Pesticide programs: contributing tolerances; reassessment,

[Federal Register: May 22, 2002 (Volume 67, Number 99)]

[Notices]

[Page 35991-35996]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr22my02-56]

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0060; FRL-7178-9]

Organophosphate Pesticides; Reassessment of Certain Non- Contributing Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

SUMMARY: As part of its ongoing review of existing organophosphate (OP) tolerances under the Food Quality Protection Act (FQPA), EPA has determined that 275 OP tolerances can be reassessed at this time. These ``non-contributor'' tolerances meet the FQPA safety standard in section 408(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) and can be reassessed for the purposes of FFDCA section 408(q). EPA has concluded that these tolerances make, at most, a negligible contribution to the cumulative risk from OP pesticides. This Notice discusses the concept and basis for this approach to reassessing selected OP tolerances based on available information relating to the OP cumulative risk assessment. EPA expects that additional tolerances will be appropriate for reassessment based on the kind of approach described in this Notice. This Notice also identifies the first non- contributor tolerances that are considered reassessed (certain tolerances for meat commodities, animal feeds, refined sugars, and other uses), and seeks comment on EPA's approach to the identification of other non-contributors.

DATES: Comments, identified by the docket control number OPP-2002-0060, for approaches for identifying other tolerances that make, at most, a negligible contribution to the cumulative risk from OP pesticides must be received on or before June 21, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify the docket control number OPP-2002-0060 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Karen Angulo, Special Review and Reregistration Division (7805C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703-308-8004; e-mail address: angulo.karen@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      This action is directed to the public in general who are interested in the use of pesticides on food. As such, the Agency has not attempted to specifically describe all the entities potentially affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

      [[Page 35992]]

   2. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

      1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. On the Home Page select ``Laws and Regulations,'' ``Regulations and Proposed Rules,'' and then look up the entry for this document under the ``Federal Register--Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/ fedrgstr/. In addition, copies of this Notice may also be accessed at http: www.epa.gov/pesticides/cumulative under the heading ``Tolerance Activities.''

      2. In person. The Agency has established an official record for this action under docket control number OPP-2002-0060. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

   3. How and to Whom Do I Submit Comments?

      You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify the docket control number OPP-2002-0060 in the subject line on the first page of your response.

      1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

      2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

      3. Electronically. You may submit your comments electronically by e-mail to: opp-docket@epa.gov, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-2002-0060. Electronic comments may also be filedonline at many Federal Depository Libraries.

   4. How Should I Handle CBI that I Want to Submit to the Agency?

      Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

   5. What Should I Consider as I Prepare My Comments for EPA?

      You may find the following suggestions helpful for preparing your comments:

      1. Explain your views as clearly as possible.

      2. Describe any assumptions that you used.

      3. Provide copies of any technical information and/or data you used that support your views.

      4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

      5. Provide specific examples to illustrate your concerns.

      6. Offer alternative ways to improve the notice.

      7. Make sure to submit your comments by the deadline in this document.

      8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

2. Background

   The Food Quality Protection Act of 1996 significantly amended the FFDCA, creating a new safety standard for judging the acceptability of tolerances for pesticide residues in food. The new statutory standard allows EPA to approve a new tolerance or leave an existing tolerance in place only if the tolerance is ``safe.'' The statute 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 data'' (FFDCA section 408(b)(2)(A)(ii)). In making the safety determination, EPA ``shall consider, among other relevant factors . . . available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity'' (FFDCA section 408(b)(2)(D)(v)). The FQPA amendments not only made the new safety standard applicable to new tolerances, but also to tolerances in existence when FQPA became law. FQPA set a 10- year schedule for EPA to reassess all existing tolerances, with interim deadlines for completion of 33% and 66% of tolerance reassessments 3 and 6 years, respectively, after the date of enactment. Pesticide tolerances subject to reassessment under FQPA section 408(q) may only remain in effect without modification if they meet the section 408(b)(2) safety standard. Finally, FQPA instructed EPA to give priority to the review of tolerances which appear to pose the greatest risk to public health.

