Federal Register Document 00-18888, Airspace Docket No. 00-AGL-16, published on July 26, 2000 (65 FR 45840), modified Class D Airspace at Gary, IN, and established Class E Airspace at Gary, IN. An error in the type of action taken concerning the Class E airspace was inadvertently made. The action described for the Class E airspace was given as a modification of existing airspace when in fact it is an establishment of new Class E airspace. This action corrects that error.

This amendment to 14 CFR part 71 revises the Class E airspace at Dexter, MO. A review of the Class E airspace for Dexter Municipal Airport, MO, indicated it does not meet the criteria for 700 feet AGL airspace required for diverse departures as specified in FAA Order 7400.2D. The criteria in FAA Order 7400.2D for an aircraft to reach 1200 feet AGL is based on a standard climb gradient of 200 feet per mile plus the distance from the Airport Reference Point (ARP) to the end of the outermost runway. Any fractional part of a mile is converted to the next higher tenth of a mile. The amendment at Dexter Municipal Airport, MO, will provide additional controlled airspace for aircraft operation under IFR, include the NDB and coordinates in the text header and comply with the criteria of FAA Order 7400.2D. The area will be depicted on appropriate aeronautical charts. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9H, dated September 1, 2000, and effective September 16, 2000, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. The amendment will enhance safety for all flight operations by designating an area where VFR pilots may anticipate the presence of IFR aircraft at lower altitudes, especially during inclement weather conditions. A greater degree of safety is achieved by depicting the area on aeronautical charts. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comments, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register, and a notice of proposed rulemaking may be published with a new comment period.

Although this action is in the form of a final rule and was not preceded by a notice of proposed rulemaking, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended or withdrawn in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of this action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy-related aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this action will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 00-ACE-31.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This amendment to 14 CFR 71 revises the Class E airspace at Moberly, MO. A review of the Class E aispace for Omar N. Bradley Airport, MO, indicates it does not meet the criteria for 700 feet AGL airspace required for diverse departures as specified in FAA Order 7400.2D. The criteria in FAA Order 7400.2D for an aircraft to reach 1200 feet AGL is based on a standard climb gradient of 200 feet per mile plus the distance from the Airport Reference Point (ARP) to the end of the outermost runway. Any fractional part of a mile is converted to the next higher tenth of a mile. The amendment at Omar N. Bradley Airport, MO, will provide additional controlled airspace for aircraft operating under IFR, eliminate the extensions to the southeast and northwest and comply with the criteria of FAA Order 7400.2D. The area will be depicted on appropriate aeronautical charts. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9H, dated September 1, 2000, and effective September 16, 2000, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. The amendment will enhance safety for all flight operations by designating an area where VFR pilots may anticipate the presence of IFR aircraft at lower altitudes, especially during inclement weather conditions. A greater degree of safety is achieved by depicting the area on aeronautical charts. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Although this action is in the form of a final rule and was not preceded by a notice of proposed rulemaking, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES . All communications received on or before the closing date for comments will be considered, and this rule may be amended or withdrawn in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of this action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy-related aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this action will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge their receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 00-ACE-30.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

In the Federal Register of January 6, 2000 (65 FR 1000), FDA published a final rule entitled “Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body” (hereinafter referred to as “the final rule”). In the final rule, FDA established regulations to define the types of statements that may be made without prior FDA review about the effects of dietary supplements on the structure or function of the body (structure/function claims), and to distinguish these claims from claims that a product treats, prevents, cures, diagnoses, or mitigates disease (disease claims).

In the preamble to the final rule, FDA stated that the final rule would become effective on February 7, 2000, approximately 30 days after publication. FDA also stated that any product that is marketed for the first time after publication of the final rule, and any new claims made for an existing product for the first time after the publication of the final rule, would be expected to be in compliance as of the effective date, February 7, 2000. However, small businesses that marketed a product as of January 6, 2000, the date of publication of the final rule, would have an additional 17 months (until July 7, 2001) to bring existing claims (i.e., claims already in the product's labeling on January 6, 2000) for those products into compliance. For all other products that were on the market as of January 6, 2000, FDA allowed an additional 11 months beyond the effective date (until January 7, 2001) to bring existing claims for those products into compliance.

FDA received one petition under § 10.35 (21 CFR 10.35) for stay of the 30-day effective date and one petition under 21 CFR 10.33 for stay and reconsideration of part of the implementation plan in the final rule. A petition for stay submitted jointly by the Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) (Docket No. 99N-0044/PSA1) (Ref. 1) (hereinafter referred to as the “joint petition”) requested that FDA stay its 30-day effective date for “pipeline” products, i.e., products that were labeled, or for which labeling had been printed, but that had not yet been marketed when the final rule was published on January 6, 2000. The joint petition requested that such products be given the 11 or 17 months for compliance afforded to products that were being marketed as of the publication date of the final rule. The joint petition stated that in the nearly 2 years between publication of the proposed and final rules, dietary supplement manufacturers and distributors had relied on the criteria and examples of acceptable structure/function claims in the proposed rule to develop marketing strategies, manufacture products, and design and produce labeling. The petition stated that in many cases, this reliance had involved a significant investment of resources.

The joint petition further stated that the implementation of the final rule will involve, among other things, package redesign, redesign of websites and promotional literature, and sometimes, new packaging equipment. The joint petition argued that the short implementation period (30 days for products not yet marketed) would not provide a long enough transition period to enable “pipeline” products to be brought into compliance. Moreover, the joint petition asserted that giving such products the same transition compliance period as products that had actually been marketed by January 6, 2000, would provide a fair and reasonable implementation plan for firms that had invested energy and resources, in good faith, developing a new product with labeling bearing claims based on the proposed rule, but that narrowly missed marketing the product by January 6, 2000.

The petition for stay and reconsideration was submitted by the American Herbal Products Association (Docket No. 98N-0044/PRC4) (Ref. 2) (hereinafter referred to as the “AHPA petition”). The AHPA petition requested that FDA reconsider two provisions of the final rule, one of which was the implementation plan. This notice will address only the request in the AHPA petition that concerns the implementation plan in the final rule; the other part of the AHPA petition will be addressed separately at a later time.

The AHPA petition requested two actions by FDA concerning the implementation plan. First, the AHPA petition requested that FDA treat certain products labeled before the February 7, 2000, effective date the same way as products marketed before the publication of the final rule on January 6, 2000. Specifically, the petition requested that FDA allow any product labeled before the February 7, 2000, effective date to be marketed during the 11-month or 17-month transition compliance period, provided that a notification has been submitted to FDA as required by section 403 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(6)), that FDA has not objected to the notification, and that the product bears the required disclaimer. Second, the AHPA petition requested that products subject to the transition compliance period be allowed to be shipped after that period has ended, provided that the label had been affixed to the product prior to the applicable 11-month or 17-month compliance date.

The AHPA petition stated that the requested relief is necessary for two reasons. First, the AHPA petition asserted that the 30-day effective date does not provide enough time to relabel products that were in the pipeline, but were not marketed, before the publication of the final rule. The AHPA petition also stated that products labeled at any point during the 11-month or 17-month transition period should be allowed to be marketed even after the applicable compliance date to reduce the costs of the rule by eliminating the need to relabel or destroy inventory not marketed by the end of the transition period. The AHPA petition further stated that there is no basis to distinguish the implementation scheme for the final rule from that used to implement the dietary supplement nutrition labeling final regulations published in the Federal Register of September 23, 1997 (62 FR 49826 at 49842), which provided that any product labeled before the effective date did not have to be relabeled to comply after the effective date.

FDA has fully evaluated the two petitions for stay and reconsideration of the implementation plan in the final rule. FDA agrees that there may be manufacturers who, relying on the criteria and examples of acceptable structure/function claims in the proposed rule, produced labeling with claims that would have been considered structure/function claims under the proposed rule, but that are classified as disease claims under the final rule. We also agree that the 30-day effective date of the final rule may not have provided a long enough transition period to enable products close to being marketed when the final rule was published to be brought into compliance. Therefore, FDA is announcing a stay of compliance for a limited class of products. Products that were labeled no later than the publication date of the final rule, January 6, 2000, or for which labeling had been printed by that date (hereinafter referred to as “eligible products”) will be eligible for the stay.

To prevent the partial stay from becoming effectively a blanket stay of the 30-day effective date for all products, FDA is requiring that any firm wishing to take advantage of the stay notify FDA of that fact before it markets its eligible products. The notification must: (1) Include the name and complete address of the firm submitting it; (2) identify the eligible products; (3) provide documentation that the eligible products were in fact labeled no later than January 6, 2000, or that labeling for the products had been printed by that date; and (4) include a certification, signed by a responsible individual, that the products are eligible for the stay. The eligible products must be described with sufficient specificity to enable FDA to identify them in the marketplace and distinguish them from other products (including other lots of the same product) that do not qualify for the stay. For example, the identification might consist of the name of the product and a unique identifier code, such as a product identification or lot code that the manufacturer uses to track its products.

FDA believes that the notification requirement is necessary for effective enforcement of the final rule. Without the notification, the agency would be unable to verify whether individual products are eligible for the stay and therefore would not be able to determine which products in the marketplace bear violative claims and are subject to enforcement action.

Firms must send the required notification to: Food and Drug Administration, Office of Nutritional Products, Labeling, and Dietary Supplements, Division of Compliance and Enforcement (HFS-810), 200 C St. SW., Washington, DC 20204. Notifications may be submitted at any time after the effective date of this final rule. It is to a manufacturers' advantage to submit such notifications as soon as possible, as only products for which FDA has received a notification qualify for the partial stay of compliance.

Small businesses that have eligible products and that submit the required notification to FDA will have 17 months after the effective date of the final rule (until July 7, 2001) to bring their eligible products into compliance, and other firms will have 11 months after the effective date of the final rule (until January 7, 2001) to bring their eligible products into compliance. We believe that this action provides a fair and reasonable implementation plan for firms that made a substantial investment in products that narrowly missed being marketed by the publication date of the final rule.

