SUPPORTING STATEMENT FOR STANDARD FORM 83 1 REPORTING AND RECORDKEEPING REQUIREMENTS FOR THE ENFORCEMENT POLICY REGARDING THE SALE AND USE OF AFTERMARKET CATALYTIC CONVERTERS PART A OF THE SUPPORTING STATEMENT 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection Enforcement Policy Regarding the Sale and Use of Aftermarket Catalytic Converters ( Renewal). 51 FR 28114 28119, 28133 ( Aug. 5, 1986); 52 FR 42144 ( Nov. 3, 1987), 67 FR 319 320 ( Jan. 3, 2002).

OMB No. 2060 0135; EPA ICR No. 1292.07.

1( b) Short Characterization The aftermarket catalytic converter policy ( 51 Fed. Reg. 28114 28119, 28113 ( Aug. 5, 1986); 52 Fed. Reg. 42144 ( Nov. 3, 1987)) allows aftermarket automobile catalytic converter manufacturers and reconditioners to compete with the automobile manufacturers for the aftermarket catalytic converter replacement market. Without this policy, it would be illegal, under section 203 of the Clean Air Act, 42 U. S. C. § 7522, to sell or install aftermarket catalytic converters that do not conform exactly to the automobile manufacturers' original equipment ( OE) versions of these parts. The policy also makes it possible for automobile repair shops, which are often small businesses, to take on a significant share of the aftermarket catalyst replacement market. In doing so, consumers are able to purchase replacement catalytic converters ( converters) at a much lower price than they would pay for an OE converter. This helps to ensure that vehicles will not create excessive air pollution because motorists are more likely to replace damaged catalytic converters if they cost much less than OE converters ( cost savings resulting from the policy are estimated to be about $ 680 million in 2005 dollars).

However, to ensure that air quality will not be compromised, it was necessary to set standards for aftermarket catalytic converters, both for performance and durability. It was also necessary to ensure that appropriate applications are installed on vehicles ( i. e., the converter has to be of a type and size appropriate for the vehicle application). To these ends, the following recordkeeping and reporting requirements exist for aftermarket converter manufacturers, reconditioners and installers:

Manufacturers: On a one time basis for each type or line of converter manufactured, the manufacturer must report information identifying the supplier, and information regarding the physical specifications of each catalytic converter line produced, and information regarding preproduction testing of the converters that show they meet standards for certain specified vehicle applications ( a single converter line can be used on a large number of vehicle applications). The 2 original policy required that once production had begun the manufacturer would submit to EPA on a semi annual basis the number of each type of catalyst manufactured and a summary of information contained on warranty cards or, at the option of the respondent, copies of warranty cards for all converters sold. This reporting regarding sales and warranty information was eliminated in March 1999, with the stipulation that records must be maintained and the information submitted to EPA upon request.

Reconditioners: On a one time basis, the catalyst reconditioner must report the identity of the company and a description of the test bench used for testing used catalytic converters and the intended vehicle application( s) for each converter type. All used converters must be tested individually to ensure they are still functional. On a semi annual basis, the catalyst reconditioner must report the names and addresses of distributors along with the number of each type of converter sold to each distributor. This reporting requirement was also eliminated in March 1999, with the stipulation that records must be maintained and the information submitted to EPA upon request.

Installers of aftermarket converters: Installers have no reporting requirements. They simply fill out the warranty card and hand it to the retail customer. They must also include a brief statement with each invoice stating the need for replacing the original converter. They also tag each removed converter with a reference to the invoice for repair. The invoices are required to be kept for 6 months. The tagged converters are required to be kept for 15 days.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection Section 203( a)( 3) of the Clean Air Act ( Act) prohibits removal or rendering inoperative of motor vehicle emission control equipment by commercial service establishments or any other person. It also prohibits the causing of such acts. In addition, it prohibits the manufacture, sale or installation of devices that defeat the emission control components or design elements. The catalytic converter is the major emission control device used by motor vehicle manufacturers. Oxidation ( twoway catalytic converters reduce hydrocarbons and carbon monoxide emissions, while oxidationreduction ( three way) converters ( widely used since 1981) additionally reduce oxides of nitrogen emissions. If a vehicle is properly maintained, the catalytic converter frequently will not require replacement for the life of the vehicle. However, catalytic converters sometimes need replacement subsequent to the automobile manufacturer emissions control warranty period, and therefore any replacement cost is paid for by the vehicle owner.

The U. S. Environmental Protection Agency ( EPA) has promoted vehicle emissions inspection programs which require converter replacement where missing or non functioning converters are discovered. The EPA believes that the success of State and local government programs of this type depends, in part, on the availability and cost of replacement converters. The average cost of a new original equipment manufacturer ( OE) converter is approximately $ 540$ 650 installed. This high cost of replacement severely limited their installation after the warranty period expired. This enforcement policy allows the sale of low cost effective alternatives to the OE converters. For the aftermarket converter industry, including the installers, this is a multimillion dollar industry. Over 2,000,000 aftermarket converters are installed each year. 3 The popularity of these low cost replacement converters and the need to ensure air quality benefits while promoting local tampering inspection programs have led the Agency to implement this policy for the manufacture, sale, and installation of new non OE and used, reconditioned OE converters. Prior to the implementation of the policy, aftermarket converter manufacturers and reconditioners were frequently selling catalysts that had little, if any, efficacy. Manufacturers who were attempting to make a quality product were not able to compete on a level playing field because muffler shops could purchase poor quality converters for half the price of better aftermarket converters and undersell the competition. The manufacturer reporting and recordkeeping requirements help ensure that proper equipment is manufactured and distributed to installers and helps ensure proper retail level installation of converters.

The installer requirements exist to enable EPA to monitor whether correct applications are made at the retail level and whether OE converters are being replaced with aftermarket converters only in appropriate circumstances ( e. g., the original equipment converter should not be replaced with an aftermarket converter while the vehicle is still under its emissions warranty). A strong incentive exists for cheating; for example installing a used, untested converter would cost less than half the price of a properly tested converter.

These are important conditions to the installation of aftermarket or reconditioned catalytic converters. An improper application ( e. g., a 2 way converter on a vehicle that needs a 3 way converter) will result in much higher emissions of harmful pollutants than a proper application would. Likewise, replacement of the original converter when the repair is not needed can result in an increase in emissions since working OE converters are more efficient than aftermarket converters.

2( b) Practical Utility/ Users of the Data USE The collection of information is necessary for the proper performance of the functions of the Agency, including that the information collected will have practical utility. Without these requirements, enforcement would be nearly impossible. Neither EPA nor a reconditioner can determine whether a used converter is effective by conducting a visual inspection of the converter. The efficacy of new aftermarket converters for particular vehicle applications cannot be determined without prototype testing and information on specifications.

All testing is to be conducted by the manufacturer or reconditioners, and therefore the Agency believes that it is important that it have access to testing records. A record of the names and addresses of dealers and distributors, as is required in the policy, allows for prompt notification of these parties in the event of such an enforcement action.

The primary use of the sales and warranty card information is for direct compliance action. Warranty cards often reveal direct evidence of misapplication or defect warranty violations. Sales information from reconditioners provides an indirect way to make sure that production is not exceeding the capacity of the test stand, and provides the Agency with a list of distributor or retail facilities for enforcement audits and testing.

The installer requirements are needed to assure installation of appropriate applications and to 4 assure that catalytic converters are only replaced when necessary. Some repair shops could gain an unfair advantage if they were to install cheaper 2 way converters on vehicles requiring 3 way converters. Repair shops could also improperly benefit, at cost to both the consumer and ambient air quality, if OE converters are replaced when they are still functional or when they are still within the warranty period.

