Pesticides: Regulating Pesticides Recent Additions | Contact Us | Print Version Search: EPA Home > Pesticides > Regulating Pesticides > Pesticide Registration ( PR) Notices > PR Notice 97 3 Registering Pesticides Pesticide Producing Establishments Reregistration Laws International Issues Adverse Effects Reporting Storage & Disposal Restricted & Canceled Uses Pesticide Tolerances Registration Information Sources Fax On Demand Telephone: ( 202) 401 0527 Item: 6101 September 4, 1997 Pesticide Registration ( PR) Notice 97 3 NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND REGISTRANTS OF PESTICIDE PRODUCTS ATTENTION: Persons Responsible for Registration of Pesticide Product SUBJECT: Guidelines for Expedited Review of Conventional Pesticide under the Reduced Risk Initiative and for Biological Pesticides I. PURPOSE The Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) as amended by the Food Quality Protection Act of 1996 ( FQPA) requires the Environmental Protection Agency ( EPA) to develop procedures and guidelin for expedited review of any pesticide. These procedures and guidelines must be in place within one year after the date of enactment of the FQPA ( by August 3, 1997). EPA has already established a Reduced Risk Initiat for conventional pesticides, has formed the Biopesticides and Pollution Prevention Division to review biological pesticides and has established Antimicrobial Division to review antimicrobial pesticides. The purpose this PR Notice is to provide the process and criteria to guide applicant in developing their submissions to these programs.

This PR Notice supersedes the reduced risk criteria published in Federal Register Notices 57 FR 32140, July 20, 1992 and 58 FR 5854, Janu 22, 1993 and PR Notice 93 9, July 21, 1993. In addition, it defines the types of pesticide products reviewed by the Biopesticides and Pollution Prevention Division and describes how an applicant can apply for biochemical pesticide classification.

The goal of the Reduced Risk Pesticide Initiative and the Biopesticides and Pollution Prevention Division is to encourage the development, registration and use of lower risk pesticide products which would result in reduced risks to human health and the environment when compared to existing alternatives. The major incentive which EPA offers for these pesticides is expedited registration review. The major goal o the Antimicrobial Division is to provide expedited review of all types o antimicrobial registration actions.

II. APPLICABILITY This notice applies to all applicants for initial registration and amended registration for conventional pesticides, as described more full in Sections IV X, and for biological pesticides, as described in Section XI. The term " conventional pesticides" as used in this notice includes pesticides other than biological pesticides and antimicrobial pesticides ( as defined in FQPA). Since certain pesticide products, such as wood preservatives and antimicrobials, are not defined as antimicrobial produ in FQPA but are handled in the Antimicrobial Division, for the purposes this notice they are considered conventional pesticides.

III. EFFECTIVE DATE This PR Notice is effective immediately.

IV. BACKGROUND ON THE REDUCED RISK INITIATIVE In July 1992, the Office of Pesticide Programs ( OPP) published a Federal Register notice announcing the need for incentives for the development and registration of reduced risk pesticides. In a subsequen Federal Register notice ( January 1993) OPP announced the initiation of t Reduced Risk effort, and in July 1993 OPP published PR Notice 93 9 which provided interim reduced risk criteria and guidance for submissions.

Since July 1993, applicants have sent thirty nine new chemical or n use submissions to OPP for consideration as reduced risk pesticides. Of the thirty nine, twenty two have been accepted by OPP as reduced risk candidates; and sixteen have been rejected. Of the twenty two accepted reduced risk submissions, fourteen have been registered. The following a list of the registered pesticides by accepted common names ( if availab and their trade name ( in parenthesis):

( 1) Hexaflumuron ( Recruit)  below ground bait station termiticide ( 2) Flumiclorac pentyl ( Resource)  post emergent herbicide on cor soybeans ( 3) Methyl Anthranilate ( Rejex It)  bird repellent on cherries, grapes, blueberries, forestry ( 4) Tebufenozide ( Confirm)  insecticide on walnuts ( 5) Hymexazol ( Tachigaren)  fungicide seed treatment on sugar bee ( 6) Fludioxonil ( Maxim)  fungicide seed treatment on corn, sorghu ( 7) ( Cadre)  herbicide on peanuts ( 8) ( Mefenoxam)  fungicide on multiple crops ( 9) Spinosad ( Spinosad)  insecticide on cotton ( 10) Azoxystrobin ( Heritage)  fungicide on turf ( 11) Alpha Metolachlor ( CGA 77102)  herbicide on multiple crops.

( 12) Hexaflumuron ( Recruit)  above ground bait station new use termiticide ( 13) Imazamox ( Raptor)  herbicide on soybeans ( 14) Azoxystrobin ( Heritage)  fungicide on grapes, bananas, peache tomatoes, pecans and peanuts The major advantage for reduced risk pesticides is expedited registration review. For FY95 and FY96 ( prior to the passage of FQPA in August 1996) the average total time required to register a new conventio pesticide was thirty eight months. For reduced risk pesticides the aver total time for registration was only fourteen months. Since passage of FQPA three new AI, reduced risk pesticides were registered in seventeen, eighteen and seventeen months, somewhat longer than the pre FQPA average but still substantially shorter than the conventional pesticide times. faster registration times reflect, in part, the expedited review status granted reduced risk actions. Not only is the initial submission grante high review priority but also any resubmission that may be necessary. If the applicant is simultaneously seeking registration in Canada, if the application has been determined by Canada to be complete, the reduced risk action can also qualify for work sharing between the two countries. While this work sharing program is still in the " pilot" stag it could result in further reduced review times and greater harmonizatio V. CHARACTERISTICS OF ACCEPTABLE AND UNACCEPTABLE SUBMISSIONS FOR THE REDUCED RISK INITIATIVE OPP has assessed fourteen of the twenty two reviews conducted by th Reduced Risk Committee of submissions that were determined to be reduced risk. Those factors that most significantly contributed to EPA' decision to grant reduced risk status are summarized below in descending order:

o human health effects  very low mammalian toxicity  toxicity generally lower than alternatives ( 10 100X)  displaces chemicals that pose potential human health concerns [ e. g., organophosphates ( OPs), probable carcinogens ( B2s)]  reduces exposure to mixers, loaders, applicators and reen workers o non target organism effects ( birds)

 very low toxicity to birds  very low toxicity to honeybees  significantly less toxicity/ risk to birds than alternativ  not harmful to beneficial insects, highly selective pest impacts o non target organism effects ( fish)

 very low toxicity to fish  less toxicity/ risk to fish than alternatives  potential toxicity/ risk to fish mitigatable  similar toxicity to fish as alternatives but significantl less exposure o groundwater ( GW)

 low potential for GW contamination  low drift, runoff potential  runoff mitigatable o lower use rates than alternatives, fewer applications o low pest resistance potential ( i. e., new mode of action)

o highly compatible with IPM o efficacy.

OPP has also assessed eleven of the sixteen reviews conducted by th Reduced Risk Committee of submissions that were determined not to be reduced risk. Those factors that most significantly contributed to an unacceptable decision by the committee are summarized below in descendin order:

o human health effects  inadequate/ inappropriate comparisons with alternatives  inadequate documentation of effects  human health risk reduction case weak  risk reduction case inadequate when compared to alternatives o non target organism effects ( birds and fish)

 toxic to birds  toxic to fish  risk reduction case inadequate when compared to alternatives o potential GW problems o unlikely to displace higher risk alternatives o lack of efficacy data o phytotoxicity.