We are not granting the request in the AHPA petition that FDA allow products labeled before the 11-month or 17-month compliance date to be shipped after that date. In the preamble to the final rule (65 FR 1000 at 1044), FDA concluded that the compliance periods of 11 and 17 months following the effective date of the final rule were reasonable and fair. The agency stated that these compliance periods, uniformly applied, are sufficiently long and that an extension of the time to comply is not needed. The purpose of the compliance period is to give firms time to develop new labels that comply with the requirements of the act and regulation and to ensure a level playing field for all firms marketing dietary supplements. We find no basis to permit some firms to continue to market products with claims that violate the act and that may give them a competitive advantage over products marketed by firms that have made the investment in time and expense to meet the applicable compliance dates.

Moreover, granting AHPA's request would create an incentive for manufacturers to perpetuate existing claims that are defined as disease claims under the final rule and, in fact, to label as many products as possible with such claims between now and the applicable compliance date. FDA believes that creating such an incentive would be unwise and that the agency should maintain the policy in the final rule, which was designed to encourage manufacturers to change their labeling in accordance with the final rule as quickly as possible, but no later than the applicable compliance date. Having a date by which all products must comply will reduce consumer confusion and greatly simplify enforcement, as after that date the agency will be able to take action against any product that bears unapproved disease claims, without also having to determine when the product was labeled.

We disagree that the basis for the effective date of the September 23, 1997, final rule implementing the nutrition labeling requirements for dietary supplements is relevant to the current rulemaking. In deciding to base the effective date of the September 23, 1997, final rule on the date of labeling, rather than the date of marketing, FDA relied on language in section 7 of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Section 7 of DSHEA states that dietary supplements “may be labeled after the date of the enactment of this Act in accordance with the amendments made by this section, and shall be labeled after December 31, 1996, in accordance with such amendments.” The final rule implements section 6 of DSHEA, which does not contain the same language as section 7 and is not subject to section 7. Therefore, the fact that FDA allowed products labeled before the effective date of the September 23, 1997, final rule to be marketed after the effective date of that rule does not compel that the same approach be taken to implement the final rule. For the reasons discussed above, namely, to encourage prompt implementation of the rule and ensure a level playing field after the compliance date, the agency is not staying the compliance dates in the implementation plan for products labeled on or before the appropriate compliance date. Consistent with the implementation plan in the final rule (65 FR 1000 at 1044), all products in interstate commerce that are subject to the final rule must be in compliance with the act and regulations by July 7, 2001 (for products marketed by small businesses), or January 7, 2001 (for other products).

Under § 10.35(a) and (d)(1), FDA may stay the effective date of a rule, or any other administrative action, upon a finding that the stay is in the public interest. FDA finds that this partial stay of compliance is in the public interest because it will allow a fair and reasonable transition compliance period for firms that made a substantial investment in dietary supplement products that were close to marketing when the final rule was published.

The Administrative Procedure Act and FDA regulations provide that the agency may issue a regulation without notice and comment procedures when the agency for good cause finds that such procedures are impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(3)(B); 21 CFR 10.40(e)(1)). Because this final rule is a stay of compliance, FDA finds that there is good cause to dispense with notice and comment procedures. Notice and comment procedures are unnecessary because this final rule does not change the substantive requirements of the final rule, only the date on which compliance with those requirements is expected for a limited class of products. Further, notice and comment procedures are not in the public interest because the final rule has already become effective, and therefore a prompt response to the petitions for stay and reconsideration is important.

The economic impact of the final rule was discussed in the Federal Register (65 FR 1000 at 1044 through 1049). A partial stay of compliance for the final rule will provide additional time for companies to relabel products and will reduce label obsolescence, as there will be additional time to use up more existing labeling. Although this rule granting a partial stay of compliance will impose some small administrative costs on those industry members that wish to take advantage of it, these costs are expected to be much smaller than the savings that will be realized from reduced inventory losses. Thus, this final rule granting a partial stay of compliance should reduce the economic impact on industry.

FDA has examined the impacts of this final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612) and the Unfunded Mandates Reform Act. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the final rule is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order.

Under the Regulatory Flexibility Act, if a rule has a significant economic impact on a substantial number of small entities, the agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. This final rule provides a stay of compliance, which will allow manufacturers additional time to use up existing product labeling. Accordingly, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires that agencies prepare a written statement of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year (adjusted annually for inflation).

The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for this rule, because this rule is not expected to result in expenditures that would exceed $100 million, adjusted for inflation, in any one year. The current inflation-adjusted statutory threshold is $110 million.

This final rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). A description of these provisions is given below with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Title: Notification of Products Eligible for a Stay of the Effective Date of FDA's Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body.

Description: Under sections 301, 403(r)(1)(B) and (r)(6), and 505(a) of the act (21 U.S.C. 331, 343(r)(1)(B) and (r)(6)), and 355(a)) FDA is responsible for preventing distribution in interstate commerce of products marketed as dietary supplements with claims about the effect of the product on a disease, unless the claim is an authorized health claim. Section 701(a) of the act (21 U.S.C. 371(a)) gives FDA the authority to issue regulations for the efficient enforcement of the act. In the final rule (65 FR 1000), FDA published a regulation that defined the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body. In the preamble to the final rule, the agency stated that the final rule would become effective on February 7, 2000, approximately 30 days after the date of the final rule's publication in the Federal Register . The final rule further provided that any product that is marketed for the first time after publication of the final rule, and any new claims made for an existing product for the first time after the publication of the final rule, would have to be in compliance as of the effective date.

In response to two petitions asking the agency to stay and/or reconsider the 30-day effective date for the final rule, FDA is granting a partial stay of compliance with the rule for those dietary supplement products that were labeled or for which labeling had been printed on or before January 6, 2000, the publication date of the final rule. A manufacturer that wishes to market products that are eligible for the stay would have to notify FDA of the identity of its eligible products; provide documentation that the products were labeled by January 6, 2000, or that labeling for the products had been printed by that date; and certify that the products that are the subject of the notification meet the eligibility criteria.

Information that is required in the notification includes: (1) The name and complete address of the firm submitting the notification; (2) a description of the products that are the subject of the notification. The description must be sufficient to enable FDA to identify the firm's qualifying products in the marketplace and distinguish them from other products (including other lots of the same product) that are not eligible for the stay. For example, the description might consist of the name of the product and a unique identifier code (such as a product identification or lot code that the manufacturer uses to track its products); (3) documentation that the products were labeled by January 6, 2000, or that the labeling for the products had been printed by that date (for example, purchase records from a label manufacturer or production records that showed that the products had been labeled by January 6, 2000); and (4) a certification, signed by a responsible individual, that the products are eligible for the stay.

FDA estimates the burden of this collection of information as follows:

These estimates are based on the number of firms that may have products that are eligible for the stay. In the final rule (65 FR 1000 at 1047), FDA estimated that 1,000 firms manufacture dietary supplement products that would be covered by the final rule. FDA also estimated that approximately 4.81 percent of the 17,400 dietary supplement products currently being marketed with structure/function claims would be required to change their labels because of the requirements in the final rule (65 FR 1000 at 1046). Therefore, assuming that products affected by the final rule are uniformly distributed throughout the industry, approximately 48 firms (4.8 percent of 1,000 firms) may have products affected by the partial stay of compliance.

The notification burden would consist of the preparation of the letter notifying FDA and accompanying documentation that the products were labeled before January 6, 2000, or that the labeling had been printed by that date. FDA believes this burden will be small since firms already have the information needed to describe their own products with specificity. With respect to the supporting documentation, the firm would already have identified the relevant documents as part of ascertaining which products are eligible for the stay. Therefore, the firm would only need to reproduce the relevant documents to accompany the notification. The notification is a one-time action, and all of a firm's eligible products can be listed in a single notification. Therefore, FDA anticipates receiving only one notification per firm.

The information collection provisions of this final rule have been submitted to OMB for review. Interested persons may send comments regarding information collection by October 10, 2000, to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer for FDA.

FDA has requested expedited processing of this information collection request under section 3507(j) of the PRA and 5 CFR 1320.13. The information to be collected under this final rule is needed before clearance could be obtained under the normal PRA clearance time periods. Further, the use of normal PRA clearance procedures is impracticable and would be likely to prevent or disrupt the collection of information because the compliance periods during which products that qualify for the partial stay may be marketed without relabeling would have ended or would be close to ending.

Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Interested persons may submit to the Dockets Management Branch (address above) written comments regarding the final rule by October 30, 2000, except that comments regarding information collection are to submitted to OMB (address above) by October 10, 2000. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

The following references have been placed on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

 1. Council for Responsible Nutrition and Consumer Healthcare Products Association, Petition for Stay of Action, February 7, 2000.

 2. American Herbal Products Association, Petition for Reconsideration and Petition for Stay of Action, February 7, 2000.

On April 19, 1999, the Postal Service announced in the Federal Register (64 FR 19039-19042) the introduction of Priority Mail Global Guaranteed (PMGG) service on an interim basis. With PMGG, the USPS provided customers with a fully featured premium international service for documents with full track and trace capability. This service was initially available from 3,000 retail locations for delivery to a total of 19 countries.

On November 4, 1999, the Postal Service announced in the Federal Register (64 FR 60106-60109) the expansion of PMGG service to permit acceptance at a total of 10,000 retail locations, with destinating locations being expanded to 65 countries and territories.

On May 26, 2000, the Postal Service announced in the Federal Register (65 FR 34096-34101) the further expansion of PMGG service to a total of 202 destinating countries and territories. A revised rate structure was also introduced.

On August 28, 2000, the Postal Service announced in the Federal Register (65 FR 52023-52028) a further expansion of PMGG service. The number of retail locations was increased to a total of 20,000, document service rates were adjusted, optional document reconstruction insurance was increased to $2,499, and delivery service was extended to China. An incorrect listing of 3-digit ZIP Codes was included in the list of participating post offices in this rule. The correct list of participating post offices by 3-digit ZIP Code is incorporated in this interim rule.

Based on the successive and successful expansion of PMGG service, the Postal Service has determined to establish it as a permanent international mail service. To effectuate this change, the Postal Service is changing the name of the service to Global Express Guaranteed (GXG) and completing the expansion to include a new classification for merchandise shipments. GXG will now consist of two mail classifications:

a. GXG Document service.

b. GXG Non-Document service.

