Labeling of Pesticide Products and Devices for Export; Clarification of Requirements
Federal Register, Volume 79 Issue 244 (Friday, December 19, 2014)
Federal Register Volume 79, Number 244 (Friday, December 19, 2014)
Rules and Regulations
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2014-29787
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 168
Labeling of Pesticide Products and Devices for Export; Clarification of Requirements
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is revising the regulations that pertain to the labeling of pesticide products and devices that are intended solely for export. Pesticide products and devices intended solely for export will be able to meet the Agency's export labeling requirements by attaching a label to the immediate product container or by providing collateral labeling that is either attached to the immediate product being exported or that accompanies the shipping container of the product being exported at all times when it is shipped or held for shipment in the United States. Collateral labeling will ensure the availability of the required labeling information, while allowing pesticide products and devices that are intended solely for export to be labeled for use in, and consistent with the applicable requirements of the importing country.
DATES: This final rule is effective February 17, 2015.
ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2009-0607, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-6304; email address: email@example.com.
Does this action affect me?
You may be potentially affected by this action if you export a pesticide product, a pesticide device, or an active ingredient used in producing a pesticide. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include, but are not limited to: Pesticide and other agricultural chemical manufacturing (NAICS code 325320), e.g., Pesticides manufacturing, Insecticides manufacturing, Herbicides manufacturing, Fungicides manufacturing, etc.
What is the agency's authority for taking this action?
This action is issued under the authority of section 25(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136w(a), to carry out the provisions of FIFRA section 17(a), 7 U.S.C. 136o(a).
What action is the agency taking?
EPA is revising the regulations that pertain to the labeling of pesticide products and devices that are intended solely for export. Pesticide products and devices intended solely for export will be able to meet the Agency's labeling requirements by attaching a label to the immediate product container or by providing collateral labeling that either is attached to the immediate product being exported or accompanies the shipping container of the product being exported at all times when it is shipped or held for shipment in the United States. Collateral labeling will ensure the availability of the required labeling information, while allowing pesticide products and devices that are intended solely for export to be labeled for use in and consistent with the applicable requirements of the importing country.
What are the impacts of this action?
There are no costs associated with this action, and the benefits provided are related to avoiding potential costs. Without these labeling provisions, registrants would be required to place export-
related labeling on the immediate package of each individual pesticide product in a shipping container that is intended solely for export. According to stakeholders, the inability to use the labeling method allowed before the regulations were amended in 2013 could significantly increase their costs and create trade barriers.
In the Federal Register of January 18, 2013 (78 FR 4073) (FRL-9360-
8), EPA published a final rule to revise its export label regulations, in 40 CFR part 168, subpart D, concerning the labeling of pesticide products and devices intended solely for export. The revisions were effective on March 19, 2013, with a compliance date of January 21, 2014.
Industry stakeholders subsequently expressed concern to EPA that certain labeling provisions allowing the use of ``supplemental labeling'' had been removed from this subpart, and that the inability of registrants to use the labeling method allowed in the previous regulations could create trade barriers and increase costs. EPA agreed and in the Federal Register of April 30, 2014 (79 FR 24347) (FRL-9909-
82), published a direct final rule to replace the provision that was inadvertently removed. Since EPA received written adverse comment on the direct final rule, EPA withdrew that direct final rule in the Federal Register of July 11, 2014 (79 FR 39975) (FRL-9913-18) and in the same Federal Register issue published a proposed rule (79 FR 40040) (FRL-9913-19) seeking to make the same changes.
In the proposed rule entitled ``Labeling of Pesticide Products and Devices for Export; Clarification of Requirements,'' EPA proposed to restore the inadvertently eliminated provisions that allowed exporters to use such ``collateral labeling'' attached to, or accompanying, the product shipping container of the export pesticide at all times when shipped or held for shipment in the United States. (As EPA explained in the direct final rule, the term ``collateral labeling'' is more appropriate than ``supplemental labeling'' to describe the materials other than labels that are acceptable for meeting these requirements.) Additionally, the document proposed to restructure 40 CFR part 168, subpart D, by moving the text in Sec. 168.68 and some of the text in Sec. 168.66 to new Sec. 168.65.
The public comment period closed on August 11, 2014. EPA received four comments. Three commenters stated their support for finalizing the proposal. Another commenter stated that ``transporting dangerous substances across any part of the U.S. without
labeling each of the individual containers is asking for a catastrophe.''
Apparently this commenter mistakenly assumes that there would be no information at all on individual containers of export pesticides that are transported in bulk with collateral labeling. This is not the case. Under FIFRA section 17(a)(1), export pesticides must be prepared or packed according to the specifications or directions of the foreign purchaser. This means that individual containers of export pesticides will still be labeled in accordance with the requirements of the importing country. The change being made to EPA's regulations will only apply to information that is required by EPA regulations, but that is not relevant to distribution of the product in the importing country. Because collateral labeling must be attached to or must accompany a shipment at all times, EPA believes that the information contained in that labeling will be accessible during transport in the United States, while avoiding any potential conflicts with labeling requirements in the importing country.
After considering the comments received, EPA has determined no changes are needed and is finalizing the regulatory text as proposed.