This survey of past decisions should assist future applicants in preparing their submissions.

VI. PROCEDURES AND GUIDELINES FOR EXPEDITED REVIEW OF CONVENTIONAL AND ANTIMICROBIAL PESTICIDES A. Background In general, FIFRA section 3( c)( 3)( A) requires EPA after receipt of application for registration of a pesticide " as expeditiously as possibl either to register it or to notify the applicant that the application do not comply with the Act. FIFRA also establishes expedited review procedures for a variety of Agency activities associated with the registration of pesticides, including expedited review for certain end u pesticides that are identical or substantially similar to currently registered pesticides (" me too" registrations) as provided in FIFRA sect 3( c)( 3)( B)( II), and for antimicrobial pesticides as provided for in FIFR section 3( h)( 2). EPA also has several programs to expedite the registration process for biological pesticides by the Biopesticides and Pollution Prevention Division, antimicrobial pesticides by the Antimicrobial Division and fast track procedures to expedite the registration of certain amendments to existing conventional pesticide registrations. As a result of these programs, EPA is already expediting many pesticide applications for registration.

FIFRA section 3( c)( 10) establishes an expedited review for applications for registration and amendments to registrations for pesticides that " may reasonably be expected to accomplish one or more of the following:

( i) Reduce the risks of pesticides to human health.

( ii) Reduce the risks of pesticides to nontarget organisms.

( iii) Reduce the potential for contamination of groundwater, surface water or other valued environmental resources.

( iv) Broaden the adoption of integrated pest management strategies, or make such strategies more available or more effective."

The statute does not establish deadlines for review of registration applications or amendments that meet the above criteria. Section 3( c)( 1 however, requires EPA to notify the applicant whether the application fo expedited review is complete no later than 30 days after receipt of the application.

B. Procedures EPA intends to establish a two step procedure for expedited review pursuant to FIFRA section 3( c)( 10). 1. Step One  Application. For step 1, the Agency will determine whether an application for registration or amended registratio qualifies for expedited review based upon whether use of the pesticide proposed by the application may reasonably be expected to accomplish one more of the criteria listed in Section VI. A. above.

To initiate the process, the applicant must submit an application f expedited review demonstrating how the use of the pesticide may reasonab be expected to accomplish one or more of the criteria listed in section VI. A. above. The applicant also must submit a reduced risk rationale pursuant to the guidelines and procedures specified in sections VII  IX this notice. The step 1 rationale may be a sentence or a paragraph in t reduced risk rationale summary as long as the claims are documented elsewhere in the reduced risk rationale.

Certain types of pesticide applications for registration and amende registration already receive expedited review pursuant to existing Agenc programs. Because the Agency is already expediting review of these registrations, it is not necessary to include them in the review program established pursuant to FIFRA section 3( c)( 10). Applications that alrea receive expedited review include applications for registration or amende registration for biological or antimicrobial pesticides, " me too" applications for registration or amended registrations of end use pesticides under FIFRA section 3( c)( 3)( B)( I) that are identical or substantially similar to other EPA registered pesticide products, and applications for certain pesticides under FIFRA section 3( c)( 3)( B)( II).

The FQPA amendments require EPA to make expedited decisions on antimicrobial pesticides as defined in FIFRA section 2( mm). Specificall FIFRA section 3( h)( 2) establishes goals for the time periods during whic EPA must review different types of applications for antimicrobials cover by the statutory definition and make decisions whether to approve or den the applications. Generally, these review and decision deadlines are 30 to 60% shorter than historic Agency performance in processing such applications.

While FIFRA antimicrobial review deadlines do not become legally binding until May 1998, as a matter of policy, the Agency has committed and, in fact, is meeting the goals specified in FIFRA section 3( h)( 2) as well as the expedited deadlines already mandated in FIFRA section 3( c)( 3)( B). For every application received by the Agency since November 1996, the Agency has made a registration decision within the review peri provided by the statute. EPA will continue to expedite review of applications for registrations and amendments to registrations for antimicrobial pesticides pursuant to its commitment.

The Agency's improved performance in review of antimicrobials is th result of several new initiatives. First, EPA has established within th Office of Pesticide Programs a new Antimicrobials Division ( AD) that is responsible for all regulatory decisions relating to antimicrobial and related pesticides. In addition to regulatory staff, the new AD organization includes scientific personnel capable of performing most of the analyses needed to make a registration decision. Thus, AD is capabl of providing " one stop shopping" for registration decisions. Second, th new AD management team has instituted a number of process improvements, including a dedicated expedited review team of " me too" applications, th have resulted in a significantly improved performance.

Thus, because EPA's current organizational and resource allocations and process improvements are providing expedited review for antimicrobia all types of applications for antimicrobial pesticides ( as defined in FQ will be outside the scope of this PR Notice.

What types of applications for expedited review will the Agency accept? An application for expedited review may be submitted only for t following types of actions: ( a) an application to register a conventional pesticide that conta an active ingredient not contained in any currently registered pesticide, provided the pesticide is not a biopesticide or an antimicrobial pesticide ( as defined in FQPA). [ See sections VI through IX for reduced risk rationale guidelines]; or ( b) an application to amend the registration of a currently registered conventional pesticide for an additional new use, provided the pesticide is not a biopesticide or an antimicrobi pesticide ( as defined in FQPA). [ See sections VII through IX f reduced risk rationale guidelines]; or a non fast track application for registration of a new formulation provided the pesticide is not a biopesticide or an antimicrobial pesticide ( as defined in FQPA). [ See section X f expedited review rationale guidelines].

2. Step 2  Reduced Risk Determination If an application for expedited review qualifies under step 1, the Agency will expedite the review of the reduced risk rationale presented by the applicant to determine whether the pesticide qualifies under the reduced risk criter described in sections VII and X below. The Agency's Reduced Risk Commit will expedite the review of the reduced risk rationale and complete its review within thirty days of receipt of a complete reduced risk rational If the Agency decides that a pesticide qualifies for reduced risk status then it will further expedite review of the remainder of the application for registration or amended registration as described in section IV of t notice.

If the Agency denies a submission reduced risk status, applica will be given only one opportunity to rebut this decision, and the applicant will have four weeks to resubmit their rebuttal. Due to limit program resources, the Agency can only allow one opportunity to rebut a decision. Pesticides that EPA determines do not qualify for reduced risk status during step 2 will be processed in accordance with existing Agenc procedures.

VII. GUIDELINES FOR REDUCED RISK RATIONALES While participation in the reduced risk pesticides program is voluntary, those who elect to participate must fully address all of the following areas: ( a) executive summary, ( b) human health effects; ( c) environmental fate and effects; ( d) other hazards; ( e) risk discussion ( pest resistance and management ( e. g., IPM); and ( g) comparative performance, ( h) other information and how application complies with FQP The Agency will consider all of these areas in determining the acceptability of these applications. However, these may not be the exclusive factors in all cases. If an applicant identifies additional criteria that substantiate the argument that their product is indeed a reduced risk pesticide, then EPA invites the applicant to submit a rationale with any supporting data to verify such a claim. The Agency w consider this additional information.

An applicant's documentation must contain both a discussion of the inherent reduced risk properties of their product, as well as a comparis of those properties with the properties of the commonly used alternative where appropriate. Comparisons must be made to conventional chemical pesticides, antimicrobial pesticides, biological pesticides, and cultura practices currently being used for pest control at the same use site( s) for the same pest( s).