The GXG Document service mail classification is for shipments that contain only documents and general correspondence for which no duty is assessed by the customs authority of the destinating country. This mail classification is a designated letter mail class pursuant to 39 U.S.C. 3623(d) and, as such, is sealed against inspection by the Postal Service. These Document service shipments may be subject to inspection in the destinating country for purposes of compliance with the customs requirements of the destinating country. The rate structure for Document service is separate and distinct from the rate structure for Non-Document service.

The GXG Non-Document service mail classification is for shipments that do not contain documents or general correspondence and for which duty may be assessed by the customs authority of the destinating country. Merchandise and all other dutiable items may be shipped using only this GXG classification. As such, this mail classification is not a letter mail class pursuant to 39 U.S.C. 3623(d). In order to provide for expedited customs clearance of these dutiable shipments, Non-Document service shipments will be subject to inspection by, among others, the Postal Service and its designated agents for purposes of aviation (air) security and to determine that the contents are eligible for shipment via Non-Document service and that the contents are adequately declared on the GXG Air Waybill/Shipping Invoice to permit expedited customs clearance. These Non-Document service shipments may also be subject to inspection in the destinating country for purposes of compliance with the customs requirements of the destinating country. The rate structure for Non-Document service is separate and distinct from the rate structure for Document service and reflects the generally higher costs inherent with handling dutiable shipments. Non-Document service is not available to some countries to which Document service is provided. See the following listing of destinating countries for specific availability.

For rate purposes, destinating countries and territories have been placed into one of eight rate groups as set forth below.

Although the Postal Service is exempted by 39 U.S.C. 410(a) from the advance notice requirements of the Administrative Procedure Act regarding proposed rulemaking (5 U.S.C. 553), the Postal Service invites public comment on the amendment to the interim rule at the above address.

The Postal Service is amending the International Mail Manual, which is incorporated by reference in the Code of Federal Regulations. See 39 CFR 20.1.

A transmittal letter changing the relevant pages in the International Mail Manual will be published and automatically transmitted to all subscribers. Notice of issuance of the transmittal will be published in the Federal Register as provided by 39 CFR 20.3.

On or about September 26, 2000, the Postal Service announced in the Federal Register a proposed rule that would amend and renumber provisions in the International Mail Manual. If that rule is adopted, GXG will be found in Section 210 of chapter 2 of the International Mail Manual.

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rules we are approving and the rule we are rescinding with the dates that they were adopted by the local air agency and submitted by the Arizona Department of Environmental Quality.

On February 2, 1996 and April 24, 1999, these rule submittals were found to meet the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review.

The rules submitted by the PCAQCD are intended to replace existing SIP rules that apply to both Pinal and Gila Counties formerly known as the Pinal-Gila Counties Air Quality Control District. 1 Therefore, the submitted rule revisions are applicable to the Pinal County Air Quality Control District only. The SIP rules as applicable to Gila County will not change. TSD has more information about these rules.

In determining the approvability of the SO 2 rules, EPA must evaluate each rule for consistency with the requirements of the CAA and EPA regulations, as found in section 110 and 40 CFR part 51 (Requirements for Preparation, Adoption, and Submittal of Implementation Plans).

While the portion of PCAQCD applicable to these submittals is in attainment with the SO 2 NAAQS, many of the general SIP requirements regarding enforceablity and SIP relaxation (see 110(l)and 193 of the Act), for example, are still appropriate for these rules.

Guidance and policy documents that we used to define specific enforceability requirements include the following:

1. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations; Clarification to Appendix D of November 24, 1987 Federal Register Document,” (Blue Book), notice of availability published in the May 25, 1988 Federal Register .

2. “SO 2 Guideline Document,” EPA-452/R-94-008.

We believe these rules are consistent with the relevant policy and guidance regarding enforceability and SIP relaxations. The rule revisions are primarily administrative, where PCAQCD renumbers existing SIP regulations to make them applicable to Pinal County only and rescinds one rule that is no longer applicable. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this, so we are finalizing the approval without proposing it in advance. However, in the Proposed Rules section of this Federal Register, we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by October 30, 2000, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on November 28, 2000. This will incorporate these rules into the federally enforceable SIP and remove the rescinded rule from the SIP for Pinal County.

40 CFR 81.303 provides the attainment status designations for air districts in Arizona. In Pinal County, there are two clearly defined sulfur dioxide nonattainment areas. One surrounds the BHP copper smelter located in San Manuel; the other surrounds the ASARCO Hayden copper smelter complex. Since Arizona statutes have exclusive jurisdiction over copper smelters, the Arizona Department of Environmental Quality prepares and executes the implementation plans for those sulfur dioxide nonattainment areas. The rules submitted by the PCAQCD applies to sources in the portion of the county designated “attainment” for sulfur dioxide.

Sulfur dioxide is formed by the combustion of fuels containing sulfur compounds. High concentrations of SO 2 affect breathing and may aggravate existing respiratory and cardiovascular disease.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, Consultation and Coordination with Indian Tribal Governments, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612, Federalism and 12875, Enhancing the Intergovernmental Partnership. 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.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This rule will not 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, as specified in Executive Order 13132, because it merely acts on a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This final rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply act on requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action acts on pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

EPA believes that VCS are inapplicable to today's action because it does not require the public to perform activities conducive to the use of VCS.

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 the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This rule is not a “major” rule as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 28, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

(c) * * *

(18) * * *

(iv) * * *

(C) Previously approved on December 17, 1979 and now deleted without replacement Rule 7-3-2.5.

The Environmental Protection Agency (EPA) is approving the Stage II (control of gasoline vapors resulting from the refueling of vehicle fuel tanks at gasoline service stations) comparability demonstration that the New York State Department of Environmental Conservation (NYSDEC) submitted on April 18, 2000. EPA is approving this submittal into the New York State Implementation Plan (SIP) because it meets the requirements of section 184(b)(2) of the Clean Air Act (CAA).

Historically, there has been a major ozone nonattainment problem in the northeastern United States. A significant portion of the problem is the result of regional transport of ozone and ozone precursors (volatile organic compounds (VOC) and oxides of nitrogen (NO X )). To address this problem of interstate transport ozone air pollution, section 184 of the CAA specifically created the Ozone Transport Region (OTR), which includes the entire states of Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Vermont, and the District of Columbia consolidated metropolitan statistical area, which includes a portion of Virginia.

The CAA established five classifications of ozone nonattainment areas. In ascending order of severity of the air pollution problem, these are: marginal, moderate, serious, severe, and extreme. In addition, there are three types of nonclassifiable ozone nonattainment areas: submarginal, transitional, and incomplete/no data. The CAA requires specific control requirements according to the designation and classification of each area.

Section 184 also provides for a specific set of additional requirements for the OTR designed to address the regional transport problem. These additional requirements include control measures for attainment as well as nonattainment areas. For the OTR, there are two requirements related to Stage II vehicle refueling controls. One is the section 182(b)(3) requirement that all moderate and above nonattainment areas must adopt Stage II vehicle refueling controls. The New York City Metropolitan Area (including portions of Orange County) is classified as a severe ozone nonattainment area, and therefore, it adopted Stage II vehicle refueling controls, which were approved by EPA on April 30, 1998 (63 FR 23665). Pursuant to section 202(a)(6) of the CAA, moderate areas were released from this requirement when EPA promulgated onboard vapor recovery rules.

The second OTR requirement is the section 184(b)(2) requirement that all areas in the OTR must adopt Stage II or alternative measures capable of achieving comparable emissions. Because states that contain serious and above nonattainment areas must implement Stage II programs under section 182(b)(3), those areas, even after promulgation of the onboard regulations, cannot take advantage of the flexibility provided by section 184(b)(2) to adopt a comparable measure instead.

Section 184(b)(2) of the CAA requires that states in the OTR to adopt Stage II or comparable measures within one year of EPA completion of a study identifying control measures capable of achieving emissions reductions comparable to the reductions achievable through section 182(b)(3) Stage II vehicle refueling controls. EPA completed its study “Stage II Comparability Study for the Northeast Ozone Transport Region” (EPA-452/R-94-011) on January 13, 1995. Therefore, New York was required to either adopt Stage II in areas outside the New York City Metropolitan area or adopt comparable regulations.

To demonstrate that it has met the CAA Stage II comparability requirement, New York relies on NO X controls in lieu of implementing the control of VOCs at gasoline service stations in the upstate portion of New York State. These NO X reductions will serve as comparable emission reductions as defined in section 184(b)(2) of the CAA.

On September 27, 1994, the Ozone Transport Commission (OTC) agreed to a Memorandum of Understanding (MOU) committing the signatory states to the development and implementation of a region-wide NO X emission reduction. The OTC MOU promotes emission reductions at utility and large industrial boilers for the purpose of reducing ozone season NO X emissions and further the effort to achieve the federal health-based standards.

The OTC NO X MOU calls for states to reduce NO X emissions from boilers and indirect heat exchangers with heat inputs greater than 250 million Btu per hour. These reductions will be realized in two phases, the first phase is implemented in 1999 and the second in 2003.

In order to comply with the 1999 reductions of the OTC NO X MOU, New York State adopted subpart 227-3 entitled the “Pre-2003 Nitrogen Oxides Emissions Budget and Allowance Program” on March 5, 1999. EPA approved subpart 227-3 as part of the SIP on April 19, 2000 (65 FR 20905). Subpart 227-3 implemented the 1999-2002 NO X emission reductions by establishing a statewide NO X Budget for all fossil fuel fired boilers and indirect heat exchangers with a maximum rated heat input capacity of 250 million Btu per hour or greater as well as emissions from other fuel fired electric generating sources with a rated output of 15 megawatts (MW) or greater.

Under EPA's interpretation of section 184(b)(2), states have the option of adopting comparable NO X control measures instead of Stage II. EPA provides the methodology for determining what level of NO X emission reductions is comparable to Stage II VOC emissions reductions for a particular area, and therefore, allowed to be substituted. NO X may not be substituted for VOC in areas where there is a waiver under section 182(f) of the CAA from some or all NO X requirements because such a waiver indicates that NO X reductions are either in excess and not necessary for attainment, or NO X reductions are otherwise not beneficial. New York State has not obtained any such waivers under section 182(f).

