[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)C8-C18
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)C8-
C18 alkylammonium chlorides where the poly(oxyethylene)
content is n=2-15 and where C8-C18 alkyl is
linear and may be saturated or unsaturated, herein referred to in this
document as methyl poly(oxyethylene)C8-C18
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: [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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
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:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
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 15th 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)C8-C18 alkylammonium chlorides
where the poly(oxyethylene) content is n=2-15 and where C8-
C18 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
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Acute dietary (all populations) Acute toxicity was not identified.
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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
C8-C18 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)C8-
C18 alkylammonium chlorides where the poly(oxyethylene)
content is n=2-15 and where C8-C18 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..
* * * * * * *
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[FR Doc. E9-18348 Filed 8-4-09; 8:45 am]
BILLING CODE 6560-50-S