Please note that the Agency does not expect the applicant to perfor any additional testing to derive the data necessary to develop rationale for the Reduced Risk Program. The applicant must summarize all data in applicant's possession or control or available through the open literatu for the product being submitted to the Agency. If data addressing one o the stated factors has been developed, but is not required for registrat of the pesticide in the United States, the applicant must provide a summ of these data as part of the Reduced Risk Rationale. If any of the required information is not known, that fact must be noted in the rationale.

If the rationale does not include a discussion of each of these factors or provide reasoning as to why the factor should not be consider in the Agency's decision, OPP will consider the rationale to be incomple and not responsive to this PR Notice. However, if the applicant believe that the factor does not apply to the new pesticide, the registrant must provide a short rationale describing this reasoning.

In situations where the Agency has already reviewed data on the act ingredient, the applicant should use the Agency's review to address the relevant factor( s). Applicants must also provide Master Record Identification ( MRID) numbers for each study, where appropriate.

A. Executive Summary. Provide an executive summary that addresse the following considerations:

1. Chemical Name.

2. Chemical Abstracts Service Registry Number.

3. Chemical Structure.

4. Chemical Class or Family Name of the Active Ingredient.

5. Mode/ Mechanism of Pesticidal Action for the Active Ingredient ( if known).

6. Proposed Use Pattern ( including site( s) of application an pest( s) controlled), Application Methods, Application Rat Frequency of Application, and Product Formulation Percentages. Also indicate whether the new chemical wil be used in combination with other registered pesticides.

7. Brief Overview Summary of the Health, Ecological and Environmental Fate Effects.

8. Tier 1 statement stating which of the four FQPA criteria being met by this application.

9. Reduced Risk Statement, articulating the specific factors that lead the applicant to the conclusion that the active ingredient offers the opportunity for risk reduction.

10. Data Matrix, providing tabular information on all data available for the active ingredient. The table should include the guideline reference number, the study title, MRID number ( if available), outcome of the Agency's evaluation ( i. e., in review, acceptable, supplemental, da waived, etc.), and date of the Agency's review ( if applicable).

B. Human Health. Clearly identify the portion of the rationale which addresses the potential effects of the active ingredient on human health. When specifying the dose levels used in the toxicity studies, present the no observable effects level ( NOEL) and the lowest observable effects level ( LOEL). Doses need to be specified in terms of mg/ kg/ day. Also, describe qualitatively and quantitatively the array of effects at all dose levels tested. In the format described in Part IX of this PR Notice, address each of the following aspects of the active ingredient and its use: 1. Acute Toxicity of the active ingredient and the formulations. Provide the toxicity category for each of acute toxicity studies conducted on the active ingredient and the formulated products.

2. Reproductive, Developmental, Mutagenic and Neurotoxic Properties of the active ingredient.

3. Oncogenic and Other Subchronic and Chronic Effects of the active ingredient.

4. Toxicity of Mammalian and Plant Metabolites.

C. Environmental Fate and Effects. Clearly identify the portion the rationale which addresses the potential ecological effects of the active ingredient and its environmental fate. The discussion should als address potential environmental degradates or metabolites of the active ingredient. Address each of the following aspects of the active ingredients and its use:

1. Mammalian Acute Toxicity 2. Avian Acute and Subacute Toxicity 3. Avian Reproductive Toxicity 4. Fish Acute and Chronic Toxicity 5. Aquatic Invertebrate Toxicity 6. Honeybee Acute Contact Toxicity 7. Effects on Terrestrial Plant Growth 8. Effects on Aquatic Plant Growth 9. Potential Exposure to Non target Organisms 10. Environmental Persistence ( Soil and Water)

11. Mobility in Soil and Water 12. Transport in Air ( Spray Drift and Volatility)

13. Bioaccumulation as Indicated by the Octanol/ Water Partiti Coefficient D. Other Hazards. Clearly identify the portion of the rationale which addresses other potential human health and environmental hazards produced by the following:

1. Potential to Deplete Stratospheric Ozone thus increasing ultraviolet radiation.

2. Potential to Present a Hazard through Storage, Transportation, Mixing, Use or Disposal based on its physical or chemical characteristics:

a. stability b. flammability c. corrosion characteristics d. explodability e. oxidizing or reducing action f. storage stability 3. Potential to Affect Endangered and/ or Threatened Plant an Animal Species as designated under the Endangered Species Act.

E. Risk Discussion. Clearly identify the portion of the rational which addresses the following items:

1. Discuss the information which supports the claims that th active ingredient presents reduced toxicity, reduced exposure to humans or non target organisms, and/ or reduce environmental burden. When discussing the ecological lev of concern ( LOCs), present the methods used to derive the and provide interpretations of what the LOCs mean.

2. Where alternative, registered pesticides or pest control practices exist, make a quantitative and/ or qualitative comparison between the risks posed by the active ingredie under consideration and all the other pesticides commonly used, and/ or the other current pest control practices.

3. The comparisons with alternative technology should also include biological pesticides as well as cultural and mechanical pest management practices.

F. Pest Resistance and Management. Clearly identify the portion the rationale which addresses the following items:

1. Describe how the active ingredient addresses the developm of pest resistance, either to the active ingredient itsel or to existing pesticides registered for the same use.

2. Discuss the suitability of the active ingredient for use or encouraging the adoption of, Integrated Pest Managemen ( IPM) programs. This discussion should include informati on the effects of the pesticide on natural predators, parasites and pathogens of each target pest, if such information is known. The degree of risk and/ or usage reduction to be achieved by the IPM program must also be addressed.

G. Comparative Performance Data ( efficacy data). These data are important to assure that risk reduction has a reasonable opportunity to accomplished by adoption of the new pesticide by growers.

1. It is desirable to have summaries of comparative performa data in which the performance of the candidate pesticide compared to that of alternative control measures under actual use or simulated actual use conditions.

2. Summaries of the available efficacy data if comparative performance data are not available.

Summaries should include statistical analysis of significant differences between the new pesticide and the commonly used alternatives Summaries should also include experimental methodologies such as application rates, application intervals, pest pressure, weather conditions, varieties of the crop used, etc. Unfavorable results must b included. Efficacy experiments performed under substantially different conditions should not be combined ( examples include differences in pest pressure, geography, strain/ race of pest and weather). Guidance for thi requirement can be obtained from standardized published tests such " Fungicide and Nematicide Tests," " Insecticide and Acaricide Tests" and methods section sections of juried professional journals.

H. Other Information. Submission of the following additional information will assist the Agency in making its decision on the active ingredient:

1. A copy of the proposed product label( s). The Agency will consider all of these criteria using a weight of evidence approach.

VIII. GUIDELINES FOR FQPA RATIONALE FOR REDUCED RISK PESTICIDES Reduced risk submissions should also provide a rationale that explains how this registration action complies with the requirements of FQPA. Such rationale should follow guidance provided in Appendix A of P Notice 97 1 ( January 31, 1997). Such rationale should address at a mini aggregate risk, special sensitivities, endocrine effects and potential common mechanisms of toxicity with other registered pesticides. Appendi is provided as an attachment to this notice.