New York State has adopted certain NO X controls in lieu of implementing the control of VOCs at gasoline service stations in the upstate portion of New York State. New York's analysis relies on the Interim Inventory projections provided in the EPA Stage II Comparability Study for the Northeast Ozone Transport Region, January, 1995. The EPA study projects for Stage II vapor recovery VOC emission reductions of 25 tons per day (tpd) for the upstate portion of New York State. The New York City Metropolitan Area is classified as a severe ozone nonattainment area, and therefore, it is not eligible for inclusion in this comparability analysis.

New York's Phase II NO X budget and allocation program established a state-wide cap of 46,959 tons for the ozone season (May 1-September 30). These 46,959 tons were allocated to the affected sources through a negotiation process involving representatives from each affected facility. The 5-month budget was divided by 153 days (total number days in the ozone season) to provide a ton per day (tpd) figure. After removing the sources located in the severe nonattainment area, the aggregated creditable reduction for Stage II substitution from remaining affected sources equates to 81.6 tpd NO X .

EPA provides a NO X to VOC substitution ratio in the percent of each total inventory basis. Ratios for each state in the OTR are presented in EPA's Stage II Comparability Study for the Northeast Ozone Transport Region, table 5-1. The 81.6 tpd of NO X equates to 102 tpd VOC when using this substitution ratio.

EPA has evaluated New York's Stage II comparability SIP revision and finds it consistent with the CAA, EPA regulations, and EPA policy. EPA is approving New York's Stage II comparability SIP revision because New York has provided a substitute control measure, Subpart 227-3, which provides greater emission reductions than Stage II and has successfully demonstrated that the substitution of Phase II NO X controls is a comparable measure to Stage II control for the upstate portion of New York State.

The EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective November 28, 2000 without further notice unless the Agency receives adverse comments by October 30, 2000.

If the EPA receives adverse comments, then EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order (E.O.) 12866, entitled “Regulatory Planning and Review.”

Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This SIP approval is not subject to Executive Order 13045 because it proposes approval of a state program implementing a Federal standard, and it is not economically significant under Executive Order 12866.

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). 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.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by state and local governments, or EPA consults with state and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts state law unless the Agency consults with state and local officials early in the process of developing the proposed regulation.

This rule will not 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, as specified in Executive Order 13132, because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions. This final rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the CAA do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, EPA certifies that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the CAA, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The CAA forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a federal mandate that may result in estimated annual costs to state, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the final approval action does not include a federal mandate that may result in estimated annual costs of $100 million or more to either state, local, or tribal governments in the aggregate, or to the private sector. This federal action approves pre-existing requirements under state or local law, and imposes no new requirements. Accordingly, no additional costs to state, local, or tribal governments, or to the private sector, result from this action.

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 the rule in the Federal Register . This rule is not a “major” rule as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 28, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and 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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

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/. To access this document, 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/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

2. In person . The Agency has established an official record for this action under docket control number OPP-301052. 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.

In the Federal Register of October 8, 1999 (64 FR 195) (FRL-6384-2), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP) for tolerance by Bayer Corporation, 8400 Hawthorne Road, Kansas City, Missouri 64120-0013. This notice included a summary of the petition prepared by Bayer Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing tolerances for combined residues of the herbicide flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo- N -[[2(trifluoromethoxy)phenyl]sulfonyl]-1 H -1,2,4-triazole 1-carboxamide, sodium salt) and its N -desmethyl metabolite in or on wheat, forage at 0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; wheat, straw at 0.05 ppm, milk at 0.005 ppm; meat of cattle, goats, hogs, horses and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses and sheep at 0.60 ppm. As a result of its review of scientific data submitted in support of this petition, the Agency has determined that additional sulfonamide metabolites should be included in the tolerance expression for both wheat and the associated animal commodities. The submitted analytical method and residue data for livestock are sufficient to establish tolerances for livestock commodities that include the additional sulfonamide metabolites. The animal tolerances requested by Bayer Corporation for flucarbazone-sodium and its N -desmethyl metabolite are adequate to cover the additional metabolites, with the exception of the tolerance for liver, which EPA has determined must be raised from 0.60 ppm to 1.5 ppm. However, before EPA can establish tolerances for wheat forage, grain, hay and straw that include the sulfonamide metabolites, the registrant must submit a revised method and additional residue data that measure not only the parent and N -desmethyl metabolite, but also the sulfonamide metabolites of concern. Therefore, EPA is establishing time-limited tolerances for combined residues of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo- N -[[2(trifluoromethoxy)phenyl] sulfonyl]-1 H -1,2,4-triazole 1-carboxamide, sodium salt) and its N -desmethyl metabolite in or on wheat, forage at 0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its metabolites converted to 2-(trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats, hogs, horses and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses and sheep at 1.5 ppm. The tolerances are being established as time-limited to allow time to develop additional analytical methodology and residue data for wheat to support revised tolerances that include the sulfonamide metabolites. These tolerances will expire and be revoked on November 1, 2005. Although EPA does not have sufficient data to establish wheat tolerances that include the sulfonamide metabolites, sufficient data are available for the Agency to estimate human exposure and risk from these metabolites as described in the “Exposure Assessment” section below.

Section 408(b)(2)(A)(i) of the 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) 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) 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 aggrege exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for combined residues of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo- N -[[2(trifluoromethoxy)phenyl] sulfonyl]-1 H -1,2,4-triazole 1-carboxamide, sodium salt) and its N -desmethyl metabolite in or on wheat, forage at 0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its metabolites converted to 2-(trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats, hogs, horses and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses and sheep at 1.5 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follows.

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 nature of the toxic effects caused by flucarbazone-sodium are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (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 lowest dose at which adverse effects of concern are identified (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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for flucarbazone-sodium used for human risk assessment is shown in the following Table 2:

1. Dietary exposure from food and feed uses. No tolerances have previously been established for flucarbazone-sodium. Risk assessments were conducted by EPA to assess dietary exposures from flucarbazone-sodium in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. An appropriate endpoint attributable to a single exposure was not identified for the general population, including infants and children. The decreased motor and locomotor activity observed at 2,000 mg/kg on the day of dosing only in the acute neurotoxicity study in rats was reversible within 18 minutes. The NOAEL of 500 mg/kg for these findings was not considered appropriate for selection as an acute dietary endpoint for the general population. An acute dietary risk assessment was performed for flucarbazone-sodium for the population subgroup, females 13 to 50 years old, based on the results of the rabbit developmental toxicity study. The Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA [1989-1992] nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessment: For all commodities, 100% crop treated was assumed. In order to account for the metabolites of concern in wheat and livestock commodities, the anticipated residue levels (parent and metabolites of concern) to be used in the dietary exposure assessment were determined. Using the ratio of the sulfonamide metabolites to the sum of the parent and N -desmethyl metabolite observed in the wheat metabolism study and the Highest Average Field Trial (HAFT) value from the crop field trial studies, the anticipated total residues (parent and metabolites of concern) expected to be in wheat were determined. A processed wheat food/feed study was not submitted in support of this petition. Therefore, in order to represent the worse case scenario, the wheat maximum theoretical concentration factor of 8x (Table 1, Residue Chemistry Test Guidelines OPPTS 860.1520) was used for all wheat commodities. Default concentration factors were used for all other commodities in DEEM®.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: For all commodities, 100% crop treated was assumed. In order to account for the metabolites of concern in wheat and livestock commodities, the anticipated residue levels (parent and metabolites of concern) to be used in the dietary exposure assessment were determined. Using the ratio of the sulfonamide metabolites to the sum of the parent and N -desmethyl metabolite observed in the wheat metabolism study, and the Highest Average Field Trial (HAFT) value from the crop field trial study, the anticipated total residues (parent and metabolites of concern) expected to be in wheat were determined. A processed wheat food/feed study was not submitted in support of this petition. Therefore, in order to represent the worse case scenario, the wheat maximum theoretical concentration factor of 8x (Table 1, Residue Chemistry Test Guidelines OPPTS 860.1520) was used for all wheat commodities. Default concentration factors were used for all other commodities in DEEM®.

iii. Cancer . The Agency concluded that flucarbazone-sodium was negative for carcinogenic potential in mice and rats and classified flucarbazone-sodium as “not likely” to be a human carcinogen according to EPA Draft Guidelines for Carcinogen Risk Assessment. Therefore, a cancer dietary exposure analysis was not performed.

Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance. EPA used anticipated residues in this case to estimate exposure to the sulfonamide metabolites of flucarbazone-sodium in wheat that are not included in the time-limited tolerance expression. As a condition of registration, EPA will require Bayer Corporation to submit revised analytical methodology and wheat residue data that measure all residues of concern, including the sulfonamide metabolites. These data must be submitted within 3 years of registration, well within the 5 year time frame specified in the regulations, and should allow the Agency to set tolerances for wheat that include these metabolites and eliminate the need for sulfonamide anticipated residue calculations in future risk assessments for flucarbazone-sodium.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for flucarbazone-sodium 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 flucarbazone-sodium.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and the Screening Concentration in Ground Water model (SCI-GROW), which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models includes consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or PAD. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to flucarbazone-sodium they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the EECs of flucarbazone-sodium (parent only) in surface water and ground water for acute exposures are estimated to be 1.42 parts per billion (ppb) for surface water and 0.2 ppb for ground water. The EECs for chronic exposures are estimated to be 1.25 ppb for surface water and 0.2 ppb for ground water.

Based on the GENEEC model, total flucarbazone-sodium EECs (parent plus metabolites) in surface water are not likely to exceed 1.45 ppb for acute exposures and 1.44 ppb for chronic (60-day) exposures. Agency interim policy recommends that the 60-day GENEEC value to be divided by an adjustment factor of 3 to obtain a value for chronic risk assessment calculations. Therefore, a surface water value of 0.48 ppb was used for chronic risk assessment.

Because the degradates of flucarbazone-sodium are so resistant to aerobic metabolism in soil, they lie outside the range of environmental characteristics from which SCI-GROW was developed. It was therefore not appropriate in this case to use the model to estimate total flucarbazone-sodium EECs in ground water. Instead, the concentration of total flucarbazone residues in soil porewater of the top 1-foot of soil immediately postapplication was estimated to be approximately 50 ppb. This number would be an upper limit on the amount of chemical that could be found in the soil porewater and was used by the Agency as an estimate of expected residues of flucarbazone-sodium and its metabolites in ground water for risk assessment purposes.

