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Product Description
Name: 1,3-dimethylurea
1,3-DIMETHYL UREA
Synonyms: N, N'-dimethylsuit; jundimethylsuit
N,N'-Dimethylurea; sym-dimethylurea
CAS: 96-31-1
Einecs rn: 202-498-7
Molecular formula: C3H8N2O
Molecular weight: 88.12
Appearance: white crystalline powder
Chromatographic purity: '98%
Moisture: '0.5%
Melting point: 103~108'
Packaging: 25Kg/bag (inner polyethylene bag, outer white woven bag), can be customized according to customer needs.
1. Used as textile auxiliaries to produce formaldehyde-free anti-wrinkle finishing products.
2. Used in cosmetics as an emollient.
3. It is used in medicine and can produce a variety of raw materials.
4. Used in chemical industry, it can synthesize a variety of chemical products.
Our 1,3-dimethylurea is of high purity and can meet customer requirements for product purity.
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The products are widely used in medicine, chemical industry and other fields. For example, 6-amino-1,3-dimethyluracil can be used to synthesize drugs and chemicals, and 1,3-dimethylurea can be used in resins, coatings, and dyes. The production of chemical products has good market prospects.
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You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
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 .
In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov, you may access this “ Federal Register ” document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
Under section 408(g) of the FFDCA, as amended by the Food Quality Protection Act (FQPA), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-- in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 19, .
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP--, by one of the following methods.
In the Federal Register of May 2, (72 FR ) (FRL--3), EPA issued a proposal to revoke, remove, modify, and establish certain specific tolerances for residues of the fungicides chloroneb and thiabendazole; the herbicides oxyfluorfen, sulfosate, and tebuthiuron; the defoliants thidiazuron and tribuphos; the insecticides cypermethrin, methidathion, and pirimiphos-methyl; and the soil microbiocide nitrapyrin. Also, the proposal of May 2, (72 FR ) provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under the Federal Food, Drug, and Cosmetic Act (FFDCA) standards.
In this final rule, EPA is revoking, removing, modifying, and establishing specific tolerances for residues of chloroneb, cypermethrin, methidathion, nitrapyrin, oxyfluorfen, pirimiphos-methyl, sulfosate, tebuthiuron, thiabendazole, thidiazuron, and tribuphos in or on commodities listed in the regulatory text of this document.
EPA is finalizing these tolerance actions in order to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standard of the FFDCA. The safety finding determination of “reasonable certainty of no harm” is discussed in detail in each Reregistration Eligibility Decision (RED) and Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision (TRED) for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications, to reflect current use patterns, to meet safety findings and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box , Cincinnati, OH -, number: 1-800-490-; fax: 1-513-489-; Internet at http://www.epa.gov/ncepihom and from the National Technical Information Service (NTIS), Port Royal Road, Springfield, VA , number: 1-800-553- or (703) 605-; Internet at http://www.ntis.gov. Electronic copies of REDs and TREDs are available on the Internet at http://www.regulations.gov and http:// www.epa.gov/pesticides/reregistration/status.htm.
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In this final rule, EPA is revoking certain tolerances because either they are no longer needed or are associated with food uses that are no longer registered under FIFRA in the United States. Those instances where registrations were canceled were because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide active ingredient. The tolerances revoked by this final rule are no longer necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but ( printed page ) imported into the United States. It is EPA's general practice to issue a final rule revoking those tolerances and tolerance exemptions for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance or tolerance exemption to cover residues in or on imported commodities or legally treated domestic commodities.
EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States.
Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed in Unit II.A. if one of the following conditions applies:
1. Prior to EPA's issuance of a FFDCA section 408(f) order requesting additional data or issuance of a FFDCA section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained.
2. EPA independently verifies that the tolerance is no longer needed.
3. The tolerance is not supported by data that demonstrate that the tolerance meets the requirements under FQPA.
This final rule does not revoke those tolerances for which EPA received comments stating a need for the tolerance to be retained.
In response to the proposal published in the Federal Register of May 2, (72 FR ), EPA received one comment during the 60-day public comment period, as follows:
Comment by a private citizen. A private citizen stated that only zero tolerance levels should be acceptable. In addition, the commenter expressed a concern for pesticide use in general and their possible toxic effects on wildlife and humans.