   Consistent with the FQPA mandate, EPA identified OP pesticides as high priority for tolerance reassessment. EPA has determined that the OPs share a ``common mechanism of toxicity,'' the inhibition of cholinesterase, and therefore the Agency will consider the cumulative risks of OPs in making the safety determination for any tolerance for a pesticide in this group. The Agency has reviewed individual OP

   [[Page 35993]]

   pesticides to determine whether they meet the current health and safety standards of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the FFDCA safety standard, and has presented its determinations in documents called ``Interim Reregistration Eligibility Decisions'' (IREDs). When the pesticide covered by an IRED shares a common mechanism of toxicity with other pesticides, the IRED addresses the aggregate risk of the chemical but does not take a position on the FFDCA standard until the Agency has also considered the potential cumulative risks of the group of pesticides. In addition to its consideration of individual OP pesticides, EPA has also conducted a preliminary cumulative risk assessment (CRA) for all of the OPs and sought public comment on the assessment. The risk assessment documents are available at www.epa.gov/pesticides/cumulative. In addition, EPA presented the assessment to its FIFRA Scientific Advisory Panel (SAP) for expert, independent scientific peer review. The SAP provided a generally favorable review of the preliminary assessment. See http:// www.epa.gov/scipoly/sap/index.htm. EPA is in the process of revising the CRA, taking into account public comment and SAP advice.

   EPA has raised with stakeholders during a number of public meetings the concept of reassessing selected OP tolerances because, based on available data and assessments, EPA could determine that they make, at most, no more than a negligible contribution to risk. Most recently, the concept of reassessing such ``non-contributors'' was an agenda topic for the February 2002 meeting of the Committee to Advise on Reassessment and Transition (CARAT).

3. What Action is the Agency Taking?

   1. Reassessment of Non-Contributor Tolerances

   In this Notice, EPA identifies several categories of non- contributor tolerances and considers these tolerances reassessed for the purposes of FQPA section 408(q) as of today's date. Pesticide tolerances subject to reassessment under FQPA section 408(q) may only remain in effect without modification if it meets the section 408(b) safety standard. This standard is met if EPA finds that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.'' In evaluating tolerances under the standard, the FQPA also instructs the Agency to consider the cumulative effects of the pesticide and other substances that have a common mechanism of toxicity. For each of the tolerances being reassessed, the Agency has issued an IRED, which found that, apart from consideration of the potential cumulative risks from all of the OPs, each of the tolerances would meet the FFDCA safety standard. EPA has now considered the impact of these cumulative risks in the reassessment of these tolerance and has determined that these tolerances make, at most, only a negligible contribution to the overall risks from OPs. Therefore, these tolerances will be maintained regardless of the outcome of the OP cumulative assessment and any potential regulatory action taken as a result of that assessment. Accordingly, EPA believes it is appropriate to consider these tolerances reassessed for the purposes of FQPA section 408(q) as of today's date.

   EPA has determined that the tolerances identified in this Notice as reassessed contribute negligible, if any, residues and/or risk to the overall risks from OPs. These OP tolerances have been divided into four broad categories: (1) Certain animal commodities, including milk, eggs, poultry, and other meats (cattle, goats, hogs, horses, and sheep); (2) certain crops that are solely used as animal feeds; (3) certain crops that are refined sugars; and (4) certain other tolerances based on the nature of their use pattern.

   In making the determination that these tolerances contribute negligible (if any) residues and/or risk, EPA considered, among other things, the nature of the use of the pesticide, the data used in conducting aggregate risk assessments for each individual OP, the potential for drinking water contamination, and other data and analyses available to the Agency (such as food residue monitoring and other information that the Agency is using for the CRA). The Agency concludes that these pesticide uses result in minimal or no detectable residues in food, and have no or negligible effects through drinking water. No tolerances are herein reassessed as a non-contributor unless all of the raw agricultural commodities (food forms) that are part of that tolerance are also considered to be non-contributors (e.g., the animal feed tolerances are solely for crops fed to animals). EPA also considered the potential impacts of future OP risk management decisions and determined that such decisions would be very unlikely to increase the use of the pesticide on these use sites in a manner or to a degree that the potential exposure under the tolerance would no longer be negligible. As part of its preliminary CRA, the Agency developed an estimate of the potential contribution that OP pesticides used in different parts of the country could make to overall risk as a result of the presence of residues of such pesticides in drinking water. Because of the nature of the available data, EPA's estimate employs assumptions that are designed not to understate potential drinking water exposure. The OP preliminary CRA concluded that drinking water was not a significant source of potential exposure. In reaching the determination to reassess these tolerances, EPA has considered this analysis, the public comment and SAP advices, as well as the information developed to assess the aggregate exposure from drinking water for each of the individual pesticides being reassessed. The Agency's assessment of these tolerances is effectively complete and the tolerances are considered reassessed. Nothing in this Notice is intended to modify in any way any determination or requirement set forth in individual pesticide IREDs. Because these tolerances are to remain in effect, all of these pesticide/use pattern combinations that are included in the preliminary CRA will remain in the CRA even though they involve exposures that pose negligible/minimal risk.

