[ Federal Register: June 11, 2002 ( Volume 67, Number 112)] [ Notices] [ Page 39978 39979] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr11jn02 68]

[ Federal Register: June 12, 2002 ( Volume 67, Number 113)] [ Notices] [ Page 40291 40292] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr12jn02 69]

[[ Page 40291]]

ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0006; FRL 6833 2]

Pesticide Product; Registration Approval AGENCY: Environmental Protection Agency ( EPA).

ACTION: Notice.

SUMMARY: This notice announces Agency approval of applications to register the pesticide products LPE E94T and LPE 94 10% Aqueous containing an active ingredient not included in any previously registered product pursuant to the provisions of section 3( c)( 5) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended.

FOR FURTHER INFORMATION CONTACT: Carol E. Frazer, Biopesticides and Pollution Prevention Division ( 7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308 8810; e mail address: frazer. carol@ epa. gov.

SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

 Examples of Categories NAICS codes potentially affected entities  Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select    Laws and Regulations,''    Regulations and Proposed Rules,'' and then look up the entry for this document under the    Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. To access a fact sheet which provides more detail on this registration, go to the Home Page for the Office of Pesticide Programs at http:// www. epa. gov/ pesticides/, and select    fact sheet.'' 2. In person. The Agency has established an official record for this action under docket control number OPP 2002 0006. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805. In accordance with section 3( c)( 2) of FIFRA, a copy of the approved label, the list of data references, the data and other scientific information used to support registration, except for material specifically protected by section 10 of FIFRA, are also available for public inspection. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of Information Office ( A 101), 1200 Pennsylvania Ave., NW., Washington, DC 20460. The request should: Identify the product name and registration number and specify the data or information desired. A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service ( NTIS), 5285 Port Royal Road, Springfield, VA 22161.

II. Did EPA Approve the Application?

The Agency approved the applications after considering all required data on risks associated with the proposed use of lysophosphatidylethanolamine ( LPE), and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the chemical and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of LPE when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects to the environment.

III. Approved Applications EPA issued a notice, published in the Federal Register of September 19, 2001 ( 66 FR 48256) ( FRL 6791 1), which announced that J P BioRegulators, Inc., Suite 125, 3230 Deming Way, Middleton, WI 53562 ( now called Nutra Park Inc., 8383 Greenway Blvd., Suite 520, Middleton, WI 53562, had submitted applications to register the pesticide products LPE E94T ( EPA File Symbol 70515 E) and LPE 94 20% Aqueous ( EPA File Symbol 70515 R) containing 94% and 20% lysophosphatidylethanolamine, respectively. The registrant subsequently submitted a lower concentration formulation with 10% LPE and 90% other ingredients for 70515 R. These products were not previously registered. The applications listed below were approved on March 26, 2002 for these growth regulator products containing 94% and 10% LPE and 6% and 90% other ingredients respectively: 1. LPE E94T ( EPA Registration Number 70515 2) for manufacturing use only product. 2. LPE 94 10% Aqueous ( EPA Registration Number 70515 1) for enhancing product ripening in the field and increasing shelf life of fruits, flowers and vegetables, an end use product from the above manufacturing use only product.

[[ Page 40292]]

List of Subjects Environmental protection, Chemicals, Pesticides and pests.

Dated: May 21, 2002. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

[ FR Doc. 02 14493 Filed 6 11 02; 8: 45 am] BILLING CODE 6560 50 S ===================================================================== ==

ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0104; FRL 7182 7]

Industrial Economics Inc.; Transfer of Data AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces that pesticide related information submitted to EPA's Office of Pesticide Programs ( OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and the Federal Food, Drug, and Cosmetic Act ( FFDCA), including [[ Page 39979]]

information that may have been claimed as Confidential Business Information ( CBI) by the submitter, will be transferred to Industrial Economics Inc. in accordance with 40 CFR 2.307( h)( 3) and 2.308( i)( 2). Industrial Economics Inc. has been awarded multiple contracts to perform work for OPP, and access to this information will enable Industrial Economics Inc. to fulfill the obligations of the contract.

DATES: Industrial Economics Inc. will be given access to this information on or before June 17, 2002.

FOR FURTHER INFORMATION CONTACT: By mail: Erik R. Johnson, FIFRA Security Officer, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 7248; e mail address: johnson. erik@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

This action applies to the public in general. As such, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select    Laws and Regulations,''    Regulations and Proposed Rules,'' and then look up the entry for this document under the    Federal Register Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/.