The requirements also facilitate knowledge on the part of the installers of aftermarket converters and of the driving public that the converters they are using are appropriate and effective and that no potential liability should exist for the installer so long as the appropriate converter is installed on each vehicle.

USERS Air Enforcement Division, Office of Civil Enforcement, Office of Enforcement and Compliance Assurance, U. S. Environmental Protection Agency. As noted above, the requirements also assist industry by assuring a level playing field and by ensuring installers and their customers that the converter to be installed is effective and appropriate for the vehicle ( e. g., 3 way converter of proper capacity on vehicle that needs 3 way).

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Nonduplication The information collection is not unnecessarily duplicative of information otherwise reasonably accessible to the Agency. The required warranty provisions and the manufacturer reports and test records are the only records of their kind available to document the information needed to determine compliance. The information can be in a variety of formats and the manufacturers' warranty card information reporting can be electronic or the manufacturer can submit the actual warranty cards.

3( b) Public Notice Required Prior to ICR Submission to OMB In compliance with the Paperwork Reduction Act, a public comment period of 60 days was announced in the Federal Register ( 70 Fed. Reg. 30941 43 ( May 31, 2005)) regarding this proposed renewal ICR. No comments were received. However, we have continued to update burden and cost information and this ICR Supporting Statement, the associated Form 83 I and the second Federal Register notice reflect these changes.

The ICR estimated burdens and costs that are being submitted to OMB for this renewal have been revised and updated to reflect wage and inflation increases, as well as estimated current workloads and corresponding burden times for installers, reconditioners and manufacturers. An additional estimate has been continued in this ICR regarding amortized startup costs for new aftermarket converter installation businesses. A second Federal Register notice is being published announcing the submission of this Policy to OMB for approval.

3( c) Consultations 5 For this ICR, EPA has contacted various affected industry respondents for information regarding burdens and costs. Following is a list of non EPA contacts, by name, phone number and affiliation:

1. Peter Nitoglia, Car Sound Exhaust System, Inc. 865.458.4681. 2. George Schafer, Eastern manufacturing, Inc., 800 533 7199. 3. Pat Haynes, Tenneco automotive, 517.796.6744. 4. Dave Miller, Miller Catalyzer, 510.732.0622. 5. Paula Couch, Brown Recycling, 800.367.9271. 6. Helamon Andre, KGC Warehouse, 417.276.3059. 7. Harley Mayer, Jr., Kataco Creek Converters, 800.275.5116. 8. Jim/ Mark Zuckerman, Meineke Muffler, New Haven, CT. 203.397.2353 9. Katie, Midas Muffler, Beaverton, OR., 503.643.5561 3( d) Effects of Less Frequent Collection The information requested from the manufacturers would normally by kept as part of their records, and should not constitute a significant burden to maintain. Additionally, the information requested is the minimum considered necessary to adequately monitor the aftermarket converter market and properly enforce the policy. Note that the manufacturers and reconditioners are voluntarily accepting recordkeeping burdens as a condition of EPA not bringing actions for violation of section 203 of the Clean Air Act. EPA is willing to allow the sale of aftermarket converters not certified to meet OE standards only if it can insure that aftermarket converters meet the less strict standards of the policy and that they are properly installed.

The product development information requested is only collected when a new product line is introduced by an aftermarket converter manufacturer. Less frequent collection of test results would allow some converters to reach the market without proof of sufficient emission testing to verify their effectiveness. Semi annual reports of production or sales information are no longer required. Test data on used converters cannot be taken on less than every converter that is recycled, since the condition of the used converters varies widely because of prior use history.

No reporting is required for installers. The recordkeeping must accompany installation since there is no way to collect the information afterward.

3( e) General Guidelines The collection is in compliance with OMB guidelines except that new aftermarket converter manufacturers are required to keep warranty cards for 5 years. Because the warranty period for the converters is 5 years, this length of time is necessary. This requirement is also in line with the applicable statute of limitations. EPA has not received negative comment regarding this maintenance period from the industry.

3( f) Confidentiality Confidentiality protections are provided pursuant to 40 C. F. R. § 2.201 et seq. 6 3( g) Sensitive Questions This section is inapplicable to this ICR.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ SIC Codes Respondents include the manufacturers of new aftermarket motor vehicle catalytic converters and reconditioners of used aftermarket converters. The SIC code is 346 ( NAICS 336399). The other respondents are automobile exhaust repair facilities. Their SIC code is 7533 ( NAICS 811112).

4( b) Information Requested ( i) Data Items, Including Recordkeeping Requirements This ICR indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified.

One time Reporting:

Parties required to submit converter testing information include all manufacturers of new non OEM converters and reconditioners of used OEM converters.

Manufacturers of New Converters Specifications Information:

1) Converter supplier and address.

2) General type of converter ( e. g., oxidation, reduction, three way, etc.).

3) Number of each type of catalyst used per can ( number of individual monoliths containing catalytic metals in each unit).

4) Substrate ( e. g., monolithic, pelleted)  give configuration construction technique ( e. g., extruded, laid up, formed, etc.), composition, supplier and address, composition of active constituents in substrate ( grams or troy ounces); for monolithic substrates, give number of cells per square inch of frontal area, design tolerances, and nominal cell wall thickness ( in mils); for pelleted substrates, specify pellet shape and dimensions, pellet bulk density, the use of more than one type of pellet ( e. g., Rh, or Pt/ Pd), any geometrical distribution of pellets, and ( if this is controlled in production) the mean impregnation depth ( in microns) of active materials with production tolerances.

5) Washcoat  give composition of active constituents, and total active material loading ( grams or troy ounces) in washcoat.

6) Active material  give composition of active constituents, loading of each active material including design tolerances, and total active material loading including design tolerances 7 ( grams or troy ounces).

7) Container  specify dimensions, volume, materials used, technique of containment and restraint, method of constructing container, canner ( if different from catalyst supplier), and insulation and shielding ( converter and/ or vehicle).

8) Physical description  dimensions ( e. g., length, width, height, etc.), weight ( lbs.), volume including design tolerances, active surface area ( BET), and total active surface area including design tolerances.

New converter manufacturers Prototype Testing:

1) Year, make, and model of vehicles tested.

2) Method of mileage accumulation.

3) Name and address of testing facility.

4) Summary of conversion efficiency test results.

5) Intended vehicle applications for each converter type tested.

Reconditioners of Catalytic Converters Information on Test Bench:

1) Name and address of testing facility.

2) Description of facilities used for testing.

3) Intended vehicle applications for each converter type.

Periodic Reporting:

Manufacturers:

Manufacturers are no longer required to submit the following information on a semiannual basis; EPA reserves the right to require information upon request:

1) The number of each type of converter manufactured.

2) A summary of the information contained on the warranty cards received, or copies of the actual warranty cards.

Reconditioners:

Reconditioners are no longer required to submit names and addresses of the persons or companies to whom the remanufacturer distributes, along with the number of each type of converter sold to each on a semi annual basis. EPA reserves the right to require this information upon request. 8 Recordkeeping by Manufacturers of New Aftermarket Converters:

The period of record retention for new aftermarket converter manufacturers for warranty cards is 5 years.

Recordkeeping by Installers:

There is no reporting. Installers are required to fill out warranty card if new aftermarket converter are installed, or provide card to vehicle owner for completion of applicable sections and submittal to manufacturer. Installers must state reason for replacement on invoice, maintain invoices for 6 months, and tag replaced converters for 15 days.

( ii) Respondent Activities The information collection is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond.

"*" indicates an item is a customary and usual business practice ( CBP), or is partially CBP.

" N/ A" indicates this was a one time cost that has already been absorbed under startup costs associated with the policy when it was promulgated or is otherwise not applicable.

NOTE: There have been losses of new aftermarket catalytic converter manufacturers since the last ICR. The overall population has been reduced from 12 to 8.

