Federal Register: December 20, 2006 (Volume 71, Number 244)
DOCID: FR Doc E6-21499
ENVIRONMENTAL PROTECTION AGENCY
Environmental Protection Agency
CFR Citation: 40 CFR Part 180
EPA ID: [EPA-HQ-OPP-2005-0532; FRL-8104-6]
ACTION: Pesticides; tolerances in food, animal feeds, and raw agricultural commodities:
DOCUMENT ACTION: Final rule.
Dimethomorph; Pesticide Tolerance
DATES: This regulation is effective December 20, 2006. Objections and requests for hearings must be received on or before February 20, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
This regulation establishes a tolerance for residues of the fungicide, dimethomorph, (E,Z) 4[3(4
chlorophenyl)3(3,4dimethoxyphenyl)1oxo2propenyl] morpholine in or on brassica, head and stem, subgroup 5A. The Interregional Research Project No. 4 (IR4), 500 College Road East, Suite 201 W, Princeton, NJ 08540 requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
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:
This listing is not intended to be exhaustive, but rather provides 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 an electronic copy of this Federal
Register document through the electronic docket 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 40 CFR part 180 through the Government Printing Office's pilot eCFR site at http://www.gpoaccess.gov/ecfr .
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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 EPAHQOPP20050532 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 on or before February 20, 2007.
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 your copies, identified by docket ID number EPAHQOPP20050532, by one of the following methods:
II. Background and Statutory Findings
In the Federal Register of March 10, 2006 (71 FR 12356) (FRL7761 6), 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 4E6848) by IR4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.493 be amended by establishing a tolerance for residues of the fungicide, dimethomorph, (E,Z) 4[3(4chlorophenyl)3(3,4dimethoxyphenyl)1oxo2propenyl] morpholine in or on Brassica head and stem (Subgroup 5A) at 2.0 parts per million (ppm). That notice included a summary of the petition prepared by BASF, the registrant. There were no comments received in response to the notice of filing.
Supporting documents including the Agency's Human Health Risk Assessment of dimethomorph and other documents are available at http://www.regulations.gov under the index of the docket for this action, docket ID number EPAHQOPP20050537.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....''
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPAPEST/1997/November/Day26/p30948.htm .
III. Aggregate Risk Assessment and Determination of Safety
Consistent with 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of dimethomorph on brassica, head and stem, subgroup 5A food commodities at 2.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance 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. Specific information on the studies received and the nature
of the toxic effects caused by dimethomorph as well as the noobserved
adverseeffectlevel (NOAEL) and the lowestobservedadverseeffect level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov under docket ID number EPAHQOPP20050532; entitled, ``Amended: Dimethomorph: Human Health Risk Assessment for Proposed Uses on Brassica Stem and Head Subgroup 5A'', dated November 15, 2006.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no appreciable risk, the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify nonthreshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for dimethomorph used for human risk assessment can be found at http://www.regulation.gov under docket ID number EPAHQOPP20050532, entitled, ``Amended: Dimethomorph: Human Health Risk Assessment for Proposed Uses on Brassica Stem and Head Subgroup 5A'', dated November 15, 2006.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.493) for the residues of dimethomorph, in or on a variety of raw agricultural commodities including: Brassica, leafy greens, subgroup 5B; lettuce, head; lettuce, leaf; potato, wet peel; taro, corm; taro, leaves; vegetable, bulb, group 3; vegetable, cucurbit, group 9; and vegetable, fruiting, group 8. Risk assessments were conducted by EPA to assess dietary exposures from dimethomorph in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a fooduse pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring as a result of a 1day or single exposure.
No such effects were identified in the toxicological studies for dimethomorph. A quantitative acute dietary exposure and risk assessment was therefore not conducted for dimethomorph. No acute risk is expected from exposure to dimethomorph.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEMFCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 19941996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
In conducting a Tier 1 chronic dietary risk assessment, the Agency made the following conservative assumptions:
a. All commodities having dimethomorph tolerances contain residues at the level of the tolerance, and
b. Treatment of 100% of all registered and proposed crops.
iii. Cancer. EPA has classified dimethomorph ``not likely'' to be human carcinogen. Therefore, a quantitative cancer dietary exposure and risk assessment was not performed.
2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for dimethomorph in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of dimethomorph. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.
Acute and chronic estimated drinking water concentrations (EDWCs) of dimethomorph in surface water were calculated using Generic Estimated Environmental Concentration (GENEEC) Model. Drinking water residues were then incorporated into the DEEMFCID(\TM\) into the food categories ``water, direct, all sources'' and ``water, indirect, all sources.''