IX. FORMATTING AND SUBMITTAL PROCEDURES FOR REDUCED RISK PESTICIDES Formatting ( A) and submittal ( B) procedures for Reduced Risk Rationales are provided below. These procedures will enable EPA to easi identify the application for priority consideration. Also, applicants should note that it is unlawful to falsify any portion of an application FIFRA Sections 12( a) ( 2)( M), 12( a)( 2)( R) and 18 U. S. C. Section 1001 make such actions unlawful and can result in civil or criminal penalties. Th Agency will not consider an application under the Voluntary Reduced Risk Pesticide Initiative if the applicant does not follow these procedures.

A. Format. The reduced risk rationale document must include the following elements in the order indicated: Title Page, Statement or Supplemental Statement of Data Confidentiality Claims, Cover Sheet to Confidential Attachment and Confidential Business Information ( CBI) Reduced Risk Attachment. Any supporting data must comply with PR Notice 86 5 requirements.

The Reduced Risk Rationale must be bound as a separate entity and consecutively paginated beginning with the title page as page 1. The to number of pages must be represented on the title page. Do not include C on the title page. On the title page, include titles and author( s).

B. Submitting a Reduced Risk Rationale Registration Application. Reduced Risk Rationale should accompany the registration application and supporting data packages. This PR Notice does not supersede established submittal procedures as addressed in PR Notice 91 5; rather, this PR Not provides additional guidance for submitting the reduced risk rationale. OPP uses distribution codes to facilitate the delivery of registration a other submissions within the program. When preparing your submission to mail or deliver to OPP, direct your submission to the Document Processin Desk and including the following distribution code: REDUCED RISK APPL.

The submission delivered via the U. S. Postal Service should be directed to OPP using the following address:

Document Processing Desk ( REDUCED RISK APPL.) Office of Pesticide Programs ( 7504C) U. S. Environmental Protection Agency 401 M Street, S. W. Washington, D. C. 20460 0001 Submissions via personal or courier delivery should be directed to Document Processing Desk between the hours of 8: 00 a. m. and 4: 00 p. m., Monday through Friday, excluding federal holidays. OPP's Document Processing Desk is located at the following address:

Office of Pesticide Programs Document Processing Desk ( REDUCED RISK APPL.) Room 266A, Crystal Mall 2 1921 Jefferson Davis Highway Arlington, VA 22202 C. Rebuttals may be submitted to Rick Keigwin, Registration Divisi ( 7505C), U. S. Environmental Protection Agency, 401 M Street, S. W., Washington, DC 20460.

X. GUIDELINES FOR EXPEDITED REVIEW OF NON FAST TRACK NEW FORMULATIONS FOR CURRENTLY REGISTERED CONVENTIONAL PESTICIDES Some new, non fast track, formulations and amendments to currently registered conventional pesticide products could result in reduced risk. To qualify, an application for expedited review under this section must first demonstrate that it meets one or more of the step 1 criteria liste in section VI. A of this notice. Secondly, the registrant must demonstra that the new formulation, when compared with all of the existing formulation( s) for the active ingredient, results in significant risk reduction. Examples of risk reduction that would most likely qualify fo expedited review include new formulations that result in ( a) at least a reduction in the amount of active ingredient applied, ( b) at least a ten fold reduction in risks to mixers, loaders and applicators, ( c) at least 50% reduction in the product's potential to leach into groundwater or ru off into surface water or ( d) a significant reduction in risk to non tar species. Actions that are accepted will qualify for expedited review bu will not be classified as reduced risk.

The process for submission of a non fast track formulation or new end use product differs from the new active ingredient/ new uses procedur For consideration of a non fast track new formulation/ end use product, t registrant shall make a submission to the Product Manager with documente rationale for consideration of expedited review. The Product Manager wi review the request and determine if the submission qualifies for expedit review. Consultation with other Product Managers or Branch Chiefs in Registration Division may be necessary. The Product Manager will notify the applicant of the expedited review status within 30 days. If denied expedited review status, there will be one opportunity for rebuttal; the submitter has four weeks to resubmit their rebuttal to the PM. Finally, the applicant holds the registrations for the old formulations that this new formulation will replace, a request for cancellation of the old formulations is also required. This cancellation request will not be processed until a registration is issued on the new formulation.

XI. BIOLOGICAL PESTICIDES A. Background. In November, 1994, EPA established a pilot divisi the Biopesticides and Pollution Prevention Division ( BPPD), with part of its mission to expedite the registration and reregistration of biologica pesticides ( biopesticides). Biopesticides are any of the following: ( 1 naturally occurring or genetically altered microorganisms, ( 2) plant pesticides ( pesticidal substances produced in a plant and the gene material necessary for the production of those substances), or ( 3) biochemical pesticides. In addition, BPPD does review the registration submissions for some other pesticidal substances which warrant a reduced data set as described below in Part C.

BPPD is now a permanent part of the Office of Pesticide Programs. date, BPPD has been successful at expediting the registration of biologi pesticides. Since the Division was established in the fall of 1994, 37 biological pesticides have been registered including the first plant pesticide products. New biopesticide active ingredients are typically registered in less than 11 months which is substantially less time than the average review time for conventional pesticides.

B. Priority for Review in BPPD. EPA believes that biological pesticides generally pose less risk than most conventional pesticides. Therefore, EPA established BPPD to provide an expedited review to all biological pesticide products. BPPD's priority of actions is based upon the order submissions are received rather than a comparison of risk amon the biopesticides. When a particular pesticide registrant requests that certain one of its submissions receives top priority amongst that compan other biological actions, BPPD honors the requests. Also, if a biopesticide would replace the use of a hazardous pesticide requested fo an emergency exemption under FIFRA Section 18, BPPD would make a case by case determination on whether to further expedite the regulatory decision.

C. Characteristics of Biopesticides 1. Microbial Pesticides. Microbial pesticides contain a bacterium, fungus, virus, protozoan or alga as the active ingredient. Approximately 50 microbial pesticide active ingredients are registered b EPA. The most widely known of these are varieties of the bacterium, Bacillus thuringensis or Bt, which can control certain moths, beetles, a mosquitoes. Data requirements for microbial pesticides are found in 40 158.740. BPPD encourages potential registrants to contact the Division a preregistration submission meeting to discuss these data requirements, and the scientific rationales for study waivers.

2. Plant Pesticides. In November of 1994, EPA published a proposed rule for regulation of plant pesticides. In that document, EPA encouraged potential registrants to follow the proposed rule until the final rule is published. To date, seven plant pesticide registrations h been issued. Once the final rule is published, EPA will propose guideli for registration of plant pesticides which will be incorporated into 40 Part 158. The guidelines will be open to public comments and appropriat public meetings will be held prior to final guidelines being issued. In the meantime, potential registrants should work closely with BPPD to determine the data requirements for their products.

3. Biochemical Pesticides. Biochemical pesticides are distinguished from conventional chemical pesticides by their nontoxic mo of action toward target organisms ( usually species specific), e. g. growt regulation or mating disruption, and by the natural occurrence of the pesticidal substance. In contrast, conventional pesticides generally ar toxic and may affect a wider range of target species. Biochemical pesticides generally fall into distinct biologically functional classes: Semiochemicals ( chemicals emitted by a plant or animal that modify the behavior of receptor organisms of similar or different species), hormone natural plant regulators, natural insect growth regulators, and enzymes. In many instances, biochemical pesticides may be synthesized rather than isolated from nature. In order for synthesized pesticides to be conside as biochemical pesticides, they must be demonstrated to be structurally similar and functionally identical to a naturally occurring biochemical pesticide.

