
physicochemical data, structure-activity relationship information, as 
well as

[[Page 38959]]

information on other surfactants and chemicals of similar size and 
functionality to determine the residues of concern for these inert 
ingredients. The residues of concern for risk assessment purposes are 
the parent compounds only.
    The registrant selected CAS Reg. No. 70750-47-9, as the test 
compound because the coco alkyl encompasses the broad range of 
C<INF>8</INF>-C<INF>18</INF> alkyl chain included in the descriptor. 
The Agency concluded that the cluster grouping was appropriate. 
Further, the Agency also concluded that it is unlikely that any 
potential environmental degradates that would be found in food and 
water will be more toxic than the parent compound. Residue estimates 
used in the dietary risk assessment were chosen to represent an upper 
bound on the combined residues of parent and any potential metabolite 
or degradate of concern.
    Quantitative dermal or inhalation risk assessments were not be 
performed for residential exposures because the MPOACs are highly 
corrosive irritating, and therefore, exposure will be self-limiting and 
will be regulated based on labeling of the formulations. There is not a 
significant concern for dermal or inhalation exposures due to expected 
low dermal and inhalation absorptions and the fact that the product is 
used in low percentages in household products (i.e., low exposure). An 
aggregate assessment need only be conducted for food, water, and 
incidental oral exposures.
    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to MPOACs, EPA considered exposure under the petitioned-for 
exemptions from the requirement of a tolerance. EPA assessed dietary 
exposures from MPOACs in food as follows:
    i. Acute exposure. No adverse effects attributable to a single 
exposure of MPOACs was seen in the toxicity databases. Therefore, acute 
dietary risk assessments for MPOACs is not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, no residue data were submitted for MPOACs. In the 
absence of specific residue data, EPA has developed an approach which 
uses surrogate information to derive upper bound exposure estimates for 
the subject inert ingredient. Upper bound exposure estimates are based 
on the highest tolerance for a given commodity from a list of high-use 
insecticides, herbicides, and fungicides. A complete description of the 
general approach taken to assess inert ingredient risks in the absence 
of residue data is contained in the memorandum entitled Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts. 
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the 
residue level of the inert ingredient would be no higher than the 
highest tolerance for a given commodity. Implicit in this assumption is 
that there would be similar rates of degradation (if any) between the 
active and inert ingredient and that the concentration of inert 
ingredient in the scenarios leading to these highest of tolerances 
would be no higher than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms. First, assuming that the 
level of residue for an inert ingredient is equal to the level of 
residue for the active ingredient will overstate exposure. The 
concentrations of active ingredient in agricultural products is 
generally at least 50% of the product and often can be much higher. 
Further, pesticide products rarely have a single inert ingredient; 
rather there is generally a combination of different inert ingredients 
used which additionally reduces the concentration of any single inert 
ingredient in the pesticide product in relation to that of the active 
ingredient. In the case of MPOACs, EPA made a specific adjustment to 
the dietary exposure assessment to account for the use limitations of 
the amount of MPOACs that may be in formulations (no more than 10% by 
weight in herbicide formulations) and assumed that the MPOACs are 
present at the maximum limitations rather than at equal quantities with 
the active ingredient. This remains a very conservative assumption 
because surfactants are generally used at levels far below this 
percentage.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Finally, a third compounding conservatism is EPA's assumption that all 
foods contain the inert ingredient at the highest tolerance level. In 
other words, EPA assumed 100% of all foods are treated with the inert 
ingredient at the rate and manner necessary to produce the highest 
residue legally possible for an active ingredient. In summary, EPA 
chose a very conservative method for estimating what level of inert 
residue could be on food, then used this methodology to choose the 
highest possible residue that could be found on food and assumed that 
all food contained this residue. No consideration was given to 
potential degradation between harvest and consumption even though 
monitoring data shows that tolerance level residues are typically one 
to two orders of magnitude higher than actual residues in food when 
distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data.
    iii. Cancer. The Agency used a qualitative SAR database, DEREK11, 
to determine if there were structural alerts suggestive of 
carcinogenicity. No structural alerts for carcinogenicity were 
identified. MPOACs are not expected to be carcinogenic. Therefore, a 
cancer dietary exposure assessment is not necessary to assess cancer 
risk.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and PCT information in the dietary 
assessment for MPOACs. 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 MPOACs in drinking water. These simulation models take 
into account data on the physical, chemical, and fate transport 
characteristics of MPOACs. Further information regarding EPA drinking 
water models used in the pesticide exposure assessment can be