A. New Aftermarket Catalytic Converter Manufacturers:

A. 1. Provide Information Re Specifications and Applications and Information re Test Results for New Product Lines N/ A( 1) Reviewing instructions; ( 2) Developing, acquiring, installing and utilizing (" DAIU") technology and systems for the purpose of collecting, validating, and verifying information; ( 3) DAIU technology and systems for the purpose of processing and maintaining information; N/ A( 4) DAIU technology and systems for the purpose of disclosing and providing information; N/ A( 5) Adjusting the existing ways to comply with any previously applicable instructions and requirements; N/ A( 6) Training personnel to be able to respond to a collection of information; ( 7) Searching data sources; ( 8) Completing & reviewing the collection of information; ( 9) Transmitting or otherwise disclosing the information.

This requirement is a one time burden that only applies to new product lines. It has already 9 been accomplished for all existing product lines, many of which are likely to be usable for many years to come. ICR assumes each manufacturer develops and tests one new line every year.

A. 2. Testing for Each New Product Line N/ A( 1) Reviewing Instructions; ( 2) DAIU technology and systems for collecting, validating and verifying information; ( 3) DAIU technology and systems for processing and maintaining information; N/ A( 4) DAIU technology and systems for disclosing and providing information; N/ A( 5) Adjusting the existing ways to comply with any previously applicable instructions and requirements; N/ A( 6) Training personnel to be able to respond to a collection of information; ( 7) Searching data sources; ( 8) Completing & reviewing collection of information; ( 9) Transmitting or otherwise disclosing the information.

This requirement is a one time burden that only applies to new product lines. In many cases it is contracted out.

A. 3. Semi Annual Reports re Manufacturing and Submittal of Warranty Cards and Maintain Warranty Cards:

These reports are no longer required on a routine basis; EPA reserves the right to require submission of information upon request.

N/ A( 1) Reviewing instructions; ( 2) DAIU technology and systems for collecting, validating and verifying information; *( 3) DAIU technology and systems for processing and maintaining information; N/ A( 4) DAIU technology and systems for disclosing and providing information; N/ A( 5) Adjusting the existing ways to comply with any previously applicable instructions and requirements; N/ A( 6) Training personnel to be able to respond to a collection of information; ( 7) Searching data sources; ( 8) Completing & reviewing the collection of information; ( 9) Transmitting or otherwise disclosing information.

B. Used Catalytic Converter Reconditioners:

B. 1. Submit Test Facility Information N/ A( 1) Reviewing instructions; ( 2) DAIU technology and systems for collecting, validating and verifying information; ( 3) DAIU technology and systems for processing and maintaining information; ( 4) DAIU technology and systems for disclosing and providing information; 10 N/ A( 5) Adjusting the existing ways to comply with any previously applicable instructions and requirements; N/ A( 6) Training personnel to be able to respond to a collection of information; ( 7) Searching data sources; ( 8) Completing & reviewing the collection of information; ( 9) Transmitting or otherwise disclosing the information.

This is a one time burden which has already been absorbed by on going facilities and we know of no new facilities.

B. 2. Perform Efficiency Test on Each Used Converter N/ A( 1) Reviewing instructions; ( 2) DAIU technology and systems for collecting, validating and verifying information; ( 3) DAIU technology and systems for processing and maintaining information; N/ A( 4) DAIU technology and systems for disclosing and providing information; N/ A( 5) Adjusting the existing ways to comply with any previously applicable instructions and requirements; N/ A( 6) Training personnel to be able to respond to a collection of information; ( 7) Searching data sources; ( 8) Completing & reviewing the collection of information; ( 9) Transmitting or otherwise disclosing the information.

B. 3. Semi Annual Report Regarding Distribution of Products:

These reports are no longer required on a routine basis; EPA reserves the right to require submission of information upon request.

N/ A( 1) Reviewing instructions; ( 2) DAIU technology and systems for collecting, validating and verifying information; ( 3) DAIU technology and systems for processing and maintaining information; N/ A( 4) DAIU technology and systems for disclosing and providing information; N/ A( 5) Adjusting the existing ways to comply with any previously applicable instructions and requirements; N/ A( 6) Training personnel to be able to respond to a collection of information; ( 7) Searching data sources; ( 8) Completing & reviewing the collection of information; ( 9) Transmitting or otherwise disclosing the information.

C. Catalytic Converter Installers C. 1. Fill Out Warranty Card ( For New Aftermarket Converters Only), State Reason for Replacement on Invoice and Place Tag on 11 Removed Converter N/ A( 1) Review instructions; *( 2) DAIU technology and systems for collecting, validating and verifying information; *( 3) DAIU technology and systems for processing and maintaining information; N/ A( 4) DAIU technology and systems for disclosing and providing information; N/ A( 5) Adjust the existing ways to comply with any previously applicable instructions and requirements; N/ A( 6) Train personnel to be able to respond to a collection of information; *( 7) Search data sources; *( 8) Complete & review the collection of information; ( 9) Transmit or otherwise disclose the information. Most of the recordkeeping and maintenance is CBP.

This ICR also makes an estimate for startup burdens and costs for new businesses.

5. THE INFORMATION COLLECTED AGENCY ACTIVITIES, COLLECTION METHODOLOGY AND INFORMATION MANAGEMENT 5( a) Agency Activities The information collection has been developed by an office within EPA ( OECA) that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public.

EPA engages in the following activities in regard to the information collection.

 Review reports,

 Conduct inspections or audits as appropriate,

 Take enforcement actions where appropriate.

5( b) Collection Methodology and Management New aftermarket catalytic converter manufacturers collect sales data and warranty cards submitted to them by retail customers who have had converters installed, or directly from the installers themselves. This is a customary business practice for many businesses. Until 1999, the new aftermarket converter manufacturers then reported semi annually to EPA manufacturing information ( types of converters and how many sold) and either a computerized list summarizing converter installations or copies of the actual warranty cards, at their option. However, routine reporting is now only required regarding specifications for new product lines. Cards must be kept 5 years because that is the length of the warranty period.

Since warranties are not required on reconditioned converters, the converter reconditioners 12 were required, prior to 1999, to provide semi annual information regarding to whom they sold reconditioned converters, how many were sold, and what types were sold. However, routine reporting is no longer required. .

No other recordkeeping or reporting is necessary for new aftermarket converter manufacturers unless they create a new line of converters, in which case data must be submitted regarding test results and appropriate applications of the converters. For used converter reconditioners, testing of each converter is necessary to determine if it is still functional. However, no specific record retention requirement exists regarding the results of individual tests, other than to include a certification with the converter that it passed testing. This short statement can be preprinted form.

If industry voices an interest in electronic reporting, EPA will facilitate such data interchange, if practical. In the meantime, we would be willing to accept computer discs or other electronic information containing warranty information instead of hard copies of the information. Since routine reporting of sales and warranty information is no longer required this does not appear to be a significant issue.

Installers have no reporting requirement. They merely fill out a warranty card for each converter installed, and include on the customary business practice invoice a pre printed statement with a blank for why replacement was appropriate. The invoice, including the " reason for replacement" statement, must be kept for 6 months. In addition, the removed converter is tagged for a 15 day period, so it can be directly related to the vehicle and to the aftermarket converter that replaced it.

5( c) Small Entity Flexibility The information collection reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the Agency, including with respect to small entities, as defined by the Regulatory Flexibility Act ( 5 U. S. C. § 601( 6)), the use of such techniques as: ( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; ( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or ( 3) an exemption from coverage of the collection of information, or any part thereof.