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).

Flucarbazone-sodium is not registered for use on any sites that would result in residential exposure.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) 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 does not have, at this time, available data to determine whether flucarbazone-sodium has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, flucarbazone- sodium 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 flucarbazone-sodium 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. Safety factor for infants and children —i. In general . FFDCA section 408 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 data base on toxicity and exposure unless EPA determines 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 (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

ii. Prenatal and postnatal sensitivity . No increased quantitative or qualitative susceptibility was seen following prenatal and/or postnatal exposures. There were no developmental findings in rats up to the limit dose of 1,000 mg/kg/day. In the rabbit developmental toxicity study, the effects seen in fetuses (decreased fetal body weight and delayed ossification) are at dose levels equal to or greater than doses where maternal toxicity (increased clinical signs and decreased food consumption) were observed. In a 2-generation reproductive toxicity study in rats, the effects seen in offspring were at dose levels equal to or greater than doses where parental toxicity were seen.

iii. Conclusion . There is a complete toxicity data base for flucarbazone-sodium and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because there is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/or postnatal exposure; a developmental neurotoxicity study is not required; the dietary (food and drinking water) exposure assessments will not underestimate the potential exposures for infants and children; and there are no registered residential uses at the current time.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water (e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure)). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to flucarbazone-sodium will occupy < 1% of the aPAD for females 13 to 50 years old. Since an appropriate endpoint attributable to a single exposure was not identified for the general population, including infants and children, an acute exposure assessment was not performed for these population subgroups. In addition, there is potential for acute dietary exposure to flucarbazone-sodium in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD for the population of concern (females 13 to 50 years old), as shown in the following Table 3:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to flucarbazone-sodium from food will utilize 1%% of the cPAD for the U.S. population, < 1%% of the cPAD for all infants less than 1 year old and 2%% of the cPAD for children 1 to 6 years old, the population subgroup with the highest estimated exposure to flucarbazone-sodium. There are no residential uses for flucarbazone-sodium that result in chronic residential exposure to flucarbazone-sodium. In addition, there is potential for chronic dietary exposure to flucarbazone-sodium in drinking water. After calculating the DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100%% of the cPAD, as shown in the following Table 4:

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Flucarbazone-sodium is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Flucarbazone-sodium is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

5. Aggregate cancer risk for U.S. population . The Agency concluded that flucarbazone-sodium was negative for carcinogenic potential in mice and rats and classified flucarbazone-sodium as “not likely” to be a human carcinogen according to EPA Draft Guidelines for Carcinogen Risk Assessment. Therefore, a cancer dietary exposure analysis was not performed.

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 flucarbazone-sodium residues.

The petitioner has proposed residue analytical methods for tolerance enforcement in wheat and livestock commodities. The analytical enforcement method for wheat employs accelerated solvent extraction, clean-up using solid phase extraction columns followed by detection and quantitation by liquid chromatography/tandem mass spectroscopy (LC/MS/MS). The analytical method for livestock commodities is a common moiety method which measures residues of flucarbazone-sodium (MKH6562) in animal tissues and milk by extracting and hydrolysing MKH 6562 and MKH 6562-related residues to MKH 6562 sulfonamide. Detection is achieved using negative ion electrospray mass spectrometry using deuterated MKH 6562 sulfonamide as an internal standard. Both methods have undergone successful validations by independent laboratories. They are currently being validated by the Analytical Chemistry Branch laboratories, BEAD (7503C), Office of Pesticide Programs. Upon successful completion of the EPA validation and the granting of this registration these methods will be forwarded to FDA for publication in a future revision of the Pesticide Analytical Manual, Vol-II (PAM-II). Prior to publication in PAM-II and upon request, the methods will be available from the Analytical Chemistry Branch (ACB), BEAD (7503C), Environmental Science Center, 701 Mapes Road, Ft George G. Meade, MD 20755-5350; contact Francis D. Griffith, Jr, telephone (410) 305-2905, e-mail griffith.francis@epa.gov. The analytical standards for these methods are also available from the EPA National Pesticide Standard Repository at the same location.

A default Maximum Residue Limit (MRL) of 0.01 ppm has been established in Canada for residues of flucarbazone-sodium and its N -desmethyl metabolite on wheat grain. This value is consistent with the tolerance being established in the United States on wheat grain. There are no Codex MRLs for this compound on wheat. Therefore, no compatibility issues exist with Codex in regard to the U.S. tolerances discussed in this review.

The registration of flucarbazone-sodium will be time-limited and conditioned upon submission of a revised method and additional residue data for wheat commodities that measure all of the metabolites of concern. In addition, the registrant must submit a 28-day rat inhalation study and additional storage stability data.

Therefore, time-limited tolerances are established for combined residues of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo- N -[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-1,2,4-triazole 1-carboxamide, sodium salt) and its N -desmethyl metabolite in or on wheat, forage at 0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its metabolites converted to 2-(trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats, hogs, horses and sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses and sheep at 1.5 ppm.

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. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301052 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 November 28, 2000.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential 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. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim&commat;epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301052, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket&commat;epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator etermines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 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 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require 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 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply. 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 FFDCA section 408(n)(4).

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).

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and 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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

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/. To access this document, 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/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

2. In person . The Agency has established an official record for this action under docket control number OPP-301063. 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.

In the Federal Register of May 16, 1997 (62 FR 27027) (FRL-5717-6), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP 8F2128) for tolerance by Monsanto, 600 13th St., NW., Suite 660, Washington, DC 20005. This notice included a summary of the petition prepared by Monsanto, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.314 be amended by establishing a tolerance for residues of the herbicide triallate, and its metabolite, TCPSA in or on sugar beet root at 0.01 part per million (ppm), sugar beet top at 0.5 ppm, and sugar beet pulp at 0.2 ppm

Section 408(b)(2)(A)(i) of the 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) 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) 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 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of the herbicide triallate and its metabolite, TCPSA in or on sugar beet root at 0.01 ppm, sugar beet top at 0.5 ppm, and sugar beet pulp at 0.2 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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 nature of the toxic effects caused by triallate ( S -2,3,3, trichloroallyl diisopropylthiocarbamate) are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

Several acute toxicology studies place technical triallate in acute toxicity category III for acute oral toxicity and primary eye irritation and in toxicity category IV for acute dermal toxicity, acute inhalation toxicity, and primary dermal irritation. Triallate is a skin sensitizer.

The dose at which no adverse effects are observed (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 lowest dose at which adverse effects of concern are identified (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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure ” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for triallate ( S -2,3,3-trichloroallyl diisopropylthiocarbamate) used for human risk assessment is shown in the following Table 2:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.314(a)) for residues of the herbicide triallate ( S -2,3,3, trichloroallyl diisopropylthiocarbamate), per se (parent only) in or on a variety of raw agricultural commodities; Barley, grain; Barley, straw; Lentils; Lentils, forage; Lentils, hay; Peas, forage; Peas, hay; Wheat, grain; and Wheat, straw. Under reregistration, the triallate tolerance expression will be revised in order to reflect the Agency's determination that triallate and its TCPSA metabolite should be regulated and assessed for dietary exposure in plant commodities. The Agency decided to regulate on the TCPSA metabolite because it is present at more than 10% of the total radioactive residue (TRR) in the plant metabolism studies. Tolerances are to be expressed as triallate for the combined residues of the herbicide triallate ( S -2,3,3- S -2,3,3-trichloroallyl diisopropylthiocarbamate) and its metabolite TCPSA (2,3,3-trichloroprop-2-ene sulfonic acid) in or on the following commodities: Sugar Beet, root; Sugar Beet, top; and Sugar Beet, pulp. No tolerances have been established for processed food/feed or animal commodities. Risk assessments were conducted by EPA to assess dietary exposures from triallate ( S -2,3,3-trichloroallyl diisopropylthiocarbamate) and its metabolite TCPSA in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. A probalistic (Monte Carlo) acute dietary analysis was conducted for triallate residues in food. This analysis is highly refined (Tier 3), and represents a realistic estimate of acute dietary exposure in food possible with current data, based on all uses supported through reregistration and the proposed used of triallate on sugar beets. The percent acute population adjusted doses (PADs) are significantly below the Agency's level of concern at the 99.9th percentile of exposure for the females 13+ subgroup ( < 2% aPAD) and for the general population ( < 1% aPAD). For acute dietary analyses, anticipated residues and percent of crop treated data were used. For the purposes of this assessment, residue field trial data were used for the acute anticipated residues calculations.

ii. Chronic exposure . In conducting the chronic dietary risk assessment the DEEM® analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The chronic (non-cancer) dietary risk from exposure through food is < 1% of the Agency's level of concern ( < 100% of the chronic PAD) for the general U.S. population and all subgroups. For chronic dietary analyses, anticipated residues and percent of crop treated data were used. For the purposes of this assessment, residue field trial data were used for the chronic anticipated residue calculations.

iii. Cancer . Triallate is classified as a Group C chemical (possible human carcinogen), based on hepatocellular carcinomas in male mice, with a positive trend and borderline significance in female mice, and increased incidence of renal tubular cell adenomas in rats. A linear low-dose (Q 1 * ) approach was used to characterize human health risk. The unit risk, Q 1 * based on the hepatocellular carcinomas in male mice, is 7.17 x 10 -2 (mg/kg/day) -1 in human equivalents. The Agency generally considers risks in the range of 1 x 10 -6 (1 in 1 million) or less as negligible risk for cancer dietary exposure. The results of this analysis indicate that the cancer dietary risk of 7.1 x 10 -8 from exposure through food, associated with the uses supported through reregistration and the proposed use of triallate on sugar beets, is below the Agency's level of concern for food alone.

iv. Anticipated residue and percent crop treated information . Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.

Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of percent crop treated (PCT) as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

A routine chronic dietary exposure analysis for triallate and its metabolite (TCPSA) was based on percent crop treated (PCT) information as follows:

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which triallate S -2,3,3-trichloroallyl diisopropylthiocarbamate may be applied in a particular area.