Agency response. The private citizen's comments did not take issue with any of the Agency's specific conclusions to modify, revoke, or establish certain tolerances. Also, the commenter did not refer to any specific studies which pertained to those conclusions. EPA believes that the tolerance actions finalized herein meet the safety standard of FFDCA section 408, 21 U.S.C. 346a. In developing REDs and TREDs, EPA worked with stakeholders, pesticide registrants, growers and other pesticide users, environmental and public health interests, the States, the U.S. Department of Agriculture (USDA), other Federal agencies, and others to develop voluntary measures or regulatory controls needed to effectively reduce risks of concern. Such options include voluntary cancellation of pesticide products or deletion of uses, declaring certain uses ineligible or not yet eligible, restricting use of products to certified applicators, limiting the amount or frequency of use, improving use directions and precautions, adding more protective clothing and equipment requirements, requiring special packaging or engineering controls, requiring no-treatment buffer zones, employing environmental and ecological safeguards, and other measures.
The Agency did not receive any specific comments, during the 60-day comment period, on the following chemicals: Chloroneb, cypermethrin, methidathion, nitrapyrin, oxyfluorfen, pirimiphos-methyl, sulfosate, tebuthiuron, thiabendazole, thidiazuron, and tribuphos. Therefore, the Agency is finalizing the amendments proposed in the Federal Register of May 2, (72 FR ). For a detailed discussion of the Agency's rationale for the establishments, revocations, and modifications to the tolerances, refer to the proposed rule of May 2, .
In addition, the Agency is making the following revisions in this final rule.
Note: Sugar beet commodities were not included in the human dietary risk assessment for thiabendazole because the use was not supported by the technical registrant. (Metabolic fate data of thiabendazole in sugar beets had been submitted to EPA and reviewed by the Agency as acceptable. Efficacy, storage, foliar use and post-harvest use data had also been submitted some years ago, but some of that data was incomplete.) Therefore, the thiabendazole RED recommended revocation of the tolerances on sugar beet commodities. Currently, there is an active end use registration for thiabendazole use on sugar beets. Since the thiabendazole RED, based on the estimated acute and chronic dietary risks of thiabendazole, which are 77% of the acute population adjusted dose (aPAD) and 2% of the chronic population adjusted dose (cPAD), the Agency determined that the addition of sugar beet commodities to the dietary risk assessment for thiabendazole would not significantly contribute to dietary or drinking water risk estimates. Consequently, the Agency did not propose to take action on the sugar beet tolerances in 40 CFR 180.242(a) on May 2, (72 FR ), but is in the process of getting the sugar beet use removed from the one remaining active registration and does expect to address the sugar beet tolerances in a future publication in the Federal Register .
EPA may issue a regulation establishing, modifying, or revoking a tolerance under FFDCA section 408(e). In this final rule, EPA is establishing, modifying, and revoking tolerances to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes, and as follow-up on canceled uses of pesticides. As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standards under FFDCA. The safety finding determination is found in detail in each post-FQPA RED and TRED for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, to meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed and electronic copies of the REDs and TREDs are available as provided in Unit II.A.
EPA has issued post-FQPA REDs for chloroneb, cypermethrin, methidathion, nitrapyrin, oxyfluorfen, pirimiphos-methyl, thiabendazole, thidiazuron, and tribuphos, and a TRED for tebuthiuron, whose RED was completed prior to FQPA. A RED for sulfosate was not needed because it was registered after November 1, , and not subject to reregistration eligibility, and its tolerances were reassessed prior to completion of a TRED, such that a TRED for sulfosate was no longer needed because EPA made a safety finding which reassessed its tolerances according to the FFDCA standard, maintaining them when new tolerances were established as noted in Unit II.A.). REDs and TREDs contain the Agency's evaluation of the data base for these pesticides, including statements regarding additional data on the active ingredients that may be needed to confirm the potential human health and environmental risk assessments associated with current product uses, and REDs state conditions under which these uses and products will be eligible for reregistration. The REDs and TREDs recommended the establishment, modification, and/or revocation of specific tolerances. RED and TRED recommendations such as establishing or modifying tolerances, and in some cases revoking tolerances, are the result of assessment under the FFDCA standard of “reasonable certainty of no harm.” However, tolerance revocations recommended in REDs and TREDs that are made final in this document do not need such assessment when the tolerances are no longer necessary.