New aftermarket catalytic converter manufacturers are substantial businesses with gross revenues in the millions of dollars per year. The catalytic converter reconditioners tend to be smaller businesses and the recordkeeping and reporting requirements are somewhat less; to wit: there are no warranty requirements and therefore no requirements to maintain warranty cards or report warranty information. More importantly, the policy allows small businesses to compete with the original equipment manufacturers in a market which was previously inaccessible to them, and which would not be legal but for this policy. Many installers are small businesses and have benefitted significantly from this multimillion dollar industry. Their requirements are minimal ( 4 5 minutes per installation, at least some of which is not an EPA imposed burden since maintaining invoices is a customary business practice).

5( d) Collection Schedule 13 Sales reports were previously required to be submitted to EPA by manufacturers and reconditioners semi annually. This routine reporting is no longer required. No other regular reporting exists, but reports must be submitted by new aftermarket converter manufacturers for new product lines. Installers do not report. Their recordkeeping occurs at the time of each installation transaction.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION Assumptions:

The estimated dollar cost for new aftermarket converter manufacturers will be different than for used OE converter reconditioners, since the policy is different for each group. The cost estimates for manufacturers and reconditioners, and for installers, are outlined below.

New Converter Manufacturers 1. The number of new aftermarket converter manufacturers is approximately 8 ( down from 12 in the previous ICR). The cost to new converter manufacturers consists of 1) the one time cost of submitting new product line specifications and testing information to EPA; and 2) the onetime cost to test two converters for each product line using the specifications outlined in the policy. There is no longer a burden for submission of semi annual reports regarding manufacturing and sales.

2. Contractor cost: Based on estimates supplied by companies that provide the testing services, the testing cost for a typical manufacturer is approximately $ 88,044 per product line. This estimate includes the cost for personnel to conduct the testing, as well as the actual cost of the testing equipment and procedures. If the typical manufacturer markets approximately one new product line every two years, the total testing cost for a typical new converter manufacturer would be $ 88,044 for two years. Under the assumption that the prevailing interest rate is 10%, the annualized cost of the development testing would be $ 88,044 amortized over 24 months at 10% compounded monthly, or $ 48,753 per manufacturer per year. We have estimated a 50% increase in the number of new product lines over the last ICR, in part because there are fewer manufacturers making the same number of converters.

3. To estimate the labor cost of tabulating and reporting the information as required, it was assumed in the 2002 ICR that the cost for a technician was $ 33.68/ hr. This cost figure was doubled to reflect the cost of benefits and overhead, and was adjusted for inflation from data on the BLS website. For this ICR we have used the newest available data from the Bureau of Labor Statistics website, which is found at http:// stats. bls. gov/ news. release/ ecec. t02. htm). While no job category necessarily perfectly fits the technical work performed by aftermarket catalytic converter manufacturers, we selected one of the highest paying job categories of those that are closely related: precision metal workers. Their hourly wage as of 2003 was $ 19.62 per hour. In reality, much of the burden can be performed by lower pay scale clerical staff. To account for benefits and overhead we have doubled this hourly wage, which results in an hourly cost of $ 39.24. To account for possible inflation since 2003, we have applied an inflation factor of 1.0571, which results in an inflation adjusted hourly cost burden of $ 41.48. 14 4. The actual hour estimates per response ( aside from the elimination of the semi annual reports as noted above) have been remained the same since the last ICR. For new converter manufacturers, putting together an EPA report on specifications of a new product line takes about 2 hours. We have eliminated reporting on manufacturing and sales information, which took about 0.5 hr.; and eliminated submission of warranty card information, which took about 1 hour to box and send to EPA. The maintaining of records, including warranty records, requires about 1 hour per year.

Reconditioners of Used Converters 1. The number of reconditioned converter businesses is six at this time, down from eight.

2. The cost to a used converter reconditioner consists of the labor costs of testing each  individual converter according to the test procedures outlined in the policy, the cost of setting up the bench testing equipment, and the cost of tabulating and reporting the information required in the policy. These cost elements are treated separately below.

3. Two technicians are needed to test each converter. The cost of a technician per hour is estimated to be somewhat less than for a new aftermarket converter manufacturer, and instead is estimated to be about the same as an automobile mechanic. For the cost of an employee burden hour, we used the same costs as for new aftermarket converter manufacturers. This gives an hourly cost per employee of $ 41.48, including the cost of benefits and overhead and adjusted for inflation to 2005 dollars.

4. An average of 2.00 minutes are required for each test.

5. Capital Costs for reconditioners equipment are based on test equipment cost of about $ 172,000, having a useful life of about 5 years. If this is amortized over 5 years the yearly cost comes to about $ 43,854 per reconditioner per year, including interest charges ( 10% interest).

6. Record keeping costs for tabulating and reporting information to Agency are based on the same labor rate as above, even though some of this work may be done by lower pay scale clerical workers.

7. Reconditioners no longer have the previous reporting burden of preparation of a semiannual report ( such reports previously took about 4 hrs.; less than 8 hrs. per year). The maintenance of these records takes about 1 hour per year.

Installers of Aftermarket Converters 1. There are approximately 30,000 automotive exhaust repair shops nationwide. It is assumed that these entities install the vast majority of aftermarket converters and it is further assumed that all of these entities install converters, and generally excludes tire/ brake shops, and other non exhaust repair facilities such as electrical diagnostic and other such facilities.

2. There are currently 2.3 2.7 million new aftermarket converters installed per year. A recent report from the Manufacturers of Emission controls Association reported a total of 3,079,249 15 new aftermarket converters produced in 2001 ( including catalytic converters manufactured for use in Mexico).

3. Typically, it takes an exhaust repair technician 4 5 minutes per installation to handle all recordkeeping requirements ( fill out warranty card if applicable, fill in blank on invoice regarding reason for replacement, and tag the converter that was removed). This estimate is based on information from shop owners as well as EPA experience with the paperwork. In many cases, blank warranty cards are simply provided to customers, further reducing burden times.

4. The cost of an employee per hour is estimated to be about the same as an automobile mechanic. For the cost of an employee burden hour, we used the most recent data from the Bureau of Labor Statistics for 2003 ($ 17.88) and doubled that figure to reflect benefits and overhead. This gives an hourly cost of $ 35.76. We adjusted for inflation to 2005 dollars, which results in an hourly cost estimate of $ 37.80.

5. Using the above assumptions, each shop averages 83 installations per year. On the average, the paperwork is assumed to take about 5 minutes per installation, or 7 hours per year. At $ 37.80 per hour, this comes to $ 263 per year per shop.

6( a) Estimates of Respondent Burden and Cost A. New Aftermarket Catalytic Converter Manufacturers 1. PROVIDE SPECIFICATIONS FOR NEW PRODUCT LINES:

One time burden for each new product line. Assume each manufacturer develops one new product line every year.

HRS. PER RESPONDENT: 2.0 COST PER RESPONDENT: $ 82.96 HRS. FOR 8 RESPONDENTS: 16 COST FOR 8 RESPONDENTS: $ 664 2. TESTING OF PROTOTYPES ( Purchased Services):

One time burden for new product lines. Assume 1 new product line per manufacturer every two years.

HRS. PER RESPONDENT: ( contracted out) ANNUALIZED COST PER RESPONDENT: $ 48,753 HRS FOR 8 RESPONDENTS: N/ A COST FOR 8 RESPONDENTS: $ 390,024 3. SEMI ANNUAL SUBMISSIONS OF MANUFACTURING DATA AND 16 WARRANTY CARDS ( reporting requirement discontinued; Recordkeeping exists):

HRS. PER RESPONDENT: 1 COST PER RESPONDENT: $ 41.48 HRS. FOR 8 RESPONDENTS: 8 COST FOR 8 RESPONDENTS: $ 331.84 4. ANNUALIZED O & M COSTS ( for postage): $ 5 * 8 parties = $ 40 for all respondents.