   No conclusions about reassessment should be drawn about tolerances that are not identified as non-contributors in this Notice. EPA expects that additional tolerances will be appropriate for reassessment based on the kind of approach described here, and that additional tolerances may be reassessed without the need for regulation upon completion of the CRA. In other words, the failure of a tolerance to be identified as a non-contributor in this or any other announcement does not imply that the pesticide/use combination will ultimately be subject to regulatory action. For tolerances reassessed as announced in this Notice or using the approach described herein, EPA has concluded that the decision to reassess these tolerances will have no impact on any subsequent determination or decisions that may be necessary if the CRA were to conclude that cumulative exposure to the OPs poses risks of concern. Categories 1 and 2--Animal Commodities (Meats, Poultry, Milk, and Eggs), and Animal Feeds

   The first two categories, tolerances for human foods derived from animal sources (referred to as animal commodities) and tolerances for commodities consumed by animals (referred to as animal feeds), are discussed together because the same

   [[Page 35994]]

   information was used to evaluate the likelihood of exposure and risk for both categories of tolerances.

   EPA has determined that certain OP tolerances, listed later in the Notice, on animal commodities and animal feeds are reassessed at this time. Currently, there are OP tolerances for many animal commodities: milk, eggs, poultry, and other meats (cattle, goats, hogs, horses, and sheep). Human exposure to pesticide residues can occur as a consequence of the use of a pesticide on animals or their feed if the residues transfer to the animal commodities that humans consume. EPA examined the potential for the transfer to such human foods of OP residues from animal feeds, and from the direct application of the OP to an animal (e.g., to control nuisance pests such as biting flies), and concludes that residue transfer generally does not occur, or if it does, the transfer is minimal. The following summarizes the factors that the Agency considered in making the decision to reassess these tolerances.

   The Agency examined the available study data for the OPs, which includes extensive livestock feeding/metabolism studies. These study results are confirmed by extensive monitoring data on animal commodities reflecting all registered uses. There are very few detectable residues in the OP monitoring data for animal commodities. The extensive monitoring data are from the U.S. Department of Agriculture's (USDA) Pesticide Data Program (PDP) and the U.S. Food and Drug Administration's (FDA) Total Diet Study (TDS) covering residues of multiple OPs in meats and poultry. The residue monitoring data showed infrequent detections, and those residues were detected at low levels. Out of approximately 400 meat samples analyzed by the TDS for multiple OPs from 1991-1999, only nine samples detected any OP residues (the residues ranged between 0.002 parts per million (ppm) and 0.009 ppm). Out of the approximately 500 poultry samples analyzed by PDP for multiple OPs for 1997 - 2000, only one sample detected an OP residue (0.01 ppm) for a pesticide that currently has a tolerance.

   For milk and eggs, extensive monitoring data are available from USDA's PDP and FDA's Surveillance Program. The residue monitoring data show no detectable OP residues in milk (there was only one trace sample detected out of approximately 1,800 samples analyzed by PDP for multiple OPs from 1996-1998). The residue monitoring for eggs also showed no detectable OP residues (only 1 trace sample was detected out of approximately 1,300 samples analyzed by FDA's Surveillance Program for multiple OPs from 1992-1998). In addition to an examination of the meat, poultry, milk, and egg monitoring data, as described above, the potential risk associated with the detected residues was addressed in the Agency's preliminary CRA of the OP pesticides. Although EPA concluded that ``OP residues would not be expected to occur in significant amounts'' in meat or milk, EPA nonetheless made the conservative assumption that all meat food forms contained OP residues equal to a level that was the highest found in the FDA monitoring program (TDS). Despite the fact that this assumption would overestimate potential exposure, the analysis in the OP preliminary CRA indicated that animal commodities do not significantly contribute to OP dietary exposure and total OP dietary risk.

   In light of all these considerations, the 172 OP meats (cattle, goats, hogs, horses, and sheep), poultry, milk, and egg tolerances listed in Table 1 are considered reassessed. In addition, because animal feeding and metabolism studies indicate that residue transfer to foods that humans eat will be minimal, and because the residues of OPs were detected only very rarely in meats, poultry, milk, and eggs, and only at very low levels, EPA concludes that OPs applied to animal feed crops (such as feed, forage, fodder, nut hulls, vines, and hays) will not be present to any significant extent in human food and such residues will make, at most, a negligible contribution to OP risk. Therefore, the 88 OP tolerances for animal feeds (such as feed, forage, fodder, nut hulls, vines, and hays) listed in Table 2 are also considered reassessed. It is important to note that these tolerances are solely for animal feeds, i.e, the tolerances do not include commodities that are also consumed by humans. EPA expects to announce other meat/poultry/egg/milk and animal feed tolerances as reassessed in future notices as appropriate in light of their individual OP assessments.

