2010-14401. Pesticide Management and Disposal; Standards for Pesticide Containers and Containment; Proposed Change to Labeling Compliance Date

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

EPA is proposing to amend the pesticide container and containment regulations to provide a 1-year extension of the 40 CFR 156.159 labeling compliance date from August 16, 2010 to August 16, 2011. This change is being proposed to address concerns raised by stakeholders and as a result of further Agency consideration.

DATES:

Comments must be received on or before July 15, 2010.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0327, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2005-0327. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Nancy Fitz, Field and External Affairs Division (FEAD) (7506P), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are a pesticide formulator. Potentially affected entities may include, but are not limited to:

• Pesticide formulators (NAICS code 32532), e.g., establishments that formulate and prepare insecticides, fungicides, herbicides or other pesticides from technical chemicals or concentrates produced by pesticide manufacturing establishments.

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 this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit CBI to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Background

On August 16, 2006, EPA promulgated a final rule titled “Pesticide Management and Disposal; Standards for Pesticide Containers and Containment” (71 FR 47330) (container and containment rule), establishing 40 CFR part 165 and amending 40 CFR part 156. The container and containment rule established regulations for the safe storage and disposal of pesticides to reduce the likelihood of unreasonable adverse effects on human health and the environment. The container and containment regulations include requirements for pesticide container design; procedures, standards, and label language to facilitate removal of pesticides from containers prior to their being used, recycled, or discarded; and requirements for containment of stationary pesticide containers and procedures for container refilling operations. The 2006 rule required that all pesticide products distributed or sold by a registrant as of August 16, 2009, bear labels that comply with the rule's label language requirements (40 CFR 156.159). On October 29, 2008, EPA promulgated a final rule that made various amendments to the container and containment rule, including extending the original labeling compliance date from August 16, 2009 to August 16, 2010.

Specifically, 40 CFR part 156, subpart H, titled “Container Labeling,” requires the following information or statements on certain pesticide product labels:

• A statement identifying the container as nonrefillable or refillable.
• On nonrefillable containers, statements providing basic instructions for managing the container and a batch code.
• Cleaning instructions for some nonrefillable containers.
• Cleaning instructions for refillable containers at the end of their useful lives.

In addition, the container and containment rule modified several existing requirements in 40 CFR 156.10, including allowing for blank spaces on the labels of some refillable containers for the net contents and EPA establishment number, and adding a reference to the container and containment regulations in 40 CFR part 156, subpart H.

The 2008 rule that amended the container and containment rule by extending the original labeling compliance date to August 16, 2010, also changed the phrase “sold or distributed” to “released for shipment” as associated with all of the compliance dates, and made several other changes to the label requirements and various minor editorial changes.

III. What is the Agency's Authority for Taking this Action?

These proposed regulations are issued pursuant to the authority given the Administrator of EPA in sections 2 through 34 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136-136y. Sections 19(e) and (f) of FIFRA, 7 U.S.C. 136a(e) and (f), grant EPA broad authority to establish standards and procedures to assure the safe use, reuse, storage, and disposal of pesticide containers. FIFRA section 19(e) requires EPA to promulgate regulations for the design of pesticide containers that will promote the safe storage and disposal of pesticides. FIFRA section 19(f) requires EPA to promulgate regulations prescribing procedures and standards for the removal of pesticides from containers prior to disposal. FIFRA section 25(a), 7 U.S.C. 136w(a), authorizes EPA to issue regulations to carry out provisions of FIFRA.

IV. What Action is the Agency Taking?

EPA is proposing to amend the container and containment regulations to provide a 1-year extension of the 40 CFR 156.159 labeling compliance date from August 16, 2010 to August 16, 2011. This change is being proposed to address concerns raised by stakeholders and as a result of further Agency consideration.

Accomplishing the label amendments required in 40 CFR part 156 subpart H is a multistep process. Registrants must identify the changes appropriate for their particular products and apply to EPA for an amended registration. EPA must review the proposed changes and determine whether they are consistent with the regulations, and advise the registrant of the Agency's findings. If the EPA approves the changes, the registrant must then seek approval of the various state pesticide regulatory agencies. Upon approval of the state agencies, the registrant must have the new labels printed and applied to its products.

In March 2010, EPA was contacted by stakeholders with concerns about being able to have all labels changed by the label compliance date of August 16, 2010. Some registrants have asserted that they will not have sufficient time to change all labels for pesticides that are released for shipment after August 16, 2010 despite efforts by registrants, EPA's Office of Pesticide Programs (OPP) and state agencies. The time constraints are due to several factors, including:

• More antimicrobial product labels than expected require alternate rinsing instructions, rather than the standard text in the regulations. Therefore, these amendments cannot be made by notification, and require more time consuming reviews by EPA.
• EPA's position on the appropriate container-related statements (particularly rinsing and treatment of rinsate) for certain pesticides has changed over time as a result of experience with product-by-product label reviews. This has resulted in reconsideration of some decisions, and has caused some confusion in the regulated community.
• The length of time for states to review and approve labels is understood to be increasing due to the furlough days for staff in some states and staffing reductions due to budget shortfalls.