B. USED CATALYTIC CONVERTER RECONDITIONERS 1. SUBMIT TEST FACILITY INFORMATION:

This is a one time burden which has already been absorbed by current reconditioners. No new facilities are anticipated within the period.

2. PERFORM EFFICIENCY TESTS ON EACH NEW CONVERTER:

HRS. PER RESPONDENT: 623 ( Represents 9345 converters tested per year per Respondent) COST PER RESPONDENT: $ 25,842 HRS. FOR 6 RESPONDENTS: 3,738 COST FOR 6 RESPONDENTS: $ 155,052 3. SEMI ANNUAL REPORTS REGARDING DISTRIBUTION OF PRODUCTS ( No reporting, but must maintain records):

HRS. PER RESPONDENT: 1 COST PER RESPONDENT: $ 41.48 HRS. FOR 6 RESPONDENTS: 6 COST FOR 6 RESPONDENTS: $ 248.88 4. AMORTIZED CAPITAL COSTS PER RESPONDENT: $ 43,854. AMORTIZED CAPITAL COSTS FOR 6 RESPONDENTS: $ 263,124.

5. ANNUALIZED O & M ( for postage): None.

C. RECORDKEEPING BY EXHAUST SYSTEM REPAIR FACILITIES 1. MAINTAIN INVOICES & REMOVAL JUSTIFICATION & TAG CONVERTERS 17 HRS. PER RESPONDENT: 7 COST PER RESPONDENT: $ 263 HRS. FOR 30,000 RESPONDENTS: 209,000 COST FOR 30,000 RESPONDENTS: $ 7,875,000 2. STARTUP COSTS: 100 STARTUPS * 5 HRS. = 500 TOTAL hours x $ 37.80 = $ 18,900 CAPITAL COSTS ( to purchase converter storage space): $ 228 * 100 = $ 22,800 for all respondents.

6( b) Summary of Respondent Costs 1. Total Yearly Costs for New Aftermarket Converter Manufacturers:

$ 48,758 per respondent, including contractor testing costs & O & M costs; $ 390,064 for all 8 respondents.

2. Total Yearly Costs for Converter Reconditioners:

$ 25,884 for yearly converter tests to check efficiency, capital costs of $ 43,854 = $ 69,737 per respondent, and $ 418,425 for all 6 respondents.

3. Total yearly costs for installers:

$ 263 for 1 respondent = $ 7,875,000 for all 30,000 installer facilities.

Total Startup costs for new businesses: 5 hrs. plus $ 228 for filing space or $ 417 per party * 100 new parties per year = $ 41,700 total.

TOTAL YEARLY BURDEN: $ 8,725,189 ( including salaries); 212,101 hrs. for all respondents, including testing ( plus 500 hrs. for 100 startups = 212,601 hrs.). Annualized cost burden other than salaries: $ 675,988.

SUMMARY OF RESPONDENTS' BURDENS AND COSTS BY CATEGORY:

I. New Aftermarket Catalytic Converter Manufacturers A. Annual Burden Hours per Party: 3. ( 24 for all 8 respondents)

B. Annualized Capital Costs per Party: $ 0.00.

C. Annualized Operating Costs per party: $ 5.00 ($ 40 for all 8) 18 D. Annualized Startup Costs: $ 0.00 ( no new entities entering the market).

E. Annual Purchased Services per Party ( for Testing of Prototypes): $ 48,753. ($ 390,024 for all 8).

II. Used Aftermarket Catalytic Converter Manufacturers A. Annual Burden Hours per Party: 624 ( testing of catalytic converters to determine they are functional; the actual recordkeeping burden is minimal). ( 3,744 for all 6)

B. Annualized Capital Costs per Party: $ 43,854. ($ 263,124 for all 6)

C. Annualized Operating Costs per Party: $ 0.

D. Annualized Startup Costs: None. There have been no new parties and none are expected in the next 3 years.

E. Annual Purchased Services per Party: $ 0.00.

III. Installers of Aftermarket Converters A. Annual Burden Hours per Party: 7 B. Annualized Capital Costs per Party: $ 0.00.

C. Annualized Operating Costs per party: $ 0.00.

D. Annual Purchased Services per Party: $ 0.00.

E. Annualized Startup Costs: Assume 100 new installers per year; Assume reviewing instructions and setting up recordkeeping systems requires 5 hrs per party and the purchase of file space of $ 228. Total startup cost would be $ 189 plus $ 228, for a total of $ 417 per party and $ 41,700 nationwide.

6( c) Estimated EPA Burden and Cost The direct cost of personnel to process and analyze the information collected is estimated to be $ 500 or about 20 hours at the cost of a grade 12 employee. An estimated travel cost of $ 5,000 would be needed to monitor compliance with the policy, in addition to travel already used for retail level inspections for automobile emissions tampering generally. The total annual cost to the government is thus estimated to be $ 5500.

6( d) Reasons for Change in Burden Burdens for new and used aftermarket converter manufacturers and reconditioners have been decreased to reflect reduced reporting since reporting sales and warranty information is no longer required. We also increased the amount of burden for testing new converters since the number 19 of new converters made has remained the same while the number of manufacturers has decreased. We have adjusted cost figures for inflation. The number of converter installation facilities, and converters being installed have stayed flat as have the burden hours per converter installation; however, total burden hours requested have increased due to the correction of an error in previous renewals ( see below for explanation). Government cost has been decreased significantly as the result of the elimination of most respondent reporting requirements.

It is important to note that a combination of errors in calculations in the previous ICR ( 67FR 319 320, Jan. 3, 2002) led to the annual burden hours for installers being represented as 3.5 hours/ year, rather than 7 hours/ year. Spread over 30,000 installer respondents this led to a shortfall of 104, 000 burden hours. This figure has been correctly calculated in this ICR renewal. There is, therefore, no increase in burden hours to the industry, rather the correction of a previous error which accounts for the higher burden hour numbers.

6( e) Burden Statement The public recordkeeping burden for this collection of information is estimated to average:

3 hours per new aftermarket converter manufacturer, on average, with $ 5 annual operational costs per year and annualized purchased services costs per year of $ 48,753; 624 hours ( including converter testing time) per used converter reconditioner, on average, with annualized capital costs per year of $ 43,854; and 7 hours per respondent for aftermarket converter installation facilities, with an additional 5 hours for the first year for startup facilities and an additional $ 228 for startup capital costs. The overall average is 7 hours per response ( 212,101 total burden hours divided by 30,014 respondents).

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions, develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. 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. The OMB control numbers for EPA's regulations are listed in 40 C. F. R. Part 9 and 48 C. F. R. Chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OECA 2005 0052, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center 20 ( EPA/ DC), EPA West, Room B102, 1301 Constitution Avenue, NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. OECA 2005 0052 and OMB control number 2060 0135 in any correspondence.

Part B of the Supporting Statement This part is not applicable..

PART B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS This section is not applicable because statistical methods are not used in the data collection associated with the aftermarket catalytic converter policy.

APPENDIX A. Summary of Comments to First Federal Register Notice No comments were received.

APPENDIX B. Citation for Information Requirements of the ICR The information requirements of this ICR are enumerated in the Agency's proposed and interim enforcement policy published in the Federal Register on August 5, 1986 ( 51 Fed. Reg. 28114). In this Federal Register notice the Agency proposed to amend 40 C. F. R. Part 85 by adding a new Appendix IX, which would consist of this enforcement policy. There are no regulations applicable to this information collection. The citations listed below for the information requirements refer to this Federal Register notice.