Although there are no strict criteria for the definition of biochemical pesticides, most biochemical pesticides are applied at very rates, are highly volatile, or are applied in bait, trap, or " encapsulat formulations, thus resulting in less exposure ( and less likelihood of adverse effects to humans and the environment than from use of most conventional pesticides). In keeping with their unique properties, biochemical pesticides have been assigned a set of data requirements whi are organized in a tiered testing scheme to ensure, to the greatest exte possible, that only the minimum data sufficient to make scientifically sound regulatory decisions will be required. The data requirements are outlined in 40 CFR Part 158.690.

4. Pesticides Which Warrant Reduced Data Requirements. The Agency recognizes that many naturally occurring pesticidal chemicals may highly toxic to their target organisms and does not intend to include th as biochemical pesticides. BPPD has elected to review certain of these naturally occurring pesticides that may operate via a toxic mode of acti toward target organisms, but which a priori also would be candidates for initial tiered data set, as required for biochemical pesticides. These " biochemical like" pesticides have not yet been formally classified into subcategory of pesticides for nomenclature purposes. These pesticides usually have uncomplicated structures and are commonly present in the environment or the human diet at significant levels or have been widely used for non pesticidal purposes. Thus, any clinical or nontarget effec are very likely to have been noticed and should be well documented. BPP has found that potential registrants for these products generally follow the same data requirements as the biochemicals, but a preregistration meeting with the Division is highly recommended before extensive testing and before formal submission of an application.

D. Guidelines for Classification as a Biochemical or a " Biochemical like" Pesticide to be Reviewed by BPPD. On request, the Biopesticides and Pollution Prevention Division ( BPPD) will evaluate products on an individual basis to classify them as biochemical pesticid pesticides warranting reduced data requirements (" biochemical like"), or conventional chemical pesticides.

BPPD has formed a Biochemical Classification Committee to evaluate written requests for classifying products proposed for BPPD review as biochemicals and similar products. A classification request should incl information to support the natural occurrence of the chemical and information bearing on its mode of action toward the target pest. Additional information to support low toxicity or low exposure levels ma be useful if available. This could include GRAS ( generally regarded as safe) status ( please cite the listing number) or information on applicat rates and/ or degradation rates. Published studies or private data shoul be attached if the supporting information is not commonly known or obvio E. Evaluation Standards 1. Natural Occurrence. Naturally occurring substances may be inorganic or organic. As noted above, if the chemical is not naturally occurring, information must be provided showing that it is structurally similar and functionally identical to a naturally occurring substance. Biochemical Classification Committee recognizes that " natural occurrence may technically include substances that occur at very low levels in the environment, but in such amounts or locations that humans and/ or nontarg organisms have not been exposed to significant levels of these chemicals The committee may decide that these substances are not biochemical pesticides if there is any indication that natural exposure levels are insufficient to indicate potential effects from the expected product exposure.

2. Nontoxic Mode of Action. A nontoxic mode of action is one that does not kill the target pest. The most obvious are repellents and attractants. The committee has also included in the nontoxic mode of action category, those chemicals that may be lethal to the target, but operate via a physical mode of action to control the target pest. For example, certain oils and/ or sticky substances can kill insects by clogg their respiratory spiracles and trachea, but such substances are not lik to have adverse effects on non target organisms or humans. Desiccants al are considered as acting via a nontoxic mode of action. Plant growth regulators are usually considered to have a nontoxic mode of action; however, some plant growth regulators may act as herbicides at higher application rates. Thus, higher application rates may result in additio data requirements ( as required for conventional chemical herbicides) or reclassification as a conventional chemical pesticide.

F. Formatting and Submittal of Request for Biochemical Classification. The classification request should be in the form of a letter and should be sent directly to the Biopesticides and Pollution Prevention Division ( 7511W), Office of Pesticide Programs, US Environmen Protection Agency, 401 M St SW, Washington, DC 20460. It should be labe " Attn.: Biochemical Classification Committee."

G. EPA Response to Request for Biochemical Classification. Submissions for classification are reviewed by a team of scientists from several divisions within OPP. The recommendations of the Committee are brought to management for approval. Decisions can include classificatio as a biochemical, classification as a " biochemical like" substance that warrants reduced data requirements, but is not a biochemical, or classification as a conventional pesticide. The potential registrant is informed by letter of the decision. Because these are preapplication requests for classification, the information submitted and the results m upon request, be treated as confidential business information.

H. Rebuttals to Denials for Biochemical Classification. In some cases, inadequate information is supplied so that a Committee recommendation cannot be made. In these cases the potential registrant asked to submit additional information. If a potential registrant disagrees with classification as a conventional pesticide ( essentially a denial of classification as a biochemical), a rebuttal can be submitted the Biochemical Classification Committee for reconsideration.

XII. FOR FURTHER INFORMATION For further information on reduced risk submissions for conventiona pesticides, contact Peter Caulkins, Associate Director, Registration Division at ( 703) 305 6550. For further information on antimicrobial pesticides, contact Bill Jordan, Associate Director, Antimicrobials Division at ( 703) 308 6411. For further information on microbial and plant pesticides, contact Phil Hutton, Chief, Microbial Pesticides Branc BPPD at ( 703) 308 8260 and for biochemicals, contact Roy Sjoblad, Chief, Biochemical Pesticides Branch, BPPD at ( 703) 308 8269.

Daniel M. Barolo, Director Office of Pesticide Programs APPENDIX A CONTENT OF SUPPLEMENTAL INFORMATION As indicated at the beginning of the PR Notice, registrants, applicants and petitioners are not currently required to submit any additional information. Nevertheless, since the new statute requires th Agency to consider additional information in order to make the necessary decisions, EPA recognizes that many registrants, applicants and petition may wish to provide the supplemental information to the Agency even with a requirement to do so. For those registrants, applicants or petitione who wish to supplement their original submissions with additional information, this Appendix describes what information the Agency would consider helpful additions for its review.(* 1) (* 1) An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it eithe displays a currently valid OMB control number or is imposed on the person by statute ( 5 CFR 1320.6( a) & ( e)). The collection of information relating to the registration, reregistration, and tolerance programs have are approved under OMB Control Numbers 2070 0024 ( expires: 6/ 30/ 99); 2070 0032 ( expires: 5/ 3/ 98); 2070 004 ( expires: 11/ 30/ 99); 2070 0060 ( expires: 5/ 31/ 98); 2070 0122 ( expir 11/ 30/ 97); 2070 0107 ( expires: 7/ 31/ 99). If you should have any comments on the collection activities, please send them to the Director, OPPE Regulatory Information Division, U. S. Environmental Protection Agency ( Mailcode 2137), 401 M St., S. W., Washington, D. C 20460. Include the OMB control number in any correspondence. Note that this address is ONLY for comments on the collection activity. not submit your information to this address.

All tolerances or tolerance exemptions and associated registration actions under FIFRA section 3 or reregistration actions under FIFRA sect 4, whether pending or future, will need to comply with the new safety standard of section 408( b)( 2) of the Federal Food, Drug and Cosmetic Ac In addition, because EPA intends to apply a similar standard to actions involving non food use pesticides that may pose significant non dietary risks to infants and children, all registration and reregistration actio also will need to comply with this standard with respect to the Agency's consideration of infants and children exposure to the pesticide.