EPA has concluded that there is insufficient time to change all labels by August 16, 2010. Since registrants can decide which registered products they wish to market at any given time, the Agency does not have a precise count of the total number of label changes that ultimately will be submitted to EPA for review. However, based upon a review of recent Agency actions and discussions with registrants, EPA estimates that the majority of label changes already have been submitted and approved. On the other hand, EPA estimates that there are at least 1,000 labels and potentially several thousand remaining pesticide product labels that EPA still needs to review. Even if all of those applications were submitted immediately, there would not be enough time for the label changes to be approved by EPA and the states, printed, and applied to all products that will be released for shipment after August 16, 2010.

Because EPA actions contributed to the large number of outstanding label changes, EPA is proposing to extend the compliance date in §156.159 by 1 year, so that pesticide products released for shipment by a registrant after August 16, 2011 would have to bear a label that complies with the container requirements. EPA believes that one additional year will provide enough time for EPA and the states to review the label changes and for registrants to incorporate the changes into their labels, provided that all applications are submitted soon. This is based on an evaluation of the resources and the time it would take for EPA to undertake a concerted effort to complete the review of these remaining labels and discussions with State regulatory agencies who estimated a range of 3 to 6 months for them to review and approve the label revisions. EPA believes that a longer extension is unjustified because the rule was published 4 years ago so registrants have had a reasonable amount of time to prepare and submit their label modification requests and because EPA has already extended the deadline by 1 year.

Because this proposed 1-year extension could not become final and effective before the current compliance date of August 16, 2010, EPA is also issuing in today's Federal Register a final rule providing for a 4-month extension of the §156.159 compliance date. EPA believes that 4 months will be sufficient to allow this proposed rule to become final and effective, and will avoid the temporary removal of a significant number of pesticides from the market while the rulemaking process for this 1-year extension is completed.

While this rulemaking process moves forward, pesticide registrants should continue to submit applications for label changes for their products prior to the current deadline of August 16, 2010. EPA will give priority to applications submitted prior to August 16, 2010, with the goal of processing them to allow sufficient time for the registrant to obtain state approvals of the new labeling by the revised compliance date. Applications submitted after August 16, 2010 will be processed on a non-priority basis only after all applications submitted prior to that date have been processed. Registrants should carefully consider this and the timing of their submission to ensure that they have sufficient time to obtain state approvals by the revised compliance date.

V. FIFRA Mandated Reviews

In accordance with FIFRA section 25(a) and (d), the Agency submitted a draft of this proposed rule to the Committee on Agriculture in the House of Representatives, the Committee on Agriculture, Nutrition, and Forestry in the United States Senate, the Secretary of Agriculture, and the FIFRA Scientific Advisory Panel (SAP). The SAP and the Secretary of Agriculture waived review of this proposed rule.

VI. Statutory and Executive Order Reviews

This action only proposes to amend an existing regulation to extend the current compliance date, it does not otherwise propose to amend or impose any other requirements. As such, this action is not subject to review by the Office of Management and Budget (OMB) as a “significant regulatory action” under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Nor does it impose or change any information collection burden that requires additional review by OMB under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The information collection activities contained in the regulations are already approved under OMB control number 2070-0133 (EPA ICR No. 1632). An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed rule does not have a significant adverse economic impact on a substantial number of small entities. The proposed extension of the compliance date is not expected to have any adverse economic impacts on affected entities, regardless of their size. In general, EPA strives to minimize potential adverse impacts on small entities when developing regulations to achieve the environmental and human health protection goals of the statute and the Agency. EPA solicits comments specifically about potential small business impacts.

State, local, and tribal governments are rarely pesticide applicants or registrants, so this proposed rule is not expected to affect these governments. Accordingly, pursuant to Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-1538), EPA has determined that this action is not subject to the requirements in sections 202 and 205 because it does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or for the private sector in any one year. In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. For the same reasons, EPA has determined that this proposed rule does not have “federalism implications” as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), because it would not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in the Order. Thus, Executive Order 13132 does not apply to this proposed rule. Nor does it have “tribal implications” as specified in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 22951, November 9, 2000). EPA is not aware of any tribal governments which are pesticide registrants. Thus, Executive Order 13175 does not apply to this action.

Since this action is not economically significant under Executive Order 12866, it is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), and Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). In addition, EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern health or safety risks, which is not the case in this proposed rule.

This action does not involve technical standards that would require the consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272).

This action does not have an adverse impact on the environmental and health conditions in low-income and minority communities. Therefore, this action does not involve special consideration of environmental justice related issues as specified in Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 156

• Environmental protection
• Labeling
• Pesticides and pests

Dated: June 9, 2010.

Lisa P. Jackson,

Administrator.

Therefore, it is proposed that 40 CFR chapter I be amended as follows:

PART

156—[AMENDED]

1. The authority citation for part 156 continues to read as follows:

Authority: 7 U.S.C. 136 through 136y.

2. Revise § 156.159 to read as follows:

§ 156.159

Compliance date.

Any pesticide product released for shipment by a registrant after August 16, 2011 must bear a label that complies with §§ 156.10(d)(7), 156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146 and 156.156.