Information Requirement Fed. Reg. Citation New Converter Manufacturers Collect and Transmit Converter specifications to EPA 51 FR 28119 Collect, file and maintain warranty information 51 FR 28117 Used Converter Reconditioners 21 Collect, file and maintain sales information and customer lists 51 FR 28118 Installers Invoices, Warranties, Tag converters 51 FR 28816


[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Rules and Regulations]
[Pages 48308-48315]
[FR Doc No: 2021-18390]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0054; FRL-8750-02-OCSPP]

Thiabendazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
thiabendazole in or on multiple commodities that are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 30, 2021. Objections and
requests for hearings must be received on or before October 29, 2021,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0054, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>,

and the telephone number for the OPP Docket is<PHONE_NUMBER>.
    Due to the public health emergency, the EPA Docket Center (EPA/DC)
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide remote customer service via email, phone,
and webform. For the latest status information on EPA/DC services and
docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0054 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 29, 2021. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0054, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-
08), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E8812) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201W, Princeton,
NJ 08540. The petition requested EPA to establish tolerances in 40 CFR
180.242 for residues of thiabendazole (2-(4-thiazolyl)benzimidazole),
including its metabolites and degradates, in or on the following raw
agricultural commodities: Animal feed, nongrass, group 18 at 0.01 parts
per million (ppm); Beet, garden, leaves at 0.01 ppm; Brassica, leafy
greens, subgroup 4-16B at 0.01 ppm; Burdock, edible, leaves at 0.01
ppm; Carrot, leaves at 0.01 ppm; Carrot, roots at 10 ppm; Celeriac,
leaves at 0.01 ppm; Chervil, turnip rooted, leaves at 0.01 ppm;
Chicory, leaves at 0.01 ppm; Fruit, citrus, group 10-10 at 10 ppm;
Fruit, pome, group 11-10 at 10 ppm; Kohlrabi at 0.01 ppm; Radish,
oriental, leaves at 0.01 ppm; Rutabaga, leaves at 0.01 ppm; Salsify,
black, leaves at 0.01 ppm; Sweet potato, tuber at 3 ppm; Vegetable,
Brassica, head and stem, group 5-16 at 0.01 ppm; Vegetable, root,
except sugar beet, subgroup 1B at 0.01 ppm; Vegetable, tuberous and
corm, subgroup 1C, except sweet potato at 10 ppm.
    The petition also proposed to remove the established tolerances for
residues of thiabendazole (2-(4-thiazolyl)benzimidazole), including its
metabolites and degradates, in or on the following raw agricultural
commodities: Potato, postharvest at 10.0 ppm; Sweet potato (postharvest
to sweet potato intended only for use as seed) at 0.05 ppm; Alfalfa,
forage at 0.02 ppm; Alfalfa, hay at 0.02 ppm; Radish, tops at 0.02 ppm;
Brassica, head and stem, subgroup 5A at 0.02 ppm; Fruit, citrus, group
10, postharvest at 10.0 ppm; Fruit, pome, group 11, postharvest at 5.0
ppm; Vegetable, root (except sugarbeet), subgroup 1B at 0.02 ppm;
Carrot, roots, postharvest at 10.0 ppm; and in paragraph (b) Sweet
potato at 10 ppm.
    That document referenced a summary of the petition prepared by
Syngenta Crop Protection, the registrant, which is available in the
docket, http://www.regulations.gov. No comments were received in
response to the notice of filing.
    A previous notice of filing was published in the Federal Register
of April 15, 2020 (85 FR 20910) (FRL-10006-54). The April 15, 2020
notice is superseded by the June 28, 2021 notice.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''

    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA 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 for thiabendazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with thiabendazole
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Decreased body weight is the most sensitive effect of exposure to
thiabendazole observed even in young rat pups during lactation.
Histopathological changes in the spleen (congestion and pigmentation)
and kidney (calculus and hyperplasia of transitional epithelium) were
noted in a subchronic rat study, and splenic erythropoiesis and
hemosiderosis were reported in a chronic dog study. Other target organs
of thiabendazole toxicity are the liver and thyroid. Increased
quantitative susceptibility was observed in the rat and rabbit
developmental toxicity studies, in which developmental effects occurred
in the absence of maternal toxicity. Increased quantitative
susceptibility was not observed in the prenatal developmental toxicity
study in mice and in the 2-generation reproduction study in rats. In an
acute neurotoxicity rat study (ACN), reduced locomotor activity was
identified, although no morphological or histopathological effects were
noted in the brain. No signs of neurotoxicity were seen in the
subchronic neurotoxicity study. Thiabendazole is classified as ``Likely
to be carcinogenic to humans at doses high enough to cause a
disturbance of the thyroid hormonal balance. It is not likely to be
carcinogenic at doses lower than those which could cause a disturbance
of this hormonal balance''.
    Additional information on the toxicological profile can be found at
http://www.regulations.gov in the document titled ``Thiabendazole:
Human Health Risk Assessment for the Establishment of Permanent
Tolerances and Registration for Use on Animal feed, nongrass, group 18;
Brassica, leafy greens, subgroup 4-16B; and Sweet Potato; and Crop
Group Conversions/Expansions to Fruit, citrus, group 10-10; Fruit,
pome, group 11-10; Kohlrabi; Vegetable, Brassica, head and stem, group
5-16; Vegetable, root, except sugar beet, subgroup 1B; and Vegetable,
tuberous and corm, subgroup 1C, except sweet potato'' (hereinafter
``Thiabendazole Human Health Risk Assessment'') in docket ID number
EPA-HQ-OPP-2020-0054.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for thiabendazole used for
human risk assessment can be found in the Thiabendazole Human Health
Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to thiabendazole, EPA considered exposure under the
petitioned-for tolerances. EPA assessed dietary exposures from
thiabendazole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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.
    In conducting the acute dietary exposure assessment, EPA used the
2003-2008 food consumption data from the U.S. Department of
Agriculture's National Health and Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA). The acute dietary exposure assessment is
partially refined and incorporated established and recommended
tolerance-level residues for some commodities, maximum field trial
residues for the remaining commodities according to blending
classification, 100 percent crop treated (PCT), and default processing
factors (except for apple juice, grapefruit juice, lemon juice, lime
juice, orange juice, pear juice, potato granules/flakes, and tangerine
juice).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the 2003-2008 food consumption data from the
USDA's NHANES/WWEIA. The chronic dietary exposure assessment is
partially refined and incorporated established and recommended
tolerance-level residues for some commodities, average field trial
residues for the remaining commodities according to blending
classification, 100 PCT, and default processing factors (except for
apple juice, grapefruit juice, lemon juice, lime juice, orange juice,
pear juice, potato granules/flakes, and tangerine juice).
    iii. Cancer. Thiabendazole is classified as ``Likely to be
carcinogenic at doses high enough to cause a disturbance of the thyroid
hormonal balance but not likely to be carcinogenic at doses lower than
those which could cause a disturbance of this hormonal balance.'' EPA
is regulating chronic exposure based on a reference dose that is lower
than (and thus protective of) the level that would cause a disturbance
in the thyroid hormonal balance, making tumor formation highly
unlikely; therefore, a cancer dietary exposure assessment is not
required. The current partially refined chronic dietary risk assessment
is conservative and is protective for cancer effects.
    iv. Anticipated residue and PCT information. EPA used some
tolerance-level residues and some anticipated residue data for
assessing tolerances. Section 408(b)(2)(E) of FFDCA authorizes EPA to
use available data and information on the anticipated residue levels of
pesticide residues in food and the actual levels of pesticide residues
that have been measured in food. If EPA relies on such information, EPA
must require pursuant to FFDCA section 408(f)(1) 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. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    EPA did not use PCT estimates in the dietary assessment for
thiabendazole; 100 PCT was assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for thiabendazole in drinking water. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the FQPA Index Reservoir Screening Tool (FIRST; surface
water) model and the Pesticide Root Zone Model for Ground Water (PRZM-
GW; groundwater), EPA used an estimated drinking water concentration
(EDWC) of 3.80 ppb for the acute dietary risk assessment and a value of
0.47 ppb for the chronic dietary risk assessment.
    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).
    Thiabendazole is currently registered for uses that may result in
residential handler and post-application exposures, including use in
paints and textiles. As an initial matter in assessing aggregate risk
of the pesticide chemical residues, the Agency takes into consideration
those residential exposure scenarios that provide the most conservative
estimate of residential exposures, including handler exposure and post-
application exposure or both.
    The residential handler exposure scenario used in the aggregate
assessment is for adult handler inhalation exposures from applying
thiabendazole-treated paint using airless sprayers. For this scenario,
the Aggregate Risk Index (ARI) approach was used since the PODs/
endpoints were similar, but the levels of concern (LOCs) were
different. An ARI greater than or equal to 1 is not of concern.
    The residential exposure scenario used for the post-application
assessment is incidental oral exposures from children 1 to <2 years old
mouthing preserved textiles (clothing) treated with thiabendazole.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to thiabendazole and any
other substances and thiabendazole 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 thiabendazole has
a common mechanism of toxicity with other substances.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The data submitted to the
Agency, as well as those from published literature, demonstrated
increased quantitative susceptibility in the rat and rabbit
developmental toxicity studies, in which developmental effects
(decreased fetal weights in rat and rabbit pups) were observed while
maternal toxicity was not observed up to the highest doses tested. No
increased susceptibility was observed in mice in utero and/or to rats
following early postnatal exposure to thiabendazole.
    3. Conclusion. EPA has determined there is reliable data to support
a conclusion that a FQPA Safety Factor (SF) of 1X will be protective
for infants and children for all scenarios, with the exception of the
assessment of inhalation exposure. The default FQPA 10X SF remains in
place for assessing the non-occupational inhalation exposure due to the
lack of a subchronic inhalation study with thyroid measurements. That
decision is based on the following findings:
    i. The toxicology database for thiabendazole is complete with the
exception of a subchronic inhalation toxicity study with thyroid
measurements. Based on a weight of evidence approach considering all
the available hazard and exposure information for thiabendazole, the
Agency determined that a developmental thyroid toxicity study is not
required at this time. Acceptable studies are available for
developmental, reproduction, chronic, subchronic, subchronic
neurotoxicity and immunotoxicity.
    ii. In an acute neurotoxicity rat study (ACN), reduced locomotor
activity in males and females at time of peak effect (approximately 3
hours post-dose) were seen without morphological or histopathological
effects on the brain. Thiabendazole was not neurotoxic in rats in a
subchronic neurotoxicity study at the highest dose tested (1,500 ppm
equivalent to 95 mg/kg/day).
    iii. As noted above, there is some evidence of increased
susceptibility in the developmental fetus from exposure to
thiabendazole. Nevertheless, the Agency has sufficient data to
understand and protect against the potential developmental effects. The
data indicating the potential for developmental toxicity presented
well-defined NOAELs and LOAELs, which the Agency took into account when
identifying endpoints. The selected points of departure for regulating
exposure are protective of both the potential for neurotoxicity and the
increased susceptibility of infants and children. There is no residual
uncertainty concerning the potential for prenatal or post-natal
toxicity that precludes the reduction of the FPQA 10X SF.
    iv. There are no residual uncertainties in the exposure database.
The dietary risk assessment is conservative and will not underestimate
dietary and/or non-dietary occupational exposure to thiabendazole. The
acute and chronic dietary assessments conducted were slightly refined
analyses. The assessments utilized tolerance-level residues, maximum
residue or average

