Daily Rules, Proposed Rules, and Notices of the Federal Government
This final rule, under the provisions of section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, amends EPA's regulations governing crop group tolerances for pesticides. Specifically, the rule expands upon existing stone fruit and tree nut crop groups by adding new commodities and establishes crop subgroups for the new stone fruit crop group. This final rule is the third in a series of planned crop group updates expected to be promulgated in the next several years.
EPA is authorized to establish tolerances for pesticide chemical residues in food under FFDCA section 408. EPA establishes tolerances for each pesticide based on the potential risks to human health posed by that pesticide. A tolerance is the maximum permissible residue level established for a pesticide in raw agricultural produce and processed foods. The crop group regulations currently in 40 CFR 180.40 and 180.41 enable the establishment of tolerances for a group of crops based on residue data for certain crops that are representative of the group. Crop group regulations are promulgated under section 408(e)(1)(C) which authorizes EPA to establish “general procedures and requirements to implement [section 408].” 21 U.S.C. 346a(e)(1)(C).
You may be potentially affected by this action if you are an agricultural producer or food manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document might apply to them. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS code 112).
• Pesticide manufacturing (NAICS code 32532).
EPA prepared an analysis of the potential costs and benefits associated with the establishment of crop groupings when it issued the first proposed rule in this series of rulemakings, which published in the
Benefits of the rule can be shown through an example of the impact of the changes to Crop Group 3 that were accomplished in a prior rulemaking (72 FR 69150, December 7, 2007). That rulemaking expanded Crop Group 3, Bulb Vegetable, from 7 to 25 crops, an increase of 18 from the original crop group. Prior to the expansion of that subgroup, adding tolerances for 18 new crops would have required at least 18 field trials at a cost of approximately $5.4 million (assuming $300,000 per field trial).
This action is intended to promote more extensive use of crop group tolerances; in particular, it will assist in making available lower-risk pesticides for minor crops both domestically and in countries that export food to the United States. In addition, expanding crop groups will greatly increase the efficiency of IR-4 and EPA in registering pesticides on specialty crops and reduce the administrative costs of both the IR-4 testing process and the EPA review process.
EPA published a notice of proposed rulemaking in the
In this section, EPA describes the major provisions of the proposed rule, the comments received on each provision and EPA's responses to those comments, including EPA's determination if any modification of the proposed rule is warranted.
EPA received one comment from a private citizen that noted that the commodity chokecherry, which was proposed to be included in the revised Crop Group 12-12: Stone Fruit Group and Cherry subgroup 12-12A, is already established in Crop Group 13-07: Berry and Small Fruit Group and Large Shrub/Tree Berry Subgroup 13-07C. As a general practice, the Agency will avoid having a commodity as a member of more than one crop group. Accordingly, EPA revisited the proposal to include chokecherry in the revised crop group.
Although chokecherry is a stone fruit, its fruit size is closer to elderberry and mulberry, the representative commodities for Large Shrub/Tree Berry Subgroup 13-07C, rather than sweet or tart cherry, the representative commodities for Cherry Subgroup 12-12A. The diameter for chokecherry is 0.3 inches (0.8 cm), elderberry is 0.3-0.5 inches (0.8-1.3 cm), mulberry is 0.5 inches (1.3 cm), and sweet cherry is 1.4 inches (3.6 cm). Cherry, the commodity proposed as the representative for chokecherry in the revised Crop Subgroup 12-12A, has a diameter that is approximately 4.7 times larger than the chokecherry, while both elderberry and mulberry are approximately the same size as chokecherry. The application of pesticides on commodities with smaller diameters (surface area to volume ratio) often results in higher residues than on larger commodities. Therefore, the EPA has determined that it is appropriate to retain chokecherry in the previously established Crop Group 13-07 and Subgroup 13-07C and will not include chokecherry in Crop Group 12-12: Stone Fruit Group or Cherry Subgroup 12-12A.
Additionally, a comment was received from the Embassy of the Republic of Korea requesting that Chinese jujube (
However, after reviewing the Korean data submitted with the comment and literature from the United States, EPA finds that Chinese jujube growth and cultural practices are similar to some stone fruits, such as cherries and small varieties of plums, and should therefore be similar to other stone fruit in terms of pesticide residue exposure.
Chinese jujube is a traditional East Asian fruit crop mainly cultivated in temperate regions of China, Korea, Taiwan, and Japan. Chinese jujube has large leaf canopies shading the small sized fruits, and the fruit is botanically considered a stone fruit or “drupe.” The Chinese jujube is also deciduous; the crop loses its leaves in the fall and has a dormant period in the winter, similar to other members of Crop Group 12-12: Stone Fruit Group. Additionally, the flower to harvest time as well as the fruit shape, size, and smooth skin texture is similar to the plum.