In preparing a package to be submitted, those seeking a registratio reregistration, tolerance, or an exemption from the requirement of a tolerance for a food use pesticide, or a registration or reregistration a non food use pesticide that may result in significant exposure to children, may need to provide additional information and/ or materials to address adequately the factors and specific questions contained here. Those who wish to submit additional information should keep in mind that the Agency will consider each factor listed below ( and perhaps others as Agency policies are developed) in addition to any data and information already required. In addition, it is important to note that the information identified here may not be definitive in all cases. Additio information or more detailed information may be needed in individual cas If a registrant, applicant, or petitioner can identify additional information that would assist the Agency in addressing the FQPA provisio EPA welcomes such information. Although the submission of this informat is not currently required by the regulations, if such information is not submitted, the Agency must rely on previously submitted data, if applicable, or on broad or default assumptions when considering the fact listed. As a result, favorable action on an application, petition, or reregistration decision may be significantly delayed or precluded altogether.

It would be helpful for any submitted documentation to contain a discussion of each of the following factors as it relates to the pestici and proposed tolerance or tolerance exemption. If information on any factor is not known, that fact, along with an explanation, should be not in the rationale. It is important to note that EPA does not expect the registrant, applicant, or petitioner at this time to perform any additio testing to derive the data necessary to develop its rationales. However if it has in its possession data from preliminary reports of ongoing studies, articles from published literature, unpublished report information, previously unsubmitted studies, or supplemental data that a otherwise pertinent to the Agency's concerns, the party is encouraged to submit them. Likewise, if a registrant, applicant, or petitioner believ that a factor is not applicable to its product, a discussion as to why t view is held should also be included. The Agency will consider all relevant factors in determining an application's completeness and in setting priorities for review.

Based on the new safety standard, EPA will need the following additional information in order to make appropriate regulatory decisions ( For details on each factor, please refer to the explanations below in parts A and B.)

1. An informative summary of the petition or application, including a summary of the supporting data, information, accompanying rationale and a statement providing permission to publish such summary, and 2. Information and discussion pertaining to a specific safety determination for infants and children including their special susceptibilities and exposure patterns to the particular pesticide.

A. Food Use Pesticides: Registration and Reregistration Actions, Experimental Use Permits, Tolerance ( or Exempti Petitions and Reassessments In the format described in Appendix C of this PR Notice, address ea of the following with respect to the pesticide and its use( s): Special Sensitivities a) Chronic Endpoints For a chemical pesticide: Discuss and/ or provide evidence as to whether or not the current Reference Dose ( RfD) is sufficient to adequately protect infants and children. Discuss and/ or provide evidence as to whether or not infants and children are more susceptible to the chemical. If you believe that an additional saf factor of 10X, to take into account potential pre and post natal toxicity to infants and children is not necessary, provide evidence support the additional safety factor, if any, you believe to be mor appropriate. Please bear in mind that the Agency may accept a different margin of safety only if, based on reliable data, EPA concludes that the margin will be safe for infants and children.

For a biochemical pesticide:(* 2) (* 2) A biochemical is a naturally occurring compound, or substantially similar to a naturally occurring compound, with non toxic mode of action to the target pest. Does the toxicity testing indicate that the establishment of an RfD warranted? If so, then discuss whether or not the RfD is sufficien to adequately protect infants and children. Discuss and/ or provide evidence as to whether or not infants and children are more susceptible to the biochemical pesticide.

For a microbial pesticide:(* 3) (* 3) Certain subpopulations are more susceptible to certain disease causing microorganisms; however, these are not the typ of microorganisms that are considered for registration or use microbial pesticides. The Agency has not registered, and does not expect to register a microbial active ingredient that is known to be a common human pathogen. To address the potential risk from microbial pesticides, the Agency requires a battery acute toxicity/ pathogenicity studies in order to perform a risk assessment. If results of the acute exposure studies indicate a toxicity concern, then subchronic or chronic studie are required. Discuss the potential for chronic dietary risks for infants and children. Discuss and/ or provide evidence as to whether or not infants and children are more susceptible to the microbial pesticid than is the adult population.

b) Acute Endpoints Discuss the potential for greater acute dietary risk for infants an children. If the chemical or biochemical pesticide demonstrates ac effects, then discuss the endpoint used to perform the assessment including relevance to infants and children and the details as to h the exposure assessment was conducted and whether the estimated ris is within the Agency's levels of concern.

c) Carcinogenic Endpoints If the chemical or biochemical has been determined to be a carcinog and has a cancer potency factor ( Q1*), discuss the aggregate exces lifetime cancer risk resulting from exposure to the chemical from residues in food and drinking water ( ground and surface water) and from residential and other non occupational source( s).

Aggregate Exposure a) Water For a chemical or biochemical pesticide: Discuss the potential for the transfer of residues ( of both the parent pesticide and any degradates) to drinking water. The discussion should include, but be limited to, information indicating whether the pesticide is persistent and/ or mobile, relevant product chemistry, and any available modeling data.

Has the chemical or any of its degradates been detected in ground water or surface water? Would this chemical or any of its degradat likely pass through primary or secondary drinking water treatment i finished water? Are any States conducting water monitoring program for this pesticide? If so, data collected by the States and all relevant information should also be included.

For a microbial pesticide: Discuss the potential for the transfer the microbial pesticide to drinking water. The discussion should include, but not be limited to, information pertaining to the biolo of the microorganism, and indicating whether the pesticide is persistent and/ or mobile or has the potential for transport in air ( spray drift and volatility data). Are any States conducting water monitoring programs for this strain? If so, data collected by the States and all other relevant information should also be included.

b) Non occupational Exposures Discuss the potential for significant exposure to the pesticide of children by routes other than dietary. Are there any non occupational, structural, or residential uses ( e. g., pet, swimm pool, lawn and garden, or topical insect repellent)? Is the pestic used in or around schools, parks, or recreation facilities? Provid all available exposure data. If the pesticide demonstrates acute effects, then discuss the endpoint used to perform the assessment, including relevance to infants and children and the details of how residential exposure assessment was conducted and whether the estimated risk is within the Agency's levels of concern.

c) Multiple Pathway Assessment Discuss the chronic and/ or acute risk of aggregate exposure via multiple pathways for the general population, and for infants and children. This should include a discussion of all assumptions used and uncertainties. You should also identify, and include in the discussion, any non pesticidal uses of the chemical ( e. g., industri pharmaceutical, cosmetic, food additive).

Cumulative Effects Discuss the mechanism and mode of action of this pesticide. Identi other chemicals that may fall into this category ( both pesticide an non pesticide chemicals). Provide information regarding common mechanisms and modes of action with other chemical substances based structural similarity, same or similar endpoints, and other relevan criteria. Provide any data and/ or evidence illustrating similariti at the cellular/ molecular level.

Discuss the appropriateness of combining exposures in this particul case. Where data are not available, discuss appropriateness of usi default assumptions and what defaults should be used.

Endocrine Effects(* 4) (* 4) As indicated in section 408( p)( 1) & ( 2), the Agency has 2 years to develop a screening method, with a total of 3 years t implement such a program.

Discuss and provide any evidence relevant to the possibility that t pesticide may have endocrine disrupter effects individually or in combination with another chemical. Include the potential for synergistic effects of your chemical in combination with other chemicals. Identify any instances of reported ( proven or alleged) adverse reproductive or developmental effects to domestic animals or wildli as a result of exposure to your chemical, or that occurred in an ar where the chemical is known to have been used. Provide all information regarding the circumstances, estimated level of exposur and details of the effect.