residue values from field-trial data, empirical or EPA's 2018 default
processing factors, and 100 PCT. The analysis also used Tier 1 drinking
water estimates. For these reasons, it can be concluded that the
analysis does not underestimate risk from acute or chronic exposure to
thiabendazole. Similarly, EPA does not believe that the non-dietary
exposures are underestimated because they are also based on
conservative assumptions.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions described in this unit
for acute exposure, EPA has concluded that acute exposure to
thiabendazole from food and water will utilize 50% of the aPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
thiabendazole from food and water will utilize 64% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Thiabendazole
is registered for uses that could result in short-term residential
exposure, and the Agency has determined that it is appropriate to
aggregate chronic exposure through food and water with short-term
residential exposures to thiabendazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate ARI of 1.88 for adults
and an MOE of 200 for children 1 to 2 years old. Because EPA's level of
concern for thiabendazole is an ARI of less than or equal to 1 or an
MOE of 100 or below, these ARIs/MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
thiabendazole is not registered for any use patterns that would result
in intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
thiabendazole.
    5. Aggregate cancer risk for U.S. population. As the risks
estimated based on the chronic reference dose are protective of cancer
effects, no separate cancer risk assessment is necessary. The chronic
dietary aggregate risk assessment is below the Agency's level of
concern; therefore, the Agency concludes that aggregate exposure to
thiabendazole is not likely to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to thiabendazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate spectrophotofluorometric methods are available in the
Pesticide Analytical Manual, Volume II (PAM II) for enforcement of
thiabendazole tolerances.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    Codex has established more restrictive (i.e., lower) MRLs for
residues in/on citrus fruits and pome fruits (7 ppm and 3 ppm
respectively, versus the existing U.S. tolerances for the old crop
groups, which are 10.0 ppm for citrus and 5.0 ppm for pome fruit.)
Therefore, harmonization with the Codex MRLs are not possible because
U.S. growers would be at risk of violative residues of thiabendazole
despite legal use according to the label. Instead, EPA is harmonizing
the tolerance for fruit, pome, group 11-10 with the Canadian MRL of 10
ppm in/on apples and pears. Additionally, Codex has established an MRL
for residues in/on potato at 15 ppm, which is higher than the revised
U.S. tolerance of 10 ppm. Per the registrant's request, the Agency is
not harmonizing with the established Codex MRL for residues in/on
potato. Instead, the U.S. tolerance is harmonized with the Canadian MRL
for potatoes at 10 ppm because Canada is a major trading partner with
the United States for potatoes.

C. Revisions to Petitioned-For Tolerances

    As mentioned in Unit II., the petitioner requested that the time-
limited tolerance in Sec.  180.242(b) at 10 ppm for residues of
thiabendazole in/on sweet potato be removed upon the establishment of a
permanent tolerance for residues of thiabendazole in/on sweet potato in
Sec.  180.242(a). EPA is not removing the time-limited tolerance on
sweet potato in Sec.  180.242(b) due to a difference between the
section 18 use pattern and the proposed use pattern for the section 3
registration. There is a potential that use under the current section
18 could result in exceedances if this tolerance was revoked.

D. International Trade Considerations

    In this rule, EPA is establishing tolerances for thiabendazole
residues in or on the Animal feed, nongrass, group 18; Vegetable,
Brassica, head and stem, group 5-16; and the Vegetable, root, except
sugar beet, subgroup 1B (all at 0.01 ppm) that are lower than the
current tolerances of Alfalfa forage, Alfalfa hay, Brassica head and
stem

subgroup 5A, and Vegetable, root (except sugarbeet), subgroup 1B (all
0.02 ppm). For the reasons explained in the Thiabendazole Human Health
Risk Assessment, the Agency believes these revised, lower tolerances
are appropriate.
    In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the
WTO of the changes to these tolerances in order to satisfy its
obligations under the Agreement. In addition, the SPS Agreement
requires that Members provide a ``reasonable interval'' between the
publication of a regulation subject to the Agreement and its entry into
force to allow time for producers in exporting Member countries to
adapt to the new requirement. Accordingly, EPA is establishing an
expiration date for the existing tolerances to allow these tolerances
to remain in effect for a period of six months after the effective date
of this final rule. After the six-month period expires, these
tolerances will be reduced or revoked, as indicated in the regulatory
text, and allowable residues on alfalfa forage, alfalfa hay, Brassica
head and stem subgroup 5A, and vegetable, root (except sugarbeet),
subgroup 1B must conform to the tolerances for Animal feed, nongrass,
group 18; Vegetable, Brassica, head and stem, group 5-16; and
Vegetable, root, except sugar beet, subgroup 1B. This reduction in
tolerance level is not discriminatory; the same food safety standard
contained in the FFDCA applies equally to domestically produced and
imported foods. The new tolerance levels are supported by available
residue data.