The Chinese jujube was introduced into the United States from China in 1908, and it is widely distributed in the southern states as both an ornamental crop and potential minor food crop. Improved varieties of Chinese jujube are available to growers from commercial nursery catalog companies, and there has been recent research in cultivating the crop in the United States as a potential profitable minor crop. For these reasons, EPA concludes it would be appropriate to include Chinese jujube as a member of Crop Group 12-12: Stone Fruit Group, and as a member of the Plum Subgroup 12-12C.
Finally, EPA has revised the taxonomic names for several commodities in Crop Group 12-12: Stone Fruit Group, in order to reflect the currently accepted taxonomic name or names. Based on the decision to remove chokecherry and add Chinese jujube to the revised Crop Group 12-12: Stone Fruit Group, the final rule expands Crop Group 12-12: Stone Fruit Group to include 22 commodities.
i. Cherry Subgroup 12-12A. (Representative commodities—Sweet cherry or Tart cherry). Five commodities are included in this subgroup.
ii. Peach Subgroup 12-12B. (Representative commodity—Peach). Two commodities are included in this subgroup.
iii. Plum Subgroup 12-12C. (Representative commodities—Plum or Prune plum). Fifteen commodities are included in this subgroup.
EPA adopts these proposals as final, with the changes noted in this section.
EPA received one comment from the American Pistachio Growers trade association that supported including pistachio in the revised tree nut crop group. They noted that including pistachiowill, “* * * provide the pistachio growers with the ability to use crop tools necessary to combat pests,” and further noted that, “* * * growers, processors, marketers, and consumers * * * will benefit from including pistachios in the tree nut group.” EPA agrees with these comments.
EPA has revised the taxonomic names for several commodities in Crop Group 14-12: Tree Nut Group, in order to reflect the currently accepted taxonomic name or names. Therefore, EPA adopts these proposals as final, with the changes noted in this section.
After fully considering all comments, EPA is finalizing the proposed rule with the revisions discussed previously. Other than these revisions, EPA is finalizing the rule as proposed, based on the rationale set forth in the proposed rule.
When a crop group is amended in a manner that expands or contracts its coverage of commodities, EPA will (1) retain the pre-existing crop group in 40 CFR 180.41; (2) insert the revised crop group immediately after the pre-existing crop group in the Code of Federal Regulations; and (3) title the revised crop group in a way that clearly differentiates it from the pre-existing crop group.
The revised crop group will retain roughly the same name and number as the pre-existing group, except the number will be followed by a dash and the final digits of the year established (e.g., Crop Group 8-10).
EPA will initially retain pre-existing crop groups that have been superseded by revised crop groups. EPA will not establish new tolerances under the pre-existing groups. Further, EPA plans to eventually convert tolerances for any pre-existing crop group to tolerances with coverage under the revised crop group. This conversion will be effected both through the registration review process and in the course of evaluating new uses for a pesticide. EPA requests that petitioners for tolerances address this issue in their petitions. For existing petitions for which a Notice of Filing has been published, the Agency will attempt to conform these petitions to this rule.
This action is not a “significant regulatory action” under the terms of Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993) and was therefore not reviewed by the Office of Management and Budget (OMB) under Executive Orders 12866 and 13563, entitled “Improving Regulation and Regulatory Review” (76 FR 3821, January 21, 2011).
This rule does not impose any new information collection requirements that would require additional review or approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b). 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's regulations in title 40 of the CFR, after appearing in the
The information collection activities associated with the submission of a petition to request a tolerance are already approved under
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 551-553, or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Under the RFA, small entities include small businesses, small organizations, and small governmental jurisdictions.
For the purpose of assessing the impacts of this final rule on small entities, a small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This final rule does not have any direct adverse impacts on small businesses, small non-profit organizations, or small local governments. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the proposed rule on small entities” (5 U.S.C. 603 and 604). Thus, an agency may certify under section 605(b) of the RFA if the rule relieves regulatory burdens or otherwise has a positive economic effect on all of the small entities subject to the rule.
As discussed previously, this rule provides regulatory relief and regulatory flexibility. The new crop groups ease the process for pesticide manufacturers to obtain pesticide tolerances on greater numbers of crops. Pesticides will be more widely available to growers for use on crops, particularly specialty crops.
Pursuant to Title II of the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538, EPA has determined that this final rule 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 the private sector in any one year. Accordingly, this rule is not subject to the requirements of sections 202, 203, 204, and 205 of UMRA.
This action will not have “federalism implications” as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), because this action will 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 final rule.
This action will not have “tribal implications” as specified in Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments:” (65 FR 67249, November 9, 2000), because it will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in the Order. Thus, Executive Order 13175 does not apply to this final rule.
EPA interprets Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. Executive Order 13045 does not apply to this rule because this action is not designated as an “economically significant regulatory action” as defined by Executive Order 12866 (see Unit III.A.), nor does it establish an environmental standard, or otherwise have a disproportionate effect on children.
This action is not a “significant energy action” as defined in Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have any adverse effect on the supply, distribution, or use of energy.
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 note.
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).
Pursuant to the Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, pesticides and pests.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q). 346a and 371.
These amendments read as follows:
(c) * * *