FIFRA Review Requirements
In accordance with FIFRA section 25(a), EPA submitted a draft of the final rule to the Secretary of Agriculture (USDA), the FIFRA Scientific Advisory Panel (SAP), and the appropriate Congressional committees. On November 3, 2014, the FIFRA SAP waived its review of this final rule. On November 3, 2014, USDA waived review of this final rule, because this action merely ``corrects the regulatory text and concerns no policy or scientific actions.''
Statutory and Executive Order Reviews
Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
This rule is not a ``significant regulatory action'' under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and was not, therefore, submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).
Paperwork Reduction Act (PRA)
According to PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, as applicable
The information collection requirements associated with reporting under 40 CFR 168 have already been approved by OMB pursuant to PRA under OMB control number 2070-0027 (EPA ICR No. 0161). This rule is not expected to involve an increase in information collection activities. There are no additional burdens imposed by this rule that requires additional review or approval by OMB.
Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic impact on a substantial number of small entities under RFA, 5 U.S.C. 601 et seq. In making this determination, the impact of concern is any significant adverse economic impact on small entities, because the primary purpose of an initial regulatory flexibility analysis is to identify and address regulatory alternatives ``which minimize any significant economic impact of the rule on small entities'' 5 U.S.C. 603. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule has no net burden effect on the small entities subject to the rule. As indicated previously, EPA is restoring a provision that was inadvertently removed from the regulation. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.
Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any State, local or Tribal governments, because no State, local, or Tribal government is known to produce, transport, formulate, package, or export unregistered pesticide products or devices. As indicated previously, EPA is restoring a provision that was inadvertently removed from the regulation.
Executive Order 13132: Federalism
This action will not have substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
This action does not have tribal implications because it is expected to only affect producers, transporters, formulators, packagers, and exporters of unregistered pesticide products and devices. Since no Indian Tribal government is known to produce, transport, formulate, package, or export unregistered pesticide products or devices, this action has no tribal implications. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000) do not apply.
Executive Order 13045: Protection of Children From Environmental Health Risks and Safety
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this action does not address environmental health or safety risks disproportionately affecting children.
Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.
National Technology Transfer and Advancement Act (NTTAA)
Since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply.
Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations
EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-
income population. As such, this
action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).
Congressional Review Act
Pursuant to the Congressional Review Act, 5 U.S.C. 801 et seq., EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 168
Environmental protection, Administrative practice and procedure, Advertising, Exports, Labeling, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: December 12, 2014.
Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
Therefore, 40 CFR chapter I is amended as follows:
The authority citation for part 168 continues to read as follows:
Authority: 7 U.S.C. 136-136y.
Revise the heading for subpart D to part 168 to read as follows:
Subpart D--Procedures for Exporting Pesticides
Add Sec. 168.65 to subpart D to read as follows:
Sec. 168.65 Applicability.
(a) This subpart describes the labeling requirements applicable to pesticide products and devices that are intended solely for export from the United States under the provisions of FIFRA section 17(a).
(b) This subpart applies to all export pesticide products and export pesticide devices that are exported for any purpose, including research.
(c) Export pesticide products and export pesticide devices are also subject to requirements for pesticide production reporting, recordkeeping and inspection, and purchaser acknowledgement provisions that can be found in the following parts:
(1) Pesticide production reporting requirements under FIFRA section 7 are located in part 167 of this chapter (as referenced in Sec. 168.85(b)).
(2) Recordkeeping and inspection requirements under FIFRA section 8 are located in part 169 of this chapter (as referenced in Sec. 168.85(a)).
(3) Purchaser acknowledgement statement provisions under FIFRA section 17(a) are located in Sec. 168.75.
Revise Sec. 168.66 to read as follows:
Sec. 168.66 Labeling of pesticide products and devices for export.
Any label and labeling information requirements in Sec. Sec. 168.69, 168.70, and 168.71 that are not met fully on the product label attached to the immediate product container may be met by collateral labeling that is either:
(a) Attached to the immediate product (container label); or
(b) Attached to or accompanies the shipping container of the export pesticide or export device at all times when it is shipped or held for shipment in the United States.
Sec. 168.68 Removed and Reserved
Remove and reserve Sec. 168.68.
In Sec. 168.69, revise paragraph (a) to read as follows:
Sec. 168.69 Registered export pesticide products.
(a) Each export pesticide product that is registered under FIFRA section 3 or FIFRA section 24(c) must bear labeling approved by EPA for its registration or collateral labeling in compliance with Sec. 168.66.
* * * * *
In Sec. 168.70, revise the introductory text of paragraph (b) to read as follows:
Sec. 168.70 Unregistered export pesticide products.
* * * * *
(b) Each unregistered export pesticide product must bear labeling that complies with all requirements of this section or collateral labeling in compliance with Sec. 168.66.
* * * * *
In Sec. 168.71, revise paragraph (a) to read as follows:
Sec. 168.71 Export pesticide devices.
(a) Each export pesticide device sold or distributed anywhere in the United States must bear labeling that complies with all requirements of this section or collateral labeling in compliance with Sec. 168.66.
* * * * *
FR Doc. 2014-29787 Filed 12-18-14; 8:45 am
BILLING CODE 6560-50-P