Residue Chemistry Information should include a discussion of compatibility with established Codex Alimentarius Commission Maximum Residue Levels ( MRLs), submission of a practical analytical method with an appropriate limit of detection, and a discussion of the potential n for tolerances for processed foods. For tolerance exemption petitions, indicate if the chemical is on the Food and Drug Administration's Generally Recognized As Safe ( GRAS) list. A summa of all tolerances and exemptions from tolerance being proposed shou also be included.

Benefits Information ( For Reregistration Actions Only)

If the information and data submitted indicate that an existing tolerance, reviewed according to the requirements of the new legislation should be determined to be unsafe ( that is, to exceed the " reasonable certainty of no harm" standard), the new law allows EPA to consider pesticide benefits information in certain instances. An " eligible pesticide chemical residue" ( for which an " eligible tolerance" may be applicable) is defined as a chemical residue for which 1) EPA is unable to identify a level of exposure that will not cau or contribute to a known or anticipated harm to human health ( that the effect is a non threshold effect);

2) an appropriate quantitative risk assessment for the lifetime ri of the non threshold effect has been determined; and 3) if there are also threshold effects associated with the chemica EPA is able to identify a level at which the residue will not cause any known or anticipated harm to human health and that the level o aggregate exposure is safe.

Registrants who suspect that an existing tolerance for their chemic which has been classified by the Agency as exhibiting a non threshold effect, may exceed the new safety standard, and wish the Agency to consi an eligible tolerance for residues of that pesticide, may need to submit the following information:

Conditions Regarding the Use of the Pesticide Information and/ or data indicating that the use of the pesticide chemical that produces the residue protects consumers from adverse health effects that would pose a greater risk than the dietary risk from the residue, OR Information and/ or data showing that the use of the pesticide chemi that produces the residue is necessary to avoid a significant disruption in the domestic production of an adequate, wholesome, an economic food supply.

Conditions Regarding the Risk of a Pesticide Evidence that the yearly risk associated with the nonthreshold effe from aggregate exposure to the residue is not greater than ten time the yearly risk allowed under the new safety standard, AND Evidence that the tolerance is limited to ensure that the lifetime risk associated with the nonthreshold effect from aggregate exposur to the residue is not greater than twice the lifetime risk allowed under the new safety standard.

It is important to note that the above information does not superse any existing benefits requirements under FIFRA, such as public health pe and benefits data necessary for a public interest finding under FIFRA section ( 3)( c)( 7).

B. Non Food Use Pesticides: Registration or Reregistration Actions In the format described in Appendix C of this PR Notice, address ea of the following with respect to the pesticide and its use( s):

Potential for Exposure to Children Describe the use pattern of your chemical. If you believe that its use( s) would not potentially result in significant exposure to infa and children, provide a discussion and rationale as to why this vie is held. For chemicals that appear not to result in a significant exposure to infants and children, no additional information is need If you believe that the use of your chemical may result in significant children's exposure, the following factors may need to be addressed:

Special Sensitivities Discuss and/ or provide evidence as to whether or not infants and children are more susceptible to the chemical than adults.

Discuss the potential for greater acute and/ or chronic risk for infants and children. If the pesticide demonstrates toxic effects, then discuss the endpoint used to perform the assessment including relevance to infants and children and the details as to how the exposure assessment was conducted and whether the estimated risk is within the Agency's levels of concern.

Aggregate Exposure Discuss the potential for the transfer of residues of both the pare chemical and any degradates or of the microbial pesticide to drinki water. For chemical pesticides, the discussion should include, bu not be limited to, information indicating whether the pesticide is persistent and/ or mobile, the potential for transport in air ( spray drift and volatility data), and any available modeling data. For microbial pesticides, the discussion should instead include information pertaining to the biology of the microorganism and indicate whether the pesticide is persistent and/ or mobile.

Has the chemical or any of its degradates been detected in ground water or surface water? Would this chemical or any of its degradat likely pass through primary or secondary drinking water treatment i finished water? Are any States conducting water monitoring program for this pesticide? If so, data collected by the States and all relevant information should also be included.

Discuss the potential for significant exposure to the chemical of children by non dietary routes. Are there non occupational, structural, or residential uses ( e. g., pet, swimming pool, lawn and garden, or topical insect repellents)? Is the pesticide used in or around schools, parks, or recreation facilities? Provide all available exposure data.

Discuss the chronic and/ or acute risk of aggregate exposure via multiple pathways for the general population, infants and children should include a discussion of all assumptions used and uncertainti Identify other non pesticidal uses of the chemical ( e. g., industria pharmaceutical, cosmetic, food additive).

Cumulative Effects Discuss the mechanism and mode of action of this pesticide. Identi other chemicals that may fall into this category ( both pesticide an non pesticide chemicals). Provide information regarding common mechanisms and modes of action with other chemical substances based structural similarity, same or similar endpoints, and other relevan criteria. Provide any data and/ or evidence illustrating similariti at the cellular/ molecular level.

Discuss the appropriateness of combining exposures in this particul case. Where data are not available, discuss appropriateness of usi default assumptions and what defaults should be used.

Endocrine Effects Discuss and provide any evidence relevant to the possibility that t chemical may have endocrine disrupter effects individually or in combination with another chemical. Include the potential for synergistic effects of your chemical in combination with other chemicals and whether or not your chemical could act as a catalyst another hormone disrupting chemical.

Identify any instances of reported ( proven or otherwise) adverse reproductive or developmental effects to domestic animals or wildli as a result of exposure to your chemical, or that occurred in an ar where the chemical is known to has been used. Provide all informat regarding the circumstances, estimated level of exposure, and detai of the effect.

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[Federal Register Volume 82, Number 139 (Friday, July 21, 2017)]
[Rules and Regulations]
[Pages 33787-33790]
[FR Doc No: 2017-15119]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9572; Directorate Identifier 2016-NM-151-AD;
Amendment 39-18963; AD 2017-15-03]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are superseding Airworthiness Directive (AD) 2014-08-02
which applied to certain Airbus Model A300 B4-600 and A300 B4-600R
series airplanes. AD 2014-08-02 required modifying the profile of
stringer run-outs of both wings, including a high frequency eddy
current (HFEC) inspection of the fastener holes for defects, and
repairs if necessary. This new AD retains the actions required by AD
2014-08-02 and revises the compliance times. This AD was prompted by
further analysis in the context of widespread fatigue damage (WFD),
which concluded that shorter compliance times are necessary to meet
specified requirements to address WFD. We are issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective August 25, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 25,
2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of May
21, 2014 (79 FR 21392, April 16, 2014).