EPA's general practice is to revoke tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse.
When EPA establishes tolerances for pesticide residues in or on raw agricultural commodities, the Agency gives consideration to possible pesticide residues in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticides residues (40 CFR 180.6). If there is no reasonable expectation of finite pesticide residues in or on meat, milk, poultry, or eggs, then tolerances do not need to be established for these commodities (40 CFR 180.6(b) and 180.6(c)).
With the exception of regional tolerances for methidathion on alfalfa forage, alfalfa hay, timothy forage, and timothy hay, which EPA is revoking with specific expiration/revocation dates, the Agency is revoking, modifying, and establishing specific tolerances, and revising specific commodity terminologies effective September 19, . With the exception of the revoked four regional tolerances for methidathion, the Agency believes that existing stocks of pesticide products labeled for the uses associated with the revoked tolerances have been completely exhausted and that treated commodities have had sufficient time for passage through the channels of trade. EPA is revoking certain methidathion tolerances with an expiration/revocation date of March 31, , for alfalfa forage, alfalfa hay, timothy forage, and timothy hay. The Agency believes that, because their regional registrations expire on December 31, , the revocation date of March 31, , allows sufficient time for passage of treated commodities through the channels of trade.
Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by the FQPA. Under this unit, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:
1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA.
2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from a tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food. ( printed page )
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international Maximum Residue Limits (MRLs) established by the Codex Alimentarius Commission, as required by section 408(b)(4) of the FFDCA. The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level in a notice published for public comment. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs and TREDs, and in the Residue Chemistry document which supports the RED and TRED, as mentioned in the proposed rule cited in Unit II.A. Specific tolerance actions in this rule and how they compare to Codex MRLs (if any) are discussed in Unit II.A. of the proposal.
In this final rule EPA establishes tolerances under FFDCA section 408(e), and also modifies and revokes specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions (i.e., establishment and modification of a tolerance and tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order , entitled Regulatory Planning and Review (58 FR , October 4, ). Because this rule has been exempted from review under Executive Order due to its lack of significance, this rule is not subject to Executive Order , Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR , May 22, ). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of (UMRA) (Public Law 104-4). Nor does it require any special considerations as required by Executive Order , entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR , February 16, ); or OMB review or any other Agency action under Executive Order , entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR , April 23, ). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of (NTTAA), Public Law 104-13, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations were published on May 4, (46 FR ) and on December 17, (62 FR ) (FRL--1), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this rule, the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In a memorandum dated May 25, , EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. (This Agency document is available in the docket, as mentioned in Unit II.A.) Furthermore, for the pesticides named in this final rule, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis. In addition, the Agency has determined that this action will not have a 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 , entitled Federalism (64 FR , August 10, ). Executive Order requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that 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.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order , entitled Consultation and Coordination with Indian Tribal Governments (65 FR , November 6, ). Executive Order , requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, 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.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order . Thus, Executive Order does not apply to this rule.
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will ( printed page ) 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 this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).
Anne E. Lindsay,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
2. Section 180.242 is amended by revising paragraphs (a)(1) and (a)(2) and the introductory text to paragraph (b) to read as follows:
3. Section 180.257 is amended by revising paragraph (a) to read as follows:
4. Section 180.272 is amended by revising the table in paragraph (a) to read as follows:
5. Section 180.298 is amended by revising the tables in paragraphs (a) and (c) to read as follows:
6. Section 180.350 is amended by revising the table in paragraph (a) to read as follows:
7. Section 180.381 is amended by revising the tables in paragraphs (a) and (c) to read as follows:
8. Section 180.390 is revised to read as follows:
9. Section 180.403 is amended by revising the table in paragraph (a) to read as follows:
10. Section 180.409 is amended by revising paragraph (a) to read as follows:
11. Section 180.418 is amended by revising the tables in paragraphs (a)(1), (a)(2), and (b) to read as follows:
12. Section 180.489 is removed.
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