II. Contractor Requirements Under contract number GS 10F 0224J, the contractor will perform the following: EPA's Office of Enforcement and Compliance Assurance ( OECA) is responsible for providing assistance to enforcement professionals from EPA and the States in determining: ( 1) A violator's economic benefit of noncompliance; ( 2) the violator's ability to pay for compliance, clean ups and civil penalties ( hereinafter referred to as    ability to pay''); ( 3) the value of a supplemental environmental project ( SEP); and ( 4) the value of compliance. This assistance is largely provided through five current computer models: Ben, Abel, Indipay, Munipay and Project. Ben calculates a violator's economic savings from violating the law. Abel, Indipay, and Munipay evaluate claims of inability to pay from for profit entities, individuals and municipalities, respectively. Project calculates the net present, after tax value of a proposed supplemental environmental project. OECA also provides support in these areas through the use of expert financial consultants where the models are insufficient. OECA must keep its models up to date, provide educational programs to ensure proper application of the models, support negotiations, trials and hearings, and provide advice to our enforcement professionals as to issues that arise in using the models. Since there are very few corporate finance, municipal finance, or accounting experts within OECA, the contractor shall provide that expertise and update the models, develop new models as appropriate and educate enforcement staff on the models. The contractor shall also provide expert advice to enforcement personnel regarding financial issues that impact enforcement litigation, and when directed, support enforcement negotiations, and appear as expert witnesses in hearings and trials. However, EPA employees will make all policy decisions in regard to finance/ accounting issues. To the extent that the work under this contract requires access to proprietary or confidential business or financial data of other companies, and as long as, such data remains proprietary or confidential, the contractor shall protect such data from unauthorized use and disclosure. All files or other information identified as CBI shall be treated as confidential and kept in a secure area with access limited to only contractor personnel directly involved in the case or special project assignment. The contractor, subcontractor, and consultant personnel are bound by the requirements and sanctions contained in their contracts with EPA and in EPA's confidentiality regulations found at 40 CFR part 2, subpart B. The contractor, subcontractors, and consultant must adhere to EPA approved security plans which describe procedures to protect CBI, and are required to sign non disclosure agreements before gaining access to CBI. All official data, findings, and results of investigations and studies completed by the contractor shall be available for EPA and Department of Justice internal use only. The contractor shall not release any part of such data without the written direction of the project officer. This contract involves no subcontractors. OPP has determined that the contracts described in this document involve work that is being conducted in connection with FIFRA, in that pesticide chemicals will be the subject of certain evaluations to be made under this contract. These evaluations may be used in subsequent regulatory decisions under FIFRA. Some of this information may be entitled to confidential treatment. The information has been submitted to EPA under sections 3, 4, 6, and 7 of FIFRA and under sections 408 and 409 of FFDCA. In accordance with the requirements of 40 CFR 2.307( h)( 3), the contract with Industrial Economics Inc., prohibits use of the information for any purpose not specified in these contracts; prohibits disclosure of the information to a third party without prior written approval from the Agency; and requires that each official and employee of the contractor sign an agreement to protect the information from unauthorized release and to handle it in accordance with the FIFRA Information Security Manual. In addition, Industrial Economics Inc. is required to submit for EPA approval a security plan under which any CBI will be secured and protected against unauthorized release or compromise. No information will be provided to Industrial Economics Inc. until the requirements in this document have been fully satisfied. Records of information provided to Industrial Economics Inc. will be maintained by EPA Project Officers for these contracts. All information supplied to Industrial Economics Inc. by EPA for use in connection with these contracts will be returned to EPA when Industrial Economics Inc. has completed its work.

List of Subjects Environmental protection, Business and industry, Government contracts, Government property, Security measures. Dated: June 3, 2002. Linda Vlier Moos, Acting Director, Information Resources and Services Division, Office of Pesticide Programs. [ FR Doc. 02 14635 Filed 6 10 02; 8: 45 am] BILLING CODE 6560 50 S


                  EPA/HQ Summary  -  Meeting with CHPA, et al

Attendees

CHPA:		 	Carolyn Hermann

Perrigo	:		Rob Somers

Pfizer:			Josh Lipnick

Sidley Austin:		Roger Martella

EPA/HQ: 	Jessica Young, Kristin Fitzgerald, Drew Lausch, Ross Elliott, Josh Smeraldi

Date:			April 21, 2016

Location:  		EPA/HQ  -  Potomac Yard

Summary

EPA HQ met with representatives of The Consumer Healthcare Products Association (CHPA) and two of their members, and CHPA's outside counsel to discuss the Hazardous Waste Pharmaceuticals Proposed Rule.

CHPA gave a PowerPoint presentation, which is attached.

Perrigo mentioned that some small retailers have chosen not to sell nicotine replacement therapies, in order to avoid becoming large quantity generators when they dispose of them.


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance 2. OMB control number b. G None a. 2060 0489 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NESHAP for Carbon Black, Ethylene, Cyanide, and Spandex ( 40 CFR part 63, subpart YY) ( Renewal)

8. Agency form number( s) ( If applicable) EPA ICR Number 1983.04 9. Keywords Carbon Black, Furnace Process, Thermal Process, Tailgas, Flare, Incinerator, Cyanide chemicals, Hydrogen Cyanide, Sodium Cyanide, Scrubber, Biotreatment, Andrussow Process, Sohio Process, BMA Process, Ethylene Process, Propylene Process, Benzene, Butadiene, Fractionation, Cracking, Spandex Production, Fiber Spinning, Recovery 10. Abstract Respondents are owners and operators of facilities in the carbon black production, cyanide chemicals production, ethylene production and spandex production source categories. Respondents would submit notification and information indicating the performance of air pollution controls. This information is needed to ensure compliance with the rule 11. Affected public ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a. G Voluntary b. G Required to obtain or retain benefits c. x Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 72 b. Total annual responses 151 1. Percentage of these responses collected electronically 20 % c. Total hours requested 13,533 d. Current OMB inventory 33,926 e. Difference ( 20,393)

f. Explanation of difference 1. Program Change 0 2. Adjustment ( 20,393) 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 359 c. Total annualized cost requested 359 d. Current OMB inventory 4,917 e. Difference ( 4,558)

f. Explanation of difference 1. Program change 0 2. Adjustment ( 4,558) 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X")

a. Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semi annually 6. X Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Marcia B. Mia, OECA/ OC/ CAMPD/ ACB MC 2223A Phone: 202 564 7042 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) 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 in 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 collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) 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;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office 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;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of:

"( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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." OMB 83 I ( Instructions) 10/ 95