2. Dietary exposure from drinking water . The Agency lacks sufficient exposure data to complete a comprehensive dietary exposure analysis and risk assessment for triallate and its metabolite TCPSA 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 environmental fate and transport and physical characteristics of triallate and TCPSA.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) and the Pesticide Root Zone/EXposure Analysis Modeling System (PRZM/EXAMS) to produce estimates of pesticides in surface source drinking water. The Screening-concentration in ground water (SCI-GROW) model was used to estimate concentrations in shallow groundwater. The primary use of the models by the Agency is to screen out pesticides with low potential of reaching concentrations in drinking water exceeding human health levels of concern. EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The GENEEC model was designed to simulate runoff from a 10 hectare (ha) field into a static 1 ha small water body. It was originally designed to assess pesticide concentrations in aquatic environments for ecological risk assessments. The PRZM/EXAMS model scenario is designed as a refined screening model which incorporates a watershed scale assessment with a flow-through index reservoir. Additionally, the PRZM/EXAMS modeling incorporates a percent cropped area (PCA) to account for the extent of cropping area within a watershed. None of the models consider the impact of water treatment (mixing, dilution, or treatment) on pesticide concentrations in raw water. In cases where the screening model predictions exceed human health levels of concern, the Agency will require targeted monitoring studies to assess the actual pesticide concentrations in drinking water.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a Percent of Reference Dose (%%RfD) or Percent of Population Adjusted Dose (%%PAD). Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to triallate and its metabolite TCPSA, they are further discussed in the aggregate risk sections below.

Based on the PRZM-EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of triallate and its metabolite TCPSA in surface water and ground water for acute exposures are estimated to be 9.452 parts per billion (ppb) for surface water and 0.21 ppb for ground water. The EECs for chronic (non-cancer) exposures are estimated to be 1.26 ppb for surface water and 0.21 ppb for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Triallate is not registered for use on any sites that would result in residential exposure.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) 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 does not have, at this time, available data to determine whether triallate has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, triallate 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 triallate 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. Safety factor for infants and children — i. In general . FFDCA section 408 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 data base on toxicity and exposure unless EPA determines 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 (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

ii. Prenatal and postnatal sensitivity . Quantitatively, there is evidence of increased susceptibility in the prenatal developmental toxicity study in rabbits; developmental effects (decreased fetal body weight and increased incidence of malaligned sternebrae) were observed in the absence of maternal toxicity.

iii. Conclusion . There is a complete toxicity data base for triallate and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures—EPA determined that some additional safety factor was needed to protect infants and children because the toxicity data indicated increased sensitivity to the young. The FQPA factor was reduced to 3x because the toxicology data base is complete; increased sensitivity was observed in only one species (rabbits); there is no quantitative or qualitative indication of increased susceptibility in the prenatal developmental toxicity study in rats, the 2-generation reproduction study in rats, or the developmental neurotoxicity in rats; adequate data are available or conservative modeling assumptions are used to assess dietary food and drinking water exposure; and there are currently no registered residential uses for triallate.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to triallate, and its metabolite, TCPSA will occupy < 1% of the aPAD for the U.S. population, 1.8%% of the aPAD for females 13 years and older, < 1%% of the aPAD for all infants ( < 1 year) and < 1%% of the aPAD for children (1-6 years). In addition, there is potential for acute dietary exposure to triallate and its metabolite TCPSA in drinking water.After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100%% of the aPAD, as shown in the following Table 3:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to triallate and its metabolite, TCPSA from food will utilize < 1%% of the cPAD for the U.S. population, < 1%% of the cPAD for Non-nursing infants ( < 1 year old) and < 1%% of the cPAD for children (1-6 years old). There are no residential uses for triallate and its metabolite TCPSA that result in chronic residential exposure to triallate and its metabolite TCPSA, as shown in the following Table 4:

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Triallate is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Triallate is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

5. Aggregate cancer risk for U.S. population . The Agency generally considers risks in the range of 1 x 10 -6 (1 in 1 million) or less as negligible risk for cancer. The results of this analysis indicate that the cancer dietary (food) risk estimate of 7.1 x 10 -8 associated with the uses supported through reregistration and the proposed use on sugar beets is not of concern. The cancer DWLOC is 0.45 ppb. The Tier II (PRZM-EXAMS) estimated average concentration of triallate + TCPSA in surface water is 0.566 ppb (mean annual with 2 incorporation) and 1.26 ppb (mean annual with no incorporation). Concentrations in ground water are not expected to be higher than 0.21 ppb. The 36-year annual mean estimated concentrations in surface water exceed the DWLOCs for triallate + TCPSA in drinking water as a contribution to cancer aggregate exposure. However, the drinking water component is based on model predictions, which are generally conservative in estimating chemical concentrations in drinking water. To address this concern, the registrant initiated a 3-year surface drinking water monitoring study in June 1999 to measure raw and finished triallate + TCPSA concentrations at five surface drinking water collection locations. Interim results of the surface water monitoring study indicated that peak and mean exposure to total parent triallate and TCPSA at all five sites are below the cancer DWLOC (0.45 ppb). Additional monitoring data will be provided on a quarterly basis, with a final report of the study expected in late 2002. Based on the interim results of the surface water monitoring study, which indicated that peak and mean exposure to total parent triallate and TCPSA are below the cancer DWLOC (0.45 ppb), the aggregate cancer risk for the U.S. Population is expected to be less than 1 x 10 -6 .

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 triallate and its metabolite (TCPSA) combined residues.

In conjunction with the regional registration of triallate on sugar beets, the registrant has proposed a GC/ECD method (designated as Method RES-099-96, Version No. 2) for tolerance enforcement purposes. The method determines residues of triallate and its TCPSA metabolite. This method has been subjected to a successful independent laboratory validation. The method has also been validated in an Agency study at Beltsville, MD. The laboratory (Analytical Chemistry Branch, BEAD) verified the limits of quantitation (LOQs) to be 0.025 ppm triallate and 0.025 ppm TCPSA in/on sugar beet roots, and 0.05 ppm triallate and 0.20 ppm TCPSA in/on sugar beet foliage. The Beltsville report (7/28/98) also estimated the limits of detection (LODs) to be 0.001 ppm triallate and 0.004 ppm TCPSA in sugar beet root, and 0.005 ppm triallate and 0.04 ppm TCPSA in sugar beet top. The expected dietary burdens of triallate to beef/dairy cattle and poultry animals were recalculated following tolerance reassessment of livestock feed items. There is no reasonable expectation of finite residues (Category 3 of 40 CFR section 180.6); therefore, tolerances are not required for milk, eggs, and animal tissues.

Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no Codex MRLs for triallate; therefore, no questions of compatibility with U.S. tolerances exists.

Completion of the 3-year surface drinking water study will be a condition of registration. Monitoring data will be provided on a quarterly basis, with a final report of the study expected in late 2002.

Therefore, the tolerance is established for the combined residues of the herbicide triallate ( S -2,3,3, trichloroallyl diisopropylthiocarbamate) and its metabolite, TCPSA (2,3,3-Trichloroprop-2-ene sulfonic acid) in or on sugar beet, root, sugar beet, top, and sugar beet pulp.

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. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301063 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 November 28, 2000.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential 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. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim @epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301063, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket @epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 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 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require 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 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. 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 FFDCA section 408(n)(4).

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).

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and 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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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/. To access this document, 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/.

2. In person . The Agency has established an official record for this action under docket control number OPP-301062. 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.

In the Federal Register of March 26, 1997, 62 FR 14418 (FRL-5594-7) and March 8, 2000, 65 FR 12244 (FRL-6491-4), EPA issued notices pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of pesticide petitions (7F4816 and 8F4946) for tolerances by American Cyanamid Company, P.O. Box 400, Princeton, NJ 08543-0400. These notices included summaries of the petitions prepared by American Cyanamid Company, the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.493 be amended by establishing tolerances for residues of the fungicide dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine, in or on dried hops cones at 60 ppm, grapes at 3.5 ppm, raisins at 6.0 ppm, tomato fruit at 0.5 ppm, and tomato paste at 1.0 part per million (ppm).

Section 408(b)(2)(A)(i) of the 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) 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) 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 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine on dried hops cones at 60 ppm, grapes at 3.5 ppm, raisins at 6.0 ppm, tomato fruit at 0.5 ppm, and tomato paste at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances are as follows.

EPA has previously 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 considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The toxicological profile for dimethomorph was addressed in the risk assessment published in the Federal Register final rule of October 13, 1998 (63 FR 54587) (FRL-6036-7).

The toxicological endpoints for dimethomorph were addressed in the risk assessment published in the Federal Register final rule of October 13, 1998 (63 FR 54587) (FRL-6036-7).

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.493) for the residues of dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)- 3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine in or on potatoes at 0.05 ppm, potatoes, wet peel at 0.15 ppm and time-limited tolerances have been established for cantaloupe, cucumber, squash and watermelon at 1 ppm (expires September 30, 2001) and on the cereal grains group: fodder at 0.15 ppm, forage and grain at 0.05 ppm, hay at 0.10 ppm, and straw at 0.15 ppm. Risk assessments were conducted by EPA to assess dietary exposures from dimethomorph as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. EPA did not select a dose and endpoint for an acute dietary risk assessment because of the lack of toxicological effects attributable to a single exposure (dose) in either the rat or the rabbit developmental toxicity studies.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM DM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following very conservative assumptions were made for the chronic exposure assessments: that all commodities having dimethomorph tolerances will contain residues of dimethomorph and those residues will be at the level of the tolerance. These assumptions result in an overestimate of human dietary exposure. All Section 18 tolerances (cantaloupes, watermelons, cucumbers, and squash) are included in this dietary risk assessment. Using the assumptions and data parameters described above, the DEEM-89 exposure analysis results in a theoretical maximum residue contribution (TMRC) that is equivalent to the following percentages of the PAD/RfD. The following Table 1 summarizes the estimated food exposures for the U.S. population, all infants ( < 1 year old), the population subgroups that include children, and the most highly exposed female and male subgroups.