[[Page 38960]]

found at http://www.epa.gov/oppefed1/models/water/index.htm.
    A screening level drinking water analysis, based on the Pesticide 
Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) was 
performed to calculate the estimated drinking water concentrations 
(EDWCs) of MPOACs. Modeling runs on four surrogate inert ingredients 
using a range of physical chemical properties that would bracket those 
of MPOACs were conducted. Modeled acute drinking water values ranged 
from 0.001 parts per billion (ppb) to 41 ppb. Modeled chronic drinking 
water values ranged from 0.0002 ppb to 19 ppb. Further details of this 
drinking water analysis can be found at http://www.regulations.gov in 
the document MPOACs- JITF, (CST No. 7 Inert Ingredients). Human Health 
Risk Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as Inert Ingredients in Pesticide Formulations, 
pages 13-14 and 28-46 in docket ID number EPA-HQ-OPP-2009-0042.
    For the purpose of the screening level dietary risk assessment to 
support this request for an exemption from the requirement of a 
tolerance for MPOACs, a conservative drinking water concentration value 
of 100 ppb based on screening level modeling was used to assess the 
contribution to drinking water for chronic dietary risk assessments for 
the parent compounds and for the metabolites of concern. These values 
were directly entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). MPOACs may be used in 
inert ingredients in pesticide products that are registered for 
specific uses that may result in both indoor and outdoor residential 
exposures. A screening level residential exposure and risk assessment 
was completed for products containing MPOACs as inert ingredients. In 
this assessment, representative scenarios, based on end-use product 
application methods and labeled application rates, were selected. The 
MPOACs may be used as inert ingredients in pesticide formulations that 
are used in and around the home. Additionally, uses are possible in 
household cleaning products and in personal care products. The Agency 
has not selected endpoints for dermal or inhalation risk assessmenst; 
therefore, only exposure scenarios which will result in oral exposures 
have been assessed for the MPOACs. The Agency conducted an assessment 
to represent worst-case residential exposure by assessing 
postapplication exposures and risks from MPOACs in pesticide 
formulations (outdoor scenarios) and MPOACs in disinfectant-type uses 
(indoor scenarios). Further details of this residential exposure and 
risk analysis can be found at http://www.regulations.gov in the 
memorandum 9entitled JITF Inert Ingredients. Residential and 
Occupational Exposure Assessment Algorithms and Assumptions Appendix 
for the Human Health Risk Assessments to Support Proposed Exemption 
from the Requirement of a Tolerance When Used as Inert Ingredients in 
Pesticide Formulations; (D364751, 5/7/09, Lloyd/LaMay in docket ID 
number EPA-HQ-OPP-2008-0710.
    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 MPOACs to share a common mechanism of toxicity 
with any other substances, and the MPOACs do not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that the MPOACs do not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional SF when reliable data available to EPA 
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The toxicity data available 
on the MPOACs consists of acute toxicity studies, mutagenicity studies, 
and an OPPTS Harmonized Guideline 870.3650 combined repeated dose 
toxicity study with the reproduction developmental toxicity screening 
test.
    There was no evidence of increased sensitivity in young animals 
because no developmental or reproductive toxicity occurred in the 
lowest dose group (doses of 25 mg/kg/day) in the reproductive 
developmental toxicity screening test. Additionally, no developmental 
or reproductive toxicity was noted in the mid-dose group (doses of 50 
mg/kg/day); however, since there were only five surviving female 
animals in this group, which is considered an insufficient number of 
animals, the study LOAEL was set at the mid-dose level. The mortality 
in rats that occurred in the study was associated with forestomach 
inflammation. Given the extremely corrosive nature of the test 
material, the Agency believes that the high mortality rate is secondary 
to the forestomach lesions seen in the rats. Further, the Agency notes 
that the severity of the effects may be related to the unique anatomy 
of the rats. Humans do not have a forestomach which serves as a storage 
reservoir in rodents; therefore effects seen in the rat forestomach are 
likely to be significantly more severe than what would be expected from 
the compound in the glandular stomachs in humans, and therefore, have 
less relevance to humans.
    There was no evidence of neurotoxicity in the OPPTS Harmonized 
Guideline 870.3650 study; functional-observational battery and motor-
activity data were similar in all the treatment groups.
    There are no residual uncertainties identified in the exposure 
databases. The dietary (food and water) exposure assessment is not 
likely to underestimate exposure to any subpopulation, including those 
comprised of infants and children.
    3. Conclusion. EPA has determined that reliable data show that 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 MPOACs is considered adequate for 
assessing the risks to infants and children (the available studies are 
described in Unit IV.D.2).
    ii. No quantitative or qualitative increased susceptibility was 
demonstrated in the offspring in the OPPTS Harmonized Guideline 
870.3650