ADDRESSES: For service information identified in this final rule,
contact Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; email<EMAIL_ADDRESS>Internet
http://www.airbus.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9572.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9572; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (telephone 800-
647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2014-08-02, Amendment 39-17826 (79 FR 21392,
April 16, 2014) (``AD 2014-08-02''). AD 2014-08-02 applied to certain
Airbus Model A300 B4-600 and A300 B4-600R series airplanes. The NPRM
published in the Federal Register on March 13, 2017 (82 FR 13405). The
NPRM was prompted by further analysis in the context of WFD, which
concluded that a shorter compliance time is necessary to meet specified
requirements to address WFD. The NPRM proposed to continue to require
modifying the profile of stringer run-outs of both wings, including a
high frequency eddy current inspection of the fastener holes for
defects, and repairs if necessary. The NPRM also proposed to require a
revised compliance time for these actions. We are issuing this AD to
prevent cracking in the bottom wing skin stringers, which could result
in reduced structural integrity of the wings.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2016-0174, dated August 30, 2016 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Airbus Model
A300 B4-600 and A300 B4-600R series airplanes. The MCAI states:

    During full-scale fatigue testing, cracks were detected in the
bottom wing skin stringers at Rib 14. In addition, operators have
also reported finding cracks in the same area on in-service
aeroplanes.
    This condition, if not detected and corrected, could impair the
structural integrity of the wings.
    Additional analysis results showed that the improved design of
the stringer run-out was necessary for aeroplanes operating beyond
the Extended Service Goal 1.
    To address this unsafe condition, Airbus issued Service Bulletin
(SB) A300-57-6046 Revision 01 to provide modification instructions,
and EASA issued AD 2013-0008 (later revised) [which corresponds to
FAA AD 2014-08-02], to require the removal of the stringer end run-
out plate at stringer 19 on the bottom wing skin and a re-profiling
modification of the stringers 10, 11, 12, 17 and 19.
    Since that [EASA] AD was issued, further analysis in the context
of Widespread Fatigue Damage (WFD), concluded that a threshold
reduction is necessary to meet the WFD requirements. Consequently,
Airbus revised SB A300-57-6046 accordingly (now at Revision 03).
    For the reasons described above, this [EASA] AD retains the
requirements of EASA AD 2013-0008R1, which is superseded, but
reduces the modification threshold, and introduces a pre-mod High
Frequency Eddy Current (HFEC) inspection.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9572.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received. FedEx Express had no
objection to the NPRM.

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Service Bulletin A300-57-6046, Revision 03,
including Appendix 01, dated February 4, 2015. The service information
describes procedures to modify the profile of stringer run-outs of both
wings, including a HFEC inspection of the fastener holes for defects,
and repairs. It also describes new compliance times for completing the
modifications. This service information is reasonably available because
the interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 29 airplanes of U.S. registry.
    The actions required by AD 2014-08-02, and retained in this AD,
take about 63 work-hours per product, at an average labor rate of $85
per work-hour. Required parts cost about $2,360 per product. Based on
these figures (accounting for updated work-hour and parts cost
estimates), the estimated cost of this AD on U.S. operators is $7,715
per product.
    We have received no definitive data that would enable us to provide
cost estimates for any on-condition actions specified in this AD. We
have no way of determining the number of aircraft that might need these
repairs.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;

    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2014-08-02, Amendment 39-17826 (79 FR 21392, April 16, 2014), and
adding the following new AD:

2017-15-03 Airbus: Amendment 39-18963; Docket No. FAA-2016-9572;
Directorate Identifier 2016-NM-151-AD.

(a) Effective Date

    This AD is effective August 25, 2017.

(b) Affected ADs

    This AD replaces AD 2014-08-02, Amendment 39-17826 (79 FR 21392,
April 16, 2014) (``AD 2014-08-02'').

(c) Applicability

    This AD applies to Airbus Model A300-B4-601, B4-603, B4-620, and
B4-622 airplanes, and Model A300-B4-605R and B4-622R airplanes,
certificated in any category, except airplanes on which Airbus
Modification 10324 or 10325 has been embodied in production.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by an evaluation by the design approval
holder indicating that certain wing skin stringers are subject to
widespread fatigue damage. We are issuing this AD to prevent
cracking in the bottom wing skin stringers, which could result in
reduced structural integrity of the wings.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Modification of Rib 14, With Revised Compliance Time and
Service Information

    This paragraph restates the requirements of paragraph (g) of AD
2014-08-02, with revised compliance times and service information.
At the time specified in paragraph (g)(1) or (g)(2) of this AD,
whichever occurs earlier, modify the profile of stringer run-outs at
rib 14 of both wings, including a high frequency eddy current
inspection of the fastener holes for defects and all applicable
repairs, in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A300-57-6046, Revision 02, dated June 21,
2013; or Revision 03, including Appendix 01, dated February 4, 2015;
except as required by paragraph (h) of this AD. Do all applicable
repairs before further flight. As of the effective date of this AD,
only Airbus Service Bulletin A300-57-6046, Revision 03, including
Appendix 01, dated February 4, 2015, may be used.
    (1) Before the accumulation of 42,500 total flight cycles, or
within 2,000 flight cycles after May 21, 2014 (the effective date of
AD 2014-08-02), whichever occurs later.
    (2) Before the accumulation of 30,000 total flight cycles, or
within 2,000 flight cycles after the effective date of this AD,
whichever occurs later.

(h) Retained Exception to the Service Information, With Revised Service
Information

    This paragraph restates the requirements of paragraph (h) of AD
2014-08-02, with revised service information.
    (1) Where Airbus Mandatory Service Bulletin A300-57-6046,
Revision 02, dated June 21, 2013, specifies to contact Airbus for
repair instructions, this AD requires contacting the Manager, ANM-
116, International Branch, Transport Airplane Directorate, FAA, or
the European Aviation Safety Agency (EASA) (or its delegated agent)
for repair instructions and doing those repairs before further
flight.
    (2) Where Airbus Service Bulletin A300-57-6046, Revision 03,
including Appendix 01, dated February 4, 2015, specifies to contact
Airbus for appropriate action: Before further flight, accomplish
corrective actions in accordance with the procedures specified in
paragraph (j)(2) of this AD.

(i) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using the service information specified in paragraph
(i)(1), (i)(2), or (i)(3) of this AD.
    (1) Airbus Service Bulletin A300-57-6046, dated January 18,
1994, which is not incorporated by reference in this AD.
    (2) Airbus Service Bulletin A300-57-6046, Revision 01, dated
April 18, 2011, which is not incorporated by reference in this AD.
    (3) Airbus Service Bulletin A300-57-6046, Revision 02, dated
June 21, 2013, which was incorporated by reference in AD 2014-08-02.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or EASA; or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (h) of this AD: If any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2016-0174, dated August 30,
2016, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2016-9572.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (l)(4) and (l)(5) of this AD.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.

    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
August 25, 2017.
    (i) Airbus Service Bulletin A300-57-6046, Revision 03, including
Appendix 01, dated February 4, 2015.
    (ii) Reserved.
    (4) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (5) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on July 11, 2017.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-15119 Filed 7-20-17; 8:45 am]
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[Federal Register Volume 79, Number 159 (Monday, August 18, 2014)]
[Notices]
[Pages 48818-48819]
[FR Doc No: 2014-19457]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2014-53]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before September 8, 2014.

ADDRESSES: You may send comments identified by Docket Number FAA-2014-
0507 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building

Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC, 20951.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 12, 2014.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2014-0507.
    Petitioner: Clayco, Inc.
    Section of 14 CFR: parts 21, 45.23(b), 61.113(a) and (b), 91.7(a),
91.9(b)(2), 91.103, 91.109, 91.119, 91.121, 91.151(a), 91.203(a) and
(b), 91.405(a), 91.407(a)(1), 91.409(a)(2), and 91.417(a) and (b).
    Description of Relief Sought: The petitioner is seeking an
exemption to allow commercial operation of its Small Unmanned Aircraft
Systems (sUASs) for aerial imaging to monitor and ensure safety of
secured and controlled environmental construction sites. The request is
exclusively for the use of the UAS manufactured by Skycatch, Inc., a
San Francisco based company.

[FR Doc. 2014-19457 Filed 8-15-14; 8:45 am]
BILLING CODE 4910-13-P