   In addition, some of these tolerances may be revoked in future Notices in the Federal Register if EPA determines that the tolerances are no longer needed. The Agency plans to issue a notice announcing the Agency's intention to revoke several animal meat tolerances because they are no longer necessary.

   Table 1.--Meats, Poultry, Milk, and Eggs

   Chemical

   Commodity

   Acephate (40 CFR part 180.108)

   Cattle, fat Cattle, mbyp Cattle, meat Eggs Goats, fat Goats, mbyp Goats, meat Hogs, fat Hogs, mbyp Hogs, meat Horses, fat Horses, mbyp Horses, meat Milk Poultry, fat Poultry, mbyp Poultry, meat Sheep, fat Sheep, mbyp Sheep, meat

   Chlorpyrifos (40 CFR part---

   [[Page 35995]]

   Table 2.--Animal Feed

   Chemical

   Commodity

   Acephate (formerly 40 CFR part 186.100) Cotton, seed, hulls Mint, hay (40 CFR part 180.108)

   Azinphos methyl (40 CFR----

   [[Page 35996]]

   Category 3--Refined Sugars

   As discussed in the OP preliminary CRA, negligible OP residues are expected to occur for refined sugars produced from beets and sugarcane based on available monitoring data (USDA's PDP and FDA's TDS) and the nature of the refining process. PDP has analyzed high fructose corn syrup and found no pesticide residues. The TDS has analyzed refined sugar and maple sugar and found no OP residues in 26 market basket surveys. Knowledge of the highly refined nature of sugars and syrups also supports the conclusion that negligible residues are expected to occur in refined sugars from sugarcane and sugar beets. The following 10 tolerances listed in Table 3 are considered reassessed:

   Table 3--Refined Sugars

   Chemical

   Commodity

   Chlorpyrifos (40 CFR part 180.342)

   Beets, sugar, molasses Beets, sugar, roots

   Disulfoton (40 CFR part-----

   Category 4 -- Use Pattern Consideration

   EPA has determined that an additional small number (five) of OP tolerances can be reassessed now based on the way the pesticides are used.

   For the following two pesticide active ingredients, cadusafos and propetamphos, negligible, if any, exposures (including in drinking water) are expected due to the nature of their use patterns. Each pesticide has one tolerance, and both are considered reassessed.

   z Cadusafos (40 CFR part 180.461): One import tolerance on bananas. Cadusafos is used exclusively on imported bananas. No detectable food residues are expected from this use based on the nature of the use pattern (e.g., when the pesticide is typically applied) and a consideration of the nature of the commodity (i.e., the protective peel of the banana fruit).

   z Propetamphos (40 CFR part 180.541): One tolerance for processed food. Propetamphos is used only as a crack and crevice treatment. It is not allowed to be used in structures that children or the elderly occupy, including homes, schools, day-cares, hospitals, and nursing homes with the exception of areas of food service within those structures when food is covered or removed prior to treatment. As the result of these restrictions, exposure is expected to be negligible.

   Chlorethoxyfos (40 CFR part 180.486) is a soil insecticide that is applied at planting to corn, and no detectable food residues are expected from this use. The chlorethoxyfos IRED states that field trials showed no residues (less than 0.01 ppm) of the parent in any of the corn raw agricultural commodities analyzed, even after treatment at a 10X rate. Chlorethoxyfos on corn was included in the OP preliminary CRA to assess its potential for contaminating drinking water. In the preliminary CRA, no drinking water risks were indicated even when high relative potency values were used (a screening relative potency factor (RPF) of 25 was used, which is approximately 200 times greater than the recently calculated RPF for this pesticide). Therefore, the following three chlorethoxyfos corn tolerances are considered reassessed: corn, pop, grain; corn, field, grain; and corn, sweet (K+CWHR) (i.e., kernel plus cob with husks removed).

4. Approach for Identifying Other Non-Contributor Categories

   EPA is evaluating other potential non-contributor tolerances. For example, it is possible that non-contributor determinations could be made for certain categories or types of tolerances for foods that are reported to have little or no consumption, or where few or no residues are detected. In evaluating candidate tolerances, EPA would consider all relevant data and factors, including information from the individual OP aggregate risk assessments, before making a reassessment determination.

   The Agency seeks comment about the use of the approach described here and the factors that are relevant to reassessment determinations based on this approach. EPA will announce the reassessment of non- contributor tolerances on the Agency's internet website (www.epa.gov/ pesticides/cumulative).

   List of Subjects

   Environmental protection, Chemicals, Pesticides and pests.

   Dated: May 14, 2002. Lois Rossi, Director, Special Review and Reregistration Division, Office of Pesicide Programs.

   [FR Doc. 02-12713Filed5-21-02; 8:45 am]

   BILLING CODE 6560-50-S