2. From drinking water . EPA used SCI-GROW (Screening Concentration In Ground Water) and GENEEC (Generic Estimated Environmental Concentration) models to determine the estimated environmental concentrations (EECs) of dimethomorph residues in ground and surface water. The EEC reported for dimethomorph residues in ground water is 0.26 parts per billion (ppb). The EEC for surface water is 28 ppb for acute and 24 ppb for chronic (56-day).

i. Acute exposure and risk . Because no acute dietary endpoint was determined, no acute risks are posed by exposure to dimethomorph.

ii. Chronic exposure and risk . EPA conducts the drinking water risk assessment by using the worst case scenario of estimated environmental concentration (EEC) found from either ground or surface water. The EEC reported for dimethomorph residues in ground water using SCI-GROW is 0.26 ppb. This is much less than the surface water EEC (24 ppb for 56 days) generated using GENEEC. Therefore, only the surface water EEC will be used in conducting the aggregate dietary (food + water) risk assessment. Based on the chronic food exposure and using default body weights and water consumption figures, chronic drinking water levels of comparison (DWLOCs) for drinking water were calculated. To calculate the chronic DWLOC, the chronic food exposure (from DEEM analysis) is subtracted from the chronic PAD/RfD. DWLOCs are then calculated using the default body weights and drinking water consumption figures. EPA's surface drinking water levels of comparison from chronic exposure to dimethomorph using modeling data are 3,400 ppb for U.S. population and for males (20+ years), 2,900 ppb for females 13-50, 970 ppb for children 7-12 years, 940 ppb for infants < 1 year and 930 ppb for children 1-6 years. These levels are all greater than the GENEEC concentration level (24 ppb for 56 days). Therefore, EPA does not expect exposure to dimethomorph in drinking water to be above the level of concern.

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). Dimethomorph is not registered for use on any sites that would result in residential exposure.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) 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 does not have, at this time, available data to determine whether dimethomorph has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. In general . FFDCA section 408 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 data base on toxicity and exposure unless EPA determines 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 (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity . EPA assessed the potential for additional sensitivity of infants and children to residues of dimethomorph in the Federal Register final rule of October 13, 1998 (63 FR 54587)(FRL-6036-7).

3. Conclusion . There is a complete toxicity database for dimethomorph and exposure data are complete or are estimated based on data that reasonably account for potential exposures. EPA determined that the 10x factor to protect infants and children be removed.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day)= cPAD − (average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . No acute dietary endpoint was identified; therefore, EPA concludes that dimethomorph poses no appreciable acute risk.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to dimethomorph from food will utilize 3% of the cPAD for the U.S. population, 6 % of the cPAD for infants ( < 1 year) and 7% of the cPAD for children (16 years). There are no residential uses for dimethomorph that result in chronic residential exposure to dimethomorph. The aggregate risk assessment for chronic (non-cancer) exposure to dimethomorph is shown in the following Table 2:

3. Short-term risk . Short-term 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, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

4. Intermediate-term risk . Intermediate-term 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, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

5. Aggregate cancer risk for U.S. population . Dimethomorph was classified as ``not likely'' to be a human carcinogen.

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.

Method FAMS 002-04 high performance liquid chromatography using ultra-violet detection (HPLC, UV detection) is adequate for determining residues of dimethomorph in tomatoes, grapes or hops. Confirmatory methods are available for tomatoes, raisins, and hops. Cyanamid Method 2577 can be used for tomatoes, FAMS 076-01 can be used for raisins, and FAMS 073-03 can be used for hops. The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no Canadian, Mexican, or Codex MRLs established for dimethomorph for the commodities associated with this request; consequently, a discussion of international harmonization is not relevant.

Therefore, tolerances are established for residues of dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine on dried hops cones at 60 ppm, grapes at 3.5 ppm, raisins at 6.0 ppm, tomato fruit at 0.5 ppm, and tomato paste at 1.0 ppm.

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. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301062 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 November 28, 2000.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential 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. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by email at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301062, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 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 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations (59 FR 7629, February 16, 1994); or require 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 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. 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 FFDCA section 408(n)(4).

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).

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and 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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

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/. To access this document, 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/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

2. In person . The Agency has established an official record for this action under docket control number OPP-301057. 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.

In the Federal Register of March 12, 1997 (62 FR 11433) (FRL-5589-7), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP) for tolerance by Aventis CropScience USA LP, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. This notice included a summary of the petition prepared by Aventis CropScience, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.499 be amended by establishing a tolerance for residues of the fungicide propyl[3-(dimethylamino)propyl]carbamate monohydrochloride, known as propamocarb hydrochloride, in or on potatoes, and the following livestock commodities: meat, meat byproducts, fat and milk of cattle, goats, hogs, horses and sheep at 0.05 part per million (ppm).

Section 408(b)(2)(A)(i) of the 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) 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) 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 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride on potatoes at 0.06 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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 nature of the toxic effects caused by propyl[3-(dimethylamino)propyl]carbamate monohydrochloride are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

The dose at which 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 dose at which the LOAEL of concern are identified 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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 - 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for propyl[3-(dimethylamino)propyl]carbamate monohydrochloride used for human risk assessment is shown in the following Table 2:

1. Dietary exposure from food and feed uses . In addition to the currently proposed tolerance for potatoes, tolerances have been established under the section 18 program (40 CFR 180.499) for the residues of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride, in or on the raw agricultural commodity, potatoes and tomatoes. Risk assessments were conducted by EPA to assess dietary exposures from propyl[3-(dimethylamino)propyl]carbamate monohydrochloride in food as follows:

i. Acute Exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Tier 1 acute analyses were performed for females 13-50 years old and the general U.S. population (including infants and children); therefore, the acute risk was analyzed at the 95th percentile. The aPAD for females 13-50 years old and the general U.S. population (including infants and children) are 1.5 mg/kg/day and 2.0 mg/kg/day, respectively. For acute dietary risk estimates, EPA's level of concern is >100% aPAD. The results of the acute analysis indicate that the acute dietary risk estimates for the general U.S. population and all population subgroups (at the 95th percentile) associated with the proposed uses of propamocarb hydrochloride do not exceed EPA's level of concern.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the DEEM® analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A Tier 1 chronic analysis was performed for the general U.S. population and all population subgroups. The cPAD for the general U.S. population and all subgroups is 0.12 mg/kg/day. For chronic dietary risk estimates, EPA's level of concern is >100% cPAD. The results of the chronic analysis indicate that the chronic dietary risk estimates for the general U.S. population and all population subgroups associated with the proposed uses of propamocarb hydrochloride do not exceed EPA's level of concern.

iii. Cancer . There is no concern for mutagenic potential, and there is no evidence of carcinogenic potential in either the rat or mouse. Propamocarb hydrochloride has been classified as “not likely to be carcinogenic in humans.” Therefore, a cancer dietary exposure analysis 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %%RfD or %%PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to propyl[3-(dimethylamino)propyl]carbamate monohydrochloride they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the EECs of propyl[3-(dimethylamino)propyl]carbamate monohydrochloride in surface water and ground water for acute exposures are estimated to be 1030 parts per billion (ppb) for surface water and 2.08 ppb for ground water. The EECs for chronic exposures are estimated to be 340 ppb for surface water and 2.08 ppb for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Propyl[3-(dimethylamino)propyl]carbamate monohydrochloride is currently registered for use on the following residential non-dietary sites: turfgrass and ornamentals at residential, recreational and golf course sites. However, the usage information in the 1995 Reregistration Eligibility Decision (RED) for propamocarb hydrochloride and the label statement that only protected handlers may be present in the treated area during application, indicate that only commercial applicators will apply the registered end-use product Banol (EPA Registration Number 432-942, contains 66.5% propamocarb hydrochloride) mainly on golf courses and there will be no use on residential or recreational turf. The risk assessment was conducted using the following residential exposure assumptions: An MOE of 100 is adequate to ensure protection from propamocarb hydrochloride via the dermal and inhalation routes for residential exposures. The high-end scenario for residential post-application exposure is the golf course use. The post-application risk assessment is based on generic assumptions as specified by the newly proposed Residential Standard Operating Procedures (SOPs) and recommended approaches by Health Effects Division's (HED's) Exposure Science Advisory Committee. Short-term post-application exposures are expected for the adult and adolescent golfer. Golfer exposure is expected through minimal hand contact with the golf ball and dermal contact to the lower legs from treated plant surfaces. Since it is assumed that the adolescent golfer would have a proportionally similar exposure to adults, a dermal post-application assessment was performed for the adult golfer only. The calculated MOE for the golfer is 980 and, therefore, does not exceed EPA's level of concern. Since the short- and intermediate-term toxicological endpoints are the same, the golfer post-application exposure assessment is expected to provide adequate exposure estimates for both the short- and intermediate-term. In the event of intermediate-term exposure, propamocarb hydrochloride residues are expected to dissipate over time. Therefore, this assessment is expected to present a high-end conservative estimate of actual exposure.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) 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 does not have, at this time, available data to determine whether propyl[3-(dimethylamino)propyl]carbamate monohydrochloride has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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 propyl[3-(dimethylamino)propyl]carbamate monohydrochloride 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. Safety factor for infants and children —i. In general . FFDCA section 408 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 data base on toxicity and exposure unless EPA determines 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 (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

ii. Prenatal and postnatal sensitivity . There is no evidence of quantitative or qualitative enhanced susceptibility to infants and children. In the rat, developmental effects occur only at doses that cause mortality in the dams. The Maternal LOAEL of 740 mg ai/kg/day is based on mortality. The Maternal NOAEL is 221 mg ai/kg/day. The Developmental LOAEL of 740 mg ai/kg/day is based on increased gestation day (GD) 20 fetal death and a possible increase in minor skeletal anomalies. The Developmental NOAEL is 221 mg ai/kg/day.

In the rabbit, developmental effects occur only at doses where there is maternal toxicity. It was felt by the Hazard Identification Assessment Review Committee (HIARC) that the post implantation loss is actually due to the increased abortions in the does. The Maternal LOAEL of 300 mg ai/kg/day is based on decreased body weight gains for GD 6-18 and possible increased abortions. The Maternal NOAEL is 150 mg ai/kg/day. The Developmental LOAEL of 300 mg ai/kg/day is based on increased post-implantation loss. The Developmental NOAEL is 150 mg ai/kg/day.