V. Conclusion

    Therefore, tolerances are established for residues of thiabendazole
in or on Animal feed, nongrass, group 18 at 0.01 ppm; Beet, garden,
leaves at 0.01 ppm; Brassica, leafy greens, subgroup 4-16B at 0.01 ppm;
Burdock, edible, leaves at 0.01 ppm; Carrot, leaves at 0.01 ppm;
Carrot, roots at 10 ppm; Celeriac, leaves at 0.01 ppm; Chervil, turnip
rooted, leaves at 0.01 ppm; Chicory, leaves at 0.01 ppm; Fruit, citrus,
group 10-10 at 10 ppm; Fruit, pome, group 11-10 at 10 ppm; Kohlrabi at
0.01 ppm; Radish, oriental, leaves at 0.01 ppm; Rutabaga, leaves at
0.01 ppm; Salsify, black, leaves at 0.01 ppm; Sweet potato, tuber at 3
ppm; Vegetable, Brassica, head and stem, group 5-16 at 0.01 ppm;
Vegetable, root, except sugar beet, subgroup 1B at 0.01 ppm; and
Vegetable, tuberous and corm, subgroup 1C, except sweet potato at 10
ppm.
    Additionally, the following tolerances are removed as unnecessary
due to the establishment of the above tolerances: Alfalfa, forage;
Alfalfa, hay; Brassica, head and stem, subgroup 5A; Carrot, roots,
postharvest; Fruit, citrus, group 10, postharvest; Fruit, pome, group
11, postharvest; Potato, postharvest; Radish, tops; Sweet potato
(postharvest to sweet potato intended only for use as seed); and
Vegetable, root (except sugarbeet), subgroup 1B.
    Finally, EPA is revising the tolerance expression for thiabendazole
in 40 CFR 180.242(a)(1) and (2) to clarify (1) that, as provided in
FFDCA section 408(a)(3), the tolerance covers metabolites and
degradates of thiabendazole not specifically mentioned; and (2) that
compliance with the specified tolerance levels is to be determined by
measuring only the specific compounds mentioned in the tolerance
expression. EPA has determined that it is reasonable to make this
change final without prior proposal and opportunity for comment,
because public comment is not necessary, in that the change has no
substantive effect on the tolerance, but rather is merely intended to
clarify the existing tolerance expression.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances 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). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances and
modifications in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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 action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 18, 2021.
Catherine Aubee,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.242:
0
a. Amend paragraph (a)(1) by:
0
i. Revising the introductory text.
0
ii. In the table:
0
A. Adding the heading ``Table 1 to Paragraph (a)(1)'';
0
B. Removing the entries for ``Alfalfa, forage''; and ``Alfalfa, hay'';
0
C. Adding in alphabetical order the entries ``Animal feed, nongrass,
group 18''; and ``Beet, garden, leaves'';
0
D. Removing the entry for ``Brassica, head and stem, subgroup 5A'';
0
E. Adding in alphabetical order the entries ``Brassica, leafy greens,
subgroup 4-16B''; ``Burdock, edible, leaves''; ``Carrot, leaves''; and
``Carrot, roots'';
0
F. Removing the entry for ``Carrot, roots, postharvest'';
0
G. Adding in alphabetical order the entries ``Celeriac, leaves'';
``Chervil, turnip rooted, leaves''; ``Chicory, leaves''; and ``Fruit,
citrus, group 10-10'';
0
H. Removing the entry for ``Fruit, citrus, group 10, postharvest'';
0
I. Adding the entry ``Fruit, pome, group 11-10'';
0
K. Removing the entry for ``Fruit, pome, group 11, postharvest'';
0
L. Adding in alphabetical order the entry ``Kohlrabi'';
0
M. Removing the entry for ``Potato, postharvest'';
0
N. Adding in alphabetical order the entry ``Radish, oriental, leaves'';
0
O. Removing the entry for ``Radish, tops'';
0
P. Adding in alphabetical order the entries ``Rutabaga, leaves''; and
``Salsify, black, leaves'';
0
Q. Removing the entry for ``Sweet potato (postharvest to sweet potato
intended only for use as seed)'';
0
R. Adding in alphabetical order the entries ``Sweet potato, tuber'';
``Vegetable, Brassica, head and stem, group 5-16''; and ``Vegetable,
root, except sugar beet, subgroup 1B'';
0
S. Removing the entry for ``Vegetable, root (except sugarbeet),
subgroup 1B'';
0
T. Adding in alphabetical order the entry ``Vegetable, tuberous and
corm, subgroup 1C, except sweet potato'' and
0
b. Amend paragraph (a)(2) by:
0
i. Revising the introductory text.
0
ii. In the table, adding the heading ``Table 2 to Paragraph (a)(2)''.
0
The additions and revisions read as follows:

Sec.  180.242   Thiabendazole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of
thiabendazole, including its metabolites and degradates, in or on the
commodities in table 1 to paragraph (a)(1). Compliance with the
tolerance levels specified to table 1 to paragraph (a)(1) is to be
determined by measuring only thiabendazole in or on the commodity.

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage 1.......................................            0.02
Alfalfa, hay 1..........................................            0.02
Animal feed, nongrass, group 18.........................            0.01

                              * * * * * * *
Beet, garden, leaves....................................            0.01
Brassica, head and stem, subgroup 5A 1..................            0.02
Brassica, leafy greens, subgroup 4-16B..................            0.01
Burdock, edible, leaves.................................            0.01

                              * * * * * * *
Carrot, leaves..........................................            0.01
Carrot, roots...........................................              10
Celeriac, leaves........................................            0.01
Chervil, turnip rooted, leaves..........................            0.01
Chicory, leaves.........................................            0.01

                              * * * * * * *
Fruit, citrus, group 10-10..............................              10
Fruit, pome, group 11-10................................              10
Kohlrabi................................................            0.01

                              * * * * * * *
Radish, oriental, leaves................................            0.01
Rutabaga, leaves........................................            0.01
Salsify, black, leaves..................................            0.01
Sweet potato, tuber.....................................               3

                              * * * * * * *
Vegetable, Brassica, head and stem, group 5-16..........            0.01

                              * * * * * * *
Vegetable, root, except sugar beet, subgroup 1B.........            0.01
Vegetable, root, except sugar beet, subgroup 1B 1.......            0.02
Vegetable, tuberous and corm, subgroup 1C, except sweet               10
 potato.................................................

                              * * * * * * *
------------------------------------------------------------------------
1 This tolerance expires on February 28, 2022.

    (2) Tolerances are established for residues of thiabendazole,
including its metabolites and degradates, in or on the commodities in
table 2 to paragraph (a)(2). Compliance with the tolerance levels
specified to table 2 to paragraph (a)(2) is to be determined by
measuring only the sum of thiabendazole (2-(4-thiazolyl)benzimidazole)
and its metabolite 5-hydroxythiabendazole (free and conjugated)
calculated as the stoichiometric equivalent of thiabendazole, in or on
the commodity.

                       Table 2 to Paragraph (a)(2)

* * * * *
[FR Doc. 2021-18390 Filed 8-27-21; 8:45 am]
BILLING CODE 6560-50-P