[[Page 38961]]

combined repeated dose toxicity study with the reproduction 
developmental toxicity screening test in rats following in utero and 
post-natal exposure.
    iii. Although mortality occurred in the OPPTS Harmonized Guideline 
870.3650 study that was associated with forestomach inflammation, the 
Agency believes that, given the extremely corrosive nature of the test 
material, the high mortality rate is secondary to the forestomach 
lesions seen in the rats. Further, the Agency notes that the severity 
of the effects may be related to the unique anatomy of the rats. Humans 
do not have a forestomach which serves as a storage reservoir in 
rodents; therefore effects seen in the rat forestomach are likely to be 
significantly more severe than what would be expected from the compound 
in the glandular stomachs in humans and therefore, have less relevance 
to humans.
    iv. There was no evidence of neurotoxicity in the OPPTS Harmonized 
Guideline 870.3650 study. Functional-observational battery and motor-
activity data were similar in all the treatment groups. Thus, no 
additional neurotoxicity data are required.
    v. While there is no chronic toxicity study, the Agency has 
concluded that since endpoint risk assessment is based on the 
forestomach lesions in rats, a very conservative hazard endpoint, 
coupled with the highly conservative exposure assessment and an absence 
of evidence of increased sensitivity, or neurotoxicity, the use of the 
standard 100X inter-species and intra-species UF are adequate to 
protect infants and children, and no additional UF is needed for 
extrapolating from subchronic to chronic exposure.
    vi. There are no residual uncertainties identified in the exposure 
databases. The food and drinking water assessment is not likely to 
underestimate exposure to any subpopulation, including those comprised 
of infants and children. The food exposure assessments are considered 
to be highly conservative as they are based on the use of the highest 
tolerance level from the surrogate pesticides for every food and 100 
PCT is assumed for all crops. EPA also made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to MPOACs in drinking water. EPA used similarly conservative 
assumptions to assess post-application exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by MPOACs.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. There was no hazard attributable to a single 
exposure seen in the toxicity database for MPOACs. Therefore, the 
MPOACs are not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account exposure estimates from chronic dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for chronic exposure, the chronic dietary exposure from food and water 
to MPOACs is 16% of the cPAD for the U.S. population and 51% of the 
cPAD for children 1-2 yrs old, the most highly exposed population 
subgroup.
    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).
     MPOACs are used as an inert ingredients in pesticide products that 
are 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 MPOACs. Using the exposure 
assumptions described in this unit, EPA has concluded the combined 
short-term aggregated food, water, and residential exposures result in 
an aggregate MOE of 190 for children. Children's residential exposure 
includes hand-to-mouth exposures. As the LOC is for MOEs that are lower 
than 100, this MOE is 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).
    MPOACs are 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 MPOACs. Using the 
exposure assumptions described in this unit, EPA has concluded the 
combined intermediate-term aggregated food, water, and residential 
exposures result in an aggregate MOE of 190 for children. Children's 
residential exposure includes hand-to-mouth exposures. As the LOC is 
for MOEs that are lower than 100, this MOE is not of concern.
     5. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to MPOACs.
    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 residues of MPOACs.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for 
MPOACs nor have any CODEX Maximum Residue Levels been established for 
any food crops at this time.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues methyl poly(oxyethylene)C<INF>8</INF>-
C<INF>18</INF> alkylammonium chlorides where the poly(oxyethylene) 
content is n=2-15 and where C<INF>8</INF>-C<INF>18</INF> alkyl is 
linear and may be saturated or unsaturated (MPOACs) for pre-harvest 
uses at a maximum of 10% by weight in herbicide formulations and 5% by 
weight in all other formulations.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735,

[[Page 38962]]

October 4, 1993). Because this final rule has been exempted from review 
under Executive Order 12866, this final rule is not subject to 
Executive Order 13211, entitled Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 21, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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. 180.920, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
       Inert Ingredients               Limits               Uses
-----------------------------------------------------------------------
                              * * * * * * *
Methyl poly(oxyethylene)C8-C18   Concentration in    Surfactants,
 alkylammonium chlorides where    formulated end      related
 the poly(oxyethylene) content    use products not    adjuvants of
 is n=2-15 and where C8-C18       to exceed 10% by    surfactants
 alkyl is linear and may be       weight in
 saturated or unsaturated (CAS    herbicide
 Reg. Nos. 3010-24-0, 18448-65-   products and 5%
 2, 70750-47-9, 22340-01-8,       by weight in all
 67784-77-4, 64755-05-1, 61791-   other pesticide
 10-4, 28724-32-5, 28880-55-9,    products.
 68187-69-9, 68607-27-2, 60687-
 90-3..
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. E9-18348 Filed 8-4-09; 8:45 am]
BILLING CODE 6560-50-S


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