In the reproduction toxicity study, offspring effects only occurred at levels resulting in maternal toxicity. The LOAEL for systemic/parental toxicity is 8000 ppm based on decreased body weights of F 0 and F 1 adults. The systemic/parental toxicity NOAEL is 1250 ppm.

iii. Conclusion . There is a complete toxicity data base for propyl[3-(dimethylamino)propyl]carbamate monohydrochloride and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because the prenatal and postnatal toxicology database is complete and there is no indication of increased susceptibility. A developmental neurotoxicity study is not required. The dietary (food and drinking water) exposure assessments will not underestimate the potential exposures for infants and children from the use of propamocarb hydrochloride.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD—(average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and ground water are less than the calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to propyl[3-(dimethylamino)propyl]carbamate monohydrochloride will occupy 1 %% of the aPAD for the U.S. population, 1 %% of the aPAD for females 13 years and older, 3%% of the aPAD for all infants  ( < 1 year old) and 3 %% of the aPAD for children 1-6 years old. In addition, there is potential for acute dietary exposure to propyl[3-(dimethylamino)propyl]carbamate monohydrochloride in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100%% of the aPAD, as shown in the following Table 3:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to propyl[3-(dimethylamino)propyl]carbamate monohydrochloride from food will utilize 7%% of the cPAD for the U.S. population, 9%% of the cPAD for all infants < 1 year old and 23 %% of the cPAD for children 1-6 years old. It has been assumed that there are no residential uses for propyl[3-(dimethylamino)propyl]carbamate monohydrochloride that result in chronic residential exposure to propyl[3-(dimethylamino)propyl]carbamate monohydrochloride, as shown in the following Table 4:

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and 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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

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/. To access this document, 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/.

2. In person. The Agency has established an official record for this action under docket control number OPP-301055. 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.

In the Federal Register of June 30, 2000 (65 FR 40632) (FRL-6592-6), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the filing of pesticide petitions (PP 9E6017, PP 9E6018 and PP 9E6018) by Cabot Corporation, 75 State Street, Boston, MA, 02109. This notice included a summary of the petitions prepared by the petitioner. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.1001 (c) and (e) be amended by revising the existing exemptions from the requirement of a tolerance for residues of dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica; CAS No. 67762-90-7, CAS No. 68611-44-8, and CAS No. 68909-20-6, respectively.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for 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(c)(2)(A)(ii) 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) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of 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...” and specifies factors EPA is to consider in establishing an exemption.

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 ploymers 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.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

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 and considered its validity, completeness and reliability and the relationship of this information 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. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d).

1. The polymers, dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica, are not cationic polymers nor are they reasonably anticipated to become cationic polymers in a natural aquatic environment.

2. The polymers do contain as an integral part of their compostion the atomic elements carbon, hydrogen, and oxygen.

3. The polymers do not contain as an integral part of their composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymers are neither designed nor can they be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymers are manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymers are not water absorbing polymers with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymers, dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica, also meet as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymers' number average MW of 1,100,000 daltons; 3,340,000 daltons; and 645,000 daltons, respectively is greater than or equal to 10,000 daltons. The polymer contains less than 2%% oligomeric material below MW 500 and less than 5%% oligomeric material below MW 1,000.

Thus, dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on their conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica.

For the purposes of assessing potential exposure under this exemption, EPA considered that dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica are 1,100,000 daltons; 3,340,000 daltons; and 645,000 daltons, respectively. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Additionally, since the polymer are not water-absorbing, it is expected that respirable fractions would be cleared from the lungs. Since dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information ” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” The Agency has not made any conclusions as to whether or not dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica share a common mechanism of toxicity with any other chemicals. However, dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica conform to the criteria that identify a low risk polymer. Due to the expected lack of toxicity based on the above conformance, the Agency has determined that a cumulative risk assessment is not necessary.

Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population from aggregate exposure to residues of dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica.

FFDCA section 408 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 data base unless EPA concludes that a different margin safety will be safe for infants and children. Due to the expected low toxicity of dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

There is no available evidence that dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica are endocrine disruptors.

An exemption from tolerance under 40 CFR 180.1001(c) and (e) was established for dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica published in the Federal Register of March 1, 2000, (65 FR 10946) (FRL-6490-9). The following uses were exempted for both dimethyl silicone polymer with silica and hexamethyldisilizane, reaction product with silica: moisture barrier, anti-caking agent, anti-settling agent. This amendment to the existing exemption adds thickening agent to the uses for dimethyl silicone polymer with silica and hexamethyldisilizane, reaction product with silica under 40 CFR 180.1001(c) and (e).

The uses exempted for silane, dichloromethyl-, reaction product with silica were: moisture barrier, anti-caking agent, anti-settling agent, anti- thickening agent. This final rule establishes that anti-thickening be revised by deleting anti, so that the uses for silane, dichloromethyl-, reaction product with silica under 40 CFR 180.1001(c) and (e) will read as follows: moisture barrier, anti-caking agent, anti-settling agent, thickening agent.

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.

The Agency is not aware of any country requiring a tolerance for dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

Accordingly, EPA finds that exempting residues of dimethyl silicone polymer with silica; silane, dichloromethyl-, reaction product with silica; and hexamethyldisilizane, reaction product with silica from the requirement of a tolerance will be safe.

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. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301055 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 November 28, 2000.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential 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. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. M3708, Waterside Mall, 1200 Pennsylvania Ave., NW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301055, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes an exemption from the tolerance requirement under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 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 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require 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 104 -113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption 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 FFDCA section 408(n)(4).

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 rule in the Federal Register . This rule is not a “major rule ” as defined by 5 U.S.C. 804(2).

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and 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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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/. To access this document, 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/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

2. In person . The Agency has established an official record for this action under docket control number OPP-301069. 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.

In the Federal Register of August 2, 2000 (65 FR 47498) (FRL-6592-1), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP) for tolerance by Zeneca Ag Products, 1800 Concord Pike, P.O. Box 15458, Wilmington, DE 19850--5458. This notice included a summary of the petition prepared by Zeneca Ag Products, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.507 be amended by establishing a tolerance for combined residues of the fungicide azoxystrobin (methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and its Z isomer (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate), in or on barley, bran at 0.2 ppm; barley, grain at 0.1 ppm; barley, hay at 15 ppm; barley, straw at 4 ppm; citrus, dried pulp at 2.0 ppm; citrus, oil at 4.0 ppm; coriander, leaves at 30 ppm; corn, field, forage at 12 ppm; corn, field, grain at 0.05 ppm; corn, field, refined oil at 0.3 ppm; corn, field, stover at 25 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 25 ppm; corn, sweet, forage at 12 ppm; corn, sweet, kernel plus cob with husks removed at 0.05 ppm; corn, sweet, stover at 25 ppm; cotton, gin byproducts at 0.02 ppm; cotton, undelinted seed at 0.02 ppm; fruit, citrus, group at 1.0 ppm; onion, dry bulb at 1.0 ppm; onion, green at 7.5 ppm; peanut at 0.2 ppm; peanut, hay at 15.0 ppm; peanut, refined oil at 0.6 ppm; soybean, forage at 25 ppm; soybean, hay at 55 ppm; soybean, hulls at 1.0 ppm; soybean, seed at 0.5 ppm; vegetable, leafy, except Brassica, group at 30 ppm; vegetable, leaves of root and tuber, group at 50 ppm; and vegetable, root, subgroup at 0.5 ppm; and vegetable, tuberous and corm, subgroup at 0.03 ppm; and increase the tolerances for residues of azoxystrobin (only) in or on cattle, fat to 0.03 ppm; cattle, meat byproducts to 0.07 ppm; goat, fat to 0.03 ppm; goat, meat byproducts to 0.07 ppm; horse, fat to 0.03 ppm; horse, meat byproducts to 0.07 ppm; sheep, fat to 0.03 ppm; and sheep, meat byproducts to 0.07 (ppm).

Section 408(b)(2)(A)(i) of the 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) 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) 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 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for the combined residues of azoxystrobin (methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and its Z isomer (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) on barley, bran at 0.2 ppm; barley, grain at 0.1 ppm; barley, hay at 15.0 ppm; barley, straw at 4.0 ppm; citrus, dried pulp at 2.0 ppm; citrus, oil at 4.0 ppm; coriander, leaves at 30.0 ppm; corn, field, forage at 12.0 ppm; corn, field, grain at 0.05 ppm; corn, field, refined oil at 0.3 ppm; corn, field, stover at 25.0 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 25.0 ppm; corn, sweet, forage at 12.0 ppm; corn, sweet (kernels plus cob with husks removed) at 0.05 ppm; corn, sweet, stover at 25.0 ppm; cotton, gin byproducts at 0.02 ppm; cotton, undelinted seed at 0.02 ppm; fruit, citrus, group at 1.0 ppm; grain, aspirated grain fractions at 30.0 ppm; onion, dry bulb at 1.0 ppm; onion, green at 7.5 ppm; peanut at 0.2 ppm; peanut, refined oil at 0.6 ppm; peanut, hay at 15.0 ppm; soybean, forage at 25.0 ppm; soybean, hay at 55.0 ppm; soybean, hulls at 1.0 ppm; soybean, seed at 0.5 ppm; vegetable, leafy, except Brassica, group at 30.0 ppm; vegetable, leaves of root and tuber, group at 50.0 ppm; vegetable, root, subgroup at 0.5 ppm; and vegetable, tuberous and corm, subgroup at 0.03 ppm; and to increase the tolerances for residues of azoxystrobin (only) in or on cattle, fat to 0.03 ppm; cattle, meat byproducts to 0.07 ppm; goat, fat to 0.03 ppm; goat, meat byproducts to 0.07 ppm; horse, fat to 0.03 ppm; horse, meat byproducts to 0.07 ppm; sheep, fat to 0.03 ppm; and sheep, meat byproducts to 0.07 ppm. EPA's assessment of exposures and risks associated with establishing or increasing the tolerances follows.

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 nature of the toxic effects caused by azoxystrobin, as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed, are discussed in the following Table 1.