Based on the Tier 1 GENEEC and Surface Water and Screening Concentrations in Ground Water (SCIGROW) models, the EDWCs of dimethomorph for chronic exposures are 28.5 parts per billion (ppb) for surface water and 0.30 ppb for ground water.
3. From nondietary exposure. The term ``residential exposure'' is
used in this document to refer to nonoccupational, nondietary exposure (e.g., for lawn and garden pest control,
indoor pest control, termiticides, and flea and tick control on pets).
Dimethomorph is not registered for use on any sites that would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the 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.''
Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to dimethomorph and any other substances and dimethomorph does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that dimethomorph has 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative .
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply an additional tenfold 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. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. The toxicology data on dimethomorph provide no indication of enhanced sensitivity of infants and children based on the results from developmental studies conducted with rats and rabbits as well as a 2generation reproduction study conducted with rats. There were no toxic effects observed in either the rat developmental toxicity or the rat 2generation reproductive toxicity studies that were lower than doses which produced toxic effects in the parents. No developmental toxicity was demonstrated in the rabbit developmental toxicity study. The developmental and reproductive toxicity data did not indicate increased susceptibility of rats or rabbits to in utero and/or postnatal exposure.
3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings:
i. The toxicity database for dimethomorph is complete.
ii. There is no evidence that dimethomorph results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2generation reproduction study.
iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% crop treated (CT) and tolerancelevel residues. Conservative ground water and surface water modeling estimates were used.
Residential exposure to dimethomorph is not expected since there are no currently registered residential uses for the pesticide. E. Aggregate Risks and Determination of Safety
In examining aggregate risk, the Agency takes into account all available reliable information concerning exposures from pesticide residues in food and other exposures including drinking water and potential residential exposure to pesticides from such uses as lawn care applications (turf), golf course and others. Aggregate risk assessment considerations must also include potential exposures from oral, dermal and inhalation routes.
1. Acute risk. No acute dietary toxicity endpoints were identified; no acute risk is expected from exposure to dimethomorph.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to dimethomorph from food + water will utilize 8.6% of the chronic population adjusted dose (cPAD) for the U.S. population, 7.0% of the cPAD for all infants < 1 year, and 19.9% of the cPAD for children 2 years. There are no residential uses for dimethomorph that result in chronic residential exposure. Risk estimates for all population subgroups are below the Agency's LOC (do not exceed 100% of the cPAD).
3. Shortterm risk. Shortterm aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
Dimethomorph is not registered for use on any sites that would result in residential exposure. Therefore, a shorttern aggregate risk assessment is not required. The aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC.
4. Intermediateterm risk Intermediateterm aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
Dimethomorph is not registered for use on any sites that would result in residential exposure. Therefore, an intermediateterm risk assessment is not required. The aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC.
5. Aggregate cancer risk for U.S. population. Dimethomorph has been classified as a Group E carcinogen showing no evidence of human carcinogenicity. This classification was based upon lack of evidence of carcinogenicity in rat and mice studies. The Agency concludes that the pesticidal uses of dimethomorph are not likely to pose a cancer risk to humans.
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, and to infants and children from aggregate exposure to dimethomorph residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A reliable method for the determination of dimethomorph residues in
brassica, head and stem subgroup 5A exist; this method is the Food and
Drug Administration (FDA) MultiResidue Method, Protocol D, as
published in the Pesticide Analytical Manual I. In addition, the method
may be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 207555350; telephone number: (410) 3052905; email address: firstname.lastname@example.org. B. International Residue Limits
There are no established or proposed Codex, Canadian or Mexican maximum residue limits or tolerance for dimethomorph in or on brassica, head and stem, subgroup 5A.
Therefore, the tolerance is established for residues of dimethomorph, (E,Z) 4[3(4chlorophenyl)3(3,4dimethoxyphenyl)1 oxo2propenyl] morpholine in or on brassica, head and stem, subgroup 5A at 2.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 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., or 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 1044). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 104113, section 12(d) (15 U.S.C. 272 note). 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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: December 8, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.493 is amended by alphabetically adding a commodity to the table in paragraph (a) to read as follows:
Sec. 180.493 Dimethomorph; tolerance for residues.
(a) * * *
Commodity Parts per million * * * * *
Brassica, head and stem, subgroup 5A................. 2.0 * * * * *
* * * * *
[FR Doc. E621499 Filed 121906; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT
Sidney Jackson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3057610; email address: email@example.com.